Fierce Biotech March 15, 2024
Geron has triumphed in its latest uphill battle. Facing questions about the trade-offs of its blood cancer drug candidate imetelstat, the biotech won over an FDA advisory committee and secured a 12 to 2 vote in its favor—triggering a surge in its share price.
After decades of setbacks, Geron reported a phase 3 win at the start of last year and outlined plans to file for FDA approval of its telomerase inhibitor imetelstat. However, details of the clinical data muddied the waters, leading this week to the publication of a FDA briefing document that raised questions about whether the benefits of imetelstat outweigh the risks in myelodysplastic syndromes (MDS).
Thursday, 12 of the experts on the FDA’s Oncologic Drugs Advisory...
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