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Brainstorm Cell Therapeutics

All articles tagged with #brainstorm cell therapeutics

biotechnology2 years ago

BrainStorm's Workforce Reduction Paves Way for ALS Cell Therapy Market Push

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.

pharmaceuticals2 years ago

FDA convenes advisory panel to review BrainStorm's ALS therapy NurOwn

BrainStorm Cell Therapeutics' ALS treatment, NurOwn, will be discussed in an FDA advisory committee meeting after receiving a refusal to file letter in November. Ionis and AstraZeneca's rare disease drug, eplontersen, has completed a positive Phase III trial. Codiak BioSciences has filed for Chapter 11 bankruptcy. ArriVent Biopharma has raised $155 million in a Series B round. Endpoints has added three new journalists to their newsroom. Kristen Hege, a cancer researcher, has put her career on hold to hike the Pacific Crest Trail. Another biotech startup has faced a Phase II pileup in Parkinson's disease.