Pipeline Prospector Aug 2023: Trial gains, Q2 results push up Lilly, Novo stocks even as indices dip
After a buoyant July, when all the three pharma indices inched up by 2 percent, August proved to be a downer. While the Nasdaq Biotechnology index (NBI) was up 1 percent, at US$ 4,150.80 (against US$ 4,129.98 in July), the SPDR S&P Biotech ETF index was down by 4 percent, at US$ 80.15 (against US$ 84.29 in July) and the S&P Biotechnology Select Industry Index (SPSIBI) was down by 5 percent, at US$ 6,161.27 (against US$ 6,544.43 in July).Many drugmakers, such as Eli Lilly, Novo Nordisk, Amgen, Regeneron, Pfizer and Bayer, announced their Q2 results last month.August was a lackluster month for deals. Only one deal over US$ 1 billion got reported last month — Novo Nordisk’s acquisition of Inversago Pharma, a privately held obesity drugmaker, for up to US$ 1.08 billion. This buyout will broaden Novo’s blockbuster weight loss portfolio.Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel) Lilly, Novo, Amgen, Regeneron post stock market gains due to upbeat Q2 resultsSeveral drugmakers posted an increase in Q2 revenues. Eli Lilly (stock up 22 percent in August) posted a 28 percent increase in its revenues for the quarter — at US$ 8.31 billion, up from US$ 6.48 billion in Q2 2022. This growth was driven by drugs such as Mounjaro (a diabetes med) that brought in US$ 979.7 million, Verzenio (a breast cancer drug) whose sales increased 57 percent at US$  926.8 million, Jardiance (a diabetes med) with revenues of US$ 668.3 million and psoriasis therapy Taltz that brought in US$ 703.9 million.Lilly posted some gains in clinical trials as well. Its oncology drug Retevmo (selpercatinib) demonstrated superior progression-free survival in phase 3 clinical trial compared to other approved multikinase inhibitors as an initial treatment for patients with a type of advanced or metastatic Rearranged during Transfection (RET) medullary thyroid cancer.Novo Nordisk (up 15 percent) posted sales growth of 30 percent on a constant exchange rates (CER) basis in the first half of 2023 to DKK 107.66 billion (US$ 15.49 billion). There was much good news on its weight loss med Wegovy (semaglutide 2.4 mg) — it met its primary goal of preventing major cardiovascular events by reporting a 20 percent drop in the risk of cardiovascular death, heart attack, or stroke in overweight and obese patients. In another phase 3 study, Wegovy reduced symptoms and physical limitations in patients with obesity and heart failure with preserved ejection fraction as compared to placebo.Amgen (up 10 percent) reported strong Q2 results, with a 6 percent increase in revenue — at US$  7.0 billion, compared to US$ 6.6 billion in Q2 2022. The growth was driven by its osteoporosis drug Evenity (US$ 281 million), leukemia drug Blincyto (US$ 206 million), cholesterol-lowering medicine Repatha (US$ 424 million) and Humira biosimilar Amjevita (US$  150 million).Another gainer was Regeneron (stock up 12 percent) —  its Q2 revenues increased by 11 percent over Q2 2022 to touch US$ 3.16 billion. Moreover, the company secured two FDA approvals last month. One, its drug Veopoz (pozelimab) bagged approval to treat an ultra rare disease, known as CHAPLE disease, in both adults and pediatric patients. Two, FDA okayed Regeneron’s Eylea HD (aflibercept) injection 8 mg — a higher dose version of Eylea 2 mg. Developed in collaboration with Bayer, Eylea HD is the first and only treatment approved in wet age-related macular degeneration (wAMD), diabetic macular edema (DME) and diabetic retinopathy (DR) for immediate dosing at eight-week and up to 16-week intervals following three initial monthly doses.Gilead (stock up 1 percent) saw its Q2 revenue increase by 5 percent — to US$ 6.6 billion, as opposed to US$ 6.3 billion in Q2 2022. Growth was driven by its HIV drug portfolio that brought in US$  4.6 billion.Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)  Pfizer reports 54% drop in Q2 revenues; BMS, Astra resolve patent lawsuitsAmong the big stock market losers in August were Pfizer (-3 percent), Roche (-5 percent), AstraZeneca (-4 percent) and Bayer (-6 percent). Pfizer reported a 54 percent drop in its Q2 revenues, at US$ 12.73 billion against US$  27.74 billion in Q2 2022, owing to reduced sales of its Covid-19 products Comirnaty and Paxlovid.But negative news ran deeper than just the Q2 results. The drug behemoth removed several phase 1 and mid-stage candidates from its pipeline, including a phase 1 respiratory syncytial virus (RSV) infection candidate, two phase 2 assets including an oral obesity and diabetes candidate and a  pneumococcal vaccine, along with an atopic dermatitis drug. In clinical trials, a heart drug from BridgeBio — acoramidis — showed better results than Pfizer’s approved drug Vyndamax (tafamidis) in transthyretin amyloid cardiomyopathy, a rare heart disease. To make matters worse, GSK sued Pfizer in a US court alleging that Pfizer’s RSV vaccine Abrysvo violates GSK’s patent rights in its rival RSV shot Arexvy.However, there was some good news too — FDA granted accelerated approval to Pfizer’s Elrexfio (elranatamab) for the treatment of relapsed or refractory multiple myeloma and approved its RSV vaccine Abrysvo for use in infants through active immunization of pregnant women.Bayer’s group turnover was down 8.2 percent to €11.04 billion (US$  11.94 billion) in Q2 2023, from US$ 13.6 billion in Q2 2022. The group’s pharmaceutical sales were down from €4.81 billion (US$ 5.16 billion) in Q2 2022 to €4.55 billion (US$ 4.88 billion) in Q2 2023. In March 2022, Bristol Myers Squibb (BMS) had sued AstraZeneca over infringement of Opdivo patents. In January this year, BMS sued Astra yet again for infringing on its Yervoy patents. In three separate lawsuits, BMS had complained that Astra’s drugs, Imfinzi and Imjudo, infringed patents on BMS’ therapies, Opdivo and Yervoy.But last month, BMS and Astra resolved patent infringement lawsuits. According to news reports, AstraZeneca has agreed to pay BMS and Ono Pharmaceutical US$ 510 million to resolve these lawsuits. Astra’s stock was down 4 percent in August.However, there was some positive news for AstraZeneca — the US Centers for Disease Control and Prevention (CDC) advisory committee on immunization practices unanimously recommended the use of Sanofi and Astra’s antibody, nirsevimab, to prevent RSV in infants and toddlers.Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)  Our viewOur Pipeline Prospector in July had ended with the caveat that even though the indices have ended the month on a stronger footing, August could be different. Though this is the second consecutive year when the markets have remained volatile, what gives us hope are the innovative drugs in the pipelines of various drugmakers — both big and small.Access the Pipeline Prospector Dashboard for August 2023 Newsmakers (Free Excel)  

