Shares of GH Research PLC GHRS have rallied 54.8% in a week after the company, on Feb. 3, 2025, announced that it has met the primary goal in a mid-stage study of its investigational, inhalable mebufotenin product candidate, GH001, to treat patients with treatment-resistant depression (TRD).

Per the data readout from the phase IIb TRD study, 40 patients treated with GH001 achieved a significant 15.2-point reduction in Montgomery-Åsberg Depression Rating Scale (MADRS) score by Day 8, while the placebo group, comprising 41 patients, showed a slight increase of 0.3 points. Please note that MADRS is a metric showing the improvement of depressive symptoms in patients compared with placebo after the treatment period.

It was observed that most patients receiving GH001 achieved remission with a 57.5% remission rate on Day 8 compared with 0% in the placebo group. Furthermore, in the open-label extension (OLE) portion of the phase IIb study, TRD patients who had remission on Day 8 after their first dosage had a 91.7% remission rate at six months.

In the past three months, shares of GH Research have surged 74% against the industry’s 8.7% decline.

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Additionally, treatment with the candidate also met all secondary endpoints in the phase IIb study on Day 8 with clinically and statistically significant improvements on Day 8 compared with placebo.

For many TRD patients, existing therapies have proven ineffective, often leading to years of severe mental distress and significant impairment in daily life. Per GH Research, a novel treatment like GH001, offering a rapid and substantial effect, especially with the convenience of infrequent, short clinic visits lasting just 1-3 hours, has the potential to revolutionize clinical practice for the TRD indication.

GH Research reported that GH001 was well tolerated, with no serious adverse events reported on Day 8 of the phase IIb TRD study. All treatment-emergent adverse events were mild or moderate, with no severe events or reports of flashbacks. Safety analysis in the OLE portion of the mid-stage study is ongoing with no serious adverse events reported to date.

GHRS’ Ongoing Clinical Pipeline Development Programs

Apart from the TRD indication, GH Research is also currently evaluating GH001 for bipolar II disorder and postpartum depression in separate mid-stage proof-of-concept studies. Last month, the company reported meeting the primary endpoints of a significant reduction in MADRS total scores on Day 8 in both studies.

The company’s second mebufotenin product candidate, GH002, is currently undergoing early-stage development as an intravenous injection for treating psychiatric and neurological disorders.

GH Research PLC Price and Consensus

GH Research PLC price-consensus-chart | GH Research PLC Quote

GHRS' Zacks Rank & Stocks to Consider

GH Research currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL, BioMarin Pharmaceutical BMRN and Alnylam Pharmaceuticals ALNY. While CSTL and BMRN currently sporta Zacks Rank #1 (Strong Buy) each, ALNY carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, Castle Biosciences’ earnings estimates for 2024 have increased from 34 cents to 45 cents per share. During the same timeframe, the loss per share for 2025 has improved from $1.84 to $1.70. In the past three months, shares of Castle Biosciences have plunged 15.6%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for BioMarin Pharmaceutical’s 2024 earnings per share have Improved from $3.28 to $3.29. Estimates for 2025 earnings per share have decreased from $4.05 to $4.01 during the same timeframe. In the past three months, BioMarin Pharmaceutical shares have lost 4.2%.

BMRN’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 28.7%.

In the past 30 days, estimates for Alnylam Pharmaceuticals’ 2024 loss per share have remained constant at 39 cents. The estimate for 2025 earnings per share is currently pegged at 41 cents. In the past three months, shares of Alnylam Pharmaceuticals have gained 2.3%.

ALNY’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.

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