August 25, 2026
elaine-chen-avatar-teal
National Biotech Reporter

Good morning. After seeing this column arguing that we should stop eating lettuce, I was contemplating a future without Caesar salad, and I don't think I could bear it.

Onto the news today.

biotech

FDA extends review of Capricor's Duchenne drug

Capricor said yesterday that the FDA has extended its deadline for deciding on the company's controversial treatment for Duchenne muscular dystrophy by three months, from Aug. 22 to Nov. 22.

The biotech initially sought approval for its drug, a cell therapy called deramiocel, to treat Duchenne-related cardiomyopathy, but was rejected in 2025. The company then refiled its application with new data and is now asking the FDA to focus instead on the therapy's ability to improve upper-limb function.

The agency's staff, however, have been skeptical of the drug's ability to significantly improve either upper-arm control or heart function in its pivotal trial. FDA advisers also recommend against approval at a hearing in July.

pharma

Roche licenses obesity drug with unique mechanism

Roche has licensed a non-GLP-1-targeting obesity drug from South Korean company Hanmi Pharm, broadening its weight loss drug portfolio.

Hanmi said yesterday that the drug mimics the effects of a neuropeptide called urocortin-2, or UCN2, and is designed to promote weight loss while preserving lean mass.

Over the past few years, Roche has attempted to catch up in the obesity race. It acquired Carmot Therapeutics, picking up several GLP-1-targeting candidates. It’s also partnered with Zealand Pharma to test an experimental amylin-targeting drug.

Under the new deal, Roche will pay Hanmi $190 million upfront and could pay up to $2.3 billion if certain milestones are met. Hanmi is also eligible to receive royalties on future sales.

pharma

Merck's suit contesting Medicare negotiations is shot down

A D.C. judge yesterday rejected Merck's lawsuit challenging Medicare price negotiations established by the Inflation Reduction Act, dealing another blow to the industry's effort to stop the program.

Earlier this year, the Supreme Court declined to take up lawsuits against the program filed by AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Novartis, and Novo Nordisk, after the drugmakers lost their appeals in lower courts.

More around STAT

More reads

  • Hospitals are plotting a long-shot push to roll back $1 trillion in Medicaid cuts, STAT
  • Option-to-acquire deals remain rare in biotech's buzzy M&A season, Endpoints
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Thanks for reading! Until next time,

elaine.chen@statnews.com

 
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