Issued on behalf of Helus Pharma
VANCOUVER – Baystreet.ca News Commentary – A growing body of clinical evidence is pushing neuroscience-based therapies from early research into late-stage development, with multiple compounds now approaching regulatory milestones across depression, anxiety, and movement disorders[1]. The global mental health medications market is projected to reach $25.76 billion in 2026 and grow to $44.26 billion by 2035, reflecting sustained institutional demand for novel CNS therapeutics[2]. Five companies are advancing programs across that landscape: Helus Pharma (NASDAQ: HELP), Acadia Pharmaceuticals (NASDAQ: ACAD), Supernus Pharmaceuticals (NASDAQ: SUPN), Neurocrine Biosciences (NASDAQ: NBIX), and Praxis Precision Medicines (NASDAQ: PRAX).
Recent commentary in Nature Neuroscience emphasized that the field's rapid growth now requires rigorous pharmacological grounding to sustain credibility with regulators and clinicians[3]. The science is maturing, and the programs behind it are keeping pace.
Helus Pharma (NASDAQ: HELP) is a clinical-stage pharmaceutical company developing treatments for depression and anxiety. Its approach centers on novel serotonergic agonists, synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity.
Originally founded as Cybin in 2019, the company rebranded to Helus Pharma in January 2026, pronounced "Heal-Us," and began trading on the NASDAQ under the ticker HELP. The name reflects its transition toward a commercial-ready pharmaceutical operation.
The company holds over 350 filed patents with more than 100 already granted, providing protection around its lead programs through at least 2041. It operates across Canada, the United States, the United Kingdom, and Ireland.
Recently, Nature Medicine published results from a randomized, placebo-controlled Phase 2a trial of SPL026 in patients with moderate-to-severe major depressive disorder. The study enrolled 34 participants across three clinical sites in the United Kingdom.
The study met its primary endpoint. Participants receiving a single 21.5 mg dose showed a mean MADRS difference of -7.35 versus placebo (p=0.023), with effects appearing within one week (p=0.002).
Response rates at two weeks reached 35% versus 12% for placebo. Remission rates were 29% versus 12%.
Effects were sustained for up to three months, with some participants maintaining improvements for up to six months. No treatment-related serious adverse events were reported.
"The findings provide clinical proof-of-concept for short-acting serotonergic modulation and further support our conviction that our novel serotonergic agonist molecules, such as HLP004, can potentially deliver meaningful outcomes with greater consistency and commercial feasibility," said Michael Cola, CEO of Helus Pharma.
HLP004, a proprietary intramuscular compound informed by the SPL026 clinical insights, is now in Phase 2 for generalized anxiety disorder. Helus expects topline data from that study this quarter.
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:
Acadia Pharmaceuticals (NASDAQ: ACAD) recently provided an update on its European regulatory submission for trofinetide, the first treatment approved for Rett syndrome in the United States, Canada, and Israel. The company reported that more than 1,000 patients are now on active treatment globally, ranging from newly diagnosed two-year-olds to adults who have lived with the condition for decades.
"We believe the strong data that supported the approval of trofinetide for the treatment of Rett syndrome in the United States, Canada, and Israel speak to the meaningful benefits that trofinetide can deliver," said Catherine Owen Adams, CEO of Acadia Pharmaceuticals. "Our commitment to the Rett syndrome community in the EU remains steadfast, and we are fully dedicated to making trofinetide available to individuals and families who urgently need a new therapeutic option."
Trofinetide is marketed in the United States as DAYBUE and addresses Rett syndrome, a rare genetic neurological disorder occurring in approximately 1 in 10,000 to 15,000 female births worldwide. The company's broader portfolio includes NUPLAZID (pimavanserin), a serotonin receptor inverse agonist approved for Parkinson's disease psychosis, positioning Acadia across both rare disease and neuropsychiatry. An ongoing real-world experience study continues to show outcomes consistent with results from the company's randomized clinical trials.
