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BioCryst Partners with Irish Affiliate of Neopharmed Gentili in ~$345M EU Commercialization Deal for Navenibart

Shots: BioCryst Pharmaceuticals has entered into a license agreement with an Irish affiliate of Neopharmed Gentili, granting the latter exclusive rights to commercialize navenibart for hereditary angioedema (HAE) in the EU As per the deal, BioCryst will receive $70M upfront & up to $275M in regulatory & sales milestone payments as well as tiered royalties…

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BioCryst

BioCryst Reports the US FDA’s NDA Acceptance and Priority Review of Orladeyo for Hereditary Angioedema (HAE)

Shots: The US FDA has accepted NDA & granted priority review to Orladeyo (berotralstat) for the treatment of HAE pts (2-11yrs.), with PDUFA action date of Sep 12, 2025. Line extension application has been filed with the EMA; further filings are planned globally incl. Japan & Canada NDA was supported by P-III (APeX-P) trial assessing Orladeyo…

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