Latest news with #GH001
Yahoo
09-07-2025
- Business
- Yahoo
GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule
GH Research (NASDAQ:GHRS) is one of the best-performing NASDAQ stocks according to analysts. On June 20, GH Research announced that it had submitted a complete response to the US FDA regarding the clinical hold on its Investigational New Drug/IND Application for GH001. The submission was made ahead of schedule, which showed the company's commitment to advancing its lead product candidate. The CEO of GH Research, Dr. Velichka Valcheva, pointed out that the response addressed the FDA's requests with comprehensive data and completed toxicology studies. GH001 is GH Research's lead product candidate, which was formulated for mebufotenin (5-methoxy-N,N-dimethyltryptamine or 5-MeO-DMT) administration via a proprietary inhalation approach. The company believes that GH001 has the potential to transform the treatment of treatment-resistant depression/TRD. This belief is supported by the observed clinical activity in their Phase 2b GH001-TRD-201 trial. In this trial, the primary endpoint was met, showing a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline of -15.5 points compared with placebo on Day 8. A biochemist in a laboratory conducting research on a new psychiatric therapy. GH Research (NASDAQ:GHRS) is a clinical-stage biopharmaceutical company that develops treatments for depression in the US. While we acknowledge the potential of GHRS as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
31-01-2025
- Business
- Yahoo
GH Research to Provide Update on Phase 2b Trial with GH001 in TRD
DUBLIN, Jan. 31, 2025 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders, today announced that it will host a conference call and live webcast on Monday, February 3, 2025, at 8.00 a.m. EST to provide an update on data from the randomized, double-blind, placebo-controlled Phase 2b trial of GH001 in treatment-resistant depression (TRD). To access the conference call, please register in advance here. A live webcast of the call will be available under 'Events & Presentations' in the Investors section of GH Research PLC's website at About GH Research PLC GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric and neurological disorders. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD). About GH001 Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our completed phase 1/2 GH001-TRD-102 trial, where 87.5% of patients with TRD achieved ultra-rapid remission with our GH001 individualized single-day dosing regimen in the Phase 2 part of the trial, we believe that GH001 has the potential to change the way TRD is treated today. Investor RelationsJulie RyanGH Research PLCinvestors@
