GH Research (NASDAQ:GHRS) has provided significant updates on its clinical programs and development plans. The company is addressing the final FDA hold topic for its GH001 IND application, related to respiratory tract histology findings in rats. The company's Phase 2b trial in treatment-resistant depression (TRD) achieved impressive results, with a 73% remission rate at 6 months and a significant -15.5 point reduction in MADRS scores.
The treatment demonstrated strong safety profiles with no serious adverse events and no treatment-emergent suicidal ideation. The company's GH002 program showed positive Phase 1 results, with plans for FDA IND submission in Q4 2025. GH Research is preparing for a global pivotal program launch in 2026, with ongoing CRO selection and regulatory preparations.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.