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Helus Pharma Unveils HLP003 Data at Psych Congress 2026, Advancing Major Depressive Disorder Treatment

By Burstable Health Team•
Helus Pharma presented new 12-month efficacy, safety, and patient experience data for its investigational oral antidepressant HLP003 at Psych Congress 2026, alongside an update on its ongoing Phase 3 PARADIGM program, signaling progress toward a potential new adjunctive treatment for major depressive disorder.
Helus Pharma Unveils HLP003 Data at Psych Congress 2026, Advancing Major Depressive Disorder Treatment

Helus Pharma, the commercial operating name of Cybin Inc., announced the presentation of four posters evaluating HLP003, its investigational oral deuterated psilocin analog, at Psych Congress 2026 in New Orleans. The company is developing HLP003 as an adjunctive treatment for major depressive disorder (MDD). The presentations come as the company advances the drug through late-stage clinical development.

Three of the posters build on Helus Pharma's completed Phase 1/2a randomized, double-blind study of HLP003. These presentations include 12-month efficacy results, analyses of anhedonia and the psychedelic experience, and expanded safety data. The fourth poster provides a trial-in-progress overview of PARADIGM, the company's ongoing Phase 3 clinical program evaluating the efficacy and safety of HLP003 as an adjunctive treatment for MDD. The full press release can be viewed at https://ibn.fm/R2a0h.

The news matters because MDD remains a leading cause of disability worldwide, and many patients do not achieve adequate relief from currently available antidepressants. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration, a status designed to expedite the development and review of drugs that may offer substantial improvement over existing therapies. The 12-month efficacy and safety data presented at Psych Congress 2026 could bolster the case for HLP003 as a durable treatment option, while the PARADIGM Phase 3 program represents the final stage before potential regulatory submission.

Helus Pharma, founded in 2019, is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs)—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company's NSAs aim to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. In addition to HLP003, Helus Pharma is developing HLP004, another proprietary NSA in Phase 2 for generalized anxiety disorder, and has an extensive research portfolio of investigational NSAs. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit www.helus.com.

PsychedelicNewsWire (PNW), a specialized communications platform focused on the psychedelics sector, disseminated the announcement. PNW is one of 75+ brands within the Dynamic Brand Portfolio at IBN, which provides wire solutions through InvestorWire, editorial syndication to 5,000+ outlets, press release enhancement, social media distribution, and corporate communications solutions.

For healthcare providers and patients, the data presented at Psych Congress 2026 offer a glimpse into a potential new class of oral antidepressants that may provide rapid and sustained relief. If HLP003 succeeds in Phase 3, it could become an important adjunctive option for treatment-resistant depression, potentially improving outcomes for millions. The psychedelic medicine field continues to attract significant investment and research interest, and Helus Pharma's progress underscores the growing momentum behind serotonergic therapies. More information is available at PsychedelicNewsWire.

Burstable Health Team

Burstable Health Team

@burstable

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