Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP), a clinical-stage pharmaceutical company developing novel serotonergic agonists (NSAs), announced the appointment of Suresh Durgam, M.D., to its board of directors, subject to approval by Cboe Canada. Durgam previously served on the company's scientific advisory board and brings more than two decades of experience in central nervous system (CNS) drug development, clinical research, and regulatory strategy.
Most recently, Durgam served as executive vice president and chief medical officer of Intra-Cellular Therapies, where he played a key role in securing U.S. Food and Drug Administration approvals for CAPLYTA across multiple indications, including schizophrenia, bipolar depression, and major depressive disorder. His track record in navigating the regulatory landscape and leading late-stage clinical programs is expected to be instrumental as Helus Pharma advances its CNS pipeline toward potential commercialization.
The appointment comes at a critical juncture for Helus Pharma, which is developing HLP003, a proprietary NSA in Phase 3 clinical development for the adjunctive treatment of major depressive disorder. HLP003 has received Breakthrough Therapy Designation from the FDA, underscoring its potential to address significant unmet needs in mental health. The company is also developing HLP004, another proprietary NSA in Phase 2 for generalized anxiety disorder. With Durgam's guidance, Helus Pharma aims to strengthen its clinical and regulatory execution as it moves these assets through late-stage development.
For investors, the addition of a board member with Durgam's credentials signals a strategic focus on execution and commercialization readiness. His experience with CAPLYTA's approvals across multiple psychiatric indications demonstrates a deep understanding of the FDA process and the complexities of bringing CNS therapies to market. This could enhance Helus Pharma's ability to design and conduct pivotal trials, anticipate regulatory hurdles, and ultimately achieve successful product launches. As the company progresses its pipeline, such expertise is likely to be a key differentiator in a competitive landscape.
Helus Pharma, the commercial operating name of Cybin Inc., was founded in 2019 and is committed to helping minds heal by developing proprietary NSAs—synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. The company's NSAs are intended to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. With class-leading data, Helus Pharma aims to improve the treatment landscape through the introduction of NSAs that provide durable improvements in mental health. The company operates in Canada, the United States, the United Kingdom, and Ireland.
For more information on Helus Pharma, visit www.helus.com. The full press release can be viewed at https://ibn.fm/lTfIt. The latest news and updates relating to HELP are available in the company's newsroom at Helus Pharma.
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