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STOCK RECAP #PipelineProspector

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Pipeline Prospector April-May 2026 highlights: Sun Pharma buys Organon for about US$ 11.8 bn; Lilly on acquisition overdrive
April and May were tough months, with oil prices rising globally due to the war in the Middle East. Yet, the world of pharmaceuticals continued to witness large M&A deals and collaborations.A highlight was the slew of deals signed with artificial intelligence firms — Bristol Myers Squibb (BMS) signed a strategic agreement with Anthropic to deploy Claude Enterprise across its entire global operations; Eli Lilly signed a DNA editing deal worth up to US$ 2.25 billion with AI-driven firm Profluent Bio; and Merck partnered with Google Cloud to enhance its digital backbone as an AI-enabled enterprise.The indices continued to inch upwards. The Nasdaq Biotechnology Index (NBI) increased from 5,819.43 at the end of April to 5,989.81 at the end of May. The SPDR S&P Biotech ETF increased from 130.62 to 136.69. The S&P Biotechnology Select Industry Index (SPSIBI) increased from 10,262.80 to 10,689.60. Meanwhile, the S&P 500 increased from 7,234.54 to 7,580.06. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)Lilly on acquisition overdrive: buys Kelonia for up to US$ 7 bn, three vaccine makers for US$ 3.8 bn Buoyed by the success of its obesity drugs Zepbound (tirzepatide) and Foundayo (orforglipron), Eli Lilly has been on a shopping spree. So far, Lilly has made 10 acquisitions in 2026.In April, Lilly acquired clinical-stage biotech, Kelonia Therapeutics, for up to US$ 7 billion, and Ajax Therapeutics for up ‌to US$ 2.3 billion in cash. Privately-held Kelonia is pioneering cancer treatments such as in vivo gene delivery. Ajax’s lead asset, AJ1-11095, is an investigational drug currently in early-stage clinical trials for the treatment of rare blood cancers.In May, Lilly announced an additional US$ 4.5 billion investment across two of its manufacturing sites in Lebanon, Indiana, bringing its total commitments in this American state to more than US$ 21 billion since 2020. Last week, Lilly announced agreements to acquire three vaccine companies — Curevo Inc, LimmaTech Biologics, and Vaccine Company —  in deals worth up to US$ 3.8 billion. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)FDA approves Astra’s new hypertension treatment; okays AbbVie’s rare blood cancer drugIn May, the US Food and Drug Administration (FDA) approved AstraZeneca’s Baxfendy (baxdrostat), a first-in-class treatment for hypertension to be used in combination with other antihypertensive medications.Additionally, FDA granted two new approvals to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for treating early-stage HER2-positive breast cancer. The drug has now been approved for use before surgery (to shrink tumors) and after surgery (to reduce the risk of recurrence). Enhertu is already approved for treating advanced breast cancer.The agency approved Arvinas and Pfizer’s Veppanu (vepdegestrant) for the treatment of an advanced type of breast cancer known as estrogen receptor-positive/human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer. The agency also approved AbbVie’s Decnupaz (pivekimab sunirine-pvzy) for the treatment of adult patients with blastic plasmacytoid dendritic cell neoplasm, an aggressive and ultra-rare blood cancer.In April, FDA granted accelerated approval to Regeneron Pharmaceuticals’ Otarmeni (lunsotogene parvec-cwha) for the treatment of a rare genetic form of hearing loss caused by a faulty gene. The agency also approved Merck’s Idyvnso, a new, two-drug single-tablet regimen of doravirine and islatravir, for treating HIV-1 infections in adults. