Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

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BioSpace

190 episodes

3 days ago

Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

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Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

BioSpace

26 minutes 26 seconds

1 month ago

Pfizer and Novo Battle Over Metsera, Tidmarsh Fights FDA Exit, UniQure and Sarepta Face Setbacks

Many of the top stories of 2025 are currently being written. We’re on the edge of our keyboards, watching and waiting as Pfizer and Novo Nordisk duke it out over the right to acquire glittery obesity startup Metsera. In the latest development, Pfizer raised its original bid of around $7.27 billion to about $8.1 billion on Monday—only to be usurped again by the indefatigable Novo, which upped its own bid to a cool $10 billion.

Meanwhile, the unprecedented drama in the uppermost ranks of the FDA—another top story of 2025—continues as CDER Director George Tidmarsh exits the agency. Tidmarsh reportedly resigned Sunday after being placed on administrative leave amid an investigation into his “personal conduct” at the agency. On Monday, however, Tidmarsh told Endpoints News that he was “second-guessing” his decision.

Speaking of the FDA, the regulator appears to have done its own 180—on uniQure’s investigational gene therapy for Huntington’s disease, three-year data from which sent the biotech’s stock into the stratosphere just five weeks ago. Despite previous agreements on protocols and statistical analyses, the agency “no longer agrees” that Phase I/II data for AMT-130 are adequate to provide primary evidence for the application, uniQure said, throwing the timeline for the BLA into question.

Another gene therapy player, Sarepta Therapeutics, took a hit this week, as two of its Duchenne muscular dystrophy drugs, Vyondys 53 and Amondys 45, failed a confirmatory trial. Sarepta still plans to file for full approval of the two exon-skipping therapies, however, based on what it called “encouraging trends” in efficacy. Finally, on the genetic medicine front, CBER director Vinay Prasad teased an upcoming paper that will detail the regulator’s thinking and a new approach to gene editing approvals.

On top of all that, Q3 earnings continue to roll in, with Pfizer, Eli Lilly, Vertex, Bristol Myers Squibb, AbbVie, and more reporting results.

One more thing: Have you ever wanted to know more about the inner workings of the Biogen-Eisai Alzheimer’s partnership? Check out this profile on BioSpace 40 under 40 honoree Neena Bitritto-Garg, Eisai alum and current CEO of Ensho Therapeutics.