some publicity in BioPharm daily update email today

[jayfish101]

Geron Corporation (NASDAQ: GERN) is diligently progressing towards the regulatory milestones for Imetelstat, its potential therapeutic for hematologic myeloid malignancies, particularly targeting myelodysplastic syndromes (MDS). The company's New Drug Application (NDA) for Imetelstat, specifically for the treatment of transfusion-dependent anemia in adult patients with lower-risk MDS, has been accepted, with a PDUFA date set for June 16, 2024. Additionally, an Advisory Committee meeting is scheduled for March 14, 2024, during which the FDA will review the NDA for Imetelstat. The meeting will provide an opportunity for discussions regarding the proposed indication and the overall benefit-risk profile of Imetelstat.

[jayfish101]

Phase 3 data presented at ASCO 2023 demonstrated encouraging results, with Imetelstat showcasing superiority over placebo in achieving transfusion independence, a key endpoint in MDS treatment. The median duration of transfusion independence for Imetelstat responders was notable, approaching one year. These findings underscore the potential of Imetelstat as a therapeutic option for patients with lower-risk MDS who have failed previous treatments or are ineligible for erythropoiesis-stimulating agents. The advisory committee meeting will be broadcast on Youtube, with briefing documents likely to be made available in the days leading up to the meeting.