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Issued on behalf of Cybin D/B/A Helus Pharma
USANewsGroup.com News Commentary
The central nervous system therapeutics sector is approaching a commercial inflection point as multiple candidates advance through late-stage trials and regulatory milestones accumulate1. The Drug Enforcement Administration raised its 2026 production quotas for controlled research compounds by 67%, reflecting expanding clinical trial activity across the therapeutics landscape2. Five companies are working to translate that momentum into approved treatments: Helus Pharma (NASDAQ: HELP), Compass Pathways (NASDAQ: CMPS), AtaiBeckley (NASDAQ: ATAI), Definium Therapeutics (NASDAQ: DFTX), and GH Research (NASDAQ: GHRS).
The World Health Organization estimates that depression and anxiety cost the global economy more than $1 trillion annually in lost productivity3. Treatment-resistant depression alone affects roughly 30% of patients diagnosed with major depressive disorder, fueling demand for novel mechanisms that can deliver rapid, durable therapeutic responses where traditional antidepressants have failed4. The pipeline is moving to meet it, and pharmaceutical capital is following.
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.
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In other industry developments and happenings in the market include:
Compass Pathways (NASDAQ: CMPS) 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 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 results replicate findings from the first Phase 3 trial, COMP005, which showed a mean difference of 3.6 points (p<0.001).
"COMP360 has demonstrated a highly differentiated profile for treatment-resistant depression, with rapid and durable effects in patients facing significant unmet need," said Kabir Nath, CEO of Compass Pathways.
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. Most treatment-emergent adverse events were mild or moderate, resolving within 24 hours. COMP360 is the first classic psychedelic to achieve two highly statistically significant Phase 3 readouts in treatment-resistant depression. The company has submitted a request to the FDA to discuss a rolling New Drug Application submission beginning in Q4 2026.
AtaiBeckley (NASDAQ: ATAI) announced a successful FDA End-of-Phase 2 meeting for BPL-003, clearing the path for Phase 3 initiation in treatment-resistant depression targeted for Q2 2026. The FDA provided clear guidance aligning with the company's Breakthrough Therapy Designation granted in October 2025, enabling a Phase 3 program designed for real-world interventional psychiatry with two-hour in-clinic sessions and few treatments per year.
"This feedback builds on our compelling Phase 2b data as well as the Breakthrough Therapy Designation granted to BPL-003 and firmly positions us to advance a robust Phase 3 clinical program," said Srinivas Rao, M.D., Ph.D., Co-Founder and CEO of AtaiBeckley.
BPL-003, a nasal spray formulation, demonstrated statistically significant antidepressant effects at 8 mg and 12 mg doses in Phase 2b trials, with rapid and durable responses sustained out to Week 8. The company, formed through the 2025 merger of atai Life Sciences and Beckley Psytech, also expects topline data in H2 2026 from its Phase 2 study of VLS-01, a DMT buccal film for treatment-resistant depression, enrolling 142 patients. AtaiBeckley recently redomiciled to the United States, was added to the NASDAQ Biotechnology Index, and reports a cash runway extending into 2029, providing financial stability through multiple anticipated clinical catalysts.
Definium Therapeutics (NASDAQ: DFTX), formerly MindMed, reported full-year 2025 financial results, highlighting $411.6 million in cash, cash equivalents, and investments sufficient to fund operations into 2028. The company rebranded in January 2026 to reflect its focus on a late-stage psychiatry pipeline anchored by DT120 ODT, a lysergide tartrate compound that holds FDA Breakthrough Therapy Designation for generalized anxiety disorder.
"With our first Phase 3 MDD trial, Emerge, now fully enrolled and advancing toward topline data, and our Phase 3 GAD studies rapidly progressing, 2026 represents a monumental year for Definium," said Rob Barrow, CEO of Definium Therapeutics.
The Emerge study in major depressive disorder is fully enrolled with topline data expected in late Q2 2026. The Voyage and Panorama trials in generalized anxiety disorder are advancing toward enrollment completion, and the company plans to start the Ascend study in major depressive disorder in early to mid-2026. Across the DT120 program, at least three Phase 3 readouts are anticipated in 2026. Definium also dosed the first patient in a Phase 2a study of DT402 (R(-)-MDMA) for autism spectrum disorder, with initial data expected this year. R&D expenses rose to $117.7 million for 2025, up from $65.3 million in 2024, driven by the DT120 program expansion across multiple indications.
GH Research (NASDAQ: GHRS) announced that the FDA lifted the clinical hold on its Investigational New Drug application for GH001, a mebufotenin (5-MeO-DMT) therapy for treatment-resistant depression, enabling U.S. patient enrollment and clearing the path for global Phase 3 initiation in 2026. The FDA had placed a clinical hold in 2023 due to insufficient risk assessment information; the company submitted a complete response in June 2025 after completing the required toxicology studies.
"This is a major milestone for GH001 as a potential ultra-rapid, durable treatment for treatment-resistant depression," said Dr. Velichka Valcheva, CEO of GH Research.
The company's Phase 2b trial demonstrated a placebo-adjusted MADRS reduction of -15.5 points at Day 8 (p<0.0001), with 57.5% of patients achieving remission at Day 8 and 73% at six months with approximately four treatments on average. GH001 features a short median psychoactive exposure of 11 minutes, requires no psychotherapy, and showed no serious treatment-related adverse events, with 99% of participants discharge-ready within one hour. The company plans to seek FDA alignment on a global Phase 3 program design replicating the Phase 2b trial protocol.
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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
- https://www.nimh.nih.gov/health/statistics/major-depression
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