Geron Corporation (NASDAQ: GERN) stock plunged over 12% on Tuesday following reports that FDA staff reviewers expressed several safety concerns regarding Geron’s anemia medication, imetelstat.
As per the Reuters report, FDA staff expressed uncertainty about the “clinical meaningfulness” of the data presented by Geron and highlighted a notable incidence of low red blood cell counts among participants in the study. Furthermore, the FDA staff reportedly indicated that the study failed to demonstrate a “disease-modifying effect.”
This development unfolded shortly after the company’s conference call discussing its fourth-quarter and full-year achievements for 2023. During the call, the company put a notable emphasis on the imminent milestones for imetelstat.
Geron provided an update on the regulatory process, revealing a set PDUFA date by the FDA for June 16, 2024, and an ODAC meeting scheduled for March 14, 2024. The company is gearing up for a potential launch in the US by mid-2024 and in Europe by 2025.
Geron (NASDAQ: GERN) Stock Reaction
GERN stock tumbled 12.15% to close at $1.88 on Tuesday. The traders had exchanged hands with 61,150,779 (61.15 million) shares compared to the average daily trading volume of 7.50 million.
