- A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.
GH Research PLC is addressing the FDA's clinical hold on its IND application.
4 reports, 2 independent
Updated Sep 2
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What happened
GH Research PLC is addressing the FDA's clinical hold on its IND application.
Who's involved
What this event is mainly aboutHow it developed
Newest first. Tap a step to see who reported it.- The FDA requested additional data regarding rat histology findings from a company, with updates being provided from Dublin.Sub-event
GH Research PLC is addressing an FDA clinical hold on its IND application.1 source
Keep exploring
Part of
A company is conducting clinical trials and seeking drug approval for the U.S. market under the FDA.Also in this story
- A partnership with BARDA has accelerated the development of SCY-247 for the company.
- A company plans to submit regulatory applications to the FDA, EMA, and Australian TGA.
- Approval leads to procurement process initiation.
- UroGen Pharma Ltd., headquartered in Princeton, is seeking FDA approval for its products for the U.S. market.
The entities involved
Related events
- The FDA placed a clinical hold on the IND application for the company Aardvark.
- The FDA recommended advancement for a new drug application submitted by a company.
- FDA issued a partial clinical hold on trials involving Biohaven Ltd. on September 11, 2026.
- FDA approval enables commercial opportunity involving CBRE Group.
- A clinical study led by Dr. Swee Lay Thein is underway at the National Institutes of Health and is subject to oversight by the Food and Drug Administration.
Coverage
Newest first; wire copies grouped- Insider MonkeyGH Research PLC (GHRS) Reports 73% Remission in Phase 2b Depression Trial We recently compiled a list of the 13 Best Psychedelic Stocks to Invest in Now. GH Research PLC stands ninth among them. GH R
- GlobeNewswireGH Research Reports Second Quarter 2025 Financial Results and Provides Business Updates Global pivotal program initiation on track for 2026 Engagement with FDA on GH001 IND complete response ongoing
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