Curated News
By: NewsRamp Editorial Staff
October 22, 2026
Helus Pharma Touts Phase 3 Progress for HLP003, Plans HLP004 Study
TLDR
- Helus Pharma's HLP003 holds FDA Breakthrough Therapy Designation and leads the race toward a 2028 NDA submission for MDD.
- Helus Pharma completed APPROACH enrollment of 223 participants and plans a 144-adult Phase 2 trial of HLP004.
- Helus Pharma's novel serotonergic agonists aim to deliver durable relief for people living with depression and anxiety.
- Helus Pharma, the commercial name for Cybin Inc., is developing synthetic molecules designed to activate serotonin pathways and promote neuroplasticity.
Impact - Why it Matters
The update from Helus Pharma signals meaningful progress in the clinical development of novel serotonergic agonists for major depressive disorder and generalized anxiety disorder—conditions that affect millions worldwide and often resist existing treatments. If HLP003 and HLP004 succeed in later-stage trials, they could offer new mechanisms of action and potentially durable relief for patients who have not responded to conventional therapies. The FDA’s Breakthrough Therapy Designation for HLP003 underscores the unmet need and regulatory recognition of its therapeutic potential. For investors, the advancement of both programs toward regulatory submission and commercialization represents a significant value catalyst, while for patients and clinicians, it offers hope for expanded treatment options in mental health care.
Summary
Helus Pharma™ (NASDAQ: HELP) (Cboe CA: HELP), the commercial operating name of Cybin Inc., provided updates on its lead drug candidates, HLP003 and HLP004, during an investor presentation on October 21, 2026. The company reaffirmed that topline results from its APPROACH Phase 3 study of HLP003 as an adjunctive treatment for major depressive disorder (MDD) remain on track for the fourth quarter of 2026. Enrollment of 223 participants in APPROACH was completed in July, while enrollment continues in EMBRACE, the second pivotal Phase 3 study. HLP003 has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), and Helus Pharma expects to submit a New Drug Application in 2028.
The company also outlined plans to initiate a Phase 2 study of HLP004 as a potential monotherapy for generalized anxiety disorder (GAD) in the first quarter of 2027. The randomized, double-blind, placebo-controlled study is expected to enroll approximately 144 adults to evaluate two 30 mg administrations of HLP004 against placebo, with primary and key secondary efficacy assessments at weeks six and 12, respectively. Helus Pharma said the advancement of both programs represents an important period as it works toward regulatory approval and potential commercialization. To view the full press release, visit https://ibn.fm/ahWlS.
Helus Pharma, founded in 2019, is a clinical-stage pharmaceutical company committed to helping minds heal by 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. With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more information, visit www.helus.com or follow the team on X, LinkedIn, YouTube, and Instagram. Helus Pharma™ is a trademark of Cybin Corp.
Source Statement
This curated news summary relied on content distributed by InvestorBrandNetwork (IBN). Read the original source here, Helus Pharma Touts Phase 3 Progress for HLP003, Plans HLP004 Study
