secwatch.observer — SEC 8-K summary
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Issuer:     GERON CORP (GERN)
CIK:        0000886744
Form:       8-K
Filed at:   2024-03-14T23:59:59+00:00
Accession:  0000950170-24-031475
Event type: regulatory
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Geron: FDA ODAC votes 12-2 in favor of imetelstat's benefit/risk for LR-MDS
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- ODAC voted 12 to 2 that imetelstat's clinical benefit/risk profile is favorable for TD anemia in LR-MDS.
- PDUFA target action date for imetelstat NDA is June 16, 2024.
- IMerge Phase 3 met primary endpoint: ≥8-week RBC-TI significantly higher vs placebo (p<0.001).
- 28% (imetelstat) vs 3% (placebo) achieved ≥24-week RBC-TI; median duration for responders was 80 weeks.
- Common Grade 3-4 adverse events: thrombocytopenia (62%) and neutropenia (68%); generally manageable.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/0000950170-24-031475-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/886744/000095017024031475/gern-20240314.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-031475

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