Intellia Prepares for Potential Launch of Lonvo-z as FDA Decision Nears
Intellia Therapeutics is preparing for a potential launch of its hereditary angioedema (HAE) treatment, lonvo-z, following the FDA's acceptance of its biologics license application. The agency has set a Prescription Drug User Fee Act (PDUFA) date of March 10 and granted priority review without an advisory committee meeting planned. Phase III data showed strong results with an 87% reduction in attack rates and a 62% rate of being free from attacks over the primary observation period. The company is building a commercial team for launch but has not yet set pricing, though it noted that annual prophylaxis costs can exceed $700,000. Intellia also continues enrolling patients in its Phase III study for transthyretin amyloidosis and evaluating refinements to patient selection criteria. The company reported approximately $630 million in cash reserves and a new $300 million debt facility, providing funding into 2028 without relying on lonvo-z revenue.
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Topics: capital funding FDA PDUFA date gene therapy hereditary angioedema (HAE) TTR amyloidosis