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A week of bolt-on deals |
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💰A triumvirate of large pharma companies pulled off acquisitions this week, apparently treating the end of the first quarter as a self-imposed deadline. The biggest comes from Merck, which scooped up Terns Pharmaceuticals off the public market for $6.7 billion — $53 per share, a 31% premium to Terns’ 60-day average stock price.
The centerpiece of the Terns deal is a drug designed to treat chronic myeloid leukemia, a slow-progressing blood cancer. Last December, Terns outlined data for the drug that justified its pivot away from obesity. Merck was evidently impressed: TERN-701 will likely compete with Novartis’ Scemblix, a newly minted blockbuster, should it win approval. Terns had planned to kick off a pivotal study later this year or in early 2027.
Novartis also got in on the action, buying out immunology biotech Excellergy for up to $2 billion. It’s a quick exit for a company that only debuted with a $70 million Series A in October. The focus on this deal is
Excellergy’s “effector cell response inhibitors,” designed to interfere with overactive immune responses related to immunoglobulin E, or IgE. Excellergy has said its lead drug could have use in food allergy, chronic hives and asthma.
Gilead rounds out this week’s deal flurry with a deal for Ouro Medicines, which is developing T cell engagers for immunologic diseases. Gilead will pay about $1.68 billion upfront, while roping in longtime partner Galapagos to conduct early work on the lead drug. That program, called gamgertamig, is a bispecific targeting BCMA and CD3. |
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Wave crashes on obesity data |
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🌊Trying to beat GLP-1s in obesity is a tough road. Wave Life Sciences underlined that reality this week when its obesity candidate yielded weight loss of just 1% more than placebo in an early-stage study. Patients received a single 240 mg dose of WVE-007, a small interfering RNA drug. The FDA’s approvability bar for obesity meds has been set by the FDA at 5%. Wave’s stock price fell nearly 50% in response.
The biotech has argued that its drug prioritizes fat loss and retains lean mass. That thesis remained relatively intact after the readout. There was a placebo-adjusted reduction in visceral fat of 14%, which just grazed significance at a p-value below 0.05. At the same dose level, total fat was reduced by 5%, lean mass increased 2% and patients’ average waist circumference fell by 3%, all on a placebo-adjusted basis.
Executives still see a path forward. The second part of the study, functioning as a Phase 2, will start by mid-year. Data could come this year or next. The company is also planning to study WVE-007 as an add-on to a GLP-1 drug, and in the post-GLP-1 maintenance setting, this year. |
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Sanofi partners with TCE startup |
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🤝Sanofi is back in on T cell engagers. After a couple years of fluctuating interest in the space, the French pharma giant is teaming up with a California startup in a licensing deal worth $180 million in upfront and near-term payments.
The pact focuses on KT501, a trispecific TCE that goes after the well-known targets of CD19, BCMA and CD3. Kali CEO Weihao Xu told Endpoints that the deal was inked in December, but the partners waited until KT501 was in the clinic to announce it. Kali said last week that it began dosing the first cohort of adults with rheumatoid arthritis.
The partnership suggests Sanofi is recommitting to TCEs. The company had made a $1 billion bet on TCEs with the purchase of Amunix in 2021, only to then divest those assets to Vir Biotechnology in 2024. Sanofi has dropped other TCEs along the way, including an anti-GPC3 nanobody-based candidate.
The Sanofi-partnered asset isn’t all Kali has in the works — it’s just one of multiple medicines the startup hopes to bring into the clinic, including two more that are expected to enter human testing this year. Read more here from Kyle. |
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Rare disease approvals buck trend |
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✅The FDA approved two rare disease treatments this week, bucking a recent trend of rejections in the space. First came a greenlight for Denali Therapeutics’ Avlayah in Hunter syndrome. The drug became the first to win accelerated approval using heparan sulfate as a surrogate biomarker, a path that eluded two rivals pursuing the same strategy: Ultragenyx and Regenxbio. Both are developing gene therapies for rare diseases under the same
genetic umbrella.
Then, the FDA’s biologics division approved a gene therapy from Rocket Pharmaceuticals for an ultra-rare immune disease. It’ll be sold as Kresladi and is approved to treat leukocyte adhesion deficiency-I (LAD-I), where patients face serious and potentially deadly bacterial and fungal infections. The nod comes after the FDA rejected the therapy in 2024, leading to layoffs and pipeline cuts at Rocket. |
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FDA warning letters |
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✉️In a warning letter released this week, the FDA raised concerns with California-based ImmunityBio for a TV advertisement and podcast that it said gave the “misleading impression” that Anktiva, the company’s treatment for a type of bladder cancer, can cure or prevent all cancers. The ad and podcast featured billionaire entrepreneur and ImmunityBio founder Patrick Soon-Shiong.
In a separate warning letter for a Daman, India-based drug manufacturing facility, the agency made the rare move of posting photographs of dilapidated buildings. The photographs are the latest sign that FDA Commissioner Marty Makary is taking a tougher stance on foreign drug manufacturers. |
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