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TOP STORIES
Follow along as BioSpace tracks job cuts and restructuring initiatives.
While an acquisition is a good exit for Soleno Therapeutics, the company’s acceptance of Neurocrine Biosciences’ $53-per-share offer came as a surprise to Stifel analysts given the potential growth of Vykat XR, approved last year for extreme hunger in patients with Prader-Willi syndrome.
Some disease areas bucked the trend of shrinking pipelines, however, with immune and cardiovascular indications seeing an upward trend in investigational assets.
Anthropic in October last year iterated its Claude AI model to better cater to biopharma purposes. Sanofi, Novo Nordisk, AbbVie and others already use Claude in their operations.
Takeda and Denali Therapeutics first partnered in early 2018 to advance drugs for neurodegenerative diseases. One asset, for Alzheimer’s disease, was previously discontinued after an FDA hold and disappointing early data.
The upcoming FDA decision for Replimune’s advanced melanoma drug could be a litmus test for the agency’s future regulatory decision-making, analysts say, with implications stretching well beyond one company.
FDA
While recent FDA guidance speaks to the agency’s support of innovative trial designs—including the use of external controls—the application of this flexibility appears to be inconsistent. One former regulator says the situation is more nuanced.
Nobel laureate Sir Michael Houghton and colleagues at Applied Pharmaceutical Innovation (API) outline how rigorous early testing, smart IP and regulatory planning, and scalable CMC choices can help founders reach first-in-human faster.
BioNTech envisioned the site making hundreds of millions of vaccines a year, but has since shifted its pipeline to other modalities while mRNA technology continues to face headwinds in the U.S.
While some large companies could start paying the full tariff in 120 days, many products, including orphan drugs, cell and gene therapies, and antibody-drug conjugates, will enjoy exemptions that waive or greatly reduce the levies.
After a flurry of deals over the past week from Eli Lilly, Merck and Biogen, analysts predict more M&A action from other big names, including Novartis, Amgen and AbbVie.
After Eli Lilly achieved the milestone approval of the weight loss pill Foundayo, Novo Nordisk launched a full-court press to defend oral Wegovy, which has been enjoying a record-breaking launch since January.
PRESS RELEASES
• Company expects approximately $2 million in non-dilutive VAT refunds from wholly owned U.K. subsidiary in 2Q-26 • Company expects to receive approximately $2 million in non-dilutive R&D tax credits repayable to the company in cash from its U.K. subsidiary in 2H-26 • Offering net proceeds, together with funds expected to be received via U.K. subsidiary, expected to provide cash runway into 2027 • Company expects to receive approvals in the U.S., U.K. and Europe for OST-HER2 in the prevention of delay of recurrent, fully resected, pulmonary metastatic osteosarcoma in the second half of 2026
34-acre campus supports 200,000 square feet of GMP manufacturing, with long-term expansion capacity exceeding one million square feet
MARKET RESEARCH REPORTS