Impressions: 1715


#PipelineProspector by PharmaCompass
07 Sep 2023
Pipeline Prospector July 2023: Indices inch up on better than expected Q2 results
July saw all three biotech indices inch up by 2 percent as several drugmakers announced their second quarter (Q2) results. Overall, most drugmakers posted better than expected Q2 results, with some even raising their guidance for 2023.During July, the Nasdaq Biotechnology Index (NBI) was up 2 percent, at US$ 4,129.98, as opposed to a 0.7 percent drop in June. The SPDR S&P Biotech ETF index was up 2 percent, at US$ 84.29, as opposed to a 1.8 percent drop in June. And the S&P Biotechnology Select Industry Index (SPSIBI) was also up 2 percent, at US$ 6,544.43, as opposed to a 2.9 percent drop in June.The month witnessed four deals of over US$ 1 billion. Towards July-end, Biogen announced the acquisition of Reata Pharmaceuticals for US$ 7.3 billion. Through this acquisition, Biogen will bolster its neuromuscular and rare disease portfolio. The announcement led to a 61 percent jump in Reata’s stock.In mid-July, Eli Lilly bolstered its weight-loss portfolio with the acquisition of New York-headquartered biopharma Versanis Bio for a potential value of US$ 1.93 billion. Novartis announced the acquisition of DTx Pharma for US$ 1.0 billion. And on July 28, AstraZeneca’s rare diseases arm — Alexion —  announced it has agreed to buy Pfizer’s early-stage rare disease gene therapy portfolio for up to US$ 1 billion, plus royalties on sales.Access the Pipeline Prospector Dashboard for July 2023 Newsmakers (Free Excel)AbbVie stock posts gains despite drop in Humira sales; J&J’s Darzalex sales up 22%The last quarter was a good one for most drugmakers, and companies like AbbVie, Novartis and Johnson & Johnson (J&J) managed to beat estimates for both earnings and sales.In the month of July, seven biosimilars to AbbVie’s Humira got launched in the US market. As a result, Humira sales plummeted 25.2 percent during the quarter (at US$ 4.01 billion). However, AbbVie’s Q2 sales, at US$ 13.86 billion (a drop of 5 percent), topped investor expectations. This resulted in a 12 percent increase in AbbVie’s stock in July. There was more good news from the American drugmaker. In Europe, AbbVie received positive Committee for Medicinal Products for Human Use (CHMP) opinion for epcoritamab for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The drug had bagged US Food and Drug Administration (FDA) approval in May 2023.J&J’s sales surged 6.3 percent in Q2, at US$ 25.5 billion, compared to US$ 24.2 billion in Q2 2022. The company’s global pharmaceutical revenue reached US$ 13.7 billion, driven significantly by the success of its oncology drug Darzalex, which posted a 22.4 percent jump in Q2 sales. Danish biotech Genmab received royalties from global Darzalex sales and its stock rose 11 percent during July.Carvykti, J&J’s CAR-T therapy for blood cancer (developed in partnership with Legend Biotech), reported robust Q2 sales of US$ 117 million, compared to US$ 24 million in Q2 2022. While J&J’s stock was up 4 percent, Legend’s stock rose 10 percent in July.Meanwhile, J&J’s Janssen reported positive phase 3 results for Rybrevant (amivantamab-vmjw) used on top of chemotherapy in patients with newly diagnosed NSCLC with EGFR exon20 insertion mutations. The company received FDA’s accelerated approval in 2021. Now, with positive trial results, the company hopes to win full approval and extend the drug to newly diagnosed patients.Access the Pipeline Prospector Dashboard for July 2023 Newsmakers (Free Excel)Oncology drugs boost Astra’s Q2 sales; BMS, Biogen post drop in quarterly revenuesAstraZeneca (stock up 7 percent) reported a total revenue increase of 9 percent at US$ 11.41 billion, compared to US$ 10.77 billion in Q2 2022. The growth was mainly driven by increased demand for oncology medicines such as Tagrisso, Imfinzi and Calquence.Astra-Merck’s Lynparza, in combination with abiraterone and prednisone/prednisolone, bagged conditional approval in Canada to treat BRCA-mutated metastatic castration-resistant prostate cancer.Novartis (stock up 5 percent) announced strong sales growth of 7 percent (at US$ 13.62 billion) as a result of impressive performance of its heart failure drug Entresto, multiple sclerosis drug Kesimpta and cancer drugs Kisqali and Pluvicto. Novartis’ Sandoz division launched the first citrate-free high-concentration formulation of Hyrimoz, a Humira biosimilar. Sandoz also received a positive CHMP opinion for its multiple sclerosis biosimilar natalizumab. If approved, it will be the first-of-its-kind biosimilar in Europe for use in all indications of reference biologic Tysabri.Amid these winners were two losers — BMS and Biogen. BMS (-5 percent) reported Q2 sales of US$ 11.22 billion that declined by 6 percent when compared to the previous year’s sales of US$ 11.88 billion. The decline prompted a cut in BMS’  full-year forecasts. This downturn comes as two of its top drugs — the multiple myeloma treatment Revlimid and the anticoagulant drug Eliquis — face competition from generics.Biogen (-5 percent) posted a 3 percent drop in its Q2 revenue, with sales at US$ 2.45 billion compared to US$ 2.58 billion in Q2 2022. The decline is attributed to a loss in multiple sclerosis revenue, which decreased by 14 percent from last year, reaching US$ 1.20 billion. In positive news, Biogen and Eisai’s Leqembi became the first med for Alzheimer’s to bag FDA’s full approval.Access the Pipeline Prospector Dashboard for July 2023 Newsmakers (Free Excel)Astra-Sanofi’s RSV therapy, GSK’s jab bag approvals; Roche, Caribou post trial gainsIn July, FDA granted approval to Sanofi-AstraZeneca’s respiratory syncytial virus (RSV) antibody therapy, Beyfortus (nirsevimab-alip), for newborns and infants. Moreover, GSK’s RSV vaccine — Arexvy — was approved by the UK health regulator in adults 60 years and older. Similarly, Moderna began its application process in the US, Australia and Europe to get an approval for its mRNA-1345 RSV vaccine in older adults. Despite positive news, Moderna stocks fell 3 percent. In trials, Roche (stock up 3 percent) posted positive results from the trial of its subcutaneous version of Ocrevus, a treatment for multiple sclerosis.  Additionally, Roche’s glofitamab became the first CD20xCD3 T-cell-engaging bispecific antibody to receive approval in Europe for relapsed or refractory diffuse large B-cell lymphoma (most common type of blood cancer). And Caribou Biosciences’ stock rose 100 percent on positive data from a phase 1 trial for its experimental CAR-T cell therapy CB-010 in relapsed or refractory B cell non-Hodgkin lymphoma, a type of blood cancer.Access the Pipeline Prospector Dashboard for July 2023 Newsmakers (Free Excel)Our viewThough pharma indices ended July on a stronger footing due to better-than-expected earnings, August opened with news that Pfizer has posted a whopping 54 percent drop in its Q2 revenues at US$ 12.7 billion, from US$ 27.72 billion in Q2 2022. Similarly, Merck reported a quarterly loss during the last quarter. While there are reasons why the two drugmakers haven’t performed well, and we also know that markets can be volatile, news on inflation easing off in some countries raises hopes that market conditions could improve in a few months.Access the Pipeline Prospector Dashboard for July 2023 Newsmakers (Free Excel) 

Impressions: 2030


#PipelineProspector by PharmaCompass
03 Aug 2023
Pipeline Prospector June 2023: Lilly, J&J, Merck stocks gain even as indices slip into red
June was a lackluster month for pharma stocks. The Nasdaq Biotechnology Index (NBI) was down 0.7 percent at US$ 4,065.95, against a 4 percent drop in May (at US$ 4054.54). SPDR S&P Biotech ETF index (XBI) was down 1.8 percent at US$ 83.95, against a 2 percent rise in May, and the S&P Biotechnology Select Industry Index (SPSIBI) was down 2.9 percent at US$ 6,409.05, against a 1 percent rise in May. Even though the indices slipped into red, several mega cap drugmakers like Eli Lilly, Johnson & Johnson (J&J) and Sanofi saw their stocks rise.There was a pick-up in dealmaking. Among the bigger deals were Novartis’ (up 4 percent) acquisition of American biotech Chinook Therapeutics (up 56 percent) for up to US$ 3.5 billion, Eli Lilly’s acquisition of Dice Therapeutics (up 47 percent) for around US$ 2.4 billion and Bausch + Lomb’s (up 22 percent) buyout of several eye-care products from Novartis for up to US$ 2.5 billion.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel)Weight loss med boosts Lilly’s stock; concerns over obesity drug drag Pfizer downEli Lilly’s (up 8 percent) stock reached an all-time high after the company set a new bar among weight loss drugs with retatrutide (a GIP, GLP-1 and glucagon receptor triple agonist). In a phase 3 trial, the drug led to an average 24.2 percent reduction in weight over 48 weeks in patients without diabetes. The market has high expectations from this class of obesity drugs. That’s why it was unkind to Pfizer (-3 percent) when it announced it had discontinued the development of its experimental obesity and diabetes drug — lotiglipron (GLP-1 receptor agonist) — due to safety concerns. Pfizer’s market cap took a nearly US$ 12 billion hit on this news. The drug behemoth is shifting focus to its other obesity drug — danuglipron.In approvals, the US Food and Drug Administration (FDA) approved Lilly and Boehringer Ingelheim’s Jardiance for the treatment of type 2 diabetes in children 10 years and older. This is the first and only SGLT2 inhibitor approved for this patient population.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel) J&J gains on new Carvykti data; Merck’s Lynparza scores win in prostate cancer trialJ&J and Legend Biotech filed for expanded use of Carvykti after presenting remarkable data from a phase 3 trial in relapsed and lenalidomide-refractory multiple myeloma. The drug was previously administered after four or more lines of therapy. Now, the companies hope to get approval for those who have received at least one prior line of therapy. With such an approval, Carvytki could get ahead of BMS’ multiple myeloma CAR-T therapy, Abecma, which was approved for fourth-line use in 2021.J&J also gained due to results from a phase 2 combination study of talquetamab and Tecvayli in relapsed or refractory multiple myeloma. Overall, J&J’s stock was up 7 percent in June, while Legend Biotech’s stock went up 11 percent.Another gainer was Merck (stock up 4 percent). Its Lynparza (olaparib) plus abiraterone combination has been approved by the FDA for the treatment of BRCA-mutated metastatic castration-resistant prostate cancer. The approval is based on data from a phase 3 trial, where the drug combo reduced the risk of disease progression or death by 76 percent compared to abiraterone alone in patients. With this approval, Lynparza has become the first poly ADP ribose polymerase (PARP) inhibitor to be approved in combination with a novel hormonal agent.Among mega-cap losers was Roche (-5 percent) whose PD-L1 inhibitor Tecentriq and Exelixis’ Cabometyx not only failed to offer any additional benefit in previously treated kidney cancer but also added toxicity.Among small cap gainers, Black Diamond Therapeutics saw its stock rise 150 percent as it announced phase 1 trial data on BDTX-1535 that showed positive results in non-small cell lung cancer (NSCLC) patients.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel) GSK gains from Zantac settlement; FDA panel backs Astra-Sanofi’s RSV drugGSK (up 6 percent) reached its first legal settlement in litigation against its heartburn medication Zantac (ranitidine). This may set a precedent for thousands of other ranitidine cases set to go to trial next year.In another Zantac lawsuit, an International Chamber of Commerce tribunal rejected Boehringer Ingelheim’s attempt to gain indemnification from Sanofi for future liabilities arising from lawsuits in the US from users of the heartburn drug. Sanofi (up 6 percent) had acquired Zantac through an asset swap with Boehringer in 2016.There were updates on respiratory syncytial virus (RSV) vaccines. The US Centers for Disease Control and Prevention (CDC) recommended that Pfizer’s Abrysvo and GSK’s Arexvy vaccines be used to prevent severe RSV infections in older adults.Similarly, an FDA panel voted unanimously that AstraZeneca (-1 percent) and Sanofi’s nirsevimab has a favorable benefit-risk profile for the prevention of RSV lower respiratory tract disease in newborns and infants. If approved, nirsevimab would be the first preventive option for newborns and infants. The drug is likely to get an FDA nod in the third quarter of this year.FDA has accepted the biologics license applications (BLAs) submitted by Vertex Pharmaceuticals (up 9 percent) and CRISPR Therapeutics for the investigational treatment exagamglogene autotemcel (exa-cel) to treat severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). FDA has granted a priority review for SCD and a standard review for TDT.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel) Doubts over Leqembi hits Biogen stock; Regeneron loses due to rejection of higher-dose Eylea variantAlzheimer’s disease experts in Europe raised doubts over the clinical benefits of Biogen and Eisai’s Leqembi. They said the benefits of Leqembi may not outweigh its potential side effects and the cost to the health system. This led to a 7 percent dip in Biogen’s stock. Last month, an FDA advisory panel unanimously agreed that a late-stage trial of Leqembi had verified the benefit of the treatment for those at an early stage of Alzheimer’s disease. The drug had bagged FDA’s accelerated approval in January this year.Similarly, Regeneron (-3 percent) was down on news that FDA has rejected a higher-dose variant of its blockbuster drug Eylea for the treatment of wet age-related macular degeneration (AMD), along with two other eye conditions common in diabetic patients. And Sarepta (-8 percent) was hit by news that analysts have voiced concerns over upcoming confirmatory trial data for its gene therapy — Elevidys — to treat Duchenne muscular dystrophy (DMD). While Elevidys has received an accelerated approval from the FDA as the first-of-its-kind gene therapy for DMD in children, analysts said the trial may not be enough to secure approval for the drug’s expanded use.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel) Our viewPharma stocks have had a tumultuous ride over the past year. While the Nasdaq Composite Index and S&P 500 have been going up, pharma indices have not seen such a rally due to reasons such as a drop in sales of Covid treatments, the loss of patent protections, and a looming recession.In stock market parlance, this means pharma stocks may be undervalued and are likely to draw investor interest. Pathbreaking research and new drug pipelines should only increase their interest.Access the Pipeline Prospector Dashboard for June 2023 Newsmakers (Free Excel) 

