GH Research submitted a response to the FDA regarding its clinical hold on GH001, a treatment for depression.
Quiver AI Summary
GH Research PLC has announced that it submitted a complete response to the U.S. FDA regarding the clinical hold of its Investigational New Drug Application for its lead product candidate, GH001, aimed at treating depression. This submission was made ahead of schedule and includes comprehensive data and completed toxicology studies to address the FDA's concerns. Dr. Velichka Valcheva, the CEO, expressed enthusiasm about this progress and the company's commitment to collaborating with the FDA to bring GH001 to patients. GH001 is administered via a proprietary inhalation method and has shown promising results in clinical trials, particularly in treating treatment-resistant depression. The company also noted that the release contains forward-looking statements about future operations and regulatory outcomes, subject to risks and uncertainties.
Potential Positives
- The submission of the complete response to the FDA's clinical hold ahead of schedule demonstrates the company's efficiency and commitment to progressing in the regulatory process.
- GH001 has shown promising clinical activity in the Phase 2b trial, meeting its primary endpoint and indicating potential for a transformative treatment in treatment-resistant depression (TRD).
- The company expresses a strong commitment to collaboration with the FDA, which may enhance the probability of successful approval and expedite the pathway to market for GH001.
Potential Negatives
- The press release indicates that the company's Investigational New Drug Application (IND) for GH001 was under a clinical hold, suggesting that there were unresolved issues or concerns regarding the drug's development.
- While the submission of the complete response to the FDA is a positive step, it implies that the company faced delays and challenges in their regulatory process that could impact timelines for bringing GH001 to market.
- The extensive use of forward-looking statements highlights uncertainty and potential risks associated with the company's future operations and the success of their product candidate, which may raise concerns for investors.
FAQ
What is GH001's purpose in treating depression?
GH001 aims to provide a transformative treatment for patients suffering from treatment-resistant depression (TRD).
What does the complete response to the IND hold mean?
It means GH Research PLC addressed the FDA's requests with comprehensive data and studies regarding their investigational drug application.
What were the results of the Phase 2b trial for GH001?
The Phase 2b GH001-TRD trial showed a significant reduction in MADRS scores, indicating effectiveness compared to placebo.
Who is leading GH Research PLC?
Dr. Velichka Valcheva is the Chief Executive Officer of GH Research PLC.
What are forward-looking statements in the press release?
They are predictions about future results and operations based on current beliefs and assumptions that may be subject to risks.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$GHRS Hedge Fund Activity
We have seen 24 institutional investors add shares of $GHRS stock to their portfolio, and 16 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- RTW INVESTMENTS, LP added 2,172,640 shares (+65.3%) to their portfolio in Q1 2025, for an estimated $23,964,219
- DEEP TRACK CAPITAL, LP added 2,000,000 shares (+inf%) to their portfolio in Q1 2025, for an estimated $22,060,000
- TORONTO DOMINION BANK added 1,967,293 shares (+inf%) to their portfolio in Q1 2025, for an estimated $21,699,241
- FMR LLC added 1,762,210 shares (+70.8%) to their portfolio in Q1 2025, for an estimated $19,437,176
- LYNX1 CAPITAL MANAGEMENT LP added 1,584,946 shares (+32.6%) to their portfolio in Q1 2025, for an estimated $17,481,954
- BVF INC/IL removed 1,572,446 shares (-15.1%) from their portfolio in Q1 2025, for an estimated $17,344,079
- CORMORANT ASSET MANAGEMENT, LP added 1,416,439 shares (+238.8%) to their portfolio in Q1 2025, for an estimated $15,623,322
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$GHRS Analyst Ratings
Wall Street analysts have issued reports on $GHRS in the last several months. We have seen 1 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- RBC Capital issued a "Outperform" rating on 03/07/2025
To track analyst ratings and price targets for $GHRS, check out Quiver Quantitative's $GHRS forecast page.
Full Release
DUBLIN, June 20, 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 that, in June, it submitted its complete response to the previously announced clinical hold of its Investigational New Drug Application (IND) for GH001 to the U.S. Food and Drug Administration (FDA).
“We are thrilled to have submitted our response to the FDA ahead of schedule, addressing their clear requests with comprehensive data and completed toxicology studies. We remain fully committed to working closely with the agency to bring GH001 to patients,” said Dr. Velichka Valcheva, Chief Executive Officer.
About GH001
Our lead product candidate, GH001, is formulated for mebufotenin administration via a proprietary inhalation approach. Based on the observed clinical activity in our Phase 2b GH001-TRD-201 trial, where the primary endpoint was met with a MADRS reduction from baseline of -15.5 points compared with placebo on Day 8 (p<0.0001), we believe that GH001 has potential to change the way TRD is treated today.
Forward-Looking Statements
This press release contains statements that are, or may be deemed to be, forward-looking statements. All statements other than statements of historical fact included in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, medical devices required to deliver these product candidates, research pipeline, ongoing and currently planned preclinical studies and clinical trials, regulatory submissions and approvals and their effects on our business strategy, including our plans and expectations for discussions with the FDA and the outcomes and resolution of such discussions related to the clinical hold on the GH001 IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. Forward-looking statements appear in a number of places in this press release and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this press release speak only as of the date hereof. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.
Investor Relations
Julie Ryan
GH Research PLC
[email protected]
