Psychedelic Biotechs Push Toward Phase 3: Five Companies Advancing CNS Treatments
Issued on behalf of Helus Pharma
VANCOUVER, BC, Feb. 27, 2026 /CNW/ -- Equity-Insider.com News Commentary -- Psychedelic compounds are edging closer to regulatory approval as pivotal trials in treatment-resistant depression and anxiety advance through late-stage development[1]. The sector is shedding its countercultural reputation as biotech firms reposition serotonergic and psychedelic-derived therapies as mainstream pharmaceutical candidates[2]. Five companies are building the clinical programs to get there: Helus Pharma (NASDAQ:HELP), AtaiBeckley (NASDAQ:ATAI), Definium Therapeutics (NASDAQ:DFTX), GH Research (NASDAQ:GHRS), and LB Pharmaceuticals (NASDAQ:LBRX).
A consensus statement from the U.S. National Network of Depression Centers published in The Lancet outlined considerations for integrating psychedelic into routine clinical practice, a signal that academic medicine is preparing for what the trials may deliver[3]. The clinical infrastructure is expanding, and the investment thesis is following.
Helus Pharma (NASDAQ:HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity.
Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation.
The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland.
Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom.
The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002).
Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%.
Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported.
"The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma.
HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter.
The company's lead asset HLP003, a proprietary oral compound granted FDA Breakthrough Therapy Designation, is advancing through two pivotal Phase 3 studies for the adjunctive treatment of major depressive disorder.
Phase 2 data on HLP003 demonstrated 100% response rates and 71% remission at 12 months after just two 16 mg doses, with an approximately 23-point reduction in MADRS scores.
The APPROACH pivotal Phase 3 study has topline data anticipated in Q4 2026, while the complementary EMBRACE Phase 3 study and EXTEND long-term extension study continue to progress.
Helus reported US$195.1 million in cash as of December 31, 2025, supporting continued advancement across its multi-asset clinical pipeline.
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In other industry developments:
AtaiBeckley (NASDAQ:ATAI) in January outlined its 2026 pipeline strategy ahead of the J.P. Morgan Healthcare Conference, reporting that its lead candidate BPL-003, a mebufotenin benzoate nasal spray for treatment-resistant depression, met its primary and all key secondary endpoints in Phase 2b. The company expects Phase 3 guidance in the first quarter and trial initiation by mid-year, with financial resources supporting operations into 2029.
"Following the strategic combination of atai Life Sciences and Beckley Psytech completed last year and the recent corporate redomiciliation to the United States, we enter 2026 with meaningful momentum and a clear vision for the impact AtaiBeckley can deliver for people living with difficult-to-treat mental health conditions," said Dr. Srinivas Rao, Co-Founder and CEO of AtaiBeckley.
The company's broader pipeline includes VLS-01, a DMT buccal film for treatment-resistant depression with Phase 2 data expected in the second half of 2026, and EMP-01, an oral R-MDMA compound for social anxiety disorder with Phase 2a results anticipated this quarter. AtaiBeckley was added to the NASDAQ Biotechnology Index in December following its formation through the merger of atai Life Sciences and Beckley Psytech. A new patent granted in December covering its R-MDMA compound extends exclusivity through 2043.
Definium Therapeutics (NASDAQ:DFTX) in January completed its rebrand from MindMed, signaling its transition from a psychedelic research platform to a late-stage psychiatry company. Its lead candidate DT120, an LSD-derived orally disintegrating tablet with FDA Breakthrough Therapy Designation for generalized anxiety disorder, has three Phase 3 readouts expected in 2026. The company also dosed its first patient in a Phase 2a study of DT402 in autism spectrum disorder.
"We are unwavering in our mission to forge a new era of psychiatry by applying scientific rigor to psychedelics," said Rob Barrow, CEO of Definium Therapeutics. "With three Phase 3 readouts expected in 2026, we are uniquely positioned to validate the strength of our science, advance care for patients, and continue delivering long-term value for our shareholders."
The three trials include Voyage for generalized anxiety disorder in the second quarter, Emerge for major depressive disorder at mid-year, and Panorama for generalized anxiety disorder in the second half. A fourth Phase 3, Ascend, targeting major depressive disorder, is planned for mid-year initiation. Generalized anxiety disorder and major depressive disorder together affect over 50 million people in the United States. The ticker changed from MNMD to DFTX effective January 13.
GH Research (NASDAQ:GHRS) in January announced that the FDA lifted the clinical hold on GH001, its proprietary inhaled mebufotenin (5-MeO-DMT) formulation for treatment-resistant depression, clearing the path for U.S. subject enrollment. The compound's Phase 2b trial met its primary endpoint with a 15.5-point placebo-adjusted MADRS reduction on Day 8 (p<0.0001). The hold had paused U.S. enrollment while the company continued advancing its European clinical program.
"The FDA clearance is a major milestone and positions us to advance GH001 as a potential ultra-rapid and durable treatment option for TRD patients," said Dr. Velichka Valcheva, CEO of GH Research. "We continue to expect initiation of our global pivotal program in 2026."
The global Phase 3 program is expected to replicate the Phase 2b design, targeting initiation in 2026. GH001 is administered via proprietary inhalation in a clinical setting, with sessions lasting under an hour. The Dublin-based company's approach to treatment-resistant depression differs from oral psychedelic programs in that it targets 5-HT receptor subtypes through a rapid-onset delivery mechanism. The company has positioned GH001 as a potential practice-changing option for the roughly one-third of depression patients who do not respond to standard antidepressants.
LB Pharmaceuticals (NASDAQ:LBRX) in January initiated its Phase 2 ILLUMINATE-1 trial of LB-102 in bipolar depression, enrolling approximately 320 patients across 30 U.S. sites. LB-102 is a novel once-daily oral benzamide antipsychotic targeting D2, D3, and 5-HT7 receptors, with Phase 2 schizophrenia data showing statistically significant benefit at all doses studied.
"The initiation of this Phase 2 trial in patients with bipolar depression marks an important step in our strategy to expand the potential of LB-102 for the treatment of mood disorders," said Heather Turner, CEO of LB Pharmaceuticals. "We look forward to a number of late-stage clinical catalysts, including results from this Phase 2 trial in the first quarter of 2028, as well as from our planned Phase 3 trial in schizophrenia which remains on track to initiate this quarter."
The company closed a $100 million private placement in February, with participation from institutional investors including Balyasny, Deep Track, and Nantahala. LB-102 could become the first benzamide antipsychotic approved in the United States, addressing a market of approximately 7 million bipolar patients domestically and 40 million worldwide. Phase 2 data in schizophrenia showed low rates of extrapyramidal symptoms and minimal sedation, differentiating LB-102 from existing antipsychotics.
Article Source: https://equity-insider.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/
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SOURCES:
- https://www.nature.com/articles/d41591-025-00062-4
- https://www.bloomberg.com/news/articles/2025-12-26/psilocybin-aims-for-mainstream-as-a-psychedelic-treatment-for-depression
- https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00450-X/fulltext
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