Pipeline Prospector October 2022: Biotech indices bounce back on positive Q3 results
After a bearish September, biotech indices bounced back last month on the back of some bullish trends, including the better-than-expected third quarter (Q3) results posted by some drugmakers. The Nasdaq Biotechnology Index (NBI) was up 7.4 percent last month, at US$ 4,103. In September, it was down 2 percent.
The S&P Biotechnology Select Industry Index (SPSIBI) was up 3 percent to US$ 6,388. In September, it was down 5 percent. And the SPDR S&P Biotech ETF (XBI) rose 3 percent in October, compared to a fall of 7 percent in September. The year-to-date (YTD) performance of NBI is down 14 percent.
Stocks of Merck, Lilly, J&J, Sanofi rise on back of strong Q3 performance
The third quarter (Q3) proved to be a good period for mega cap drugmakers. Barring and , most mega cap drugmakers posted positive Q3 results. This led to an upward revision of their stocks. In fact, despite a drop in sales, Roche and BMS also saw an upward movement in their stocks (2 percent and 10 percent, respectively).
stock soared 15 percent in October on the back of several positive developments and improved performance. Merck’s to in Q3, higher than market expectations of around US$ 14.1 billion. The Q3 sales represent an increase of 14 percent over the same period last year.
Merck’s experimental drug for pulmonary arterial hypertension – – in patients with a progressive blood vessel disorder in a late-stage clinical trial. The company had acquired the drug through its buyout of last year. Moreover, the European Commission indication for Merck’s 15-valent pneumococcal vaccine — Vaxneuvance — to include pneumonia and acute otitis media for children aged six weeks to less than 18 years.
Merck jointly develop and sell a personalized mRNA vaccine along with . Moreover, its blockbuster is being tested in combination with Moderna’s experimental vaccine — mRNA-4157 — in a mid-stage trial to treat patients with high-risk melanoma. In a phase 3 trial, Merck’s showed and a significantly better safety profile against Roche’s standard-of-care treatment in kidney transplant recipients.
’s stock rose 11 percent in October. Overall, its 2 percent to US$ 6.94 billion. Mounjaro (), Lilly’s new diabetes medicine, generated in sales. The US Food and Drug Administration (FDA) has granted a to Mounjaro to treat obesity. Despite bullish Mounjaro sales and growth in Q3, Lilly slashed its
’s stock was up 7 percent in to its upbeat Q3 results and an accelerated to its multiple myeloma drug — Tecvayli. third quarter by 1.9 percent year-on-year to US$ 23.79 billion. Growth was driven by sales of cancer drug and Crohn’s disease drug .
Pfizer posts 6% drop in sales over Q3 2021; AbbVie’s Humira misses sales forecasts
stock was up 7 percent in October. , adjusted Pfizer earnings soared 40 percent to US$ 1.78 per share. However, its revenue fell by six percent year-on-year to US$ 22.64 billion against unusually strong sales in Q3 of 2021.
Data from the of its bivalent respiratory syncytial virus (RSV) perfusion vaccine candidate — RSVpreF — has been encouraging, when administered to pregnant women to protect their infants from RSV disease after birth. In the late-stage study, the vaccine was 81.8 percent protective against severe RSV disease through theinfants’ lives and 69.4 percent effective through the first six months of life. If approved, this vaccine could be the first maternal vaccine available to help prevent this potentially life-threatening respiratory illness in babies.
In a breast cancer drug and androgen receptor inhibitor combo significantly reduced tumor progression or death in patients with metastatic castration-resistant prostate cancer (mCRPC). Pfizer also raised its guidance for the year, 2022 sales forecast for its Covid vaccine — Comirnaty — to from US$ 32 billion. The New York-based pharma plans to and US$ 130 for its Covid shot from next year.
The third quarter was a mixed bag for . Though its shares gained 6 percent in October and its Q3 roughly 3 percent to US$ 14.81 billion, the majority of the revenue was from its immunology portfolio. sales grew by 2.5 percent to US$ 5.56 billion, missing expectations of US$ 5.59 billion. AbbVie’s drug Rinvoq () its as a treatment for adults with active non-radiographic axial spondyloarthritis (nr-axSpA). And Botox’s cosmetic nearly 17 percent to US$ 637 million, though it missed the US$ 641 million forecast.
GSK’s stock surges 10%, Moderna gains on vaccine approval
stock gained 10 percent on positive developments. An FDA expert panel GSK’s investigational drug — — to treat anemia in some patients with chronic kidney disease (CKD). If approved, this will be GSK’s first drug approval since the spin-off of its consumer health division.