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)Sun Pharma acquires Organon for ~US$ 11.8 bn; Gilead buys Tubulis for up to US$ 5 bnApril and May saw several big and mid-size M&A deals. Sun Pharmaceutical Industries made the largest overseas acquisition by an Indian drugmaker in April, as it acquired New Jersey-based Organon in an all-cash deal valued at about US$ 11.75 billion, including debt.Gilead announced the acquisition of Germany-based clinical-stage biotech Tubulis GmbH in early April for up to US$ 5 billion to strengthen its cancer drugs pipeline. With this acquisition, Gilead will gain access to Tubulis’ next-generation antibody-drug conjugates (ADCs).In the first week of May, Rome-based Angelini Pharma announced the acquisition of American rare-disease drug maker Catalyst Pharmaceuticals for €3.5 billion (US$ 4.1 billion). Additionally, Neurocrine Biosciences acquired Soleno Therapeutics for US$ 2.9 billion in cash. The deal gives Neurocrine access to Vykat XR (diazoxide choline), the first drug approved in the US to treat a rare genetic disorder known as hyperphagia. And Italy’s Chiesi Group announced the acquisition of US-listed KalVista Pharmaceuticals in an all-cash deal valued at about US$ 1.9 billion. The acquisition will strengthen Chiesi’s rare diseases strategy. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)China’s Hengrui in up to US$ 15.2 bn deal with BMS, Innovent in oncology tie-up with PfizerLast month, China’s Jiangsu Hengrui Medicine struck global ‌collaboration and licensing deals with BMS that include an upfront payment of US$ 600 million and potential milestone payments of up to US$ 15.2 billion. The deal covers ‌four cancer and blood-disease drug candidates from Hengrui, four immunology candidates from BMS and five additional projects the companies will work on together.Last week, Innovent Biologics and Pfizer entered into a strategic global licensing and collaboration agreement worth up to US$ 10.5 billion to develop 12 early-stage cancer medicines.In April, Australia’s Telix Pharmaceuticals entered into a collaboration with Regeneron Pharmaceuticals to jointly develop and commercialize next-generation radiopharmaceutical therapies. Telix will receive US$ 40 million upfront and earn up to US$ 2.1 billion in milestone payments and royalties. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)Celcuity’s therapy beats Novartis’ Piqray in breast cancer trial; Moderna’s mRNA flu scores late-stage win US biotech Celcuity announced positive results from a large phase 3 trial testing its experimental drug gedatolisib in patients with a HR-positive, HER2-negative breast cancer who carry a mutation in the PIK3CA gene and whose cancer had worsened despite earlier treatment.Moderna’s mRNA flu vaccine (mRNA-1010) outperformed the standard flu shot in a phase 3 trial, with the mRNA shot performing about 27 percent better.Merck’s experimental drug sacituzumab tirumotecan, developed in collaboration with China’s Kelun-Biotech, showed positive results in a late-stage trial in certain patients with advanced or recurrent endometrial cancer, a type of uterine cancer.In April, there was also news that Novo Nordisk’s experimental oral drug etavopivat successfully met two co-primary endpoints in a late-stage trial on adults and adolescents with sickle cell disease, a debilitating, life-threatening disease. And AstraZeneca’s ‌experimental treatment tozorakimab showed benefit in reducing moderate-to-severe exacerbations of chronic obstructive pulmonary disease (COPD) in a late-stage trial. Access the Pipeline Prospector Dashboard for May 2026 Newsmakers (Free Excel)Our viewDespite macroeconomic and geopolitical headwinds, pharmaceutical companies have continued to expand through acquisitions, deals, and collaborations. AI is bringing about a structural shift and becoming central to competitive strategy. Overall, the sector is not only weathering global uncertainty, but actively reshaping itself for the next phase of growth.