Supernus Pharmaceuticals (NASDAQ: SUPN) reported third-quarter revenues of $192.1 million, up 9% year over year, driven by a 52% increase in combined sales from its four growth products: Qelbree, GOCOVRI, ZURZUVAE, and ONAPGO. ZURZUVAE, the first oral treatment approved for postpartum depression, joined the portfolio through the company's acquisition of Sage Therapeutics in a deal valued at up to approximately $795 million.
"Our strong operating results continued into the third quarter of 2025, reflecting continued momentum from Qelbree and GOCOVRI, collaboration revenue from ZURZUVAE, and an encouraging start to the launch of ONAPGO," said Jack Khattar, President and CEO of Supernus Pharmaceuticals. "Our focus for the remainder of the year and into 2026 will be on the performance of our four growth products and the high-level operating performance across the business to deliver sustained growth and long-term value for shareholders."
The company's pipeline includes SPN-820, a novel mTORC1 mechanism compound entering Phase 2b for major depressive disorder, directly overlapping with the therapeutic space targeted by psychedelic and serotonergic programs. ONAPGO, the first subcutaneous apomorphine infusion device for advanced Parkinson's disease, generated $6.8 million in its first full quarter post-launch from over 1,300 enrollment forms across more than 450 prescribers.
Neurocrine Biosciences (NASDAQ: NBIX) recently reported full-year 2025 net product sales of $2.83 billion, up 22% year over year, with fourth-quarter sales of $798.3 million representing a 29% increase over the prior year period. INGREZZA, the company's treatment for tardive dyskinesia, generated $2.51 billion in annual sales with 2026 guidance of $2.7 to $2.8 billion.
"In 2026, we are focused on delivering strong, sustainable growth for INGREZZA and CRENESSITY while advancing our pipeline anchored by Phase 3 programs, including osavampator in major depressive disorder and direclidine in schizophrenia," said Kyle W. Gano, Ph.D., CEO of Neurocrine Biosciences.
CRENESSITY, approved for congenital adrenal hyperplasia, contributed $301.2 million in its first full year on the market with over 2,000 new patient enrollments. The company holds $2.54 billion in cash and investments and has initiated a Phase 2 trial of NBI-1065890, a next-generation VMAT2 inhibitor for tardive dyskinesia. Its Phase 3 programs in major depressive disorder and schizophrenia connect its commercial-stage platform to the same CNS indications targeted by earlier-stage psychedelic programs. Osavampator, a novel AMPA receptor positive allosteric modulator, represents a differentiated mechanism of action for MDD and is expected to generate data this year.
Praxis Precision Medicines (NASDAQ: PRAX) this week reported fourth-quarter and full-year 2025 results alongside a corporate update, disclosing two NDA submissions to the FDA for ulixacaltamide in essential tremor and relutrigine in developmental epileptic encephalopathies. Ulixacaltamide received Breakthrough Therapy Designation in December and is the first investigational therapy with positive Phase 3 results in essential tremor, a condition affecting approximately 7 million patients in the United States.
"After a landmark fourth quarter, filled with a breadth of clinical and regulatory advancements across our portfolio, we started 2026 with two NDA submissions for ulixacaltamide and relutrigine," said Marcio Souza, President and CEO of Praxis Precision Medicines. "Pending their expected positive reviews, we will be positioned to transition into a commercial company."
The company reported $926.1 million in cash and investments as of December 31, with an additional $621.2 million raised through a January 2026 public offering, funding operations into 2028. Phase 3 topline results for vormatrigine are expected in the second quarter of 2026, with the broader portfolio representing four clinical-stage assets targeting ion channel dysfunction in the central nervous system. More than 200,000 patients have expressed interest in the company's ESSENTIAL3 program for essential tremor.
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 CITED:
1. https://psychopharmacologyinstitute.com/publication/2025-in-review-fda-approvals-practice-guidelines-and-label-changes-in-psychiatry/
2. https://www.towardshealthcare.com/insights/mental-health-medications-market-sizing
3. https://www.nature.com/articles/s41593-025-02186-9
