Praxis hopes to initiate a Phase III later in 2023, but an analyst said it is unclear if regulators will align with the company on a proposed primary endpoint.

The US firm has faced yet another clinical setback as its Phase II candidate, NYX-458, failed to improve cognitive impairment in patients with Parkinson’s disease and Alzheimer’s, triggering the cessation of its only other program as priorities shift to preserving funds.

CEO Barry Greene and team spoke with Scrip about Sage and Biogen’s focus on short-term, episodic dosing, and said doctors and payers – pending zuranolone’s approval – are responding to the sales pitch.

Christopher Viehbacher told his first earnings call as CEO that a review is under way to reverse Biogen’s fortunes, but noted Leqembi will not be a meaningful contributor while treatment and reimbursement bottlenecks remain.