RegulatoryCompany release

Intellia's CRISPR therapy lonvo-z for hereditary angioedema gets FDA priority review, March 2027 goal date

🇺🇸 Intellia Therapeutics, Inc. (NTLA) · Thu 12 Nov 2026

The FDA has accepted Intellia's BLA for the one-time in vivo gene-editing therapy lonvoguran ziclumeran, with a PDUFA date of 10 March 2027 and no advisory committee currently planned.

Intellia Therapeutics has published an investor presentation on lonvoguran ziclumeran, known as lonvo-z and formerly NTLA-2002, a one-time in vivo CRISPR-based therapy for hereditary angioedema (HAE). The company says the US Food and Drug Administration has accepted its biologics licence application (BLA) and granted priority review.

The presentation gives a PDUFA goal date of 10 March 2027. Intellia also says the agency has indicated that it does not currently plan to convene an advisory committee for the application. Such plans can change during a review.

The deck also covers data from the Phase 3 HAELO study and the company's commercial readiness plans. The summary available to VigiEye does not include the trial figures or the launch details, so they are not reported here.

As general context, priority review is an FDA designation that sets a shorter target review timeline for therapies that may offer significant improvements in treating serious conditions. The PDUFA date is the agency's goal for completing its action on the application.

What it means for your team

  • Regulatory teams tracking gene-editing products can log 10 March 2027 as the FDA action goal for lonvo-z, with no advisory committee currently planned.
  • Market-access teams in HAE should note that Intellia is already presenting commercial readiness plans ahead of the decision, but the launch details need to be checked in the full deck.
  • Pharmacovigilance and quality teams should note that this is a one-time in vivo editing therapy; the presentation's HAELO safety and manufacturing information should be reviewed directly.

Company's press release (SEC filing): Intellia Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Intellia Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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