GH Research

Stifel Nicolaus analyst Paul Matteis maintains a Buy rating on GHRS stock, citing GH Research's positive phase 2a study results in postpartum depression and bipolar II disorder, favorable safety profile of GH001, and regulatory progress. H.C. Wainwright also reiterated a Buy rating with a $40 target.

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Phase 2a trials for GH001 showed significant MADRS score reductions in postpartum depression (–35.4 points, 100% remission) and bipolar II disorder (–16.8 points, 33% remission). GH001 was well tolerated with no serious adverse events. Additional toxicology studies completed support safety. IND hold response planned for mid-2025. Phase 2b TRD trial data expected Q1 2025.

GH Research met primary endpoints in Phase 2a trials for GH001 in postpartum depression and bipolar II disorder, showing significant MADRS score reductions. No serious adverse events were reported. Completed FDA-requested inhalation toxicology studies in non-rodents and rats, with no respiratory toxicity in dogs. Plans to submit full IND hold response by mid-2025. Phase 2b trial in TRD on track for Q1 2025 data.

GH Research PLC announced its drug GH001 met primary goals in Phase 2 POC studies for postpartum depression and bipolar II disorder, showing significant MADRS score reductions. GH001 was well tolerated, and GHRS shares rose over 5% pre-market.

GH Research PLC reported positive Phase 2a trial results for GH001 in postpartum depression and bipolar II disorder, showing significant MADRS score reductions and high remission rates. GH001 was well tolerated with no serious adverse events. The company is preparing responses to FDA requests and plans to submit a full response to the IND hold by mid-2025. Top-line data from a Phase 2b trial in treatment-resistant depression is expected in Q1 2025.

GH Research PLC (GHRS) is advancing GH001, an inhaled mebufotenin for psychiatric disorders, with Phase 2b trial data expected by end of 2024 or early 2025. Trials for postpartum depression and bipolar disorder are ongoing. The FDA has placed a clinical hold on its U.S. IND due to inhalation toxicology concerns. GHRS had $193.8M cash as of Sep.30, 2024, and its shares closed at $7.74 on Dec.13, 2024.

GH Research PLC reported a $12.1 million Q3 net loss, with rising R&D and G&A costs, but maintains $193.8 million in cash. It completed enrollment for its phase 2b trial of GH001 for treatment-resistant depression, with top-line data expected in Q4 2024 or Q1 2025. The FDA has placed its GH001 IND on clinical hold due to insufficient risk assessment, and it plans to end its bipolar II disorder trial in Q4 2024 due to recruitment issues.

GH Research's share price is €7.30, with a Cash Flow from Operations per share of €-0.68 for the trailing twelve months ended in Jun. 2024. The Price-to-Operating-Cash-Flow Ratio is not provided. The average Operating Cash Flow per Share Growth Rate over the past 3 years was -287.70% per year.

GH Research PLC reports Phase 2b trial for GH001 in treatment-resistant depression on track for Q3 2024 completion, with a 6-month extension expected by Q1 2025. Phase 2a trials for postpartum depression and bipolar II disorder are also progressing. The company has $214.0 million in cash, sufficient until 2026. GH001 and GH002, targeting psychiatric disorders, show promising results in clinical trials.