Why Is GHRS Stock Rising Today?

• The company is targeting the initiation of Phase 3 clinical trials this year.
• In an update about the GH001 Phase 2b clinical trial, GH Research stated that the primary endpoint was met with a highly significant placebo-adjusted reduction from baseline.
• It added that there were no treatment-related serious adverse events during the six-month trial duration.

GH Research PLC (GHRS) shares gained more than 42% in Monday’s opening session after the company announced a positive development in its depression treatment trials.

GH Research announced on Monday that the U.S. Food and Drug Administration (FDA) had lifted the clinical hold on GH001, its lead product candidate.

FDA Lifts Hold

In a filing with the U.S. Securities and Exchange Commission (SEC), GH Research stated that the FDA has cleared GH001 for a clinical investigation in the United States, subject to the enrollment of participants. The company is targeting the initiation of Phase 3 clinical trials this year.

“We continue to expect initiation of our global pivotal program in 2026. We look forward to meeting with the FDA to align on the design for the pivotal Phase 3 program,” said GH Research CEO Dr. Velichka Valcheva.

GH Research is a Dublin, Ireland-based clinical-stage biopharmaceutical company, focusing on the development of proprietary mebufotenin therapies for the treatment of patients with treatment-resistant depression (TRD).

GH001 Phase 2b Data

In an update about the GH001 Phase 2b clinical trial, GH Research stated that the primary endpoint was met with a highly significant placebo-adjusted reduction from baseline.

The company stated that a full analysis of the open-label extension (OLE) phase showed a 73% remission rate at six months with infrequent treatment visits and no mandated psychotherapeutic intervention.

Further, the company said that a safety analysis showed 100% of the patients from the double-blind (DB) part continued in the OLE. It added that there were no treatment-related serious adverse events during the six-month duration of the trial.

OLE is a phase of clinical trials in which participants may continue receiving the experimental treatment after completing the initial controlled phase.

How Did Stocktwits Users React?

Retail sentiment on Stocktwits regarding GH Research trended in the ‘extremely bullish’ territory at the time of writing. 

One Stocktwits user expects GHRS stock to rally further when the markets open.

GHRS stock is up 48% year-to-date and 108% over the past 12 months.

Also See: Why Is DVLT Stock Gaining Today?

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