Impressions: 1672


#PipelineProspector by PharmaCompass
06 Jul 2023
Pipeline Prospector May 2023: Uncertainty over debt ceiling deal impacts indices
In April, the biotech indices had crawled up post the drubbing in March due to the collapse of Silicon Valley Bank. That rally could have gained momentum had the policymakers in the US not struggled to arrive at a debt ceiling deal, which was sealed only this month.As a result, the Nasdaq Biotechnology Index (NBI) was down 4 percent in May at US$ 4054.54, against US$ 4,187.32 in April. The SPDR S&P Biotech ETF index (XBI) was up 2 percent at US$ 83.33, against US$ 80.20 in April, and the S&P Biotechnology Select Industry Index (SPSIBI) was up 1 percent at US$ 6458.99, against US$ 6,094.82 in April.May was not a good month for deals — only two deals over US$ 1 billion were announced. This includes Ironwood’s acquisition of VectivBio (up 55 percent) for US$ 1 billion and Sobi’s acquisition of CTI BioPharma (up 80 percent) for US$ 1.7 billion.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel)FTC’s lawsuit to block deal hits Amgen, Horizon stocks; AbbVie’s Humira sales down 25 percentOne of the biggest losers last month was AbbVie, with its stocks dipping 10 percent. Not only did its first quarter (Q1) results drag its stock down, but the weaker-than-expected performance of its blockbuster drugs — Skyrizi and Rinvoq — also played spoiler. Sales of Humira dipped by another 25 percent in Q1 due to the loss of patents. In positive news, Rinvoq received its seventh FDA approval – this time to treat patients with moderate to severe Crohn’s disease. And its Epkinly (epcoritamab-bysp), co-developed with Genmab, became the first and only bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL) in adults. Both Amgen (-8 percent) and Horizon Therapeutics (-10 percent) saw their stocks dip as the US Federal Trade Commission (FTC) filed a lawsuit to block the former’s US$ 27.8 billion takeover of the rare disease drugmaker. The lawsuit raises concerns that Amgen can exploit its market position to guard the monopolies of two Horizon drugs. Additionally, the US Supreme Court ruled against Amgen’s bid to revive patents on its cholesterol-lowering drug Repatha in a legal clash with Sanofi and Regeneron.Johnson & Johnson (-5 percent) also faced losses on the bourses as a federal bankruptcy judge ordered the company and talc claimants to conduct settlement talks, after hearing J&J’s bankruptcy strategy. In April, J&J had offered to pay US$ 8.9 billion over 25 years to over 60,000 claimants in settlement.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel) Novartis slides after Adakveo revocation news; Gilead dips despite patent lawsuit winThe European Medicines Agency (EMA) has recommended revoking the marketing authorization of Novartis’ sickle cell disease drug Adakveo (crizanlizumab-tmca). The decision comes after Adakveo failed to demonstrate effectiveness in a phase 3 trial. Novartis’ stock slid 7 percent in May.Novo Nordisk (-4 percent) had a different problem at hand — due to soaring demand, it had to halt the promotion of its popular weight-loss drug Wegovy. Moreover, FDA rejected Novo’s experimental drug candidate concizumab as a treatment for hemophilia A and B.Gilead Sciences saw a 7 percent drop in its stock. On May 9, the drugmaker scored a win in an HIV patent infringement case filed by the US government. Meanwhile, an antitrust trial against Gilead and Teva began in California, accusing both companies of colluding to delay generic competition for Gilead's HIV medications.Sales of Regeneron’s wet macular degeneration drug — Eylea — dropped by 5 percent to US$ 1.43 billion in Q1. Though the Q1 sales for Regeneron increased by 7 percent (year-on-year) to US$ 3.16 billion, the stock market reacted to the drop in Eylea sales, which coincided with the launch of Roche’s Vabysmo in January this year. Overall, Regeneron’s stock dropped 9 percent in May.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel) Lilly, Roche post gains due to trial wins; Apellis’ new eye drug gets off to good startEli Lilly’s share surged to 6 percent as its experimental Alzheimer’s drug — donanemab — slowed cognitive decline by 35 percent compared to a placebo in a late-stage trial. Lilly plans to file for full approval of this drug by June-end. Similarly, Roche (up 3 percent) said its multiple sclerosis drug, fenebrutinib, reduced brain lesions in a mid-stage trial.Apellis saw its stock increase 7 percent last month due to a good start for its new vision loss drug — Syfovre — which bagged FDA approval in mid-February and was launched on March 1. In just a month, it brought in US$ 18.4 million for Apellis. Amongst mid-cap players, ImmunoGen reported positive top-line data from a late-stage trial of its ovarian cancer therapy Elahere, which pushed its stock up by 133 percent.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel) Falling Covid sales, Alnylam’s lawsuits hit Pfizer stock; Bayer’s pharma revenues dipDuring Q1 2023, Pfizer's revenues dropped to US$ 18.3 billion owing to a 64 percent drop in Comirnaty revenues (which were at US$ 13.5 billion) and a 58 percent drop in Paxlovid revenues (of approximately US$ 8 billion) as against Q1 2022. Pfizer saw a 5 percent drop in its stock in May. Pfizer and Valneva are pushing back a regulatory filing for their Lyme disease vaccine by a year (now planned for 2026) after the companies were forced to pull half of the participants from a phase 3 study in February. The month also saw Alnylam (-6 percent) file its third set of lawsuits against the two largest manufacturers of Covid vaccines — Pfizer and Moderna (-4 percent). Alnylam is accusing the two drugmakers of violating its lipid particle delivery technology with their lucrative Covid-19 vaccines. In mid-May, Moderna hit back at Alnylam’s ‘baseless’ infringement claims. Alnylam had first sued Moderna in March 2022.Bayer’s Q1 earnings were down 2 percent at €14.4 billion (US$ 15.7 billion), with its pharma business witnessing a 5 percent drop in Q1 revenues, at €4.4 billion (US$ 4.7 billion). Sales of its blood thinner Xarelto were down 13 percent in Q1 2023. Bayer’s stock was down 9 percent in May.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel) Our viewThrough much of May, pharma indices reacted negatively to the standoff in debt ceiling deal talks. An in-principle agreement between President Joe Biden and House Speaker Kevin McCarthy was reached only towards the end of May and Biden signed the debt ceiling bill early this month.Post the deal, the indices are climbing up once again. However, Morgan Stanley is of the view that the deal could drive up stock market uncertainty. Seems like it could be months before the stock market regains stability.Access the Pipeline Prospector Dashboard for May 2023 Newsmakers (Free Excel) 

