Helus Pharma expressed support for a White House Executive Order aimed at accelerating research, regulatory pathways, and patient access to psychedelic treatments for serious mental health conditions.
Key takeaways
The White House issued an Executive Order to accelerate psychedelic research, regulatory pathways, and patient access, which Helus Pharma supports.
The Executive Order includes potential FDA review prioritization for therapies with Breakthrough Therapy designation and calls for timely rescheduling of approved therapies.
Helus Pharma's lead program, HLP003, is in Phase 3 development and has received FDA Breakthrough Therapy designation for adjunctive treatment of major depressive disorder.
The company believes the Executive Order will help advance novel treatment options for conditions like major depressive disorder and generalized anxiety disorder.
Helus Pharma is a clinical stage pharmaceutical company developing novel serotonergic agonists (NSAs) for mental health conditions and operates in multiple countries.