Pasatru demonstrated strong efficacy in a Phase III trial, helping patients reduce lesions and flare-ups.
The FDA granted the approval for Genglycos based on a 48-week Phase III study involving 46 participants.
The deal provides BioMarin with a potential rival to AstraZeneca’s blockbuster Strensiq in hypophosphatasia.
The Novartis-backed biotech will now prepare for registrational studies on KYN-5356 in CIAS.
AQPotency enables drug discovery teams to assess and rank candidate molecules’ likely interactions with specific disease targets.
If sworn in by the Senate, Overton would take the helm during a tumultuous period for the agency defined by several resignations, firings and redundancies.
