GH Research to Announce IND Status for GH001

GH Research (Nasdaq: GHRS) said it will provide an update on the Investigational New Drug (IND) status for GH001 and on its global pivotal Phase 3 program in treatment-resistant depression (TRD).

Rhea-AI Summary

GH Research (Nasdaq: GHRS) said it will provide an update on the Investigational New Drug (IND) status for GH001 and on its global pivotal Phase 3 program in treatment-resistant depression (TRD).

The company plans to deliver the update on Monday, January 5, 2026 at 7:00 a.m. EST. The announcement focuses on regulatory progress and the Phase 3 program timeline.

Argus Jan 5 session

+16.77% close to close Open Argus

Details

News Market Reaction – GHRS

On Jan 5, the first trading day after this news, GHRS closed 16.77% above the previous close.

Data tracked by StockTitan Argus for the Jan 5 session.

Key Figures

Update date: January 5, 2026 Update time: 7:00 a.m. EST

Update date

January 5, 2026

Scheduled IND status and Phase 3 program update

Update time

7:00 a.m. EST

Planned release time for IND-status announcement

Historical Context

4 past events · Latest: Nov 06

4 events

1. Nov 06

   Q3 2025 earnings

   24h Move

   -1.3%

   Strong Phase 2b TRD data and solid cash position with IND dialogue ongoing.

2. Oct 09

   Conference presentations

   24h Move

   +0.1%

   Announcement of ECNP symposium talk and posters on GH001 TRD data.

3. Aug 07

   Q2 2025 earnings

   24h Move

   -0.4%

   Remarkable Phase 2b remission rates and strengthened cash via $150M offering.

4. Jul 23

   Development update

   24h Move

   -14.7%

   Global pivotal program plans and resolution work on final FDA hold topic.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

investigational new drug application, fda, phase 3, treatment-resistant depression

4 terms

investigational new drug application regulatory

"status of its Investigational New Drug Application (IND) for GH001"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

fda regulatory

"with the U.S. Food and Drug Administration (FDA)"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

phase 3 medical

"its global pivotal Phase 3 program in treatment-resistant depression"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

treatment-resistant depression medical

"global pivotal Phase 3 program in treatment-resistant depression (TRD)"

A form of major depression that does not improve after a person has tried standard treatments such as common antidepressant medications and therapy; think of it as a stubborn problem that doesn’t respond to the usual fixes. It matters to investors because it represents a large unmet medical need and a higher-risk, higher-reward area for drug developers, with potential for premium pricing, regulatory scrutiny, and durable demand if an effective new therapy is approved.

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DUBLIN, Jan. 02, 2026 (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 reported that it will provide an update on the status of its Investigational New Drug Application (IND) for GH001 with the U.S. Food and Drug Administration (FDA) and its global pivotal Phase 3 program in treatment-resistant depression (TRD) on Monday, January 5, 2026, at 7.00 a.m. EST.

About GH Research PLC

GH Research PLC is a clinical-stage biopharmaceutical company dedicated to transforming the lives of patients by developing a practice-changing treatment in depression. GH Research PLC's initial focus is on developing its novel and proprietary mebufotenin therapies for the treatment of patients with TRD.

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 the potential to change the way TRD is treated today.

Investor Relations:
Julie Ryan
GH Research PLC
investors@ghres.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When will GH Research (GHRS) provide the IND status update for GH001?

GH Research will provide the IND status update on Monday, January 5, 2026 at 7:00 a.m. EST.

What will GH Research (GHRS) update investors about regarding GH001?

The update will cover the IND status for GH001 with the FDA and progress on the global pivotal Phase 3 TRD program.

Which regulatory agency is GH Research (GHRS) discussing for GH001 IND status?

The company is discussing the IND status with the U.S. Food and Drug Administration (FDA).

What condition is GH001 being developed to treat for GH Research (GHRS)?

GH001 is being developed to treat treatment-resistant depression (TRD).

How can investors follow GH Research's (GHRS) January 5, 2026 update?

Investors should check the company's investor relations channels for the scheduled update on January 5, 2026 at 7:00 a.m. EST.