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GH Research’s Strategic Path Forward: Overcoming Regulatory Hurdles and Capitalizing on Market Opportunities

GH Research’s Strategic Path Forward: Overcoming Regulatory Hurdles and Capitalizing on Market Opportunities

H.C. Wainwright analyst Patrick Trucchio has reiterated their bullish stance on GHRS stock, giving a Buy rating today.

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Patrick Trucchio has given his Buy rating due to a combination of factors related to GH Research’s progress and potential. The company recently received feedback from the FDA regarding its Investigational New Drug Application for GH001, an inhaled psychedelic formulation. The FDA’s request for additional data or justification concerning respiratory tract findings in rats is seen as manageable, with GH Research confident that these findings are specific to rats and not applicable to humans. Importantly, the FDA did not raise further concerns about dog toxicology results or the inhalation device, which were previously considered significant hurdles.
Trucchio believes that GH Research is well-positioned to resolve the FDA’s remaining questions, potentially lifting the IND hold by the second half of 2025. Additionally, the company plans to start a global pivotal program for GH001 in treatment-resistant depression by 2026, aligning with expectations. The recent decline in GHRS shares is viewed as an overreaction, creating an attractive buying opportunity for investors, given the strong Phase 2b data and progress in addressing regulatory challenges.

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