Psychedelic Medicine Advances: Here Are Five Companies Targeting CNS Disorders
Issued on behalf of Helus Pharma
VANCOUVER, BC, Feb. 26, 2026 /CNW/ -- USA News Group News Commentary – The first psilocybin compound to achieve two positive Phase 3 results in treatment-resistant depression cleared that milestone this week, signaling a potential shift in how regulators and investors view psychedelic-based psychiatry[1]. The pathway is widening at the federal level, where the Drug Enforcement Administration raised its 2026 psilocybin production quota by 67%[2]. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), Relmada Therapeutics (NASDAQ: RLMD), Alto Neuroscience (NYSE: ANRO), and Axsome Therapeutics (NASDAQ: AXSM).
The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity[3]. The pipeline is moving to meet it, and the capital 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.
CONTINUED… Read this and more news for Helus Pharma at:
In other industry developments:
Compass Pathways (NASDAQ: CMPS) this week reported positive results from two pivotal Phase 3 trials evaluating COMP360, a synthetic psilocybin compound, in patients with treatment-resistant depression. The larger trial, COMP006, enrolled 581 participants across international sites and demonstrated a highly statistically significant reduction in symptom severity, with a p-value below 0.001 and a mean treatment difference of 3.8 points on the MADRS depression scale at Week 6.
The company has submitted a request to the FDA to discuss a rolling submission and review, a pathway that could shorten the timeline to a potential approval filing. Across both Phase 3 studies, 39% of participants receiving the 25 mg dose achieved a clinically meaningful reduction in depression scores at Week 6, with durable effects observed through 26 weeks after just one or two administrations.
COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression, a condition that affects roughly one-third of patients who do not respond to standard antidepressants. Most treatment-emergent adverse events were mild or moderate, with the vast majority resolving within 24 hours. The company expects 26-week durability data from COMP006 in early Q3 2026.
Relmada Therapeutics (NASDAQ: RLMD) in January confirmed that the FDA has aligned on the registrational development pathway for NDV-01, a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle invasive bladder cancer. The agency indicated that a single-arm, open-label pivotal trial is appropriate for second-line refractory high-grade patients with carcinoma in situ, one of the most treatment-resistant bladder cancer populations.
"A single-arm pivotal study in this setting represents a meaningful opportunity to advance an in-office, bladder-sparing therapy for patients who have few if any effective alternatives," said Raj S. Pruthi, MD, Chief Medical Officer at Relmada Therapeutics. "This study represents the fastest path to approval for NDV-01."
The company anticipates initiating both registrational trials in the first half of 2026. NDV-01 is designed to be administered in-office in under five minutes without anesthesia or specialized equipment, with bladder retention and gradual drug release over ten days. Non-muscle invasive bladder cancer represents 75% to 80% of all bladder cancer cases, with over 744,000 prevalent cases in the United States and recurrence rates of 50% to 80% over five years.
Alto Neuroscience (NYSE: ANRO) recently completed enrollment in its Phase 2 proof-of-concept trial of ALTO-101, a novel transdermal PDE4 inhibitor for cognitive impairment associated with schizophrenia. The randomized, double-blind, placebo-controlled crossover study enrolled 83 patients across 13 clinical sites in the United States, with topline data expected around the end of Q1 2026.
"This milestone brings us closer to potentially delivering a first-of-its-kind treatment for the millions of patients suffering from the debilitating cognitive effects of schizophrenia," said Amit Etkin, MD, PhD, founder and CEO of Alto Neuroscience. "Our baseline results have already replicated findings from three independent datasets, reinforcing our confidence in ALTO-101's mechanism and our biomarker-driven approach."
There are currently no approved pharmacologic treatments for cognitive impairment in schizophrenia, a condition affecting nearly all patients with the disorder and a primary driver of long-term functional disability. ALTO-101 is delivered through a proprietary transdermal system developed with MEDRx, designed to reduce the gastrointestinal side effects common to oral PDE4 inhibitors while maintaining central nervous system target engagement. The FDA has granted ALTO-101 Fast Track Designation for this indication.
Axsome Therapeutics (NASDAQ: AXSM) in December announced that the FDA has accepted and granted Priority Review to its supplemental New Drug Application for AXS-05, a novel NMDA receptor antagonist and sigma-1 agonist, for the treatment of Alzheimer's disease agitation. The PDUFA target action date is April 30, 2026.
"Up to 76% of people with Alzheimer's disease experience agitation, representing a significant unmet medical need for patients and their caregivers, and currently there is a dearth of approved treatments," said Herriot Tabuteau, MD, CEO of Axsome Therapeutics. "We look forward to continuing to work with the FDA for the remainder of the review."
AXS-05 previously received FDA Breakthrough Therapy designation for Alzheimer's agitation in 2020 and is already approved in the United States as Auvelity for the treatment of major depressive disorder in adults. The supplemental NDA is supported by four randomized, double-blind, controlled Phase 3 trials and a long-term safety study. Approximately 7 million Americans live with Alzheimer's disease, and the company's patent estate for AXS-05 extends through at least 2043.
Article Source: https://usanewsgroup.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.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/
- https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment
- https://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-up
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