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Intellia Therapeutics (NTLA) FDA Events

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FDA Events for Intellia Therapeutics (NTLA)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Intellia Therapeutics (NTLA). Over the past two years, Intellia Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as nex-z, NTLA-2001, NTLA-2002, and NTLA-3001. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Intellia Therapeutics' Drugs in FDA Review

nex-z - FDA Regulatory Timeline and Events

nex-z is a drug developed by Intellia Therapeutics for the following indication: For Transthyretin (ATTR) Amyloidosis with Polyneuropathy. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NTLA-2001 - FDA Regulatory Timeline and Events

NTLA-2001 is a drug developed by Intellia Therapeutics for the following indication: Transthyretin (ATTR) Amyloidosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NTLA-2002 - FDA Regulatory Timeline and Events

NTLA-2002 is a drug developed by Intellia Therapeutics for the following indication: Hereditary Angioedema (HAE). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

NTLA-3001 - FDA Regulatory Timeline and Events

NTLA-3001 is a drug developed by Intellia Therapeutics for the following indication: For the Treatment of Alpha-1 Antitrypsin Deficiency. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Intellia Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Intellia Therapeutics (NTLA) has reported FDA regulatory activity for the following drugs: NTLA-2001, NTLA-2002, nex-z and NTLA-3001.

The most recent FDA-related event for Intellia Therapeutics occurred on June 15, 2025, involving NTLA-2002. The update was categorized as "Follow-up data," with the company reporting: "Intellia Therapeutics, announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom."

Current therapies from Intellia Therapeutics in review with the FDA target conditions such as:

  • Transthyretin (ATTR) Amyloidosis - NTLA-2001
  • Hereditary Angioedema (HAE) - NTLA-2002
  • For Transthyretin (ATTR) Amyloidosis with Polyneuropathy - nex-z
  • For the Treatment of Alpha-1 Antitrypsin Deficiency - NTLA-3001

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:NTLA) was last updated on 7/10/2025 by MarketBeat.com Staff
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