GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule
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 .
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Disclosure: None. This article is originally published at Insider Monkey.
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