Impressions: 1168


#PipelineProspector by PharmaCompass
08 Jun 2023
Biotech indices inch up post SVB bloodbath; Covid drugmakers report drop in Q1 sales
In March, the collapse of Silicon Valley Bank (SVB) had dragged the biotech indices down. SVB had made considerable investments in the biotech space, and its downfall had left many life sciences and healthcare companies vulnerable.Within a month of the SVB storm, biotech indices have bounced back. The Nasdaq Biotechnology Index (NBI) gained 1 percent to end April at US$ 4,187.32. It was down 1.3 percent in March. The S&P Biotechnology Select Industry Index (SPSIBI) was up 2 percent at US$ 6,094.82, and the SPDR S&P Biotech ETF (XBI) increased 4 percent to US$ 80.20. Both SPSIBI and XBI had dropped by 8.3 percent and 8.2 percent, respectively, in March.In April, several drugmakers announced their first quarter (Q1) results. The month also saw three major M&A deals — Merck’s US$ 10.8 billion buyout of Prometheus Biosciences, Astellas Pharma’s US$ 5.9 billion acquisition of Iveric Bio and GSK’s US$ 2 billion deal to buy Bellus Health.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Pfizer reports 29% drop in Q1 revenues, falls behind GSK in RSV vaccine raceWe have seen this happening for many months now, with Pfizer’s stock consistently falling since January. The Q1 results only echoed that sentiment — Pfizer’s revenues fell 29 percent to US$ 18.3 billion due to a 77 percent drop in sales of its Covid-19 vaccine Comirnaty. This led to a further 5 percent drop in the drug behemoth’s stock in April. What was going right for Pfizer was its experimental respiratory syncytial virus (RSV) vaccine. But GSK raced ahead of Pfizer this month when the US Food and Drug Administration (FDA) approved its RSV vaccine — Arexvy — for adults aged 60 years and older. The Prescription Drug User Fee Act (PDUFA) date for the Pfizer jab for older adults is this month too. GSK also announced the acquisition of Canada-based drug developer Bellus Health (up 114 percent) for US$ 2 billion.Among other Covid drugmakers, Moderna’s stock also suffered a 17 percent loss last month. What was worse, its experimental messenger RNA-based influenza vaccine failed to demonstrate effectiveness against influenza B. Moderna is planning to go ahead with a phase 3 study of mRNA-4157 (its investigational individualized neo-antigen therapy) and Keytruda combo in patients with adjuvant melanoma this year.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel) Wegovy helps boost Novo’s Q1 revenues; Vabysmo brings gains for RocheIn April, both Novo Nordisk and Eli Lilly posted gains in the bourses. Wegovy’s success in the US helped Novo’s obesity care segment notch up a 131 percent increase in Q1 sales. Novo’s diabetes and obesity drug sales rose 33 percent and were at DKK 48.8 billion (US$ 7.11 billion). Overall, the Danish drugmaker posted an impressive 27 percent growth in its Q1 sales — which were at DKK 53.4 billion (US$ 7.7 billion) — while its stock rose 5 percent in April.Lilly is seeking to compete with Wegovy’s dominance in the obesity market with its own drug, Mounjaro. It recently posted favorable data from a late-stage trial, where Mounjaro achieved 21 percent weight reduction in non-diabetic patients, compared to 15 percent for Wegovy. Lilly is now conducting another Phase 3b trial to test Mounjaro against Wegovy. And in a separate trial, Mounjaro led to a 16 percent weight loss in patients with type 2 diabetes. The drugmaker‘s stock rose by a handsome 15 percent.Roche Group’s pharmaceutical division posted 9 percent growth in Q1 sales — at CHF 11.7 billion (US$ 12.7 billion) — due to strong demand for newer medicines. Eye diseases drug Vabysmo, approved last year, turned out to be the strongest growth driver, generating CHF 432 million (US$ 486 million) in global sales. Roche expects the drug to generate US$ 2 billion in revenue this year. The Swiss drugmaker also shared post-hoc analyses from four additional phase 3 studies showing Vabysmo to be more effective at drying retinal fluid than Regeneron’s Eylea in Age-related macular degeneration (AMD) and Diabetic Macular Edema (DME). Roche’s stock gained 11 percent.In addition, FDA approved Roche’s Polivy as part of a five-drug combination for previously untreated diffuse large B-cell lymphoma (DLBCL), the first new treatment in nearly 20 years to significantly improve outcomes in first-line DLBCL. In Q1, Roche reported a decline of 3 percent in group sales due to lower demand for Covid tests.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Higher sales of key drugs take Novartis’ Q1 sales up 8%; J&J lowers 2023 guidanceNovartis’ Q1 sales grew 8 percent to US$ 12.95 billion, driven by strong performance of its heart failure drug Entresto, cancer meds Pluvicto and Kisqali, and multiple sclerosis drug Kesimpta. Based on higher Q1 sales, the Swiss drugmaker has raised its outlook for 2023.Novartis and partner BeiGene’s experimental drug tislelizumab showed promising results in treating certain types of gastric cancer in a late-stage trial. The partners hope this data will help make tislelizumab the first-line therapy for patients with advanced forms of gastric cancer. While Novartis’ stock went up 11 percent, BeiGene’s stock gained 17 percent in April.Though J&J’s Q1 results exceeded analyst expectations, the drugmaker lowered the 2023 guidance for its pharmaceutical business. Leaked data from a phase 3 trial showed that J&J and Legend’s cancer drug Carvykti performed better-than-expected in patients with multiple myeloma. J&J’s stock went up 4 percent. Legend’s stock rose 46 percent.Among small cap companies, Madrigal’s stock rose 24 percent in April on news of a breakthrough therapy designation for its drug Resmetirom as a treatment for nonalcoholic steatohepatitis.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Merck acquires Prometheus for US$ 10.8 bn; Astellas buys Iveric Bio for US$ 5.9 bnApril proved to be a good month for both Merck and AstraZeneca, even though the two drugmakers reported a drop in their Q1 revenues due to decreased sales of their Covid-19 products.While Merck reported a 9 percent drop in Q1 sales (at US$ 14.5 billion), with sales of its Covid-19 antiviral pill Lagevrio (molnupiravir) dropping 88 percent, Astra reported a 4 percent decrease in revenue (at US$ 10.88 billion) in Q1. Stocks of both drugmakers rose by 6 percent.In early April, FDA had granted accelerated approval to Merck’s Keytruda in combination with Seagen and Astellas Pharma’s Padcev as a first-line treatment for adults with locally advanced or metastatic urothelial carcinoma. Later in the month, Merck announced it is acquiring San Diego-based biotech Prometheus Biosciences for US$ 10.8 billion to strengthen its immunology pipeline. Prometheus’ stock skyrocketed 76 percent on the news.A combination of AstraZeneca's cancer drugs — Imfinzi and Lynparza — met its main goal in a late-stage trial for patients with advanced epithelial ovarian cancer. Additionally, Astra’s Ultomiris also received a positive recommendation from the European Medicines Agency (EMA) for adult patients with neuromyelitis optica spectrum disorder.Japanese drugmaker Astellas Pharma announced its biggest deal last month when it acquired New Jersey-based eye drug developer Iveric Bio for US$ 5.9 billion, taking its stock up 9 percent. The deal will give Astellas access to Iveric Bio’s ophthalmology treatments, including its lead drug candidate for geographic atrophy — Zimura. Iveric Bio’s stock gained 22 percent.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Disappointing Q1 sales drag AbbVie, BMS stocks downBoth AbbVie and Bristol Myers Squibb reported a drop in Q1 sales. AbbVie was hit due to weaker-than-expected performance of its blockbuster drugs Skyrizi and Rinvoq and dwindling sales of Humira (which experienced a sales drop of 25.2 percent in the face of biosimilar competition in the US). Its Q1 sales fell by 9.7 percent to US$ 12.25 billion, and its stock was down 6 percent. In positive news, FDA expanded the approval of AbbVie’s Qulipta as a preventive treatment for chronic migraine in adults. Rinvoq also received an add-on authorization in the EU as a treatment for moderate-to-severe active Crohn’s disease.BMS’ Q1 sales dropped 3 percent to US$ 11.3 billion, primarily due to an erosion in Revlimid’s sales in the face of competition from generic drugs. Revlimid’s revenues fell by 37 percent in Q1 compared to the same period last year. BMS’ stock experienced a 4 percent drop.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)Our viewThe collapse of three US banks over the last three months has dealt a blow to the US economy. Globally, the business scenario hasn’t improved much, with inflation, high interest rates, ongoing Russia-Ukraine war, supply chain kinks and other uncertainties continuing to pose challenges.If the biotech indices are able to hold up in these difficult times, it is an indication of strength and resilience within the sector.Access the Pipeline Prospector Dashboard for April 2023 Newsmakers (Free Excel)

