GERN - FDA Casts Doubts On Geron's Blood Cancer Drug But Analyst Sees High Probability For Imetelstat's Potential Approval For MDS Anemia Treatment | Benzinga
The FDA’s Oncologic Drugs Advisory Committee will meet virtually on March 14, 2024, to review Geron Corporation’s (NASDAQ:GERN) imetelstat application seeking approval for transfusion-dependent anemia in adult patients with lower-risk Myelodysplastic Syndromes (MDS).
June 16, 2024, is the PDUFA date for imetelstat NDA for transfusion-dependent anemia in adult patients with lower-risk MDS.
The injectable drug imetelstat was being studied in patients with lower-risk myelodysplastic syndromes, a type of blood cancer that requires frequent blood transfusions for managing anemia.
On Tuesday, FDA’s staff flagged concerns related to its Phase 3 trial, according to the FDA briefing documents.
“FDA acknowledges that the results of Study MDS3001-Phase 3 met the statistical goals for the primary endpoint of 8-week red ...