Impressions: 597

https://www.pharmacompass.com/pipeline-prospector-blog/pipeline-prospector-april-may-2026-highlights-sun-pharma-buys-organon-for-about-us-11-8-bn-lilly-on-acquisition-overdrive

#PharmaFlow by PHARMACOMPASS
04 Jun 2026

WEEKLY NEWS RECAP #Phispers

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FDA issues warning letter to Intas’ plant in north India; okays Axsome’s drug for Alzheimer’s-related agitation
In Phispers this week, India’s Intas Pharmaceuticals received a warning letter from the US Food and Drug Administration (FDA) over serious violations of current good manufacturing practice (CGMP) at its plant in Dehradun in north India.The regulator expanded the approval of Axsome Therapeutics’ Auvelity (dextromethorphan HBr and bupropion HCl) to treat agitation associated with dementia in patients with Alzheimer’s disease. FDA also approved Arvinas and Pfizer’s Veppanu (vepdegestrant) to treat an advanced type of breast cancer.Over recent months, Eli Lilly has announced several acquisitions. This week, it announced an additional US$ 4.5 billion investment across two manufacturing sites in Lebanon, Indiana, bringing its investment in the state since 2020 to US$ 21 billion. Novartis announced its plans to add its seventh facility —  an active pharmaceutical ingredient (API) plant in Morrisville, North Carolina — in the US under its US$ 23 billion investment commitment.In deals, Belgian biopharma UCB announced the acquisition of privately-held Candid Therapeutics in a deal worth up to US$ 2.2 billion. Madrigal Pharmaceuticals struck a license agreement worth up to US$ 1 billion with Arrowhead Pharmaceuticals for its RNA interference (RNAi) therapy to treat metabolic dysfunction-associated steatohepatitis (MASH), a severe form of fatty liver disease.American biotech Celcuity announced positive results from a large phase 3 trial testing its experimental drug gedatolisib in patients with a specific type of advanced breast cancer. And Moderna’s mRNA flu vaccine (mRNA-1010) outperformed the standard flu shot in a phase 3 trial.Intas’ Dehradun plant in India receives FDA’s warning letter over GMP violationsIndia’s Intas Pharmaceuticals has received a warning letter from the FDA over serious manufacturing violations at its facility in Dehradun (India), following an inspection in September 2025. The warning letter highlights significant CGMP violations.The letter said Intas’ investigations into out-of-specification (OOS) assay results were inadequate. Moreover, their corrective and preventive actions (CAPAs) to address the problem were not robust. In addition, a quality assurance employee had instructed a software vendor to make undisclosed changes to electronic batch records — alterations that were not captured in the audit trail or managed through the quality system.The Dehradun plant had received an FDA Form 483 last year. The company had provided a response which the FDA found to be “inadequate”. This is not Intas’ first brush with the FDA. In November 2023, its Gujarat plant had been put on import alert due to data manipulation.FDA approves Axsome’s drug to treat Alzheimer’s-related agitationFDA has expanded the use of Axsome Therapeutics’ approved drug Auvelity (dextromethorphan HBr and bupropion HCl) for the treatment of agitation associated with dementia in patients with Alzheimer’s disease.The drug is the first FDA-approved treatment for this condition that is not an antipsychotic. FDA initially approved Auvelity in 2022 to treat major depressive disorder in adults. Axsome Therapeutics has projected peak sales for Auvelity to reach US$ 8 billion.Approves Arvinas’ drug for advanced breast cancer: FDA has approved Arvinas and Pfizer’s Veppanu (vepdegestrant) to treat an advanced type of breast cancer known as estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer. This is the first time the FDA has approved a new kind of protein degrading therapy, known as PROTAC.Lilly commits additional US$ 4.5 bn across two sites in IndianaEli Lilly has announced an additional US$ 4.5 billion investment across two of its manufacturing sites in Lebanon, Indiana, bringing its total capital expansion commitments in this American state to more than US$ 21 billion since 2020. Lilly’s total capital expansion commitments in the US since 2020 have now exceeded US$ 50 billion.The investment aims to support production of Lilly’s recently approved once-daily oral weight-loss pill Foundayo (orforglipron) and retatrutide, its next-generation obesity candidate in late-stage development.Novartis adds seventh facility in US: Swiss drug major Novartis has announced its plans to add its seventh facility in the US under its US$ 23 billion investment commitment  — a 56,200-square-foot API plant in Morrisville, North Carolina. The facility will produce ingredients for solid dosage tablets, capsules, and RNA therapeutics, and will be Novartis’ fifth site in the state.UCB buys Candid for up to US$ 2.2 bn for its autoimmune disease therapiesBelgian biopharma UCB has ‌agreed to buy privately-held Candid Therapeutics in a deal worth up to US$ 2.2 billion. UCB will pay US$ 2 billion in upfront payments and up ‌to US$ 200 million in potential future milestone payments for Candid Therapeutics, which is headquartered in California and is working on treatments for autoimmune diseases. Candid is focused on developing treatments for autoimmune and inflammatory diseases through the use of novel T-cell engagers (TCEs).Madrigal in MASH deal with Arrowhead: Madrigal Pharmaceuticals has struck an exclusive worldwide license agreement with Arrowhead Pharmaceuticals for its RNAi therapy to treat MASH. Madrigal will pay US$ 25 million upfront, with up to US$ 975 million in milestone payments.GSK in obesity deal with China’s SiranBio: GSK has licensed a siRNA therapy (outside Greater China) from China’s SiranBio which is currently in a phase 1 trial. GSK is paying the Chinese firm US$ 55 million upfront and is liable to pay up to US$ 1 billion in milestone payments. The drug can reduce visceral abdominal fat while preserving lean muscle mass.Celcuity’s therapy beats Novartis’ Piqray in phase 3 breast cancer trialCelcuity, a US biotech focused on cancer treatments, has announced positive results from a large phase 3 trial testing its experimental drug gedatolisib in patients with a specific type of advanced breast cancer. The trial enrolled patients with HR-positive, HER2-negative breast cancer who carry a mutation in the PIK3CA gene and whose cancer had worsened despite earlier treatment. The trial found that both a three-drug combination (gedatolisib + AstraZeneca’s Faslodex + Pfizer’s Ibrance) and a two-drug combination (gedatolisib + Faslodex) significantly delayed cancer progression compared to Novartis’ Piqray (alpelisib) plus Faslodex — the regimen against which gedatolisib was tested.Moderna’s mRNA flu vaccine outperforms standard shot: Moderna’s mRNA flu vaccine (mRNA-1010) outperformed the standard flu shot in a phase 3 trial, with the mRNA shot performing about 27 percent better. The trial enrolled over 40,000 adults aged 50 and above across 11 countries.

