Verge Genomics' only clinical-stage ALS drug has failed, prompting the company to shift its focus to a partnership model for its AI-driven discovery platform.
Amylyx Pharmaceuticals will remove its ALS drug Relyvrio from the market in the U.S. and Canada after a Phase 3 study involving 664 people failed to show a benefit. The decision will also lead to a 70% reduction in staff. Relyvrio had received FDA approval in 2022, but its efficacy was a subject of contention, with regulators initially advising against its approval until further testing was conducted.
BrainStorm Cell Therapeutics is laying off 30% of its staff as it reevaluates its trial design for its ALS drug, NurOwn, after withdrawing its Biologics License Application (BLA). The company aims to realign its resources for a new clinical trial following a refusal-to-file letter from the FDA and a 17-1 vote by an advisory committee stating that the drug did not demonstrate substantial evidence of effectiveness in a previous study.