Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as chief executive officer, effective immediately. The move comes at a critical juncture for the clinical-stage pharmaceutical company, which is advancing its lead candidate HLP003 through Phase 3 development and positioning itself for potential commercialization.
Halstead brings over 25 years of biopharmaceutical leadership experience, most recently serving as president of Intra-Cellular Therapies. During his tenure there, he oversaw the development and commercialization of CAPLYTA, a treatment for bipolar depression, and supported pipeline expansion that contributed to the company's $14.6 billion acquisition by Johnson & Johnson in 2025. His appointment is seen as a strategic step to leverage his expertise in late-stage development and commercial readiness.
The appointment coincides with significant clinical milestones for Helus Pharma. Enrollment has been completed in the Phase 3 APPROACH trial for HLP003, with topline data expected in Q4 2026. The company continues enrollment in the EMBRACE pivotal study, also for HLP003, which has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for the adjunctive treatment of major depressive disorder. Additionally, Helus Pharma is advancing HLP004 for generalized anxiety disorder, currently in Phase 2 development.
The company's proprietary novel serotonergic agonists (NSAs) are designed to activate serotonin pathways that are believed to promote neuroplasticity, aiming to provide durable improvements in mental health. With a focus on addressing unmet needs in depression and anxiety, Helus Pharma's pipeline includes a broader research portfolio of investigational NSAs.
This leadership change and the progress in clinical trials underscore the company's commitment to bringing innovative treatments to market. The appointment of a CEO with a proven track record in commercializing psychiatric medications could be pivotal for Helus Pharma's transition from a clinical-stage to a commercial-stage entity.
For more information, visit the full press release at https://nnw.fm/wCjAp.