Impressions: 1445


#PipelineProspector by PharmaCompass
11 May 2023
Pipeline Prospector March 2023: Silicon Valley Bank collapse hits biotech indices; Pfizer buys out Seagen
Biotech indices have witnessed a lot of volatility throughout 2022 and 2023. Just when they were beginning to look up, the collapse of Silicon Valley Bank (SVB) in mid-March dragged them down once again. The bank's fall left many biotech firms uncertain about their future, as life sciences and healthcare accounted for 12 percent of SVB’s deposits of US$ 173 billion.The indices regained some ground by the end of the month — the Nasdaq Biotechnology Index (NBI) increased by 0.6 percent to US$ 4,125, but the S&P Biotechnology Select Industry Index (SPSIBI) and the SPDR S&P Biotech ETF (XBI) both registered declines, falling by 8.3 percent to US$ 5,898 and 8.2 percent to US$ 76.21, respectively. In February, the NBI had fallen by 6 percent, while the SPSIBI and XBI had both experienced declines of 7 percent and 8 percent, respectively.Several mega and large cap companies, such as Sanofi, Eli Lilly, Novartis, AstraZeneca, Novo Nordisk, GSK and Moderna, posted gains in March.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel)Sanofi’s Dupixent succeeds in COPD trial, buys Provention Bio for its diabetes drug The biggest mega cap gainer on the bourses was Sanofi (its stock rose 17 percent in March). Its blockbuster anti-inflammatory drug Dupixent, developed along with Regeneron, succeeded in a late-stage clinical trial for chronic obstructive pulmonary disease (COPD), a disease that causes a progressive decline in lung function. If approved, Dupixent would become the first biologic treatment for COPD. Analysts estimate the label expansion to add US$ 3.5 billion in peak sales for Dupixent. In a further boost, the European Commission approved Dupixent for children aged six months to five years with severe atopic dermatitis. Regeneron’s stock was up 6 percent.In mid-March, Sanofi said it will purchase US-based Provention Bio (up 167 percent) for US$ 2.9 billion. The deal builds on an existing co-promotion agreement between the two companies, with Sanofi gaining full ownership of Provention Bio’s type 1 diabetes therapy Tzield. Also, Sanofi and partner Sobi’s treatment for severe hemophilia A (a hereditary bleeding disorder) in previously treated patients under 12 years, efanesoctocog alfa, met its primary endpoint in a phase 3 pivotal study.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Novartis’ Kisqali proves effective in breast cancer trial; Astra’s Enhertu posts gainsNovartis (10 percent) and AstraZeneca (8 percent) were the other mega cap gainers in March. Novartis’ breast cancer drug Kisqali plus endocrine therapy following surgery proved to be effective in a phase 3 trial in treating patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer who are at risk of recurrence. The Swiss pharma also shared positive long-term data for its gene therapy, Zolgensma, as a treatment for spinal muscular atrophy, a genetic disease that affects muscle movement. Its subsidiary Sandoz received FDA approval for Hyrimoz, a biosimilar of adalimumab.AstraZeneca and partner Daiichi Sankyo (up 15 percent) announced positive results from a mid-stage trial of their blockbuster cancer drug Enhertu in multiple HER2-expressing advanced solid tumors. Astra and Merck’s Lynparza received authorization in the UK as a treatment for patients with metastatic castration-resistant prostate cancer (mCRPC).Similarly, AbbVie’s blockbuster drug Skyrizi achieved a win in a late-stage trial for adults with moderate-to-severe active ulcerative colitis, a type of bowel disease that affects the large intestine. The drug also showed positive results in a late-stage trial in adults with moderate-to-severe plaque psoriasis who still experience symptoms after six months of treatment with Novartis’ Cosentyx (secukinumab) and Lilly’s Taltz (ixekizumab).But AbbVie also faced a setback — FDA denied approval to AbbVie’s Parkinson’s therapy ABBV-951 and requested for more information on the device used to administer the medication. Overall, AbbVie’s stock rose 3 percent last month.In good news for Roche, a panel of external advisers to the FDA voted 11-2 in favor of expanding the use of its med Polivy in combination with other drugs for adults with diffuse large B-cell lymphoma. Roche also joined forces with Lilly to develop a blood test that can detect early signs of Alzheimer’s disease.Meanwhile, a combination of Roche’s immunotherapy Tecentriq and Exelixis’ cancer drug Cabometyx failed a late-stage trial in advanced renal cell carcinoma. Roche’s stock remained unchanged in March. Similarly, Merck’s anti-TIGIT therapy vibostolimab, in combination with Keytruda, failed to improve progression-free survival in patients with metastatic non-small cell lung cancer in a phase 2 trial. In a separate phase 2/3 study, Keytruda and chemotherapy significantly improved overall survival in patients with unresectable malignant pleural mesothelioma, a rapidly progressing cancer that develops in the lining of the lungs. Merck’s stock fell 1 percent. FDA brought out a draft guidance for accelerated approvals to improve clinical trials of cancer drugs.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) GSK, Pfizer’s RSV jabs get FDA panel’s backing; Pfizer buys out Seagen for US$ 43 bnA panel of external experts to the FDA backed both GSK (6 percent) and Pfizer’s respiratory syncytial virus (RSV) experimental vaccines, setting the stage for a race between the two rivals to bring out the first shot in the US against the disease. The final results of a trial published in the New England Journal of Medicine showed that Pfizer’s experimental maternal RSV vaccine was 82 percent effective in preventing serious illnesses in children when given to pregnant mothers.Though Pfizer announced its biggest buyout in recent times, its stock saw no change in March. It is acquiring cancer treatment specialist Seagen (up 12 percent) for US$ 43 billion as part of its move to mitigate a hit in revenues from declining sales of its Covid-19 products and patent expirations of some top drugs in the coming years. FDA approved Pfizer’s Zavzpret nasal spray for the treatment of acute migraine. It, however, recalled 4.2 million units of its Nurtec ODT prescription migraine drug because it failed to meet child-resistant packaging requirements.In March, Moderna (11 percent) and partner Merck said they will present phase 2 data of their investigational personalized cancer vaccine, mRNA-4157, at an oncology conference in April. The experimental drug, in combination with Keytruda, received FDA’s breakthrough therapy designation in February. Meanwhile, the vaccine maker said it will open offices in South San Francisco and Seattle as part of its plan to rapidly advance its pipeline of messenger RNA medicines amid declining Covid-19 vaccine sales.BioNTech said it expected the sale of its Covid-19 vaccine to fall from €17.3 billion (US$ 18.7 billion) in 2022 to €5 billion (US$ 5.4 billion) this year. The German mRNA company will allocate up to €2.6 billion (US$ 2.8 billion) towards R&D this year. Its stock fell 5 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Insulin makers cut prices by up to 75 percent; Vertex posts gains in cell therapy for diabetes March saw a lot of activity in the field of diabetes. FDA accepted Lilly’s application for Jardiance as a treatment for children 10 years and older who are suffering from type 2 diabetes. Last month, Lilly (9 percent) decided to slash the list prices of its commonly prescribed insulin products, Humalog and Humulin, by 70 percent in the US. Rival Novo Nordisk (11 percent) also said it would cut the US prices of its insulin therapies by up to 75 percent.Large cap biopharma Vertex Pharmaceuticals’ cell therapy candidate VX-264 received investigational new drug application clearance from the FDA as a potential treatment for type 1 diabetes. Vertex’s stock went up 8 percent. And small cap firm Biomea Fusion posted positive topline data from a phase 1/2 study evaluating its lead pipeline candidate — BMF-219 — in patients with type 2 diabetes. Biomea’s stock skyrocketed 129 percent.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) Our viewDespite showing some signs of a revival in January, the first quarter of 2023 has been lackluster for biotech indices. In terms of M&As, the industry witnessed the Pfizer-Seagen deal and the Sanofi-Provention Bio deal. But we are expecting a lot more from 2023.In April, FDA is likely to take some important drug approval decisions — such as the one on the expanded use of Pfizer’s pneumococcal vaccine Prevnar 20 for use in infants and children, approval of Emergent BioSolutions’ anthrax vaccine and Daiichi Sankyo’s cancer drug quizartinib, which is under priority review, among many others. These decisions are bound to have an impact on the bourses. We are looking forward to an eventful month.Access the Pipeline Prospector Dashboard for March 2023 Newsmakers (Free Excel) 

Impressions: 1666


#PipelineProspector by PharmaCompass
06 Apr 2023
Pipeline Prospector Feb 2023: Low demand for Covid drugs hammers down Lilly, Moderna stocks
The year had opened on a buoyant note. But February quickly dashed any hopes of a market rebound and reinforced that volatility isn’t going anywhere in a hurry.After beginning the year on a positive note, biotech indices dipped in February. The Nasdaq Biotechnology Index (NBI) was down 6.3 percent (at US$ 4,075), the S&P Biotechnology Select Industry Index (SPSIBI) fell 7 percent to US$ 6,451 and the SPDR S&P Biotech ETF (XBI) dropped 7.7 percent to US$ 82.85. In January, NBI was up 4.4 percent, SPSIBI had increased by 8.7 percent, while XBI had risen by 9 percent.Many drugmakers announced their 2022 results last month. Several mega cap drugmakers, such as Eli Lilly, Johnson & Johnson and Pfizer saw their stocks get hammered for a straight second month. February didn’t witness any significant deal or buyout.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel)Low demand for Covid drugs impacts Lilly, J&J; Moderna, Roche issue lower guidanceIn our last month’s report, we had carried news about Lilly and J&J posting lower revenues due to a drop in sales of their Covid-19 treatments. Not only did Lilly’s Q4 revenues decrease, its diabetes drug Mounjaro also failed to live up to investors’ expectations. All this news resulted in a 9 percent drop in Lilly’s stock.It was a tough month for J&J (-7 percent drop in stock) as well, whose Q4 revenues declined by 4 percent to US$ 23.7 billion and its Covid-19 vaccine experienced a 57 percent drop in sales. J&J’s autoimmune disease drug Remicade saw a 37 percent drop in sales due to competition from biosimilars. And, after a court rejected J&J’s two-step bankruptcy strategy for its talcum powder lawsuits, the US Supreme Court rejected the drugmaker’s appeal against a US$ 302 million verdict in a lawsuit filed by the state of California, accusing J&J of hiding the dangers associated with its pelvic mesh devices. Though Roche (-5 percent) posted a 2 percent increase in 2022 sales (at US$ 67.6 billion/CHF 63.3 billion), its guidance for 2023 cautions of a US$ 5.5 billion sales drop due to its Covid-19 therapy and diagnostic kits. Gilead (-5 percent) failed to register any growth in its 2022 revenues largely due to a 30 percent drop in sales of its Covid-19 treatment Veklury.Moderna (-20 percent) said it expects the annual sales of its Covid-19 vaccine to be around US$ 5 billion in 2023 – less than a third of the US$ 18.4 billion it had hauled in 2022 – due to falling demand for its vaccine. Its messenger RNA-based influenza vaccine demonstrated a strong immune response against A strains of the flu, but proved less effective against the less common influenza B strain.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel)Astra posts 19% rise in 2022 revenues, Keytruda pushes up sales for MerckBolstered by a rise in the sales of its immunology, neuroscience and aesthetics treatments, AbbVie’s 2022 revenue grew by 3.3 percent to US$ 58 billion. Its stock rose 5 percent in February.AstraZeneca reported 2022 revenue of US$ 44.35 billion, a growth of 19 percent over 2021. Cancer treatments accounted for 35 percent of its business, with its blockbuster drugs Lynparza, Tagrisso, Imfinzi and Farxiga registering significant sales growth. Astra plans to deliver at least 15 new medicines this decade and initiate at least 30 new late-stage clinical trials this year. Astra's stock went up 3%.Buoyed by the sales of diabetes and obesity drugs, which brought in US$ 22.8 billion (DKK 156.4 billion), Novo Nordisk’s 2022 sales reached US$ 25.3 billion (DKK 177 billion), a growth of 26 percent year-over-year. Novo’s stock was up 2 percent.Merck (2 percent) reported an increase of 22 percent in 2022 sales, reaching US$ 59.3 billion. This growth was mainly driven by its blockbuster cancer drug Keytruda and human papillomavirus (HPV) vaccine Gardasil. The drugmaker continued to experiment with Keytruda across different types of cancer, achieving success in two trials while experiencing setbacks in two others. Meanwhile, Merck said it expects sales of its Covid-19 pill Lagevrio (molnupiravir) to decline from US$ 5.7 billion in 2022 to just around US$ 1 billion in 2023.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Seagen gains on buyout report; GSK kept quiet about Zantac’s cancer risksSeagen’s stock surged by 30 percent last month. The cancer treatment specialist announced positive full-year results, with its revenue growing by 25 percent in 2022 due to an increase in sales of its antibody-drug conjugates. The Wall Street Journal reported that Pfizer was in early-stage talks to buy Seagen for over US$ 30 billion.Pfizer’s stock continued to slide. After registering a drop of 14 percent in January, Pfizer’s stock lost 7 percent in February. The drugmaker and its French partner Valneva decided to discontinue half of the total number of recruited participants in the US in a phase 3 trial of their experimental Lyme disease vaccine due to violations of clinical trial regulations by a third-party contractor.GSK’s stock dropped 3 percent in February. A damning report brought out by Bloomberg said GSK’s scientists knew for decades about the cancer risks associated with its popular heartburn drug Zantac (ranitidine), but the drugmaker chose to keep quiet about them.In positive news, an external panel of experts supported both Pfizer and GSK’s respiratory syncytial virus (RSV) vaccines. The US Food and Drug Administration granted full approval to GSK’s Jemperli (dostarlimab) in endometrial cancer. Moreover, the agency’s panel of external advisors backed GSK’s proposed single-arm trials to gain accelerated approval of Jemperli in rectal cancer.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Apellis’ geographic atrophy drug bags FDA nod; FTC scrutinizes Amgen-Horizon dealSanofi (-4 percent) decided to halt a late-stage clinical trial of its oral drug for myasthenia gravis – tolebrutinib – that it had acquired through its US$ 3.7 billion takeover of Principia Biopharma. Despite its 2022 revenues growing by 7 percent to US$ 47.1 billion (€43 billion), Sanofi fell short of meeting market expectations. In a positive update, FDA approved Sanofi’s Altuviiio to prevent and treat bleeding episodes in people with hemophilia A. The Federal Trade Commission has issued a second request for information regarding Amgen’s US$ 28.3 billion acquisition of Horizon Therapeutics. Amgen’s stock dropped 6 percent. And in a setback to Jazz Pharmaceuticals, a US appeals court has upheld an injunction that states a patent related to the drugmaker’s narcolepsy drug should be removed from FDA’s Orange Book. Jazz’s stock lost 11 percent in February.Among mid- to small-cap companies, Apellis Pharmaceuticals’ drug Syfovre (pegcetacoplan) has been approved by FDA as the first-ever treatment for geographic atrophy, a major cause of blindness. Apellis’ stock went up 20 percent in February. And Ambrx Biopharma’s stock shot up 200 percent after it posted encouraging initial data from an ongoing phase 1 trial of its experimental prostate cancer drug.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) Our viewThe drop in sales of Covid drugs is contributing to a negative outlook around financial performance of some large drug companies. With the pandemic receding, this was bound to happen. Even though January raised hopes of market watchers, February has proven that we truly live in a VUCA (short for volatility, uncertainties, complexity and ambiguity) world.Access the Pipeline Prospector Dashboard for February 2023 Newsmakers (Free Excel) 

