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DUBLIN - GH Research PLC (NASDAQ:GHRS), a $752 million market cap biotech company whose shares have surged 73% over the past six months, announced Friday it has submitted its complete response to the U.S. Food and Drug Administration regarding a clinical hold on its Investigational New Drug Application for GH001, the company’s inhalable depression treatment candidate. According to InvestingPro analysis, the company currently trades above its Fair Value.
The clinical-stage biopharmaceutical company completed its submission in June, addressing the FDA’s requests with data and toxicology studies. The company did not provide specific details about the FDA’s concerns that led to the clinical hold. InvestingPro data shows the company maintains a strong financial position with more cash than debt and a healthy current ratio of 29.7x.
"We are thrilled to have submitted our response to the FDA ahead of schedule, addressing their clear requests with comprehensive data and completed toxicology studies," said Dr. Velichka Valcheva, Chief Executive Officer of GH Research.
GH001, the company’s lead product candidate, is formulated for mebufotenin administration through a proprietary inhalation approach. The drug previously met its primary endpoint in a Phase 2b trial for treatment-resistant depression, showing a reduction in the Montgomery–Åsberg Depression Rating Scale (MADRS) of 15.5 points compared to placebo on Day 8.
The Dublin-based company is developing GH001 as a potential treatment for treatment-resistant depression. The FDA’s decision on lifting the clinical hold will determine whether the company can proceed with clinical trials in the United States.
The information in this article is based on a company press release statement. Wall Street remains optimistic about GHRS’s prospects, with analyst price targets ranging from $25 to $40 per share. Get access to more detailed financial insights and 6 additional ProTips with InvestingPro.
In other recent news, Cantor Fitzgerald has initiated coverage of GH Research PLC with an Overweight rating, setting a price target of $25.00. The analysts at Cantor Fitzgerald have expressed confidence in the company’s potential within the mental health sector, particularly through the use of psychedelics for treating disorders such as depression, PTSD, and anxiety. They highlight a significant unmet need for effective treatments, pointing out the limitations of current options. The report notes the expanding infrastructure of interventional psychiatry practices in the U.S. that are preparing to offer psychedelic therapies. According to Cantor Fitzgerald, the total addressable market for psychedelics could reach $50 billion annually, potentially benefiting 1 to 1.5 million patients each year. The analysts also acknowledge the presence of companies like JNJ in the psychedelic market and suggest the possibility of other large pharmaceutical firms entering the sector through acquisitions.
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