“I think Takeda is a bit, I don't wanna say cagey about, exact PDUFA, but I think the guidance is a third quarter PDUFA.”
→ Read the source episode
FDA issues approval or rejection decision on Takeda/Protagonist's polycythemia vera drug in Q3 (July-September)
Yaron Werber predicts Ascendis will have until March 2027 to convert patients if they lose the ITC patent case, with initial decision expected August 21, 2026.
Yaron Werber predicts ITC will issue initial decision on BioMarin vs. Ascendis patent case by August 21, 2026, with final decision by December 21, 2026.
Jake Beecroft predicts that achieving an Australia-like accelerated first-in-human trial system in the US will require an act of Congress.
Cullinan's lung cancer drug has a February PDUFA date for second-line indication following positive first-line phase three data.
Yaron Werber predicts BioNTech will report phase three stage 2 data for CTLA-4 in second-line squamous lung cancer showing survival benefit vs. docetaxel.
John predicts Coursera will run two studies (biomarker and outcomes-based) for their PCSK9/angiotensinogen siRNA program
Summaries are ours; the quote is a verbatim transcript excerpt. Our resolution criteria are editorial and disputable. How this works.