Gh Research Plc Stock Price, News & Analysis

GH Research (NASDAQ:GHRS) has provided significant updates on its clinical programs and development plans. The company is addressing the final FDA hold topic for its GH001 IND application, related to respiratory tract histology findings in rats. The company's Phase 2b trial in treatment-resistant depression (TRD) achieved impressive results, with a 73% remission rate at 6 months and a significant -15.5 point reduction in MADRS scores.

The treatment demonstrated strong safety profiles with no serious adverse events and no treatment-emergent suicidal ideation. The company's GH002 program showed positive Phase 1 results, with plans for FDA IND submission in Q4 2025. GH Research is preparing for a global pivotal program launch in 2026, with ongoing CRO selection and regulatory preparations.

GH Research PLC (GHRS) has announced the submission of its complete response to the FDA regarding the clinical hold on its Investigational New Drug Application (IND) for GH001, a treatment in development for depression. The company submitted the response in June 2025, ahead of their planned schedule. According to CEO Dr. Velichka Valcheva, the response includes comprehensive data and completed toxicology studies addressing the FDA's specific requests. The company emphasized its commitment to working with the FDA to advance GH001's development for patient treatment.

GH Research (Nasdaq: GHRS) announced the acceptance of multiple presentations at the American Society of Clinical Psychopharmacology Annual Meeting 2025, showcasing clinical data for their drug candidate GH001. The presentations include results from a Phase 2b trial in treatment-resistant depression (TRD), a Phase 2a trial in postpartum depression, and early-stage trials. Notably, in the postpartum depression trial, all ten participants achieved remission by Day 8. Additionally, a separate presentation at the International Society for Bipolar Disorders Conference will present Phase 2a results showing GH001's efficacy in bipolar II disorder, where it demonstrated a 52% mean reduction in depressive symptoms by Day 8. The drug was well-tolerated across all trials with no serious adverse events reported.

GH Research (NASDAQ: GHRS) reported significant progress in Q1 2025, with their Phase 2b trial of GH001 for treatment-resistant depression (TRD) meeting its primary endpoint. The trial showed a -15.5 point placebo-adjusted MADRS reduction and achieved a 57.5% remission rate compared to 0% in the placebo group. The company's cash position stands at $315.3 million, bolstered by a $150 million public offering. The company reported progress in proof-of-concept trials for bipolar II disorder and postpartum depression. Their IND application for GH001 remains on clinical hold, with a full response planned for mid-2025. Q1 financial results showed R&D expenses of $7.9 million (down from $8.7 million YoY) and G&A expenses of $4.9 million (up from $2.9 million YoY), resulting in a net loss of $10.8 million ($0.19 per share).

GH Research (GHRS) reported significant progress in its clinical trials and financial results for 2024. The company's Phase 2b trial of GH001 for treatment-resistant depression met its primary endpoint, showing a significant placebo-adjusted MADRS reduction of -15.5 on Day 8. The trial achieved a 57.5% remission rate compared to 0% in placebo group.

The company's financial position remains strong with $182.6 million in cash and equivalents as of December 31, 2024, plus additional net proceeds of $139.8 million from a February 2025 public offering. R&D expenses increased to $35.0 million in 2024 from $29.8 million in 2023. Net loss widened to $39.0 million ($0.75 per share) compared to $35.6 million ($0.68 per share) in 2023.

GH Research PLC (Nasdaq: GHRS) has announced the pricing of its public offering of 10,000,000 ordinary shares at $15.00 per share, aiming to raise approximately $150 million in gross proceeds. The offering is expected to close on February 6, 2025.

The company has granted underwriters a 30-day option to purchase up to an additional 1,500,000 ordinary shares at the public offering price, less underwriting discounts and commissions. The joint book-running managers for the offering are Cantor, Stifel, and RBC Capital Markets, with Canaccord Genuity and Citizens JMP acting as co-lead managers.

GH Research PLC (Nasdaq: GHRS) has announced a proposed public offering of $150 million of ordinary shares in the United States. The company plans to grant underwriters an option to purchase up to an additional $22.5 million of ordinary shares at the public offering price, less underwriting discounts and commissions.

The offering will be managed by joint book-running managers Cantor, Stifel, and RBC Capital Markets, with Canaccord Genuity and Citizens JMP acting as co-lead managers. The offering will be conducted through a prospectus supplement and accompanying prospectus, with the registration statement already declared effective by the SEC on March 17, 2023.

GH Research (NASDAQ: GHRS) announced successful Phase 2b trial results for GH001, their inhalable mebufotenin product candidate for treatment-resistant depression (TRD). The trial's primary endpoint was met, showing a significant -15.5 point placebo-adjusted MADRS reduction in depression scores on Day 8 (p<0.0001).

The trial involved 81 TRD patients, with 40 receiving GH001 and 41 receiving placebo. Key achievements include a 57.5% remission rate in the GH001 group compared to 0% in placebo. The drug demonstrated strong safety profiles with no serious adverse events reported. In the ongoing open-label extension (OLE), 77.8% of completers maintained remission at 6 months, with most patients requiring only 1-4 treatments over this period.

GH Research PLC (Nasdaq: GHRS) has announced a conference call and webcast scheduled for February 3, 2025, at 8:00 a.m. EST. The purpose is to provide updates on data from their Phase 2b trial of GH001 in treatment-resistant depression (TRD). The trial is characterized as randomized, double-blind, and placebo-controlled. The event will be accessible through advance registration and will be available on the company's website under the Events & Presentations section.