Helus Pharma Secures FDA Breakthrough Therapy Pathways, Names Interim CEO
Helus Pharma welcomed the White House Executive Order on FDA prioritization for Breakthrough Therapy psychedelic treatments, bolstering regulatory momentum for its Phase 3 HLP003 program. The board reinstated Eric So as interim CEO while searching for a permanent CEO before HLP003's Q4 topline data readout.
1. Executive Order Advances Regulatory Framework
Helus Pharma applauded the Executive Order outlining potential prioritization of FDA reviews for Breakthrough Therapy-designated psychedelic treatments, expanded federal funding for state programs, and strengthened coordination among HHS, FDA, and VA. The Order's call for timely rescheduling of approved therapies underpins regulatory support for Helus’s Phase 3 HLP003 program and broader NSA pipeline.
2. CEO Transition Ensures Leadership Continuity
The board dismissed Michael Cola and reinstated co-founder Eric So as interim CEO, citing the need for continuous leadership during the search for a permanent chief executive. Under So's stewardship, the company will maintain focus on advancing its clinical pipeline, including the Q4 topline data readout for HLP003 in the APPROACH trial.