Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint Inhibitor for Patients with Metastatic Colorectal Cancer
Exelixis, Inc. (EXEL)
Last exelixis, inc. earnings: 2/25 04:05 pm
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Source: Business Wire
– The FDA assigned a Prescription Drug User Fee Act target action date of December 3, 2026 –– Application is based on results from the phase 3 STELLAR-303 pivotal trial, in which zanzalintinib in combination with atezolizumab improved median overall survival and significantly reduced the risk of death versus regorafenib in the intention-to-treat population – ALAMEDA, Calif.--(BUSINESS WIRE)--Exelixis, Inc. (Nasdaq: EXEL) today announced that its New Drug Application (NDA) for zanzalintinib, in combination with atezolizumab (Tecentriq®), has been accepted for review in the U.S. for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, and, if RAS wild-type, an anti-epidermal growth factor receptor (EGFR) therapy. The Food and Drug Administration (FDA) assigned a standard review with a Prescription Drug User Fee Act target action date of December 3, 2026.“We are
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EXEL
News
- Exelixis (NASDAQ:EXEL) was given a new $49.00 price target on by analysts at Morgan Stanley.MarketBeat
- Exelixis Announces U.S. FDA Accepted the New Drug Application for Zanzalintinib in Combination with an Immune Checkpoint Inhibitor for Patients with Metastatic Colorectal Cancer [Yahoo! Finance]Yahoo! Finance
- Alterome Therapeutics Appoints Leo Faoro, MD, MBA, as Chief Medical Officer [Yahoo! Finance]Yahoo! Finance
- Exelixis Files Zanzalintinib With FDA As Valuation Signals Upside Potential [Yahoo! Finance]Yahoo! Finance
- Assessing Exelixis (EXEL) Valuation After Recent Share Price Volatility [Yahoo! Finance]Yahoo! Finance
EXEL
Earnings
- 11/4/25 - Beat
EXEL
Sec Filings
- 1/16/26 - Form 4
- 1/16/26 - Form 4
- 1/16/26 - Form 4
- EXEL's page on the SEC website