GH Research to Announce IND Status for GH001

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.

Key Figures

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

Market Reality Check

$13.24 Last Close

Volume Relative volume at 0.37x with volume 87,475 vs 20-day average 234,402 ahead of the IND-status update. low

Technical Shares at $12.70, trading just below the 200-day MA of $12.83 and about 38.05% under the 52-week high.

Peers on Argus

GHRS was modestly higher pre-announcement, while peers showed mixed moves: MNMD +3.64%, KALV +3.46%, GYRE +0.57%, with PRAX and ZBIO slightly negative.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Nov 06	Q3 2025 earnings	Positive	-1.3%	Strong Phase 2b TRD data and solid cash position with IND dialogue ongoing.
Oct 09	Conference presentations	Positive	+0.1%	Announcement of ECNP symposium talk and posters on GH001 TRD data.
Aug 07	Q2 2025 earnings	Positive	-0.4%	Remarkable Phase 2b remission rates and strengthened cash via $150M offering.
Jul 23	Development update	Positive	-14.7%	Global pivotal program plans and resolution work on final FDA hold topic.

Pattern Detected

Recent positive clinical and earnings updates often saw muted or negative next-day price reactions, suggesting a tendency toward downside or underreaction on good news.

Recent Company History

Over the last six months, GH Research reported strong Phase 2b TRD data with a 73% remission rate at 6 months and significant MADRS score reductions, while working through a remaining FDA hold topic on the GH001 IND. Q2 and Q3 2025 earnings highlighted substantial cash balances and plans for a global pivotal program in 2026. Despite these seemingly positive milestones, the stock often reacted flat to negative the next day, framing today’s IND-status update notice against a backdrop of cautious price responses.

Market Pulse Summary

The stock is surging +18.7% following this news. A strong positive reaction aligns with growing attention on GH001’s regulatory trajectory and upcoming pivotal plans. Prior updates showed robust Phase 2b data and a planned global program in 2026, yet price responses were often muted. A large move on this announcement may reflect renewed focus on potential resolution of IND questions and Phase 3 readiness. Investors would likely monitor follow-up disclosures on January 5 and any changes in development timelines or trial design.

Key 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.

AI-generated analysis. Not financial advice.

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

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.