GSK said vaccination with Shingrix conferred “at least” against shingles in adults 50 years and older. The company’s its respiratory syncytial virus (RSV) vaccine are being The European Medicines Agency (EMA) has also for its long-acting injectable HIV prevention drug . And, the FDA a single vial, ready-to-use version of GSK’s meningococcal disease vaccine — Menveo — in people between 10 to 55 years.
posted strong on the back of continued demand for its HIV portfolio, further growth in its flagship therapy and an increase in its oncology revenues. The company’s stock gained 25 percent in October. Its cancer drug has received an for use in heavily pretreated HR-positive, HER2-negative breast cancer.
stock increased 26 percent due to Omicron booster shot by the FDA for use in children at least six years of age. Earlier, the shot had been authorized for use in adults 18 years and older. Moderna’s Spikevax bivalent original/Omicron BA.4-5 shot recommendation as a booster dose for Covid-19 in individuals 12 years of age and older. It also received a of Spikevax in Europe for immunization from Covid-19 in children between six months to five years.
stock rose 23 percent as its drug Brukinsa () received for the treatment of rare blood cancers in six Central and South American countries. The drug a positive recommendation from the EMA for the treatment of adult patients with chronic lymphocytic leukemia (CLL). Brukinsa achieved superior progression-free survival (PFS) when compared with Imbruvica (ibrutinib) in a final analysis of a sNDA for Brukinsa for the treatment of adult patients with CLL or small lymphocytic lymphoma (SLL) is currently being reviewed by the FDA.
stock rose 10 percent, as its blockbuster eye drug (developed along with ) extended by six more months, providing it protection from competition till the first half of 2024. Bayer’s subsidiary has signed a potential oncology deal with to discover and four novel oncology targets. Bayer’s , a contraceptive, has been Europe to provide up to eight years of pregnancy protection, the longest for any device of this kind.
Positive trial data pushes Vaxcyte stock up 84 percent; Vertex posts strong earnings
released its and the numbers were strong enough to give the stock a boost. Vertex reported revenue of US$ 2.33 billion, up 18 percent year-on-year. Vertex’s revenue growth in Q3 was driven by its cystic fibrosis medicine , which reported sales of US$ 2.01 billion in Q3, up from US$ 1.56 billion in the same period a year ago. The company’s stock grew by 5 percent in October.
Among the small companies, saw an 84 percent rise in its stock as it from its 24-valent vaccine. After approval of 20-valent vaccine — — the Vaxcyte's shot — VAX-24 — was just as safe. It induced greater immune responses in 16 of the 20 valents it shares with Pfizer’s vaccine.
saw a 71 percent rise in its stock as it reported from a phase 1 trial for its IL-17 candidate, DC-806, for psoriasis. plans to advance DC-806 into a dose-ranging phase 2b clinical trial in patients with moderate-to-severe psoriasis.
saw a 70 percent rise in its stock after it discussed with the FDA the potential to pursue an in the US for INBRX-101 in patients with a lung disease known as emphysema caused due to alpha-1 antitrypsin deficiency (AATD).
Low demand for Covid meds drags Roche’s revenue; generics eat into BMS’ topline
Q3 sales due to a slump in Covid treatments and diagnostic testing. These factors outweighed gains from its hemophilia treatment and multiple sclerosis drug . Its to US$ 14.84 billion from expected US$ 15.54 billion. Covid-19 diagnostic from CHF 1 billion (US$ 1.01 billion) this time last year to CHF 600 million (US$ 610.69 million).
(BMS) posted of US$ 11.2 billion, a decrease of 3 percent. BMS said its Q3 sales fell from last year as generic competition of its blockbuster cancer drug in the US, as well as the effect of the weak euro and pound.
For , a strong dollar was a drag on the value of sales generated outside the United States. Its to US$ 12.54 billion and were below market expectations (of US$ 12.88 billion). Overall, the innovative medicines business grew 4 percent in constant currency to US$ 10.3 billion, with sales up 4 percent to. Meanwhile, Novartis’ stock rose by 5 percent in October.
Among the small companies, stocks after its chronic kidney disease (CKD) drug candidate — — failed a phase 3 trial in metabolic acidosis and CKD. The drug failed to delay the occurrence of renal death, end-stage renal disease, and other factors. Similarly, shares are down by 81 percent as its REL-1017 failed a major depressive disorder trial.
Incyte buys Villaris, Myovant accepts revised buyout deal from Sumitovant
Like September, October also wasn’t a month for big M&As. Amongst the important deals, Delaware-based biotech agreed to buy for . will give Incyte exclusive global rights to Villaris’ lead candidate — auremolimab — being investigated for vitiligo.
South Korean drugmaker is acquiring for in cash, helping in the US anti-cancer drug market. LG Chem will gain access to Aveo’s kidney cancer drug , which has received an FDA approval for third-line treatment of relapsed or refractory advanced renal cell carcinoma.
Swiss medical technology company has with for an acquisition potentially valued at US$ 1.14 billion. And Eli Lilly genetic medicine developer for about in cash to discover and develop treatments for hearing loss.
Amongst alliances, signed a potential biobucks with to develop bispecific antibodies. Lilly US$ 496 million biobucks deal with to discover new targeted therapies that activate a specific isoform of AMP-activated protein kinase (AMPK) for metabolic diseases. And signed with to co-fund the development of MK-8189, which is being evaluated in a phase 2b trial to treat schizophrenia.
The stock market in 2022 has been one of the most volatile markets on record. Given the inflation, job cuts, the ongoing Russia-Ukraine war and the looming recession, volatility is here to stay.
What’s encouraging is the better-than-expected quarterly results posted by many drugmakers. While stock market gains and losses are notional, revenues and earnings are for real. And it's these quarterly gains that should eventually bring big wins for the biopharma sector in the long run.
Pharma & Biotech Newsmakers in October 2022
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