2024-03-05 10:30:29 ET
Summary
- Geron Corporation's lead candidate, imetelstat, is awaiting FDA approval for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes.
- The company reported a loss from operations of $194 million in 2023, with $378.1 million in cash at the end of the year.
- Geron stock has risen by 12% since December, but faces potential risks from an upcoming FDA Advisory Committee meeting and competition from Bristol-Myers Squibb's Reblozyl.
- If approved, and despite the competition, GERN stock could recapture former highs of $3.5 per share, making this is a potentially exciting, albeit risky, "buy" opportunity.
Investment Overview
I last updated on Geron Corporation ( GERN ), the Foster City, California-based biotech primarily focused on securing commercial approval in the U.S. for its lead candidate, imetelstat, in the indication of transfusion-dependent anemia in adult patients, with low-to-intermediate-1 risk myelodysplastic syndromes ("MDS"), in a note for Seeking Alpha back in early December last year.
I gave the company and its stock a "Buy" rating, based on my belief that the FDA is likely to approve Imetelstat for approval when its Prescription Drug User Fee Act ("PDUFA") date arrives on June 16th this year. The PDUFA date is the date by which the agency must either approve a company's drug for commercial sale, or send a Complete Response Letter ("CRL") to the company, outlining its reasons for declining to do so....
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For further details see:
Geron Post 2023 Earnings - Gearing Up For Critical Imetelstat AdCom, PDUFA