Company announcementCompany-reported
What was reported
CAMBRIDGE, Mass., September 8, 2026 -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of March 10, 2027. Additionally, FDA has advised the company that it is not currently planning to hold an advisory committee to discuss the application.U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 8, 2026 · Open the source ↗
What the evidence supports
Intellia Therapeutics furnished a press release to the SEC (Form 8-K, Item 7.01) about a company announcement. It shows what the company chose to disclose on that date.
What remains unknown
Claims in the release are the company's own and have not been independently verified. Furnishing a document to the SEC does not mean the SEC reviewed or endorsed it.
Source passages
Exact excerpts from the source, with links. Quotes are checked character for character against our stored copy.
Press release headlineIntellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 8, 2026 · Open the source ↗
Press release lead paragraphCAMBRIDGE, Mass., September 8, 2026 -- Intellia Therapeutics, Inc. (Nasdaq: NTLA), a leading biopharmaceutical company focused on revolutionizing medicine leveraging CRISPR gene editing and other core technologies, today announced the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of March 10, 2027. Additionally, FDA has advised the company that it is not currently planning to hold an advisory committee to discuss the application.U.S. Securities and Exchange Commission (EDGAR) · Exhibit 99.1 to 8-K · Sep 8, 2026 · Open the source ↗
Revision history
- Revision 1 · Oct 28, 2026, 20:54 UTC
Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE)
Spotted an error? Tell us. Corrections are published, never silent: see all corrections.