S&P 500 slips, but losses kept in check as Nvidia climbs ahead of results
DUBLIN - GH Research PLC (NASDAQ:GHRS), a clinical-stage biopharmaceutical company valued at $551.5 million, announced today significant results from its Phase 2b clinical trial for GH001, an inhalable mebufotenin product candidate for treatment-resistant depression (TRD). The trial met its primary endpoint, demonstrating an ultra-rapid anti-depressant effect with a notable reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) score on Day 8 post-treatment. The news has contributed to the stock’s impressive 20% gain over the past week, according to InvestingPro data.
Patients treated with GH001 experienced a significant decrease in MADRS scores compared to the placebo group, with a 57.5% remission rate on Day 8, in stark contrast to 0% in the placebo group. All other secondary endpoints were met, showing substantial improvements in depression-related scales. While the company is not yet profitable, with an EBITDA of -$48.41 million in the last twelve months, analysts maintain a strong bullish consensus with price targets ranging from $18 to $40 per share. Get access to more detailed financial insights and 8 additional ProTips with InvestingPro.
During the trial, GH001 was well tolerated, and no serious adverse events or treatment-emergent suicidal ideation or behavior were reported. The majority of patients were ready for discharge within an hour after the last dose, with no post-discharge restrictions required.
As of January 22, 2025, the ongoing open label extension (OLE) phase of the trial has reported a 77.8% remission rate at the 6-month visit among completers, with a majority receiving 1-4 treatments over the six months. To date, no serious adverse events have been reported in the OLE.
Professor Michael E. Thase, MD, from the Perelman School of Medicine at the University of Pennsylvania, highlighted the potential of GH001 to be a practice-changing treatment due to its large and rapid effect on patients who have not benefited from established treatments.
GH Research CEO Dr. Villy Valcheva expressed optimism about the future commercial success of GH001, emphasizing its ultra-rapid reduction in depressive symptoms and sustained remission through infrequent treatments.
The company will host a conference call and live webcast to discuss the trial results. These findings present a promising advancement in the treatment of TRD, a condition that often renders patients unresponsive to conventional therapies.
This report is based on a press release statement from GH Research PLC.
In other recent news, GH Research has made substantial strides in its clinical trials. The company has reported significant findings from its Phase 2a trials for its lead product candidate, GH001, focusing on postpartum depression and bipolar II disorder. Both trials met their primary endpoints. 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.
GH Research has also announced the appointment of Dr. Velichka Villy Valcheva as its new Chief Executive Officer. The company is on track to complete its European Phase 2b trial of GH001, an inhalable compound for treatment-resistant depression, with the expectation to release top-line data between the fourth quarter of 2024 and the first quarter of 2025. Furthermore, GH Research reported a strong cash position of $182.6 million, indicating robust financial health. These are among the recent developments that reflect GH Research’s continued commitment to advancing its clinical programs.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.