Impressions: 1501


#PipelineProspector by PharmaCompass
09 Mar 2023
Pipeline Prospector Jan 2023: Mega cap drugmakers face rout at bourses even as biotech indices inch upwards
After facing the worst year since 2008, biotech indices opened 2023 on a positive note. All the three indices posted gains in January — while the Nasdaq Biotechnology Index (NBI) was up 4.4 percent (at US$ 4,360), the S&P Biotechnology Select Industry Index (SPSIBI) rose 8.7 percent to US$ 6,896 and SPDR S&P Biotech ETF (XBI) increased 9 percent to US$ 88.90. In December 2022, the NBI was down 3.4 percent to US$ 4,213, while XBI had risen only 0.1 percent and SPSIBI had witnessed no change.Several major drugmakers have shared their financial results for 2022 since last month. Pfizer posted an operational growth of 30 percent with 2022 revenues touching an all-time high of US$ 100.3 billion. Merck posted a 22 percent increase, with sales of Keytruda growing 22 percent to US$ 20.9 billion. GSK generated £29.3 billion (US$ 36.3 billion) in revenue in 2022, an increase of 13 percent over 2021 figures, and Amgen posted a gain of 1 percent.Drugmakers like Eli Lilly and Johnson & Johnson saw a huge drop in sales of their Covid-19 products. Lilly suffered a 9 percent drop and J&J saw a 4 percent decline in Q4 2022 revenue. More companies are expected to release their 2022 results this month.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel)Lower 2023 forecast, vaccine’s safety concern hammer Pfizer’s stockDespite the indices showing signs of recovery, stocks of several mega cap companies ended the month in the red. Pfizer’s stock suffered the biggest loss, dropping 14 percent in January, due to an interplay of various factors even as the drug behemoth reported best-ever sales in 2022, owing to its Covid-19 vaccine Comirnaty and antiviral pill Paxlovid. First, the US Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) launched an investigation into the possibility of a stroke in older adults who had received its updated Covid-19 booster shot. Second, despite the stellar results, Pfizer’s forecast for 2023 was lower by 33 percent, with an estimated revenue of US$ 67 to 71 billion. With the pandemic receding, there has been a considerable drop in demand for Covid products. Pfizer’s Covid vaccine partner BioNTech also saw its stock go down 6 percent. The other big loser was AbbVie (drop of 9 percent) – its blockbuster immunology drug Humira (adalimumab) saw its exclusive run come to an end in the US with Amgen launching a copycat — Amjevita. Seven other biosimilars are due to be launched later this year.A federal appeals court in Philadelphia blocked J&J’s plan to use the Texas two-step bankruptcy strategy to resolve around 40,000 lawsuits alleging that its talc products cause cancer. In another setback, its Janssen unit halted a late-stage global trial of its HIV vaccine after the drug was found to be ineffective at preventing infection. All these factors led to a 8 percent drop in J&J stocks.AstraZeneca’s stock tumbled 6 percent in January due to factors such as a second cancer lawsuit filed by Bristol Myers Squibb, wherein it claimed Astra’s cancer treatment Imjudo infringes on two patents related to its blockbuster drug Yervoy. FDA also revoked the emergency use authorization (EUA) for AstraZeneca’s Covid-19 treatment Evusheld, expecting it to fail against the currently dominant Omicron sub-variant.January wasn’t a great month for Merck either, whose stock plummeted 4 percent. The drugmaker halted a late-stage trial of its blockbuster immunotherapy drug Keytruda in prostate cancer after interim data showed that the drug failed to extend survival or help improve patients’ lives. Meanwhile, the drugmaker said it has identified the source of a potential cancer-causing agent – Nitroso-STG-19 – in its popular diabetes drugs Januvia and Janumet, and plans to resolve the issue by the end of the year.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Bayer gains on sales forecast for Kerendia, Nubeqa; lawsuit settlements benefit TevaThree large cap companies — Bayer AG (14 percent), Teva (10 percent) and Vertex Pharmaceuticals (12 percent)  – posted double digit gains on the bourses last month. Bayer hiked sales targets for two of its meds – heart drug Kerendia and prostate cancer treatment Nubeqa – to US$ 3.2 billion each.Israeli drugmaker Teva said it has either already settled with or confirmed participation of 48 US states to move forward with its US$ 4.25 billion proposed national settlement agreement to resolve thousands of lawsuits over its alleged role in the US opioid crisis.Vertex Pharmaceuticals said it plans to file for the US approval of its CRISPR gene-editing therapy exa-cel as a treatment for beta-thalassemia and sickle cell disease in the first quarter. If approved, the drug is expected to generate peak annual sales of over US$ 2 billion. Vertex has already applied for the drug’s authorization in the EU and UK. Vertex is also testing a non-opioid drug, VX-548, for acute pain in a late-stage trial.Among small cap companies, Massachusetts-based Theseus Pharmaceuticals posted a 180 percent surge in its stock price in January. The drugmaker said it plans to release clinical data from a phase 1/2 trial of its lead candidate – THE-630 – for advanced gastrointestinal stromal tumor patients, later this year. Analysts expect THE-630 to compete against Pfizer’s Sutent (sunitinib), with projected sales of over US$ 1 billion by 2035. Theseus is also developing two other early-stage candidates.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Accelerated nods bring gains for Biogen, Seagen; Lilly loses on Alzheimer’s setback Biogen’s second Alzheimer’s drug – Leqembi (lecanemab) — received FDA’s accelerated approval to treat patients who are in the earliest stages of the neurodegenerative disease. However, Eli Lilly’s bid for an accelerated approval pathway for its experimental Alzheimer’s disease drug donanemab suffered a setback. FDA rejected the drug as Lilly did not provide enough data from patients who were treated for at least a year. However, days later Lilly’s cancer drug Jaypirca (pirtobrutinib) won accelerated approval as a treatment for mantle cell lymphoma, a rare form of blood cancer. FDA also accepted Lilly-Boehringer Ingelheim’s application for cancer drug Jardiance (empagliflozin) as a treatment for chronic kidney disease (CKD) in adult patients. Overall, while Biogen’s stock was up 5 percent in January, Lilly’s was down 7 percent.In another cancer drug update, FDA granted accelerated approval to Seagen’s Tukysa (tucatinib) to treat HER2-positive unresectable or metastatic colorectal cancer. Seagen’s stock rose 8 percent last month. And BeiGene’s cancer drug Brukinsa (zanubrutinib) received an approval in the US as a treatment for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), pushing its stock up 11 percent. The drug has also received authorization in the UK.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) Our viewAs always, the new year began with the JP Morgan Healthcare Conference (San Francisco, January 9 to 12). For  the last three years, the conference has been lackluster insofar as M&As were concerned. But this year, there were a number of buyouts – AstraZeneca said it will acquire US-based drug developer CinCor Pharma for up to US$ 1.8 billion. Italy’s privately-held Chiesi Farmaceutici announced it is buying Ireland-based rare diseases drugmaker Amryt Pharma for up to US$ 1.48 billion. And Ipsen picked up Albireo for US$ 952 million. Stocks of CinCor, Amryt and Albireo shot up by over 100 percent following the takeover news. While we do hope these buyouts signal an uptick in M&A activity, we also know that drugmakers who made billions from the pandemic are now facing a steep Covid cliff. Among these are Pfizer, BioNTech, Moderna, Gilead Sciences, AstraZeneca and Merck. The 2022 results announced so far confirm this trend. Insofar as biotech indices are concerned, we hope January has set the tone for the coming months.Access the Pipeline Prospector Dashboard for January 2023 Newsmakers (Free Excel) 

