Psychedelics-Tied GH Skyrockets On FDA Go-Ahead For Depression Drug

Biotech stock GH Research catapulted Monday after the FDA gave it the go-ahead to resume testing its depression drug.

Investors Business Daily • Jan 5, 2026

FDA Lifts Hold On GH Research's Depression Drug Trial After Two Years

The U.S. Food and Drug Administration (FDA) on Monday lifted the clinical hold on GH Research Plc's (NASDAQ: GHRS) Investigational New Drug Application (IND) for GH001.

Benzinga • Jan 5, 2026

GH Research Announces FDA Lifts Clinical Hold on GH001, Clearing Path for Global Phase 3 Initiation in 2026

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design Phase 3 initiation targeted for 2026 DUBLIN, Jan. 05, 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 that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on its Investigational New Drug Application (IND) for GH001. This clearance enables U.S. subject enrollment and progresses the company toward alignment of its development across major jurisdictions.

GlobeNewsWire • Jan 5, 2026

GH Research: GH001 Shows Robust Data Ahead Of FDA IND Decision

GH Research is advancing GH001, an inhaled mebufotenin therapy for treatment-resistant depression, with a critical FDA IND update imminent. GH001 demonstrated robust Phase 2b efficacy—a 15.5-point MADRS reduction at Day 8 and 73% six-month remission—with infrequent dosing and strong safety. GHRS maintains a disciplined cost structure, $293.9M in cash, and a projected runway exceeding five years at current burn rates.

Seeking Alpha • Jan 4, 2026

GH Research to Announce IND Status for GH001

DUBLIN, Jan. 02, 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 that it will provide an update on the status of its Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA) and its global pivotal Phase 3 program in treatment-resistant depression (TRD) on Monday, January 5, 2026, at 7.00 a.m. EST. 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.

GlobeNewsWire • Jan 2, 2026

Wall Street Analysts Think GH Research (GHRS) Could Surge 130.59%: Read This Before Placing a Bet

The average of price targets set by Wall Street analysts indicates a potential upside of 130.6% in GH Research (GHRS). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.

Zacks Investment Research • Nov 10, 2025

GH Research Reports Third Quarter 2025 Financial Results and Provides Business Updates

Engagement with FDA on GH001 IND complete response ongoing Full dataset from the Phase 2b clinical trial of GH001 in TRD reported in July 2025 Long-term clinical data on safety and efficacy from Open-Label Extension presented at ECNP in October 2025 Cash, cash equivalents and marketable securities of $293.9 million as of September 30, 2025 DUBLIN, Nov. 06, 2025 (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 September 30, 2025, and provided updates on its business. Business Updates GH001 Update In July 2025, we announced that we received a communication from the U.S. Food and Drug Administration (FDA) relating to our complete response to the clinical hold of our Investigational New Drug Application (IND) for GH001, with only one hold topic remaining.

GlobeNewsWire • Nov 6, 2025

Depression-Focused GH Research Shares Could See Significant Upside: Analyst

Needham initiated coverage on Monday for GH Research PLC (NASDAQ:GHRS), citing the company's lead drug candidate, GH-001, which had demonstrated impressive efficacy in Phase 2 versus competition.

Benzinga • Oct 13, 2025

GH Research Announces Novel Therapies Symposium Presentation and Posters at the 2025 ECNP Congress

DUBLIN, Oct. 09, 2025 (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 acceptance of a Novel Therapies Symposium Presentation at the 38th Annual European College of Neuropsychopharmacology Congress (ECNP) in Amsterdam, the Netherlands from October 11 – 14, where Professor Wiesław J. Cubała, MD, PhD, Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, will present long-term clinical data on the safety and efficacy from the open label extension (OLE) of a randomized, double-blind, placebo-controlled Phase 2b clinical trial with GH001 in patients with treatment-resistant depression (TRD) (GH001-TRD-201).

GlobeNewsWire • Oct 9, 2025

GH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates

Global pivotal program initiation on track for 2026 Engagement with FDA on GH001 IND complete response ongoing The fully completed Open-Label Extension analysis confirms a 73% remission rate at 6 months with infrequent treatment visits and no psychotherapy Treatment was well tolerated and no treatment related serious adverse events were reported. There was no evidence of treatment-emergent suicidal ideation or behavior Cash, cash equivalents and marketable securities of $308.7 million as of June 30, 2025 DUBLIN, Aug. 07, 2025 (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, 2025, and provided updates on its business.

GlobeNewsWire • Aug 7, 2025