Helus Pharma Highlights Clinical Program Advancements at Investor Presentation Held on October 21, 2026
Globe Newswire•21/10/2026•16:10 ET
0
Key Highlights
- ➤HLP003 Phase 3 topline data readout remains on track for Q4 2026
- ➤HLP004 Phase 2 GAD monotherapy study expected to initiate in Q1 2027
- ➤HLP003 APPROACH study completed enrollment of 223 participants in July 2026
- ➤HLP003 received FDA Breakthrough Therapy Designation for potential expedited review
- ➤Helus Pharma expects to file HLP003 New Drug Application with FDA in 2028
Expert Statements
Michael Halstead, Chief Executive Officer of Helus Pharma
“The continued advancement of our two lead candidates represents an important period for Helus Pharma, with several key catalysts anticipated in the near term. We remain focused on achieving our key development milestones and advancing these programs towards regulatory approval and potential commercialization, positioning the Company for its next stage of growth”
Amir Inamdar, Chief Medical Officer of Helus Pharma
“highlighted the key evidence that supported the selection of 30 mg as the optimum dose for further development in a monotherapy GAD study”
Topline data readout from APPROACH Phase 3 study of HLP003 in development for the potential adjunctive treatment of major depressive disorder (“MDD”) on track for Q4 2026(1,2)
HLP004 Program progressing with Phase 2 monotherapy study for the potential treatment of generalized anxiety disorder (“GAD”) expected to initiate in Q1 2027(1,)(,)(2)(,3)
Get started
Create a free account to read the full story.