“if they lose, which is an if, to then, that that goes into effect. And so right now, they're basically racing to convert patients and at the very least, obviously, grow the market because the drug really based on clinical data does look better than BioMarin's. So it's very much a landmark case that's very much patent related, but also very much for patient, benefit, you know, would be considered as well. So we'll see what happens August 21.”
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ITC issues initial decision on patent infringement by August 21, 2026; if Ascendis loses, injunction would take effect by March 2027
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.
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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