GH Research (GHRS) — GH Research outlined plans for a global pivotal program for GH001, its inhaled 5-MeO-DMT (mebufotenin) candidate, and released its complete Phase 2b treatment-resistant depression dataset, including a placebo-adjusted 15.5-point MADRS reduction at Day 8 (p<0.0001) and a 73% six-month remission rate in the open-label extension without mandated psychotherapy.
The company said only one topic remains on its US FDA clinical hold, tied to respiratory-tract histology findings in rats. The update maps GHRS's path toward Phase 3 while flagging the IND hold as the key US gating item.
Source: globenewswire.com
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