Intellia announces FDA acceptance for hereditary angioedema therapy
The agency grants priority review and sets a PDUFA target date of March 10, 2027. Phase 3 data showed significant attack reduction.
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Clinical-stage genome editing company
intelliatx.comLast updated
In short: Intellia announced positive Phase 3 data for its HAE therapy lonvo-z and secured a $400 million loan to extend its cash runway into 2028.
The agency grants priority review and sets a PDUFA target date of March 10, 2027. Phase 3 data showed significant attack reduction.
The company highlighted positive Phase 3 HAELO results for lonvo-z, anticipates FDA BLA acceptance in H2 2026, and ended Q2 with $628 million cash.
Data showed 87% reduction in monthly attacks and favorable safety, with BLA submission initiated.
Includes positive Phase 3 lonvo‑z data, a rolling BLA filing, resumed nex‑z Phase 3 screening, and approximately $207 million raised, supporting operations into 2028.
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