STAT+: Metsera’s drug shows potential in early clinical trial

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Morning. Today, we take a look at the dramatic budget cuts at the NIH proposed by the Trump administration, see how top government health officials appear to be taking a softer line than some expected on gene therapies, and more. 

The need-to-know this morning

• Merck said its experimental, oral PCSK9 inhibitor lowered levels of bad cholesterol in people with genetically high cholesterol, achieving the goals of two Phase 3 studies. No data were reported in its press release. Merck is conducting a large, cardiovascular outomes study.
• Keros Therapeutics said it will return $375 million in “excess capital” to shareholders. The decision was made at the end of a strategic review of its operations, and notably, after Adar1 Capital Management, a biotech hedge fund and Keros’ largest shareholder, accused management of wasting money.
• Avidity Biosciences said it received clearance from the FDA to seek accelerated approval for an RNA-based drug to treat facioscapulohumeral muscular dystrophy (FSHD). Separately, the company reported new study results showing its drug, called del-brax, improved function in patients with FSHD. 
• Axsome Therapeutics said the FDA issued a “refuse to file” letter, turning back its application seeking the approval of a treatment for fibromyalgia.
• Struggling “zombie” biotech Elevation Oncology is being acquired by Concentra Biosciences and will be shut down. 

Metsera’s amylin drug shows early potential

Metsera, the obesity-focused biotech, said this morning that its drug candidate targeting the amylin hormone showed marked efficacy in an early trial and the potential to have longer-lasting effects than current weight loss treatments on the market that are injected weekly.

Continue to STAT+ to read the full story…