Jazz Pharmaceuticals (JAZZ) FY 2025 Conference September 03, 2025 09:30 AM ET Company ParticipantsMohit Bansal - MD & Co-Head of Therapeutics ResearchAmal Melhem-Bertrandt - VP - Oncology Therapy AreaPhilip Johnson - EVP & CFOMohit BansalThank you very much for joining us today. My name is Mohit Bansal. I'm one of the biopharma analysts here at Wells Fargo, and this is my first session, not the conference's first session. I'm happy to have the team from Jazz Pharmaceuticals with us. We have Phil Johnson, th ...

Core Viewpoint - Biohaven's stock experienced significant volatility, dropping nearly 20% due to a regulatory delay regarding its promising drug, trotziluzole, despite a generally positive market day for other stocks [1][2]. Regulatory Update - The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for Biohaven's drug, troriluzole, by three months, with a new decision expected in the fourth quarter of this year [4]. - The extension is due to the FDA's need for additional time to review recent submissions from Biohaven [5]. Drug Potential - Troriluzole targets spinocerebellar ataxia (SCA), a rare brain disorder with no current treatment options, and has received fast-track, priority review, and orphan drug designation from the FDA [6]. - Investor sentiment remains optimistic about the drug's potential, although the delay has raised concerns about the future approval process [7].