Nuvalent Announces FDA Acceptance of New Drug Application for Zidesamtinib for the Treatment of TKI Pre-treated Patients with Advanced ROS1-positive NSCLC [Yahoo! Finance]
Nuvalent, Inc. - Class A (NUVL)
NASDAQ:AMEX Investor Relations:
nuvelinc.com/company/investor_relations.html
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Source: Yahoo! Finance
CAMBRIDGE, Mass. Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for zidesamtinib, an investigational ROS1-selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least 1 prior ROS1 tyrosine kinase inhibitor (TKI). The application has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 18, 2026. Nuvalent, Inc. (PRNewsfoto/Nuvalent, Inc.) Nuvalent's NDA submission is based on results for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global registrational ARROS-1 Phase 1/2 clinical trial. These data were reported along with preliminary data from the ongoin
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News
- Does Nuvalent's Recent Trial Success Justify the Stock's 36% 2025 Rally? [Yahoo! