DUBLIN, April 20, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression, today issued a statement welcoming the White House Executive Order, signed on April 18, 2026, to accelerate medical treatments for serious mental illness, including innovative psychedelic medical treatments (the Executive Order). The Executive Order directs coordinated federal action to accelerate the development of, and expand patient access to, innovative therapies for serious mental illness. GH Research continues to advance GH001, its proprietary inhaled mebufotenin product candidate, toward initiation of a global pivotal Phase 3 program in treatment-resistant depression (TRD) in 2026.
“We commend the Administration for recognizing the magnitude of the mental health crisis and the urgent need for innovative, evidence-based therapies for patients with serious mental illness. The Executive Order’s emphasis on scientific rigor and cross-agency coordination is well aligned with the approach required to deliver practice-changing treatments, and we remain focused on advancing GH001 toward a global pivotal Phase 3 program,” said Dr. Velichka Valcheva, Chief Executive Officer of GH Research.
About GH Research PLC
GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC’s initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has the potential to change the way TRD is treated today.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding the potential impact of the Executive Order on the regulatory environment and on the development of psychedelic medical treatments, including our mebufotenin product candidates, and our plans and expectations with respect to the initiation, timing, progress and design of our global Phase 3 pivotal program for GH001, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, the risk that the Executive Order may not be implemented as anticipated, may be modified, delayed, challenged, rescinded or superseded, and may not, in practice, accelerate the development or approval of psychedelic medical treatments, including our mebufotenin product candidates; the risk that we may not be able to initiate or complete our global Phase 3 pivotal program for GH001 on the timelines we are targeting or at all; the risk that we may not obtain FDA alignment on the pivotal program design on favorable terms or at all; and those other risks described in our filings with the U.S. Securities and Exchange Commission from time to time. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Relations
Julie Ryan
GH Research PLC
[email protected]