“The PDUFA date is in February. They've now got a first line, study that just read out this week, that was also positive.”
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FDA issues approval or rejection decision on Cullinan's lung cancer drug by February PDUFA date
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 BioNTech will report phase three stage 2 data for CTLA-4 in second-line squamous lung cancer showing survival benefit vs. docetaxel.
Jake Beecroft predicts that achieving an Australia-like accelerated first-in-human trial system in the US will require an act of Congress.
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.
Takeda's polycythemia vera drug (in collaboration with Protagonist) has a third quarter PDUFA date.
John predicts Coursera will run two studies (biomarker and outcomes-based) for their PCSK9/angiotensinogen siRNA program
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