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6 November, 2025 |
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The White House's announcement of its deal for weight loss drugs with Lilly and Novo will happen any minute, with the president expected to announce significant cuts to the cash price for the products. Our reporter Max Bayer is at the White House and we'll alert as soon as we have more. |
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Drew Armstrong |
Executive Editor, Endpoints News
@ArmstrongDrew
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Maziar Mike Doustdar, Novo Nordisk CEO (Ritzau Scanpix/Sipa USA/Sipa via AP Images) |
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by Drew Armstrong
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Novo Nordisk has once again upped its bid for Metsera, according to sources familiar with the matter, in an effort to beat out a raised Pfizer offer that was delivered late Wednesday. The exact details of the new offers weren't immediately clear. The people who described them spoke on condition of anonymity. Metsera shares MTSR were up about 13% on Thursday as investors bet the bidding war would drive up the final price. The companies either didn't immediately respond to questions or didn't have a comment. Pfizer and Novo have been trading blows in court, in Washington and around the bidding table, as they seek to win what both are treating as a crucial prize in the market for anti-obesity and weight loss treatments. On Monday, Pfizer raised its bid to as much as $8.1 billion. Then, on Tuesday, Novo hiked its proposal to as much as $10 billion
— a total that Pfizer then matched. | |
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by Max Gelman
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Vera Therapeutics built its case for a rare kidney disease drug Thursday morning, revealing a fuller Phase 3 dataset after toplining the results earlier this year. If the company can convince the FDA — Vera plans to file for accelerated approval before 2025 ends — it will secure its first product approval and transition to a
commercial biotech. But Vera is also expected to face a crowded market should its drug, called atacicept, get approved. Executives hope Thursday’s data can help set its candidate apart. One potential competitor is Otsuka's experimental drug, which has an FDA decision date of Nov. 28, in the same setting of IgA nephropathy (IgAN). A readout from Otsuka’s drug in June caused Vera’s stock VERA to fall 30%
at the time, as investors compared the two programs. | |
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by Max Bayer
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Johnson & Johnson’s Caplyta has won FDA approval as a new adjunctive treatment for patients with major depressive disorder, bolstering the acquisition that gave the large pharma control of the drug. The new approval is Caplyta’s first foray into the depression market after its original approval as an antipsychotic for schizophrenia, and for depressive symptoms associated with bipolar I and II. The decision was based on two Phase 3 studies that found that a once-daily oral dose of Caplyta, when tacked onto an antidepressant, spurred a statistically significant improvement in depression symptoms. Caplyta was the foundation of J&J’s $14.6 billion acquisition of Intra-Cellular Therapies earlier this year, which followed Phase 3 readouts in major depressive disorder in 2024. J&J is looking to win a slice of the depression market, specifically the more than half of patients whose first-line treatments don't help enough because of weak efficacy or side effects. | |
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by ENDPOINTS |
Plus, news about Cullinan, 4DMT, Axsome, AstraZeneca, Noema, UroGen Pharma, Halozyme and Benitec: ↩️ Dyne delays myotonic dystrophy plans again: Dyne said it now expects to submit an application for FDA approval of its myotonic dystrophy type 1 drug, called DYNE-101, in the third quarter of 2027. Earlier this year, the
company changed the primary endpoint of its study, delaying its filing to late 2026. — Lei Lei Wu 🤝 Dynavax and Vaxart make a deal: Dynavax said it has an exclusive license to Vaxart’s oral Covid-19 vaccine that is currently in a Phase 2b trial. Vaxart
will receive a $25 million upfront fee; Dynavax will also have a $5 million equity investment in Vaxart. There’s also an additional $50 million for Vaxart after the |
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