Domo signs strategic collaboration agreement with AWS for AI solutions
Investing.com - GH Research PLC (NASDAQ:GHRS), which has seen its shares surge over 80% in the past six months, is awaiting a response from the FDA regarding the clinical hold on its investigational new drug application for GH001, according to Canaccord Genuity. According to InvestingPro data, the company currently maintains a market capitalization of approximately $960 million.
Canaccord Genuity analyst Sumant Kilkami reiterated a Buy rating and $35.00 price target on GH Research on Wednesday. The firm noted that GH Research submitted its complete response to the FDA "in June" regarding the clinical hold on GH001, an inhaled mebufotenin (5-MeO-DMT) treatment. InvestingPro analysis shows strong analyst consensus, with price targets ranging from $25 to $40.
The FDA typically has 30 days to respond following such submissions, meaning a decision could come at any time. GH Research previously announced positive data from its European Phase 2b trial for GH001 in treatment-resistant depression (TRD).
Resolution of the clinical hold could allow GH Research to request an end-of-Phase 2 meeting with the FDA to discuss a Phase 3 program for GH001 in TRD that would include U.S. sites.
Canaccord Genuity reported that GH Research management characterized its submission as ahead of schedule and believes it addressed the FDA’s requests with "comprehensive data and completed toxicology studies."
In other recent news, GH Research PLC has submitted a response to the U.S. Food and Drug Administration regarding a clinical hold on its Investigational New Drug Application for GH001, an inhalable depression treatment candidate. The company addressed the FDA’s requests with data and toxicology studies, though specific details about the FDA’s concerns were not disclosed. GH001, which previously showed promising results in a Phase 2b trial for treatment-resistant depression, is awaiting the FDA’s decision to proceed with clinical trials in the United States. Meanwhile, Cantor Fitzgerald has assumed coverage of GH Research with an Overweight rating and a price target of $25.00. The firm highlighted the potential transformative impact of psychedelics on mental health disorders and noted the significant unmet need for effective treatments. Cantor Fitzgerald estimates the total addressable market for psychedelics could reach $50 billion annually, indicating ample opportunity for multiple companies. The analysts also noted the growing infrastructure in the U.S. for delivering psychedelic therapies and mentioned the potential for large pharmaceutical firms to enter the sector through acquisitions.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.