RegulatoryCompany release

FDA sets 10 March 2027 goal date for Intellia's one-time hereditary angioedema gene-editing therapy

🇺🇸 Intellia Therapeutics, Inc. (NTLA) · Fri 13 Nov 2026

The agency has accepted Intellia's BLA for lonvoguran ziclumeran with priority review and does not currently plan an advisory committee, the company said at an investor event.

Intellia Therapeutics has said the US Food and Drug Administration accepted its biologics licence application for lonvoguran ziclumeran (lonvo-z, formerly NTLA-2002) under priority review, with a PDUFA goal date of 10 March 2027. The company disclosed the timeline in materials for an investor event.

Lonvo-z is a one-time in vivo CRISPR-based therapy for hereditary angioedema (HAE). According to Intellia's presentation, the FDA does not currently plan to convene an advisory committee for the application. That position could change as the review progresses.

The deck also covers positive results from the Phase 3 HAELO study. The summary available to VigiEye does not include detailed efficacy or safety figures, so those are not reported here.

Intellia also outlined commercial readiness work under way ahead of a possible approval. No pricing, launch-timing or access details are available in the material reviewed.

What it means for your team

  • Regulatory teams should note the 10 March 2027 PDUFA date and the absence of a currently planned advisory committee, which the agency may revisit.
  • Pharmacovigilance and safety teams will want to see the full HAELO data, as the long-term follow-up of a one-time gene-editing therapy is a key question for any HAE product.
  • Market-access teams in HAE should anticipate a potential one-time treatment entering a field built around chronic therapy, though pricing and payer positioning have not been disclosed.

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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