Issued on behalf of Cybin D/B/A Helus Pharma
VANCOUVER — Baystreet.ca News Commentary — The convergence of precision medicine, novel mechanisms, and regulatory support is driving a renaissance in neuropsychiatric drug development1. Federal production quotas for controlled substances used in clinical research rose sharply in 2026, reflecting a growing pipeline of psychedelic and serotonergic candidates moving through late-stage trials2. Four companies are targeting neuropsychiatric conditions with differentiated strategies: Helus Pharma (NASDAQ: HELP), Praxis Precision Medicines (NASDAQ: PRAX), Acadia Pharmaceuticals (NASDAQ: ACAD), and Johnson & Johnson (NYSE: JNJ).
More than one billion people globally live with a mental health condition, and existing treatments leave many undertreated or unresponsive3. In the United States, roughly 21 million adults experience at least one major depressive episode annually, with approximately 30% classified as treatment-resistant, creating a deep commercial runway for differentiated neuropsychiatric therapies4.
Helus Pharma™ (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing novel serotonergic agonists for serious mental health conditions, including major depressive disorder and generalized anxiety disorder.
Helus announced topline results from a Phase 2 signal detection study evaluating HLP004 as a potential adjunctive treatment for adults with moderate-to-severe generalized anxiety disorder who remained symptomatic despite ongoing standard-of-care antidepressant therapy. GAD affects more than 20 million adults in the United States, and no adjunctive pharmacologic treatment for the condition has ever been approved.
In the study, 36 patients were randomized to HLP004 20 mg or 2 mg and received two intramuscular doses three weeks apart. Patients receiving 20 mg adjunctive to standard of care achieved a mean HAM-A reduction of 10.4 points (p<0.0001) at six weeks. At six months, the pooled study population showed 67% responders and 39% remitters. Acute drug effects lasted approximately 90 minutes, with most participants ready for discharge within three hours.
“Patients living with generalized anxiety disorder remain significantly underserved, with many continuing to struggle despite currently available treatments,” said Michael Cola, CEO of Helus Pharma. “We are encouraged by these data and the potential for HLP004 to bring hope to GAD patients.”
“These Phase 2 results support the continued development of HLP004, and I am encouraged by the magnitude of improvement observed over standard of care treatments, together with the rapid onset and short in-clinic treatment experience for this patient population with limited options,” noted Dr. Andrew Cutler, Clinical Professor of Psychiatry at SUNY Upstate Medical University and Senior Advisor to Helus Pharma.
Helus also recently appointed Dr. Freda Lewis-Hall to its Board of Directors and as Chair of the company’s Scientific Advisory Committee. Lewis-Hall served for more than a decade on Pfizer’s Executive Leadership Team as Executive Vice President and Chief Medical Officer. During her tenure, she helped lead the spinout of SpringWorks Therapeutics, which was later acquired by Merck KGaA for approximately $3.4 billion.
“What distinguishes Helus Pharma is its disciplined approach at the intersection of rigorous science, a thoughtfully advancing clinical portfolio, and focused execution in areas of significant unmet need in mental health,” said Dr. Lewis-Hall.
Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026 and began trading on the NASDAQ under the ticker HELP. The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041.
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:
https://usanewsgroup.com/2026/02/24/this-fda-breakthrough-depression-drug-just-hit-nature-medicine-wall-street-says-its-worth-22-share/
In other industry developments and happenings in the market include:
Praxis Precision Medicines (NASDAQ: PRAX) reported fourth quarter and full-year 2025 financial results, highlighting pipeline progress across its neuroscience portfolio. The company submitted a New Drug Application for ulixacaltamide in essential tremor, supported by positive Phase 3 data and FDA Breakthrough Therapy Designation, with commercial launch preparations underway and potential approval in 2026.
“After a landmark fourth quarter, we started 2026 with two NDA submissions,” said Marcio Souza, president and CEO of Praxis. “Together, these four assets have a revenue potential of over $20 billion.”
Relutrigine, a sodium channel modulator with FDA Breakthrough Therapy and Orphan Drug Designations for developmental and epileptic encephalopathies, advanced through the Phase 2 EMBOLD study with robust seizure improvements in SCN2A and SCN8A patient populations. The company is accelerating commercial preparations for PRAX-100 targeting SCN2A loss-of-function mutations. Vormatrigine demonstrated fast-acting efficacy and seizure freedom potential in Phase 2 RADIANT data, positioning it as a best-in-class sodium channel modulator. With multiple NDA submissions and pivotal data expected in 2026, Praxis ended 2025 with $489.5 million in cash and marketable securities, supporting operations into late 2027.
Acadia Pharmaceuticals (NASDAQ: ACAD) reported fourth quarter and full-year 2025 financial results, surpassing $1 billion in annual revenue for the first time with GAAP total revenues of $1.07 billion (up 12% year-over-year). NUPLAZID GAAP net sales reached $680 million for the year, driven by volume growth in Parkinson’s disease psychosis, while DAYBUE generated $391 million (up 12%) for Rett syndrome. Q4 GAAP net income reached $274 million, boosted by a $250 million non-cash tax benefit from releasing the deferred tax asset valuation allowance.
“Acadia closed 2025 with another strong quarter, capping a milestone year,” said Catherine Owen Adams, CEO of Acadia Pharmaceuticals.
The company issued 2026 guidance for total revenues of $1.22 to $1.28 billion, including NUPLAZID net sales of $760 to $790 million and DAYBUE net sales of $460 to $490 million. Acadia shipped first patient supply of DAYBUE STIX, a bioequivalent powder formulation targeting approximately 400 additional patients by 2028, with broader launch planned for early Q2 2026. The company anticipates topline results from the Phase 2 RADIANT study of remlifanserin in Alzheimer’s disease psychosis between August and October 2026 and ended 2025 with $820 million in cash and investments.
Johnson & Johnson (NYSE: JNJ) presented new data at the 2026 American College of Neuropsychopharmacology Annual Meeting, highlighting multiple treatments for major depressive disorder and treatment-resistant depression. The company acquired Intra-Cellular Therapies for $14.6 billion in early 2025, gaining control of CAPLYTA (lumateperone) and subsequently securing FDA approval as an adjunctive therapy for MDD, opening a U.S. market over 10 times larger than its initial schizophrenia indication.
“At Johnson & Johnson, we are tackling the greatest unmet needs for patients living with depression, schizophrenia and bipolar disorder with the ultimate goal of remission from disease,” said Bill Martin, Ph.D., Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Innovative Medicine.
Phase 3 analyses showed CAPLYTA combined with antidepressants achieves MDD symptom remission in adult patients, building on existing approvals for schizophrenia (2019) and bipolar depression (2022). Seltorexant, a selective orexin-2 receptor antagonist currently in development, demonstrated better tolerability than quetiapine XR for MDD with insomnia symptoms, while SPRAVATO (esketamine) showed reduction in anhedonia symptoms in treatment-resistant depression patients. CAPLYTA’s once-daily dosing, no titration requirement, and favorable tolerability profile with low weight gain, metabolic, and motor side effects position it strongly against established antidepressants.
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:
1. https://www.statnews.com/2026/02/17/compass-pathways-comp360-psilocybin-severe-depression-trial-results/
2. https://www.federalregister.gov/documents/2026/01/05/2025-24277/established-aggregate-production-quotas-for-schedule-i-and-ii-controlled-substances-and-assessment
3. https://www.who.int/news/item/02-09-2025-over-a-billion-people-living-with-mental-health-conditions-services-require-urgent-scale-up
4. https://www.nimh.nih.gov/health/statistics/major-depression
