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.

GH Research (NASDAQ:GHRS) is a clinical-stage biopharmaceutical company that develops treatments for depression in the US.

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Disclosure: None. This article is originally published at Insider Monkey.