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Nuvalent (NUVL) FDA Events

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FDA Events for Nuvalent (NUVL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Nuvalent (NUVL). Over the past two years, Nuvalent has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as NVL-330, NVL-520, NVL-655, and zidesamtinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Nuvalent's Drugs in FDA Review

NVL-330 - FDA Regulatory Timeline and Events

NVL-330 is a drug developed by Nuvalent for the following indication: For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). 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.

NVL-520 - FDA Regulatory Timeline and Events

NVL-520 is a drug developed by Nuvalent for the following indication: Advanced ROS1-positive Non-small cell lung cancer (NSCLC) and other advanced solid tumors. 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.

NVL-655 - FDA Regulatory Timeline and Events

NVL-655 is a drug developed by Nuvalent for the following indication: ALK inhibitors. 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.

zidesamtinib - FDA Regulatory Timeline and Events

zidesamtinib is a drug developed by Nuvalent for the following indication: ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib. 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.

Nuvalent FDA Events - Frequently Asked Questions

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

In the past two years, Nuvalent (NUVL) has reported FDA regulatory activity for the following drugs: NVL-655, zidesamtinib, NVL-330 and NVL-520.

The most recent FDA-related event for Nuvalent occurred on June 24, 2025, involving zidesamtinib. The update was categorized as "Positive Data," with the company reporting: "Nuvalent, announced positive pivotal data for zidesamtinib, a novel ROS1-selective inhibitor, in TKI (tyrosine kinase inhibitor) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC) from the global ARROS-1 Phase 1/2 clinical trial."

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

  • ALK inhibitors - NVL-655
  • ALK-selective inhibitor, neladalkib, and novel ROS1-selective inhibitor, zidesamtinib - zidesamtinib
  • For pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC). - NVL-330
  • Advanced ROS1-positive Non-small cell lung cancer (NSCLC) and other advanced solid tumors - NVL-520

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:NUVL) was last updated on 7/10/2025 by MarketBeat.com Staff
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