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  • Servier acquires Day One for $2.5B & uniQure's fight with the FDA heats up

Servier acquires Day One for $2.5B & uniQure's fight with the FDA heats up

AuthorAuthor

Joachim Eeckhout & Eduardo Longoria
March 09, 2026

Good morning! The new pitch in obesity is not just weight loss, but weight loss that patients can tolerate. Zealand Pharma has understood that and says its Roche-partnered amylin analog petrelintide delivered up to 10.7% mean weight loss at 42 weeks in a phase 2 trial, while posting what the company called “placebo-like tolerability.”

Why it matters: Tolerability has become one of the biggest commercial fault lines in obesity, especially for patients who struggle with GLP-1 side effects. Typical side effects like nausea or vomiting are often a reason for patients to quit the treatment, so a pill without those effects could conquer a non-negligible part of the market, even if its weight loss benefits are lower.

Yes, but: Despite the great tolerability, analysts called the weight-loss profile underwhelming. Unfortunately for Zealand, the stock market agreed as its share price fell by over 30% after the news was published.

Bottom line: Less vomiting, but not enough to stop investors from getting sick to their stomachs.

— Joachim E.

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SNAPSHOT

Servier expands rare cancer push with $2.5B acquisition of Day One

Leaves against a setting sun

Servier agreed to acquire Day One Biopharmaceuticals for about $2.5B, gaining control of Ojemda (tovorafenib), an FDA-approved therapy for relapsed or refractory pediatric low-grade glioma (pLGG) and a pipeline of targeted cancer treatments.

Why it matters: The deal strengthens Servier’s strategy to lead in rare and mutation-driven cancers, particularly brain tumors. By adding Ojemda to its portfolio, Servier expands treatment options for pediatric patients and deepens its presence in the growing market for targeted oncology therapies.

Backstory: Day One focuses on targeted therapies for pediatric cancers and rare diseases. One of these targeted therapies is Ojemda, a type 2 RAF inhibitor targeting BRAF-altered tumors. Ojemda was approved by the FDA in April 2024 for children 6 months and older with relapsed or refractory pLGG. This complements one of Servier’s acquired drugs from Agios Pharmaceuticals, Voranigo, a glioma therapy for patients aged 12 and above with IDH1 or IDH2 mutations.

Big picture: Servier is positioning itself as a global leader in rare oncology, an area often overlooked by larger pharmaceutical companies due to smaller patient populations. Its cancer business grew 55% in fiscal 2024–2025, now accounting for 32% of company revenue, up from 24% the previous year. The company’s nonprofit governance structure allows it to pursue therapies that may be scientifically promising but commercially challenging.

Zoom in: The purchasing deal is expected to close in Q2 of 2026 with a price of $21.50 per share, a 68% premium over Day One’s March 5 closing price. The acquisition also gives Servier access to Day One’s clinical pipeline, including additional tovorafenib studies and programs in adenoid cystic carcinoma and other solid tumors.

What’s next: After closing the deal, Servier plans to integrate Day One’s assets and continue developing expanded indications for tovorafenib while leveraging its global oncology infrastructure. Servier aims to reach €10B ($11.5B) in annual revenue by 2030, from €6.9B in 2025.

SNIPPETS

What’s happening in biotech today?

📊 Data duel: A senior FDA official publicly criticized uniQure, accusing the company of presenting “distorted” data to support its Huntington’s disease gene therapy, AMT-130, and defending the agency’s demand for a new randomized, sham-controlled trial. The FDA argues such trials are necessary for heterogeneous diseases with subjective endpoints and potential placebo effects, especially for invasive treatments like AMT-130, which involves brain injections. UniQure claims the FDA previously agreed that external control data could support approval and argues that a sham surgery trial could be unethical. The dispute has intensified broader tensions between the FDA and the rare disease community, with critics accusing agency leadership of slowing approvals for innovative therapies while the FDA insists rigorous evidence is required.

🍄 Psychedelic slip: Helus Pharma’s stock fell 37% after mid-stage Phase 2 results for its psychedelic drug HLP004 in generalized anxiety disorder raised concerns about dosing, as two doses, 20 mg and a control-like 2 mg dose, produced nearly identical improvements in anxiety symptoms. In the 36-patient study, the higher dose improved HAM-A anxiety scores by 10.4 points versus 9.9 points for the lower dose, suggesting little dose-response effect, which analysts say may indicate suboptimal dose selection or limited drug activity. The higher dose also caused more side effects, including visual hallucinations. Helus said the trial was exploratory and plans to discuss next steps with the FDA while continuing development of its psilocybin-based treatments.

🏆 Trial triumph: The FDA has approved Johnson & Johnson’s combination of Tecvayli (teclistamab) and Darzalex Faspro (daratumumab and hyaluronidase) for adults with relapsed or refractory multiple myeloma who have received at least one prior therapy, including a proteasome inhibitor and an immunomodulatory drug. The decision is based on results from the Phase III MajesTEC-3 trial, which showed the regimen significantly improved outcomes compared with standard treatments, reducing the risk of disease progression or death by 83% and achieving higher response rates and better overall survival after three years (83.3% vs. 65%). Safety profiles were broadly similar across groups, with common events including cytopenias, infections, and mostly mild cytokine release syndrome. The approval adds a new treatment option aimed at addressing relapse in multiple myeloma patients.

🚗 CAR license: Liberate Bio has secured exclusive and non-exclusive licences from Carisma Therapeutics and the University of Pennsylvania for patents covering chimeric antigen receptor (CAR) designs optimized for myeloid cells such as monocytes and macrophages. The intellectual property complements the company’s lipid nanoparticle (LNP) delivery platform, which enables selective in vivo programming of these immune cells, supporting development of CAR-M (CAR-Macrophage) therapies. Using its Raptor platform to screen LNPs in non-human primates, Liberate has identified candidates capable of selectively reprogramming myeloid cells, including a lead LNP that achieved over 99% depletion of circulating B cells in primate studies. The company plans to advance its first in vivo CAR-M candidate into IND-enabling studies and pursue initial clinical testing through an investigator-initiated trial in the second half of 2026.

 🔄 CEO switch: Flagship Pioneering–backed biotech Alltrna is conducting its third round of layoffs, cutting 19 employees and reducing its workforce to 36 as it prepares to advance its first engineered tRNA drug candidate toward clinical trials. Alongside the restructuring, CEO Michelle Werner is stepping down and will transition to an advisor and board role, while CFO Joanne Protano will become president and lead the company into its clinical-stage phase. Founded in 2021, Alltrna is developing tRNA-based therapies designed to correct premature stop codon mutations that truncate proteins and cause genetic diseases, with its lead program targeting Arg-TGA mutations in liver-related disorders currently in IND-enabling studies.

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