GH Research Secures FDA Clearance for GH001 Clinical Trial

Written by Emily J. Thompson, Senior Investment Analyst

GHRS-2.35%

ATAI0%

JNJ+1.33%

Source: Benzinga

Updated: Jan 05 2026

0mins

Source: Benzinga

FDA Approval: The U.S. FDA lifted the clinical hold on GH Research Plc's GH001 trial, enabling the company to advance this potential ultra-rapid treatment for treatment-resistant depression, marking a significant milestone.
Trial Progress: In February 2025, GH001's Phase 2b trial met its primary endpoint, demonstrating a significant reduction of 15.2 points in the Montgomery-Åsberg Depression Rating Scale (MADRS) on Day 8, compared to a 0.3 point increase in the placebo group, indicating its strong antidepressant effect.
Market Outlook: GH Research anticipates initiating its global pivotal program in 2026, with the CEO stating that discussions with the FDA will align the design for the Phase 3 trial, further propelling the product's market entry.
Stock Reaction: GH Research shares surged 34.52% to $17.86 at the time of publication, reflecting positive market sentiment towards the FDA approval and optimistic expectations for future growth.

GHRS

$16.21+Infinity%1D

Analyst Views on GHRS

Wall Street analysts forecast GHRS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for GHRS is 28.60 USD with a low forecast of 19.00 USD and a high forecast of 35.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

6 Analyst Rating

6 Buy

0 Hold

0 Sell

Strong Buy

Current: 16.600

Low

19.00

Averages

28.60

High

35.00

Current: 16.600

Low

19.00

Averages

28.60

High

35.00

RBC Capital

Outperform

maintain

$33 -> $40

2026-01-23

New

Reason

RBC Capital

Price Target

$33 -> $40

AI Analysis

2026-01-23

New

maintain

Outperform

Reason

RBC Capital raised the firm's price target on GH Research to $40 from $33 and keeps an Outperform rating on the shares. Following the firm's Psychedelics Symposium and discussions with the management, payers, and doctors, RBC is increasingly optimistic on GH's long- term sales opportunity, with GH001, the analyst tells investors in a research note.

Cantor Fitzgerald

initiated

$25

2025-06-04

Reason

Cantor Fitzgerald

Price Target

$25

2025-06-04

initiated

Reason

Cantor Fitzgerald assumed coverage of GH Research with an Overweight rating and $25 price target. Data generated for psychedelics across a number of mental health disorders have been "transformational," and the unmet need is "enormous" and growing, the analyst tells investors in a research note. The firm says sees the psychedelic total addressable market ultimately reaching $50B per year, which would be roughly 1M-1.5M patients treated per year, still only modest penetration, and believes there is room for plenty of successful options and companies offering psilocybin and novel synthetic products.

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Guggenheim

Eddie Hickman

Strong Buy

Initiates

$32

2025-03-13

Reason

Guggenheim

Eddie Hickman

Price Target

$32

2025-03-13

Initiates

Strong Buy

Reason

Guggenheim analyst Eddie Hickman initiated coverage of GH Research with a Buy rating and $32 price target.

RBC Capital

Brian Abrahams

Buy

Initiates

$31

2025-03-07

Reason

RBC Capital

Brian Abrahams

Price Target

$31

2025-03-07

Initiates

Buy

Reason

RBC Capital initiated coverage of GH Research with an Outperform rating and $31 price target. The firm says the "dramatic" antidepressive effects observed in the Phase IIb study of GH001, the company's psychedelic with "many favorable properties" facilitating administration and delivery, should be replicable in Phase III and position the drug as a treatment of choice in the future paradigm. With the stock off its post-data highs, RBC sees a "compelling entry point." While the stock's major near-term catalysts may be more limited, there should be appreciation as GH's development progress ensues and enthusiasm for psychedelics continues to build, contends the firm.

About GHRS

GH Research PLC is a clinical-stage biopharmaceutical company. The Company is engaged in offering treatment for psychiatric and neurological disorders. The Company's pipeline includes GH001, GH002 and GH003. The Company focuses on developing its 5- Methoxy-N, N-Dimethyltryptamine, (5-MeO-DMT), therapies for the treatment of patients with Treatment Resistant Depression (TRD). Its product candidate, GH001, is formulated for 5-MeO-DMT administration via an inhalation approach. With GH001, the Company has completed two Phase 1 healthy volunteer clinical trials and a Phase 1/2 clinical trial in patients with treatment-resistant depression (TRD). The GH002 is a 5-MeO-DMT product candidate formulated for administration via an injectable approach. GH002 has completed pre-clinical development to support early clinical trials. The GH003 is a 5-MeO-DMT product candidate formulated for administration via an intranasal administration approach.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.