Welcome to our dedicated page for Gh Research Plc news (Ticker: GHRS), a resource for investors and traders seeking the latest updates and insights on Gh Research Plc stock.
GH Research PLC (NASDAQ: GHRS) is a clinical-stage biopharmaceutical company focused on developing novel and proprietary mebufotenin therapies, with an initial emphasis on treatment-resistant depression (TRD). News about GH Research frequently centers on clinical trial results, regulatory milestones, and scientific presentations related to its lead inhalable product candidate GH001 and its intravenous candidate GH002.
Investors and observers following GHRS news can expect updates on Phase 2b and open-label extension data for GH001 in TRD, including reported outcomes such as placebo-adjusted MADRS score reductions, remission rates at key time points, and detailed safety and tolerability findings. The company also reports on proof-of-concept trials of GH001 in postpartum depression and bipolar II disorder, highlighting reductions in depressive symptoms and the absence of treatment-related serious adverse events in these early-stage studies.
Another recurring theme in GH Research news is its regulatory interaction with the U.S. Food and Drug Administration (FDA). Press releases have described the clinical hold on the GH001 IND, the completion of requested inhalation toxicology studies and device verification work, submission of a complete response, and ultimately the FDA’s decision to lift the clinical hold, clearing GH001 for U.S. clinical investigation. News items also cover plans for a global pivotal Phase 3 program in TRD and supporting device-bridging studies in healthy volunteers.
GH Research regularly announces scientific conference participation, including oral presentations and posters at meetings such as ECNP, ASCP, ISBD, and ACNP, where external investigators present data on GH001’s efficacy, safety, psychoactive profile, and impact on quality of life. Financial result releases provide additional context on the company’s cash position, research and development spending, and progress across its clinical programs. For a consolidated view of these developments, this news page aggregates GHRS press releases and related coverage in one place.
GH Research PLC (Nasdaq: GHRS) announced significant advancements in its clinical trials and product development. The company received initial approvals for a Phase 2b trial of GH001 for treatment-resistant depression (TRD), set to begin in Q1 2023. A proprietary aerosol delivery device for GH001 is in progress, with an IND submission anticipated in Q3 2023. Additionally, a Phase 1 trial for GH002 has started, expected to conclude in Q4 2023. The company has filed a new patent application, expanding its portfolio to 11 families. Mebufotenin has been selected as the International Nonproprietary Name for 5-MeO-DMT.
GH Research PLC (Nasdaq: GHRS) reported Q3 2022 financial results, showing a net loss of $0.4 million ($0.008 loss per share), a reduction from a $1.8 million loss in Q3 2021. Cash reserves stand at $256.9 million, expected to fund operations into 2025. R&D expenses rose to $4.6 million, up from $2.6 million year-over-year, while G&A expenses decreased slightly to $2.0 million. The company is advancing clinical trials for its product candidate GH001 aimed at treatment-resistant depression, bipolar II disorder, and postpartum depression, with trials expected to commence in early 2023.
GH Research PLC (Nasdaq: GHRS) reported its Q2 2022 financial results, showing a net profit of $0.3 million ($0.006 per share), compared to a net loss of $2.1 million in Q2 2021. The company had $265.4 million in cash, sufficient to fund operations through 2025. R&D expenses rose to $4.2 million due to increased clinical activity, while G&A expenses surged to $2.5 million mainly due to higher insurance and employee costs. GH001 clinical trials for treatment-resistant depression have advanced, with regulatory applications planned for mid-Q3 2022. The company remains focused on 5-MeO-DMT therapies.
GH Research PLC (Nasdaq: GHRS) reported first quarter 2022 financial results, revealing a cash position of $270.8 million, projected to cover expenses until 2025. R&D expenses surged to $4.7 million, up from $692k, driven by increased clinical trial activities. General and administrative expenditures also rose to $3.3 million, compared to $448k in 2021. The net loss was $5.8 million, or $0.111 per share, compared to a loss of $1.1 million or $0.038 per share in Q1 2021. Positive developments include plans for clinical trials on GH001 targeting treatment-resistant depression, bipolar disorder, and postpartum depression.
GH Research PLC (Nasdaq: GHRS) announced its financial results for the year ended December 31, 2021. The company reported a cash position of $276.8 million, a significant increase from $5.9 million in 2020. R&D expenses surged to $8.6 million as clinical trials accelerated. The net loss expanded to $9.2 million or $0.211 loss per share, compared to $446 thousand loss in 2020. GH001, their inhalable 5-MeO-DMT product for treatment-resistant depression, showed promising Phase 2 trial results. The company plans further trials in 2022, aiming for a multi-center Phase 2b trial and additional indications.
GH Research PLC (Nasdaq: GHRS) reported its Q3 2021 financial results, highlighting a substantial cash position of $280.7 million as of September 30, improving from $5.9 million at the end of 2020. R&D expenses surged to $2.6 million due to intensified technical and clinical activities, contrasted with $55 thousand in Q3 2020. The net loss was $1.8 million, or $0.035 per share. Notably, the company announced positive results from the Phase 2 part of its clinical trial for GH001 in treatment-resistant depression, achieving 87.5% remission in patients at day 7.
GH Research PLC (Nasdaq: GHRS) announced successful results from the Phase 2 part of its clinical trial for GH001, an inhalable 5-MeO-DMT therapy targeting treatment-resistant depression (TRD). The primary endpoint was met, with 87.5% of patients achieving remission by day 7 (p0.0001). Secondary endpoints were also met, showing a mean MADRS score change of -24.4 points (76%) at day 7 (p<0.0001). GH001 was well tolerated with no serious adverse events reported. Preliminary safety results from a Phase 1 trial confirmed the safety profile beyond day 7.
GH Research PLC (NASDAQ: GHRS) announced its business updates and financial results for Q2 2021, revealing significant developments in its clinical programs and corporate structure. The company raised $167.7 million through an IPO, issuing 11.5 million shares at $16.00 each. Cash reserves surged to $292.6 million. R&D expenses rose to $2 million due to ongoing clinical trials, while G&A expenses increased to $719,000 as a result of IPO preparations. The net loss for the quarter was $2.1 million, translating to a loss per share of $0.053.