GH Research: FDA Lifts Clinical Hold on GH001, Clearing Path to Phase 3 and Supporting Buy Rating

Analyst Ami Fadia of Needham maintained a Buy rating on GH Research, retaining the price target of $19.00.

Ami Fadia has given his Buy rating due to a combination of factors tied to recent regulatory progress and its implications for GH Research’s lead asset. The key driver is the FDA’s decision to remove the long-standing clinical hold on GH001’s IND, which clears the way for the company to move into Phase 3 development, currently anticipated to begin in 2026. This resolution removes a major source of uncertainty that had weighed on the stock since the hold was imposed in September 2023 over information gaps related to patient safety assessment. With this overhang resolved, she expects a favorable re-rating of the shares as investors refocus on the drug’s clinical and commercial potential.
A further element behind the Buy recommendation is the expectation that the Phase 3 program will broadly mirror the prior Phase 2b trial design, providing continuity in the clinical path and reducing development risk. Management’s plan to engage with the FDA to align on a global pivotal strategy adds additional clarity and credibility to the forward roadmap. The sharp positive reaction in after-hours trading, even before full details were released, underscores strong market sensitivity to regulatory milestones and supports the view that the stock can continue to move higher as the Phase 3 program advances.

In another report released on December 22, H.C. Wainwright also reiterated a Buy rating on the stock with a $35.00 price target.