Psychedelics guidance from the FDA set to benefit developers, including AtaiBeckley, Jefferies says
The US Food and Drug Administration's finalized guidance on psychedelic drug development signals the agency remains receptive to helping developers navigate the approval process, a development that Jefferies said could benefit companies including Compass Pathways (NASDAQ:CMPS), AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC), Cybin Inc. (NYSE-A:CYBN, FRA:R7E), GH Research (NASDAQ:GHRS), Awakn Life Sciences (NEO:AWKN) and others in the sector. The firm wrote on Monday that the final guidance, alongside the FDA's plans to hold a public hearing on September 14, points to a more supportive regulatory environment that could reduce regulatory risk for psychedelic drug developers.
GH Research: Rapid Onset And Short Action Change The Treatment Paradigm
GH Research is advancing GH001, an inhalable mebufotenin therapy, in treatment-resistant depression. GH Research's Phase 2b data was strong, and a global Phase 3 program is expected in 2026. While the rapid onset and short psychedelic experience duration offered by GH001 are compelling it remains to be seen how the drug stacks up against peers under real-world conditions.
GH Research FY25 Results: Strong Cash Position As GH001 Advances Toward Phase 3
GH Research PLC remains well-capitalized with $280.7 million in cash, supporting its lead candidate GH001 for Treatment-Resistant Depression. GHRS's investment thesis centers on replicating strong Phase 2b efficacy for GH001 in a pivotal Phase 3 trial, with rapid, durable antidepressant effects and operational simplicity. The FDA has cleared GH001 for U.S. clinical investigation, positioning GHRS for a global Phase 3 program starting in 2026 without immediate capital constraints.
GH Research: GH001 Shows Robust Data Ahead Of FDA IND Decision
GH Research is advancing GH001, an inhaled mebufotenin therapy for treatment-resistant depression, with a critical FDA IND update imminent. GH001 demonstrated robust Phase 2b efficacy—a 15.5-point MADRS reduction at Day 8 and 73% six-month remission—with infrequent dosing and strong safety. GHRS maintains a disciplined cost structure, $293.9M in cash, and a projected runway exceeding five years at current burn rates.
Wall Street Analysts Think GH Research (GHRS) Could Surge 130.59%: Read This Before Placing a Bet
The average of price targets set by Wall Street analysts indicates a potential upside of 130.6% in GH Research (GHRS). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
atai Life Sciences poised to lead treatment-resistant depression market with psychedelic candidate
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) is gaining momentum in the psychedelics space, with Jefferies analysts highlighting the company's potential to leapfrog rival GH Research (NASDAQ:GHRS) and establish a leading position in the treatment-resistant depression (TRD) market with its intranasal 5-MeO-DMT candidate BPL-003. The analysts maintain a ‘Buy' rating and $7 price target on atai, about double the stock's price at the time of writing.
atai Life Sciences poised to lead treatment-resistant depression market with psychedelic candidate BPL-003
atai Life Sciences (NASDAQ:ATAI, ETR:9VC) is gaining momentum in the psychedelics space, with Jefferies analysts highlighting the company's potential to leapfrog rival GH Research (NASDAQ:GHRS) and establish a leading position in the treatment-resistant depression (TRD) market with its intranasal 5-MeO-DMT candidate BPL-003. The analysts maintain a ‘Buy' rating and $7 price target on atai, about double the stock's price at the time of writing.
Wall Street Analysts Believe GH Research (GHRS) Could Rally 107.25%: Here's is How to Trade
The average of price targets set by Wall Street analysts indicates a potential upside of 107.3% in GH Research (GHRS). While the effectiveness of this highly sought-after metric is questionable, the positive trend in earnings estimate revisions might translate into an upside in the stock.
GHRS Stock Rallies 55% in a Week: Here's What You Should Know
GH Research stock soars 55% in a week after the company meets the primary goal in a mid-stage depression study of its lead candidate, GH001.
Does GH Research (GHRS) Have the Potential to Rally 225.18% as Wall Street Analysts Expect?
The mean of analysts' price targets for GH Research (GHRS) points to a 225.2% upside in the stock. While this highly sought-after metric has not proven reasonably effective, strong agreement among analysts in raising earnings estimates does indicate an upside in the stock.
3 Fast-Growing Stocks Analysts See Doubling in Price
Comparing and selecting stocks for investment may involve any number of increasingly complex strategies and approaches, but sometimes simpler is better: targeting a stock with significant upside potential at an opportune moment. Certainly, achieving this goal is easier said than done, and there is no guarantee that a company expected to make sizable gains will follow through on that promise.
GH Research (GHRS) Moves to Buy: Rationale Behind the Upgrade
GH Research (GHRS) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).