Impressions: 2086

https://www.pharmacompass.com/radio-compass-phisper/fda-issues-warning-letter-to-intas-plant-in-north-india-okays-axsome-s-drug-for-alzheimer-s-related-agitation

#Phispers by PHARMACOMPASS
07 May 2026

NEWS #PharmaBuzz

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https://ir.celcuity.com/news-releases/news-release-details/celcuitys-gedatolisib-combination-regimens-doubled-likelihood

PRESS RELEASE
03 Jun 2026

https://www.globenewswire.com/news-release/2026/06/02/3305149/0/en/celcuity-s-gedatolisib-combination-regimens-doubled-the-likelihood-of-survival-without-disease-progression-or-death-compared-to-alpelisib-plus-fulvestrant-in-the-pik3ca-mutant-coho.html

GLOBENEWSWIRE
02 Jun 2026

https://www.globenewswire.com/news-release/2026/06/01/3304375/0/en/celcuity-to-hold-conference-call-to-discuss-results-for-the-pik3ca-mutant-cohort-of-the-phase-3-viktoria-1-clinical-trial-of-gedatolisib-regimens-in-hr-her-advanced-breast-cancer-o.html

GLOBENEWSWIRE
01 Jun 2026

https://www.globenewswire.com/news-release/2026/05/14/3294803/0/en/celcuity-s-phase-3-viktoria-2-trial-of-gedatolisib-as-a-first-line-treatment-for-hr-her2-advanced-breast-cancer-expanding-to-include-endocrine-sensitive-patients.html

GLOBENEWSWIRE
14 May 2026

https://www.fiercebiotech.com/biotech/celcuitys-gedatolisib-beats-novartis-piqray-phase-3-breast-cancer-study

FIERCE BIOTECH
05 May 2026

https://www.globenewswire.com/news-release/2026/05/01/3286249/0/en/celcuity-s-phase-3-viktoria-1-trial-achieves-primary-endpoint-with-clinically-meaningful-improvement-in-progression-free-survival-in-pik3ca-mutant-cohort.html

GLOBENEWSWIRE
01 May 2026