Core Insights - GH Research PLC has announced two peer-reviewed publications from its Phase 2b clinical program of GH001 for treatment-resistant depression (TRD), highlighting significant findings regarding the efficacy of GH001 [1][2][3] Publication Details - The primary trial results of GH001 have been published in JAMA Psychiatry, detailing the complete results from a randomized, double-blind, placebo-controlled Phase 2b trial, including all primary and secondary efficacy endpoints, safety and tolerability data, and initial results from a 6-month open-label extension [2][3] - A supporting article demonstrating that GH001's efficacy is independent of prior treatment failures will be published in Psychopharmacology Bulletin [3] Efficacy Findings - The new analysis indicates that GH001 does not follow the established pattern of declining remission rates with successive treatment failures, as seen in the STAR*D trial [4] - Remission rates for GH001 were consistently high across subgroups with varying numbers of prior treatment failures, suggesting potential benefits for patients with extensive treatment histories [4][7] - Day 8 remission rates ranged from 53.9% to 63.6% for patients with 2 to ≥5 prior treatment failures, with Month 6 remission rates ranging from 61.5% to 85.7% [7] Product Information - GH001 is a proprietary mebufotenin therapy administered via inhalation, which has shown a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) by −15.5 points compared to placebo on Day 8 (P<0.0001) [9] - The company believes that GH001 has the potential to change the treatment landscape for TRD based on the observed clinical activity in the Phase 2b trial [6][9]

Core Insights - Biotech companies experienced significant gains in after-hours trading, driven by investor interest despite limited news catalysts [1] Company Updates - GH Research PLC (GHRS) saw the largest increase, rising 22.36% to $16.20 ahead of a key update on its Investigational New Drug Application (IND) for GH001 with the FDA, scheduled for January 5, 2026 [2] - Phathom Pharmaceuticals, Inc. (PHAT) increased by 5.03% to $16.50, with the rise attributed to investor positioning rather than new announcements [3] - Forte Biosciences, Inc. (FBRX) gained 3.56%, closing at $24.45, continuing its upward trend in the biotech sector without any new updates [3] - OKYO Pharma Limited (OKYO) advanced 5.38% to $2.35, influenced by prior disclosures regarding share acquisitions by its Executive Chairman [4] - Zai Lab Limited (ZLAB) rose 5.60% to $18.30, reflecting ongoing investor interest in international biotech firms [5] - LifeMD, Inc. (LFMD) added 3.15% to $3.60, with no corporate updates released [5] - Werewolf Therapeutics, Inc. (HOWL) climbed 3.58% to $0.67, indicating speculative interest in smaller-cap biotech stocks [6] - Corvus Pharmaceuticals, Inc. (CRVS) increased by 7.24% to $7.85, extending its upward momentum without any new announcements [6]