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By PharmaCompass
2025-11-06
Impressions: 207
October was abuzz with dealmaking. Pharma majors such as Novartis, Novo Nordisk, and Bristol Myers Squibb (BMS) led the acquisition wave, targeting innovative platforms in rare muscle disorders, metabolic diseases, and next-generation cell therapy for autoimmune diseases.
The US Food and Drug Administration (FDA) approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women. The agency also expanded the indication for Teva Pharmaceuticals and Medincell’s schizophrenia drug received Uzedy (risperidone), allowing it to be used for the maintenance treatment of bipolar I disorder in adults.
In clinical trials, companies such as Eli Lilly and AstraZeneca reported positive data, while Moderna and Alector announced late-stage trial setbacks.
The pharma indices continued to march upwards. The Nasdaq Biotechnology Index (NBI) rose nine percent, climbing from 4,916.11 at the end of September to 5,366.46 in October, while the SPDR S&P Biotech ETF (XBI) gained 13 percent from 100.11 to 112.71. The S&P Biotechnology Select Industry Index (SPSIBI) also advanced 13 percent from 7,805.59 to 8,789.9.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
Novartis to acquire Avidity for US$ 12 bn; Novo in up to US$ 5.2 bn deal to buy Akero
Novo Nordisk announced it will acquire Akero Therapeutics, a San Francisco-based clinical-stage biotech, in a deal valued at up to US$ 5.2 billion. The agreement includes an upfront payment of US$ 4.7 billion, with additional milestone payments contingent on FDA approval of Akero’s lead candidate, efruxifermin, by mid-2031. Efruxifermin is being developed as a treatment for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease.
Bristol Myers Squibb announced the acquisition of privately-held biotech Orbital Therapeutics in a US$ 1.5 billion all-cash deal. Orbital is developing new generation, RNA-based medicines.
France’s Ipsen announced the acquisition of ImCheck Therapeutics for up to €1 billion (approximately US$ 1.16 billion) to enhance its oncology pipeline.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
FDA approves Bayer’s non-hormonal drug to treat hot flashes in menopausal women; okays Teva’s Uzedy for bipolar I disorder
October brought good news for menopausal women dealing with hot flashes. FDA approved Bayer’s Lynkuet (elinzanetant) — the first-of-its-kind oral non-hormonal drug to treat moderate to severe hot flashes in menopausal women.
Teva Pharmaceuticals and Medincell received FDA’s approval for expanding the indication of Uzedy (risperidone). An injection of Uzedy can be administered once a month as a maintenance treatment of bipolar I disorder in adults. Uzedy was approved in 2023 for schizophrenia.
FDA also expanded the approval of Novo Nordisk’s Rybelsus (semaglutide) for use in adults with type 2 diabetes to reduce the risk of major adverse cardiovascular events. Rybelsus, the first and only FDA-approved GLP-1 drug, was first approved in 2019.
Meanwhile, Glaukos’ Epioxa (riboflavin 5'-phosphate) was cleared by the FDA for treating keratoconus, a rare, progressive eye disorder that thins and bulges the cornea. The non-surgical therapy offers an incision-free option for patients at risk of vision loss.
FDA also approved Regeneron’s immunotherapy Libtayo (cemiplimab) to help prevent relapse in adults with high-risk cutaneous squamous cell carcinoma after surgery and radiation.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
Innovent, Takeda sign up to US$ 11.4 bn oncology deal; J&J to spin off its orthopedics business
Innovent Biologics has signed a deal worth up to US$ 11.4 billion with Takeda Pharmaceutical to co-develop two next-generation cancer therapies. The collaboration covers an antibody-drug conjugate (ADC) and a fusion protein, targeting a range of solid tumors, including lung, colorectal, gastric, and pancreatic cancers. Takeda will hold commercialization rights for both therapies outside the US and Greater China, while the companies will jointly develop and commercialize one of the drugs, IBI363, in the US.
Novo Nordisk has signed a deal worth up to US$ 2.1 billion with Omeros Corporation for rights to develop and commercialize zaltenibart (OMS906), Omeros’ experimental drug for rare blood and kidney disorders. The deal strengthens Novo Nordisk’s rare disease portfolio.
Massachusetts-based Zenas BioPharma entered into a licensing agreement worth over US$ 2 billion with China’s InnoCare Pharma for orelabrutinib, an oral treatment for multiple sclerosis (a chronic disease in which the immune system attacks the brain and spinal cord). And Johnson & Johnson announced it will spin off its orthopedics business, DePuy Synthes, into a separate company within 18 to 24 months.
Besides these deals, the month saw several capacity expansions. Merck broke ground on a US$ 3 billion plant at its Elkton, Virginia campus, as part of a wider US$ 70 billion commitment to expand manufacturing, R&D, and capital projects in the US. Similarly, AstraZeneca announced a US$ 4.5 billion investment to build a state-of-the-art manufacturing facility in Virginia, as part of its US$ 50 billion investment plan for the US.
Eli Lilly said it plans to invest over US$ 1 billion in India over the next few years to boost drug manufacturing and supply through partnerships with local producers. Lilly will also invest over US$ 1.2 billion to expand its manufacturing site in Puerto Rico.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
Lilly’s orforglipron scores trial wins in diabetes; Astra-Daiichi breast cancer med shows promise
In a phase 3 trial, AstraZeneca’s experimental drug baxdrostat significantly lowered blood pressure in patients with treatment-resistant hypertension. AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan), an antibody-drug conjugate, significantly improved survival in patients with metastatic triple-negative breast cancer compared to chemotherapy in a phase 3 clinical trial.
In trial failures, Moderna said it will stop developing its experimental vaccine, mRNA-1647, designed to prevent cytomegalovirus (CMV), a virus that can cause birth defects, after it failed to meet the main goal in a phase 3 trial. Similarly, Alector stopped developing its GSK-partnered experimental dementia drug, latozinemab, after it failed to help patients in a major phase 3 trial.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
Our view
With drugs like Bayer’s Lynkuet bagging approval, we see both innovation and competition steering the pharma industry into 2026. Novo Nordisk’s US$ 8.5 billion bid to acquire US-based obesity biotech Metsera, surpassing Pfizer’s US$ 7.3 billion offer, underscores where much of the excitement lies — the rapidly expanding US$150 billion weight loss drugs market. The pharmaceutical industry seems to be on a high-speed treadmill, with no scope for sluggishness.
Access the Pipeline Prospector Dashboard for October 2025 Newsmakers (Free Excel)
Pharma & Biotech Newsmakers in October 2025
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Image Credit : Novo, Novartis Dip, Despite Buyouts by PharmaCompass license under CC BY 2.0
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