GH Research Files Complete FDA Response on GH001 Clinical Hold

Rhea-AI Filing Summary

GH Research PLC (NASDAQ: GHRS) filed a Form 6-K reporting that it has submitted a complete response to the U.S. FDA concerning the clinical hold on its Investigational New Drug (IND) application for GH001. The submission was made in June 2025 and disclosed to investors via a press release dated 20 June 2025 (attached as Exhibit 99.1).

The filing does not disclose FDA feedback, timelines, or whether the hold will be lifted. Management expressly states it will not update the press release or forward-looking statements, underscoring regulatory uncertainty. No financial statements, earnings metrics, or other operational updates accompany the filing.

Investor takeaway: The response filing is an incremental regulatory step that could enable clinical trials of GH001 to resume if the FDA is satisfied. However, material impact remains contingent on the FDA’s decision; therefore, the risk profile for GHRS is largely unchanged until further notice.

Positive

• Regulatory progress: GH Research submitted a complete response to the FDA addressing the clinical hold on GH001, a prerequisite to resuming U.S. clinical trials.

Negative

• Unresolved uncertainty: The filing offers no indication that the FDA will lift the hold or provide a timeline, leaving trial delays and cash-burn risks intact.

Insights

Biotech Equity Analyst

TL;DR: GHRS submits FDA hold response—positive step but outcome unknown; stock impact modest until FDA decision.

The company’s complete response addresses the FDA’s concerns surrounding GH001, its lead 5-MeO-DMT product for treatment-resistant depression. Filing the response is procedurally positive, indicating GHRS gathered the data or protocol changes requested. Yet there is no confirmation that safety or CMC issues are fully resolved, nor a projected review timeline (typically 30 days for partial holds, but variable). Investors should view the news as necessary but not sufficient for value inflection. Capital needs and trial delays remain key risk factors until the hold is officially lifted.

Regulatory Risk Specialist

TL;DR: Regulatory milestone reached; materiality pending FDA verdict—overall neutral impact.

Submitting a complete response signals GH Research has met internal readiness to satisfy FDA queries. Nonetheless, the disclosure lacks detail on the nature of prior deficiencies (e.g., toxicology, manufacturing, clinical design). Because the FDA can respond with additional requests or maintain the hold, investor visibility on timing and probability of trial resumption remains low. Absent new guidance, today’s filing should be classified as moderately positive process news but not yet a catalyst.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER

THE SECURITIES EXCHANGE ACT OF 1934

For the month of June, 2025.

Commission File Number: 001-40530

GH Research PLC

(Exact name of registrant as specified in its charter)

Joshua Dawson House

Dawson Street

Dublin 2

D02 RY95

Ireland

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of

Form 20-F or Form 40-F:

Form 20-F ☒ Form 40-F

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On June 20, 2025, GH Research PLC (the “Company”) 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”). A copy of the press release is exhibited hereto as Exhibit 99.1.

The fact that this press release is being made available and furnished herewith should not be deemed an admission as to the materiality of any information contained in the materials. The information contained in the press release is being provided as of June 20, 2025, and the Company does not undertake any obligation to update the press release in the future or to update forward-looking statements to reflect subsequent actual results.

1

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release dated June 20, 2025

2

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	GH Research PLC
Date: June 20, 2025
	By:	/s/ Julie Ryan
	Name:	Julie Ryan
	Title:	Vice President, Finance

3

FAQ

What did GH Research PLC (GHRS) announce in its June 20 2025 Form 6-K?

The company reported it has submitted a complete response to the FDA regarding the clinical hold on its IND for GH001.

Does the filing confirm that the FDA has lifted the clinical hold on GH001?

No. The document only states that a response was submitted; it does not indicate any FDA decision.

Why is the submission of a complete response important for GHRS investors?

It is a necessary regulatory step toward resuming U.S. clinical trials of GH001, the company’s lead asset.

Were any financial results or earnings figures included in this 6-K?

No financial data was provided; the filing focuses solely on the regulatory update.

What is the next potential catalyst following this submission?

An FDA decision on whether to lift, modify, or maintain the clinical hold on the GH001 IND.