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Exelixis (EXEL) FDA Events

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FDA Events for Exelixis (EXEL)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Exelixis (EXEL). Over the past two years, Exelixis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as CABOMETYX, cabozantinib, Cabozantinib, STELLAR-303, XL309, XL495, and Zanzalintinib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Exelixis' Drugs in FDA Review

CABOMETYX (cabozantinib) + OPDIVO (nivolumab) - FDA Regulatory Timeline and Events

CABOMETYX (cabozantinib) + OPDIVO (nivolumab) is a drug developed by Exelixis for the following indication: Unresectable or Metastatic Renal Cell Carcinoma. 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.

cabozantinib - FDA Regulatory Timeline and Events

cabozantinib is a drug developed by Exelixis for the following indication: For neuroendocrine 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.

Cabozantinib (CABOMETYX) - FDA Regulatory Timeline and Events

Cabozantinib (CABOMETYX) is a drug developed by Exelixis for the following indication: Differentiated thyroid cancer (DTC). 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.

STELLAR-303 - FDA Regulatory Timeline and Events

STELLAR-303 is a drug developed by Exelixis for the following indication: In Patients with Metastatic Colorectal Cancer. 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.

XL309 - FDA Regulatory Timeline and Events

XL309 is a drug developed by Exelixis for the following indication: USP1 inhibitor. 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.

XL495 - FDA Regulatory Timeline and Events

XL495 is a drug developed by Exelixis for the following indication: inhibitor of PKMYT1. 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.

Zanzalintinib - FDA Regulatory Timeline and Events

Zanzalintinib is a drug developed by Exelixis for the following indication: For Advanced Kidney Cancer. 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.

Exelixis FDA Events - Frequently Asked Questions

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

In the past two years, Exelixis (EXEL) has reported FDA regulatory activity for the following drugs: cabozantinib, Cabozantinib (CABOMETYX), STELLAR-303, XL495, XL309, CABOMETYX (cabozantinib) + OPDIVO (nivolumab) and Zanzalintinib.

The most recent FDA-related event for Exelixis occurred on June 22, 2025, involving STELLAR-303. The update was categorized as "Top-line results," with the company reporting: "Exelixis, Inc. announced positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant improvement in overall survival (OS) versus regorafenib in the intent-to-treat (ITT) population of patients with previously treated non-microsatellite instability (MSI)-high metastatic colorectal cancer (CRC)."

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

  • For neuroendocrine tumors - cabozantinib
  • Differentiated thyroid cancer (DTC) - Cabozantinib (CABOMETYX)
  • In Patients with Metastatic Colorectal Cancer - STELLAR-303
  • inhibitor of PKMYT1 - XL495
  • USP1 inhibitor - XL309
  • Unresectable or Metastatic Renal Cell Carcinoma - CABOMETYX (cabozantinib) + OPDIVO (nivolumab)
  • For Advanced Kidney Cancer - Zanzalintinib

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