Impressions: 1370


#PipelineProspector by PharmaCompass
09 Feb 2023
Pipeline Prospector Dec 2022: Biotech indices fall on close of a volatile year
The year 2022 was a difficult one for the biotech sector. Marked with geopolitical unrest, rising interest rates, the Russian-Ukraine war, inflation, and most of all, a stricter regulatory environment, biotech companies had a tough going. Biotech stocks were on a roller coaster ride through the year, with the first few months witnessing bearish trends. The sector bounced back in the second half of 2022 due to M&A deals, strong earnings performance, new drug approvals and pipeline successes. But the joy was short-lived – the indices dipped once again in December.The Nasdaq Biotechnology Index (NBI) fell 3.4 percent to US$ 4,213. In November, it was up 5 percent. There was no change in the S&P Biotechnology Select Industry Index (SPSIBI) last month. It was up 1.1 percent in November. And the SPDR S&P Biotech ETF (XBI) rose 0.1 percent in December, as opposed to 1 percent rise in November.For the full year, NBI fell 11 percent, while both SPSIBI and XBI plummeted 28 percent. Overall though, biotech companies can take heart from the fact that 2022 was the worst year for S&P 500 and Nasdaq Composite since 2008.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel)Novo gains post Wegovy launch in Denmark; Sanofi’s stock rises post legal winDecember was a big month for Novo Nordisk as the Danish drugmaker launched its diabetes drug Wegovy (semaglutide) in its home market, fulfilling its promise to launch the med outside of the US by 2022-end. Wegovy also received an add-on approval from the US Food and Drug Administration (FDA) to treat obesity in teens 12 years and above just before Christmas. All the good news resulted in an 8 percent rise in Novo’s stock. Another mega cap company that made gains on the bourses last month was French drugmaker Sanofi — its stock rose 7 percent. A big reason behind this was the dismissal of about 50,000 lawsuits by a US district judge. The lawsuits had claimed that the heartburn drug – Zantac – causes cancer. Shares of GSK and Sanofi also made gains due to the dismissal, adding more than US$ 20 billion in combined value soon after the court’s decision. Sanofi’s blockbuster dermatitis and asthma drug Dupixent (dupilumab) also received marketing authorization in Europe as the first and only targeted medicine for prurigo nodularis, a chronic and debilitating skin disease.In early 2022, Novo had faced supply bottlenecks for Wegovy. Last month, its chief rival Eli Lilly met the same fate as it failed to meet the demand for its newly approved diabetes injection Mounjaro (tirzepatide). FDA added Mounjaro to its list of drugs facing shortages, along with a second diabetes med, Trulicity (dulaglutide). Lilly’s stock was down 2 percent in December.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) FDA’s Aduhelm nod gets flayed post probe; Roche suspends Alzheimer’s drug trialIt wasn’t a good month for Biogen, whose stock dropped by 9 percent in December. Three patient deaths got linked with Eisai and Biogen’s second Alzheimer’s drug — Leqembi (lecanemab). And, towards the end of the month, there was news that an 18-month-long investigation conducted by two House of Representatives’ committees found FDA’s approval process of Biogen’s controversial Alzheimer’s disease drug — Aduhelm (aducanumab) — to be “rife with irregularities”.There was more bad news on drugs for Alzheimer’s. Roche (down 2 percent) decided to suspend most trials of its Alzheimer’s drug – gantenerumab – after it failed to slow advancement of the disease in late-stage studies. In another setback to the Swiss drugmaker, a combination of Tecentriq (atezolizumab) and Exelixis-Ipsen’s Cabometyx (cabozantinib) failed to meet the primary endpoint in a phase 3 lung cancer trial. Ipsen’s stock fell 6 percent.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Madrigal zips past rivals in NASH race; Prometheus’ colitis drug posts trial winAmong mid-cap companies, Pennsylvania-based Madrigal Pharmaceuticals’ shares soared by over 300 percent in December after its experimental drug to treat nonalcoholic steatohepatitis (NASH) – resmetirom – met the main goal in a late-stage study. The trial’s success has propelled Madrigal to the forefront of a race to develop the first treatment for NASH, a form of non-alcoholic fatty liver disease. Madrigal plans to move FDA for an accelerated approval of resmetirom this year.Another mid-cap company Prometheus Biosciences saw its stock soar 171 percent after its lead drug candidate – PRA023 – met the endpoints in a phase 2 study in patients with moderate-to-severely active ulcerative colitis.A small cap company named Icosavax saw its stock soar 125 percent after it announced a positive outcome for its respiratory syncytial virus (RSV) vaccine from a phase 1/1b study. Icosavax is a US-based, clinical stage vaccine company. A single dose of the shot, IVX-121, demonstrated a response against RSV that lasted six months.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Horizon’s stock rises after Amgen acquires it for US$ 27.8 billionThe biggest biopharma deal of 2022 was Amgen’s acquisition of Horizon Therapeutics for US$ 27.8 billion. News of Amgen and Sanofi’s buyout interest in Horizon had led to a 61 percent rise in the rare disease drugmaker’s stock in November. Last month, Horizon’s shares increased by 10 percent after Amgen finally announced the acquisition.Another significant deal inked in December was Japanese drugmaker Takeda’s (up 7 percent)  acquisition of  Nimbus Therapeutics’ experimental psoriasis drug for up to US$ 6 billion. This is Takeda’s biggest buyout since it purchased Shire for US$ 62 billion in 2019. The deal is also among the pharma industry’s largest single-asset purchases since Amgen bought Otezla from Celgene in 2019 for US$ 13.4 billion.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Moderna’s mRNA vaccine-Keytruda combo succeeds in mid-stage skin-cancer trialA combination of Moderna’s experimental messenger RNA cancer vaccine and Merck’s blockbuster immunotherapy Keytruda (pembrolizumab) was successful in a mid-stage skin cancer trial. Moderna’s stock grew 19 percent following the news, but it nosedived soon after. Merck is also carrying out clinical trials of Keytruda that can be injected under the skin. The drugmaker is testing at least two versions of the drug in the hope that a new formulation will allow it to retain the drug’s patent edge and protect it from competition.Novartis’ stock reported a 2 percent growth in December. Its drug Pluvicto showed survival benefits in a late-stage prostate cancer trial. Its rare blood disease drug iptacopan was also successful in treating paroxysmal nocturnal hemoglobinuria in a late-stage trial.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) Our viewSoothsayers do not have positive things to say about 2023. The Ukraine-Russia war has played havoc with food and energy costs, causing the highest rates of inflation. And a global recession seems inevitable in 2023.Even as the world grapples with these challenges, innovation is likely to save the day for the biotech sector. In 2023, Eisai and Biogen’s Leqembi became the first drug to receive an accelerated approval from the FDA. Several other pathbreaking drugs will come up for approval this year, including vaccines and therapies for RSV, new treatments for Alzheimer’s disease, a gene therapy for Duchenne muscular dystrophy and several treatments for obesity. The heady mix of recession and innovation may also trigger more M&A activity. And we hope these innovations result in a better year for the sector.Access the Pipeline Prospector Dashboard for December 2022 Newsmakers (Free Excel) 

