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BioCryst Pharmaceuticals, Inc.

https://www.biocryst.com/

Latest From BioCryst Pharmaceuticals, Inc.

Finance Watch: A SPACtacular Week For Biopharma Deals And Dollars

Public Company Edition: Four health care special purpose acquisition vehicles went public and two others announced mergers, but only one biopharma firm priced an IPO during the week of 19-23 October. Replimune’s $250m offering led recent FOPOs.

Financing Deals

EU Accelerated Assessment Tracker

Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

European Performance Tracker Review Pathway

Makena Will Get Extended Time On Market, Even If AMAG’s Appeal Fails

AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.

Review Pathway Gynecology & Urology

Gene Therapy Approval Standards: Available Treatments Influence US FDA’s View On Durability

CBER’s Peter Marks says agency assesses the importance of durability of effect differently for a gene therapy that treats a disease that has no other available therapies versus a condition for which there are multiple approved treatments. Marks’ comments shed more light on the complete response letter for BioMarin’s hemophilia gene therapy Roctavian.

Gene Therapy Regenerative Medicine
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