Restructuring Edition: Financial market conditions are improving, but gains have not stopped some companies from cutting costs or shutting down. MEI may wind down if it does not identify another strategic alternative and Aslan has begun to liquidate, while others have cut jobs.

Failure of the EMBARK confirmatory trial convinced US FDA reviewers the Duchenne muscular dystrophy gene therapy did not show clinical benefit, but biologics center director Peter Marks invoked totality of evidence to grant full approval.

With several new drugs progressing for the estimated 70,000 patients in China with DMD, a recent setback for Nippon Shinyaku's contender and progress for Chinese gene therapy developers are adding both uncertainty and likely competition in an untapped market with pressing medical need.

Executives from several AI-focused biotechs emphasize that generating a truly innovative medicine, as opposed to a me-too drug, depends not just on the quantity, but on the quality of data used by the algorithm.