Impressions: 1145


#PipelineProspector by PharmaCompass
12 Jan 2023
Pipeline Prospector November 2022: Positive news on RSV vaccines, cancer drugs bring gains for Big Pharma
After bouncing back in October, biotech indices continued to rally in November. The Nasdaq Biotechnology Index (NBI) was up 5 percent to US$ 4,344 last month. In October, it was up 7.4 percent.The S&P Biotechnology Select Industry Index (SPSIBI) was up 1.1 percent to US$ 6,514. In October, it was up 3 percent. And the SPDR S&P Biotech ETF (XBI) rose 1 percent in November, as against 3 percent in October.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)RSV therapy, vaccines bring gains for Sanofi-Astra, Pfizer, GSKSeveral mega cap drugmakers posted impressive gains on the bourses last month. These include Novo Nordisk (15 percent), AstraZeneca (13 percent), Novartis (10 percent), Gilead (10 percent), AbbVie (9 percent), Merck (9 percent), Sanofi (5 percent) and Pfizer (4 percent).Novo Nordisk’s stock rose in early November on raised FY22 outlook as its diabetes drug Ozempic (a once-weekly semaglutide injection) drove Q3 sales. On a year-over-year basis, Ozempic has reported an 86 percent increase in sales. The markets took well to news that Novartis is considering the sale of its ophthalmology and respiratory units — its stock went up 10 percent in November. According to Bloomberg, the ophthalmology unit could fetch about US$ 5 billion.There was ample news on respiratory syncytial virus (RSV) therapies and vaccines. RSV is a major cause of respiratory illness in children. Sanofi and AstraZeneca’s drug Beyfortus (nirsevimab) bagged authorization in both Europe and the UK as the first preventive RSV treatment in newborns and infants.In early November, Pfizer reported a positive update on its RSV vaccine — RSVpreF. The drugmaker said its vaccine is highly effective at protecting newborns when the shot is given to mothers late in their pregnancy. And this week, the US Food and Drug Administration accepted for priority review Pfizer’s application for the use of the shot in adults aged 60 years and older. The agency is slated to announce its decision by May 2023.Another gainer was GSK (3 percent) — it scored a priority review from the FDA for its RSV vaccine candidate for older adults, a month before Pfizer. Other companies developing vaccines and drugs for RSV are Moderna (mRNA-1345), Merck (clesrovimab) and Bavarian Nordic. The FDA also granted priority review to Takeda’s (15 percent) biologics license application (BLA) for its dengue vaccine candidate, Qdenga (TAK-003).Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)Lilly stock rises 4% despite fake tweet incident; Amgen gains on obesity drug newsThe biggest event that rattled the bourses in mid-November was a fake tweet that erased over US$ 15 billion off Eli Lilly’s market capitalization. Impersonating the pharma giant, the tweet said Eli Lilly is providing insulin for free. The account — @EliLillyandCo — had a ‘verified’ blue check mark, a symbol that Twitter has been using for years to denote an account’s authenticity. As a result of this fake tweet, Lilly’s stock plummeted 5 percent.Post this event, top drugmakers in the US halted ad spending on Twitter. However, Lilly’s stock recovered when later in the month the FDA approved its long-acting insulin — Rezvoglar — as an “interchangeable” product with Sanofi’s Lantus (insulin glargine). Lilly also said it plans to double the manufacturing capacity for its type 2 diabetes drug Mounjaro by 2023-end. Overall, Lilly’s stock was up 4 percent in November.In other diabetes news, Provention Bio’s Tzield (teplizumab) won an FDA approval as a preventive treatment for type 1 diabetes in individuals aged eight years or older. This is the first drug to delay the onset of  type 1 diabetes. Provention Bio’s stock was up 29 percent in November.Similarly, Amgen’s stock gained 5 percent on positive news from a phase 1 trial of its new obesity drug — AMG 133. Buoyed by the trial’s success, the drugmaker is now planning to initiate a larger mid-stage study early next year. Amgen also published in-depth results from a phase 2 trial of its drug Olpasiran. It was found that the drug reduced levels of lipoprotein, which is a risk factor for cardiovascular disease. Amgen is now moving ahead swiftly with its phase 3 program, playing catch-up with a similar drug (pelacarsen) being developed by Novartis and its partner Akcea.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)Trial data on Alzheimer’s drugs causes volatility in Roche, Biogen, Eisai stocksNovember was quite a newsy week for experimental Alzheimer’s drugs. While some drugs failed, others showed promise. Roche said its drug – gantenerumab – fell short of demonstrating that it may help patients with early-stage Alzheimer’s preserve abilities such as remembering, solving problems, orientation and personal care. Roche was developing the drug with partner MorphoSys. Roche’s stock was down 2 percent. And MorphoSys’ stock slid 20 percent following the news.Roche’s loss was competitors’ gain. Stocks of its rivals in the Alzheimer’s drug race, such as Biogen, Eli Lilly and Prothena, jumped after the Roche announcement.However, Biogen and Eisai’s stocks plunged around November-end, after reports of a second death in a late-stage trial of lecanemab. Eisai said the drug is not associated with an increased risk of death. After Eisai unveiled trial results, the stocks of both companies went up.Lilly’s donanemab also showed promise in an early symptomatic Alzheimer’s study. In the study’s co-primary outcomes, brain amyloid plaque clearance was achieved in 37.9 percent of donanemab-treated participants, compared with 1.6 percent of Aduhelm-treated patients at six months. Similarly, Axsome announced positive data from a phase 3 Alzheimer’s agitation study evaluating its candidate, AXS-05. Currently, there is no approved therapy for this indication. Axsome’s stock went up by 51 percent last month.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)AbbVie, Merck report oncology gains; Astra’s drug combo bags second FDA nodOncology was another area where Big Pharma made big gains. The FDA accepted for priority review the BLA for AbbVie and Genmab’s treatment for relapsed/refractory large B-Cell lymphoma (LBCL) — epcoritamab. If approved, epcoritamab will become the first subcutaneous bispecific antibody available for the treatment of LBCL. AbbVie’s stock rose 9 percent, while Genmab’s was up 21 percent in November.In other AbbVie news, its blockbuster immunology drug Skyrizi (risankizumab-rzaa) has been approved by the FDA as a treatment for adults with moderate-to-severe Crohn’s disease. Skyrizi is the first specific anti-interleukin 23 (IL-23) monoclonal antibody to treat Crohn’s disease. And its other blockbuster drug Rinvoq (upadacitinib) has been recommended by UK’s NICE as a once-daily pill to treat those with moderate-to-severely active ulcerative colitis (UC).Merck’s blockbuster drug Keytruda and chemotherapy combo has met the primary goal in a phase 3 study for treating gastroesophageal junction adenocarcinoma, a type of gastric cancer. England’s NICE recommended Merck’s blockbuster drug Keytruda in combination with chemotherapy in adults with early-stage triple-negative breast cancer who are at high risk of recurrence or locally advanced breast cancer.AstraZeneca’s drug combo – Imjudo (tremelimumab) and Imfinzi (durvalumab) – has received its second FDA approval within a month. In October, the combo received its first approval to treat adult patients with unresectable hepatocellular carcinoma (HCC). An FDA panel voted overwhelmingly (16 to 1) in favor of AstraZeneca and Avillion’s PT027 (albuterol/budesonide) for the treatment of asthma in people aged 18 years and older.However, not every performer saw their stocks rise. Despite ample positive news, Regeneron saw its stock down 1 percent in November. First, the FDA approved Regeneron’s PD-1 inhibitor — Libtayo (cemiplimab-rwlc) — in combination with platinum-based chemotherapy as a first-line treatment for adult patients with advanced non-small cell lung cancer (NSCLC) with no EGFR, ALK or ROS1 aberrations. Second, Regeneron’s Evkeeza (evinacumab) bagged FDA's priority review status for use in children aged five to 11 years with the ultra-rare genetic disorder homozygous familial hypercholesterolemia (HoFH). And third, Regeneron inked a potential US$ 2 billion deal with CytomX Therapeutics to co-develop next-generation bispecific cancer treatments.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)4D Molecular’s stock rises 178% on positive wet AMD drug data; Verve down 40%Among mid and small-cap drugmakers, 4D Molecular Therapeutics was the biggest gainer. Its stock went up 178 percent due to positive interim data of 4D-710 for cystic fibrosis and wet age-related macular degeneration (wet AMD) indications.Incyte and Mirati Therapeutics (31 percent) have entered into a clinical trial collaboration and supply agreement to investigate the combination of INCB99280, Incyte’s small molecule PD-L1 inhibitor, and adagrasib, a KRASG12C selective inhibitor. This week, Mirati’s stock was down after the company posted results from a phase 2 trial of its experimental drug adagrasib in combination with Merck’s Keytruda.Vir Biotechnology (22 percent) has presented new data evaluating the potential of VIR-2218 and VIR-3434 to achieve a cure for chronic hepatitis B virus (HBV) infection.Amongst the mid and small cap losers were Verve Therapeutics (-41 percent) and Apellis Pharmaceuticals (-16 percent). FDA has halted Verve’s plan to test a new gene editing therapy for heart disease in the US. This week, the company divulged that it has received a letter from the FDA asking for more information to resolve the clinical hold. In the case of Apellis, the agency has delayed a decision on its eye disease drug after the biotech submitted updated data.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)Horizon’s stock rises 61% on buyout talks; Merck acquires Imago BiosciencesIn M&A news, Horizon Therapeutics is said to be on the block and has drawn buyout interest from players like Amgen and Sanofi. Horizon, which makes drugs for rare, autoimmune and severe inflammatory diseases, saw its stock rise 61 percent in November. The company’s shares continued to rise since it released its third-quarter earnings. The encouraging sales of its thyroid eye disease treatment Tepezza and gout therapy Krystexxa boosted its annual guidance.In acquisitions, Merck announced it will acquire cancer drug developer Imago BioSciences for US$ 1.35 billion in a bid to expand its portfolio of blood disorder treatments. Its lead drug — bomedemstat — is currently undergoing mid-stage studies for treating certain types of rare blood cancers. Imago BioSciences’ stock went up 100 percent in November.AstraZeneca is acquiring Netherlands-based targeted cancer therapy developer, Neogene Therapeutics, for up to US$ 320 million in a bid to build its pipeline of cell-based cancer treatments. AstraZeneca has also inked a potential US$ 402 million licensing deal with British drug discovery firm C4X Discovery Holdings (C4XD) to develop an oral treatment for chronic obstructive pulmonary disease (COPD), along with other inflammatory and respiratory illnesses. Viatris has announced it will acquire two eye disease drug developers — Oyster Point Pharma and Famy Life Sciences — for around US$ 700 million.In collaborations, Australian vaccine maker CSL Seqirus inked a potential US$ 4.5 billion licensing deal with Arcturus Therapeutics to gain access to the US drug developer’s messenger RNA vaccine technology. And Sanofi entered into a potential US$ 1.2 billion partnership with artificial intelligence-based drug development firm Insilico Medicine to develop drugs for up to six new targets.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)Our viewThe year 2022 has been a year most biotech companies may want to forget. The Ukraine-Russia war, stricter regulatory environment post the Covid lockdowns, rising interest rates, global inflation and other uncertainties sent key stock indices down during most months of the year. Even though the markets have been on a rebound, the year-to-date performance of the NBI is still down nearly 9 percent.As we wrap up 2022, there is optimism that the trend of the last three months will continue. While it’s difficult to predict what 2023 will be like, there is hope that uncertainties will reduce and the many pathbreaking drugs in the pipeline will keep cheering the markets.Access the Pipeline Prospector Dashboard for November 2022 Newsmakers (Free Excel)

Impressions: 2409


#PipelineProspector by PharmaCompass
08 Dec 2022