ApprovalJun 6, 2024873 days ago
FDA approval of Rytelo
The FDA approved Geron’s Rytelo (imetelstat) for Lower-risk MDS anemia on Jun 6, 2024. The company can now sell it in that market.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
DetailsRegulatory approval
- Company
- Geron Corporation GERN
- Drug
- Rytelo (imetelstat)
- For
- Lower-risk MDS anemia
- When
- Jun 6, 2024
- Checked
- Checked by a person when it was added
Check the sourcesdon’t take our word for it
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- GERN headlines on this site
Geron Corporation
1 upcoming · 2 past catalysts
More from GERN
Geron expects to report results from its Phase 3 study of imetelstat (RYTELO) for JAK-inhibitor relapsed/refractory intermediate-2/high-risk myelofibrosis in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- IMpactMF Phase 3 interim analysis (overall survival) in relapsed/refractory myelofibrosis · Clinical trial results (readout / topline data)
- Drug
- imetelstat (RYTELO)
- For
- JAK-inhibitor relapsed/refractory intermediate-2/high-risk myelofibrosis
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Prior guidance placed the interim OS analysis in 2H 2026; on the Q2 2026 call management said projected timelines are unchanged but it is evaluating a modification to the interim event threshold, calls a positive interim an upside scenario, and keeps final OS analysis in 2H 2028 as base case. Timing risk is real.
- Checked
- Checked by a person when it was added
- Verify it
- Source: fool.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- GERN headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page