DUBLIN - GH Research PLC (NASDAQ:GHRS), a biopharmaceutical company specializing in psychiatric and neurological disorders with a market capitalization of $467 million, has reported significant findings in its recent phase 2a proof-of-concept trials for its lead product candidate, GH001. According to InvestingPro data, the company maintains strong financial health with a FAIR overall rating, despite being in its pre-revenue phase. The trials focused on postpartum depression (PPD (NASDAQ:PPD)) and bipolar II disorder (BDII), with both meeting their primary endpoints.
In the PPD trial, 10 patients experienced a notable reduction in depression severity, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), with a 35.4-point decrease from baseline (p
GH001, an inhaled formulation of mebufotenin, was well tolerated in both trials, with no serious adverse events linked to the treatment. The majority of treatment-emergent adverse events were mild or moderate, with no incidents of hypomania or mania in the BDII trial.
Additionally, GH Research completed an inhalation toxicology study in dogs, with no adverse findings in the respiratory tract, and a rat study supporting the belief that previous histology findings are species-specific. The company is preparing to respond to the FDA's request for additional device design verification as part of the IND hold, with a full response planned for submission in mid-2025.
The company also announced that top-line data from its Phase 2b trial in treatment-resistant depression (TRD) are expected in the first quarter of 2025, with an ongoing open-label extension study slated for completion around the same time.
As of December 31, 2024, GH Research reported a cash position of $182.6 million, a decrease from the previous year's $222.7 million. InvestingPro analysis highlights that the company holds more cash than debt on its balance sheet, with liquid assets significantly exceeding short-term obligations at a current ratio of 15.8x. This strong financial position provides substantial runway for its ongoing clinical development programs.
GH Research focuses on developing treatments for conditions with unmet medical needs, such as TRD. The company's proprietary inhalation approach for GH001 has previously shown promise in a phase 1/2 trial, with a high percentage of TRD patients achieving rapid remission. Wall Street appears optimistic about the company's potential, with analyst price targets ranging from $18 to $40 per share, suggesting significant upside potential from the current price of $8.98. Get more detailed insights and additional ProTips by subscribing to InvestingPro.
This article is based on a press release statement from GH Research PLC.
In other recent news, GH Research PLC has reported significant developments in its clinical trials and corporate leadership. The company's third-quarter financial results highlighted progress on its lead candidates, GH001 and GH002, being developed for various depressive disorders. Analyst firms H.C. Wainwright and Canaccord Genuity have maintained their Buy ratings on GH Research, with H.C. Wainwright reaffirming a $40 price target and Canaccord Genuity adjusting its target from $31 to $28.
The clinical trials include a European Phase 2b trial of GH001, an inhalable psychedelic compound, for treatment-resistant depression. The company has completed enrollment for this trial and expects to release top-line data between the fourth quarter of 2024 and the first quarter of 2025. A six-month open-label extension of the same trial is also on track for completion in the first quarter of 2025.
GH Research has also announced the appointment of Dr. Velichka Villy Valcheva as its new Chief Executive Officer. Another key development is the company's anticipation of releasing top-line data from its Phase 2a trial for postpartum depression. These recent developments underscore GH Research's ongoing commitment to advancing its clinical programs and addressing significant unmet medical needs in the field of depression.
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