GH Research

GHRS

時価総額 $12.5億

I initiate coverage on GH Research PLC with a "Buy" rating, driven by renewed momentum in its GH001 program for treatment-resistant depression [TRD]. The company resolved the FDA clinical hold on its IND for GH001, positioning it for a pivotal phase 3 TRD trial expected to start in 2026. GH001 demonstrates competitive advantages: shortest-acting psychedelic [11-minute psychoactive phase] and reduced treatment visits versus SPRAVATO and BPL-003.

Alignment with FDA on CMC and device plans for Phase 3 Successfully completed GH001-HV-106 and GH001-HV-109 Phase 1 trials  Further strengthening of US and EU mebufotenin patent estate Phase 2a results in postpartum depression published in The Journal of Clinical Psychiatry Cash, cash equivalents and marketable securities of $362.7 million as of June 30, 2026 DUBLIN, Aug. 06, 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 reported financial results for the quarter ended June 30, 2026, and provided a business update. Business Updates Global Pivotal Program of GH001 in TRD We have completed GH001-HV-106, our Phase 1 clinical pharmacology trial of our proprietary aerosol delivery device in healthy volunteers, and GH001-HV-109, our IND-opening Phase 1 trial of GH001 in healthy volunteers in the United States.

GH Research PLC (NASDAQ:GHRS) and Definium Therapeutics Inc. (NASDAQ:DFTX) stocks are trading higher in response to Eli Lilly and Co. (NYSE:LLY) agreeing to acquire AtaiBeckley Inc. (NASDAQ:ATAI) in a deal valued at up to $3.80 billion.

The US Food and Drug Administration's finalized guidance on psychedelic drug development signals the agency remains receptive to helping developers navigate the approval process, a development that Jefferies said could benefit companies including Compass Pathways (NASDAQ:CMPS), AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC), Cybin Inc. (NYSE-A:CYBN, FRA:R7E), GH Research (NASDAQ:GHRS), Awakn Life Sciences (NEO:AWKN) and others in the sector. The firm wrote on Monday that the final guidance, alongside the FDA's plans to hold a public hearing on September 14, points to a more supportive regulatory environment that could reduce regulatory risk for psychedelic drug developers.

DUBLIN, June 04, 2026 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS) today announced the publication of the full results from its Phase 2a trial in postpartum depression (PPD) and the acceptance of two oral presentations at the 37th World Congress of Neuropsychopharmacology (CINP 2026). The peer-reviewed article, titled “Inhaled Mebufotenin (GH001) for Adult Patients with Postpartum Depression: A Phase 2a Open-Label Clinical Trial,” has been published in The Journal of Clinical Psychiatry (DOI: 10.4088/JCP.25m16284).

GH Research is advancing GH001, an inhalable mebufotenin therapy, in treatment-resistant depression. GH Research's Phase 2b data was strong, and a global Phase 3 program is expected in 2026. While the rapid onset and short psychedelic experience duration offered by GH001 are compelling it remains to be seen how the drug stacks up against peers under real-world conditions.

GH Research PLC (NASDAQ:GHRS) reported a wider-than-expected loss for the first quarter on Thursday.

Phase 2b results in TRD published in JAMA Psychiatry GH001-HV-106 study enrolment completed; doses selected for the global Phase 3 pivotal program of GH001 in TRD GH001-HV-109 US IND-opening study enrolment completed Cash, cash equivalents and marketable securities of $267.3 million as of March 31, 2026 Net cash proceeds of an additional $111.2 million from underwritten offering received in April 2026 DUBLIN, May 14, 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 reported financial results for the quarter ended March 31, 2026, and provided a business update. Business Updates Scientific Presentations and Publications In March 2026, the results of our Phase 2b trial in TRD (GH001-TRD-201) were published in JAMA Psychiatry.

DUBLIN, April 29, 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 announced the pricing of an underwritten offering in the United States of 6,527,779 of its ordinary shares at an offering price of $18.00 per share for total gross proceeds of approximately $117.5 million, before deducting underwriting discounts and commissions and offering expenses. All of the ordinary shares are being offered by GH Research PLC.

The White House psychedelics executive order accelerates research, clinical trials and "Right to Try" access for drugs like psilocybin, MDMA and ibogaine. The order does not change their legal status, but reinforces a federal move toward medical, evidence-based framework for other alternative medicines, like cannabis, experts say.