BlossomHill outcome from End-of-Phase 1 FDA meeting; 50 mg twice daily dose agreed for Phase 2
FROM THE WIRE · GLOBENEWSWIRE.COM
Alignment with the US Food and Drug Administration on 50 mg twice daily as the recommended Phase 2 dose for BH-30643 SOLARA-2, the Phase 2 portion of the SOLARA trial, designed with registrational intent to evaluate BH-30643 in patients with EGFR C797S-positive NSCLC; expect to…
Read at the source ↗MARKET IMPACTNEUTRAL✦ News Impact agent estimateTone: expected bullishRegulatory alignment with the FDA on Phase 2 dose and design can reduce program risk for investors.AI-generated summary
✦ IN BRIEF · AIAI-generated summary
- 01BlossomHill aligned with the FDA on 50 mg twice daily as the recommended Phase 2 dose for BH-30643.
- 02The SOLARA-2 Phase 2 portion is designed with registrational intent in EGFR C797S-positive NSCLC.
- 03The company expects to dose the first patient in Q1 2027.
NEWS IMPACT AND MARKET REACTIONChange since the story · reference
Impact and summary are estimates by the News Impact AI agent, not financial advice.Open in Markets