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Helus Pharma reports news on clinical-stage pharmaceutical development for novel serotonergic agonists in mental health. Recurring updates cover HLP003 for major depressive disorder, HLP004 for generalized anxiety disorder, clinical and regulatory disclosures, research collaborations, and medical or scientific leadership.
Company news also includes governance changes, executive and advisory appointments, shareholder voting matters, capital-structure disclosure, operating and financial results, and participation in healthcare and life-sciences forums tied to the company's depression and anxiety pipeline.
Helus Pharma (HELP)/b) announced that CEO Michael Halstead will participate in a fireside chat at the Morgan Stanley 24th Annual Global Healthcare Conference in New York City. The session will be webcast live on Wednesday, September 16, 2026 at 8:30 a.m. EDT. A replay of the webcast will later be available on the Events & Presentations page of Helus Pharma’s investor relations website.
Helus Pharma (HELP) will participate in the H.C. Wainwright 28th Annual Global Investment Conference in New York City from September 14-16, 2026. CEO Michael Halstead is scheduled for a fireside chat on Monday, September 14, 2026 at 9:00 a.m. EDT, which will be webcast live. Registration is available via the provided webcast link, and a replay will be posted on the Events & Presentations page of Helus Pharma’s investor relations website.
Helus Pharma (HELP) will participate in a fireside chat at the Cantor Global Healthcare Conference in New York City, with CEO Michael Halstead speaking.
The session will be webcast live on Friday, September 11, 2026 at 8:00 a.m. EDT, with a replay available on the company’s investor relations Events & Presentations webpage.
Helus Pharma (Nasdaq: HELP; Cboe CA: HELP), a clinical-stage company developing novel serotonergic agonists for CNS disorders, appointed Regina Donohue as Chief People Officer and Suresh Durgam, M.D., to its Scientific Advisory Board on August 18, 2026.
According to Helus Pharma, Donohue previously served as Chief Human Resources Officer at Intra-Cellular Therapies, where she built the people strategy and HR infrastructure as the company grew into a 1,000+ employee commercial-stage organization and launched its first product. She earlier helped establish LEO Pharma’s U.S. subsidiary and led its HR function.
Helus Pharma said Durgam most recently was Executive Vice President and Chief Medical Officer at Intra-Cellular, overseeing global clinical development, data science, regulatory affairs, drug safety and medical affairs. He played a pivotal role in securing multiple FDA approvals for CAPLYTA (lumateperone) in schizophrenia, bipolar depression and adjunctive major depressive disorder.
Helus Pharma (Nasdaq: HELP) reported first quarter fiscal 2027 results and pipeline progress for the period ended June 30, 2026. The company appointed Michael Halstead as CEO, completed enrollment in APPROACH, its Phase 3 pivotal study of HLP003 in major depressive disorder, with topline data still expected in Q4 2026, and finished a drug-drug interaction study showing no meaningful pharmacokinetic interaction with six CYP450 substrates.
Enrollment continues in EMBRACE, the second Phase 3 PARADIGM study, and patients are rolling into EXTEND for long-term safety and durability data. HLP004 Phase 2 data in generalized anxiety disorder showed statistically significant, clinically meaningful improvement and durable responses. Helus Pharma ended the quarter with $166.4 million in cash, completed a $50 million underwritten offering, and reported a quarterly net loss of $47.8 million, driven by higher R&D and operating expenses as Phase 3 programs advanced.
Helus Pharma (Nasdaq: HELP; Cboe CA: HELP) announced that CEO Michael Halstead will join a fireside chat at the Canaccord Genuity 46th Annual Growth Conference, held August 11-12, 2026, in Boston. The session will be webcast live on Wednesday, August 12, 2026, at 12:00 p.m. EDT, with a replay available on the company’s investor relations Events & Presentations page.
Helus Pharma (Nasdaq, Cboe CA: HELP) appointed Michael Halstead as Chief Executive Officer, effective immediately, as the company advances HLP003 and HLP004 in neuropsychiatric indications. Enrollment in APPROACH, the first pivotal Phase 3 study of HLP003 as an adjunctive treatment for major depressive disorder, is complete, with topline data expected in Q4 2026.
Enrollment continues in EMBRACE, the second pivotal PARADIGM study, and participants are rolling over into EXTEND, the long-term extension trial. Halstead brings 25 years of industry experience, including leadership of Intra-Cellular Therapies through the development and commercialization of CAPLYTA and its US$14.6 billion sale to Johnson & Johnson, plus prior transaction and integration roles at Warner Chilcott. According to Helus Pharma, the company’s portfolio of more than 350 patent applications and over 100 granted patents underpins its growth strategy.
Helus Pharma (Nasdaq: HELP) announced completion of enrollment, ahead of schedule, in APPROACH, its first Phase 3 pivotal study of HLP003 as an adjunctive treatment for major depressive disorder (MDD). The trial enrolled 223 adults with moderate to severe MDD (MADRS ≥24) inadequately responding to stable antidepressants and randomized them 1:1 to 16 mg HLP003 or placebo, each given as two doses three weeks apart.
According to Helus Pharma, the primary endpoint is MADRS change at six weeks versus placebo, with a key secondary endpoint at 12 weeks. Topline data are on track for Q4 2026. HLP003, a deuterated psilocin analogue, has FDA Breakthrough Therapy Designation and earlier Phase 2 data showed a ~23‑point mean MADRS reduction 12 months after dosing, with high response and remission rates. Enrollment continues in EMBRACE, the second pivotal study, and eligible participants may roll into the EXTEND long‑term extension. The company also reports a broad NSA patent portfolio with over 350 applications and more than 100 granted patents worldwide.
Helus Pharma (Nasdaq: HELP) reported fiscal 2026 results and pipeline progress. Cash was $157.3 million as of March 31, 2026, and a $50 million underwritten offering closed on June 25, 2026.
Lead asset HLP003 Phase 3 APPROACH is >88% enrolled with topline data expected in Q4 2026, while HLP004 showed ~10-point HAM-A improvement in GAD. Fiscal 2026 net loss was $148.0 million, with higher cash-based operating expenses of $131.7 million supporting late-stage trials.
Helus Pharma (Nasdaq: HELP, Cboe CA: HELP) closed a US$50 million underwritten offering of 10,309,280 common shares at US$4.85 per share. Underwriters received a US$3 million cash commission.
Net proceeds are intended to fund HLP003 (Phase 3 for major depressive disorder), HLP004 for generalized anxiety disorder, HLP005, and for working capital and general corporate purposes. Phase 3 APPROACH data for HLP003 are expected in Q4 2026.