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GH Research Announces Primary Endpoint Met in Phase 2b Trial with GH001 in TRD Demonstrating -15.5 Point Placebo-adjusted MADRS Reduction
Newsfilter· 2025-02-03 12:00
Core Insights - GH Research PLC has successfully met the primary endpoint in a Phase 2b clinical trial for GH001, an inhalable mebufotenin product candidate aimed at treating treatment-resistant depression (TRD) [1][6] Trial Details - The trial involved 81 patients with TRD, where 40 received GH001 and 41 received a placebo, without any psychotherapeutic intervention [2] - GH001 demonstrated a significant reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score, with a decrease of -15.2 points on Day 8 compared to +0.3 points in the placebo group, resulting in a difference of -15.5 points (p<0.0001) [2][7] Secondary Endpoints - All secondary endpoints were met, showing clinically and statistically significant improvements on the CGI-S, HAM-A scales, and the Q-LES-Q-SF Questionnaire on Day 8 compared to placebo [3][7] Safety and Tolerability - GH001 was well tolerated, with no serious adverse events reported during the double-blind portion of the trial. All treatment-emergent adverse events (TEAEs) were mild or moderate, and no severe adverse events were observed [4][7] - No clinically significant changes were noted in vital parameters, and 97.4% of patients were discharge ready within 1 hour of the last dose, with no evidence of treatment-emergent suicidal ideation or behavior [4][7] Remission Rates - As of January 22, 2025, 77.8% of open-label extension (OLE) completers were in remission at the 6-month visit, with the majority receiving 1-4 treatments during this period [5][7] - Patients who achieved remission on Day 8 after their first active treatment had a 91.7% remission rate at 6 months [7] Company Perspective - The CEO of GH Research highlighted the significance of the Phase 2b data, emphasizing the potential of GH001 to change treatment practices for TRD due to its rapid and profound effects [6]
GH Research to Provide Update on Phase 2b Trial with GH001 in TRD
Newsfilter· 2025-01-31 21:01
Core Insights - GH Research PLC is a clinical-stage biopharmaceutical company focused on transforming the treatment of psychiatric and neurological disorders [3] - The company will host a conference call on February 3, 2025, to provide updates on the Phase 2b trial of GH001 for treatment-resistant depression (TRD) [1][2] Company Overview - GH Research PLC is dedicated to developing novel therapies for psychiatric and neurological disorders, with a primary focus on mebufotenin for TRD [3] - The lead product candidate, GH001, utilizes a proprietary inhalation method for administration [4] Clinical Trial Insights - In the completed Phase 1/2 trial (GH001-TRD-102), 87.5% of patients with TRD achieved ultra-rapid remission with the individualized single-day dosing regimen [4]
GH Research Announces Primary Endpoint Met in Two Phase 2a POC Trials with GH001 and Completion of All FDA Requests to Address IND Hold with No Findings of Respiratory Toxicity in Non-Rodents
Globenewswire· 2025-01-10 12:00
Primary endpoint met in phase 2a POC trial in postpartum depression with a MADRS reduction from baseline of –35.4 points (p<0.0001, n=10) and 100% of patients in remission at Day 8Primary endpoint met in phase 2a POC trial in bipolar II disorder with a current major depressive episode with a MADRS reduction from baseline of –16.8 points (p=0.0099, n=6) and 33% of patients in remission at Day 8In both trials, GH001 was well tolerated and no treatment-related serious adverse events were reportedInhalation tox ...
Does GH Research (GHRS) Have the Potential to Rally 225.18% as Wall Street Analysts Expect?
ZACKS· 2024-11-20 15:55
GH Research PLC (GHRS) closed the last trading session at $9.61, gaining 15.8% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $31.25 indicates a 225.2% upside potential.The average comprises four short-term price targets ranging from a low of $18 to a high of $40, with a standard deviation of $10.37. While the lowest estimate indicates an increase of 87.3% from the current price l ...
GH Research Reports Third Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-11-14 12:00
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression completed enrolment of the double-blind phase in Q3 2024Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy volunteers is ongoing in the UKCash, cash equivalents, other financial assets and marketable securities of $193.8 million DUBLIN, Nov. 14, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GHRS), a clinical-stage biopharmaceutical company dedicated to transforming the treatment of psychiatric ...
3 Fast-Growing Stocks Analysts See Doubling in Price
MarketBeat· 2024-11-11 12:16
Comparing and selecting stocks for investment may involve any number of increasingly complex strategies and approaches, but sometimes simpler is better: targeting a stock with significant upside potential at an opportune moment. Certainly, achieving this goal is easier said than done, and there is no guarantee that a company expected to make sizable gains will follow through on that promise. However, looking to Wall Street analyst ratings and predictions can be a helpful place to start. In a screen of stock ...
After Plunging -18.19% in 4 Weeks, Here's Why the Trend Might Reverse for GH Research (GHRS)
ZACKS· 2024-09-09 14:35
GH Research PLC (GHRS) has been beaten down lately with too much selling pressure. While the stock has lost 18.2% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier. Guide to Identifying Oversold Stocks We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a momentum oscillator ...
GH Research Reports Second Quarter 2024 Financial Results and Provides Business Updates
GlobeNewswire News Room· 2024-09-03 11:05
Phase 2b clinical trial of GH001 in patients with treatment-resistant depression on track for expected completion of double-blind phase in Q3 2024 and expected completion of 6-month open-label extension phase in Q1 2025 Phase 1 clinical trial to evaluate proprietary aerosol delivery device in healthy adult subjects approved in the UK and recruiting Cash, cash equivalents, other financial assets and marketable securities of $204.5 million DUBLIN, Sept. 03, 2024 (GLOBE NEWSWIRE) -- GH Research PLC (Nasdaq: GH ...
Recent Price Trend in GH Research (GHRS) is Your Friend, Here's Why
Zacks Investment Research· 2024-05-13 13:55
While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.Often, the direction of a stock's price movement reverses quickly after taking a position in it, making investors incur a short-term capital loss. So, it's important to ensure that there are enough factors -- such as sound fundamentals, positive earnings estimate revisions, ...
Wall Street Analysts Predict a 166.89% Upside in GH Research (GHRS): Here's What You Should Know
Zacks Investment Research· 2024-05-10 14:56
Shares of GH Research PLC (GHRS) have gained 9% over the past four weeks to close the last trading session at $11.99, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $32 indicates a potential upside of 166.9%.The average comprises four short-term price targets ranging from a low of $18 to a high of $40, with a standard deviation of $10.17. While the lowest estimate indicates an ...