DIGITAL BIOLOGY
Overview
The FDA cleared Merck's Lipfendra as the first oral PCSK9 inhibitor, Eli Lilly moved into psychedelics with a $2.8 billion deal for AtaiBeckley, and researchers in Science reported AI-designed CRISPR enzymes that outperform the natural version.
This week
FDA approves Merck's Lipfendra, the first oral PCSK9 inhibitor
The FDA approved Merck's enlicitide, sold as Lipfendra, as the first oral PCSK9 inhibitor for adults with high LDL cholesterol, including heterozygous familial hypercholesterolemia. Across two randomized trials of more than 3,000 patients, the once-daily pill lowered LDL cholesterol by roughly 56 to 59 percent versus placebo at 24 weeks, reaching territory that until now required an injected antibody. [Merck | 3 MIN]
Eli Lilly buys into psychedelics with a $2.8 billion AtaiBeckley deal
Eli Lilly agreed to acquire AtaiBeckley for about $2.8 billion upfront, at $6.75 per share, plus contingent payments of up to $2.50 per share tied to program milestones. The deal brings Lilly into psychedelics: the lead candidate, an intranasal 5-MeO-DMT program called BPL-003, has begun Phase 3 work in treatment-resistant depression. It is one of the largest bets a major drugmaker has placed on the class. [STAT | 3 MIN]
AI-designed CRISPR enzymes outperform their natural template
A study in Science used an inverse-folding AI model to design synthetic versions of TnpB, a compact ancestor of the CRISPR-Cas12 enzymes, that do not exist in nature. In human cells the best synthetic nucleases reached 46 to 50 percent editing versus 28 percent for the natural enzyme, and up to roughly fourfold higher editing at some targets. Their small size could help in gene-editing settings where delivery space is tight. [Science | 4 MIN]
GSK halts camlipixant after mixed Phase 3 cough trials
GSK stopped development of camlipixant in refractory chronic cough after mixed Phase 3 results. CALM-1 met its primary endpoint at 12 weeks, but CALM-2 missed the same endpoint at 24 weeks and key secondary measures failed, which GSK said made the benefit unlikely to transform care. The program came from GSK's roughly $2 billion acquisition of Bellus Health. [GSK | 3 MIN]
Chai Discovery raises $400 million for AI molecular design
Chai Discovery raised $400 million in a Series C led by Index Ventures, roughly tripling its valuation from seven months earlier. The structure-prediction company will expand compute and data work on its Chai-3 models, which it says are already in use at Lilly, Novartis, and Pfizer. [Fierce Biotech | 3 MIN]