Curated News
By: NewsRamp Editorial Staff
August 03, 2026
Helus Pharma Names Michael Halstead CEO as Phase 3 Trials Advance
TLDR
- Helus Pharma's new CEO Michael Halstead, with a track record including CAPLYTA and a $14.6B acquisition, positions the company for commercial success.
- Helus Pharma advances HLP003 through Phase 3 trials with enrollment complete and topline data expected in Q4 2026, alongside HLP004 in Phase 2.
- Helus Pharma's novel serotonergic agonists aim to provide durable mental health improvements, addressing unmet needs in depression and anxiety.
- Former Intra-Cellular Therapies president leads Helus Pharma, having overseen CAPLYTA's development and a $14.6 billion Johnson & Johnson acquisition.
Impact - Why it Matters
This leadership change is significant for investors and patients alike. Michael Halstead's proven track record in bringing a major psychiatric drug to market and navigating a high-profile acquisition could accelerate Helus Pharma's path to commercialization. With Phase 3 data expected in 2026, the appointment signals confidence in the company's pipeline and may influence investor sentiment. For patients with major depressive disorder, successful development of HLP003 could offer a new, potentially durable treatment option, addressing a critical unmet need in mental health.
Summary
Helus Pharma, the commercial operating name of Cybin Inc. (NASDAQ: HELP) (Cboe CA: HELP), has appointed Michael Halstead as its new chief executive officer, effective immediately. Halstead brings 25 years of biopharmaceutical leadership, most recently serving as president of Intra-Cellular Therapies, where he oversaw the development and commercialization of CAPLYTA® and supported pipeline expansion, contributing to the company's $14.6 billion acquisition by Johnson & Johnson in 2025. His appointment comes at a pivotal time as Helus Pharma advances its lead candidate, HLP003, through Phase 3 development for major depressive disorder (MDD). The company has completed enrollment in the Phase 3 APPROACH trial, with topline data expected in Q4 2026, and is continuing enrollment in the EMBRACE pivotal study. Additionally, HLP004, a proprietary novel serotonergic agonist (NSA), is in Phase 2 for generalized anxiety disorder.
Helus Pharma, founded in 2019, is dedicated to developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company aims to address the large unmet need for individuals suffering from depression, anxiety, and other mental health conditions. With Breakthrough Therapy Designation from the U.S. Food and Drug Administration for HLP003, Helus Pharma is positioned to potentially transform the treatment landscape for MDD. The company operates in Canada, the United States, the United Kingdom, and Ireland. For more details, visit the full press release at https://nnw.fm/wCjAp and explore investor resources at NetworkNewsWire.
Source Statement
This curated news summary relied on content disributed by InvestorBrandNetwork (IBN). Read the original source here, Helus Pharma Names Michael Halstead CEO as Phase 3 Trials Advance
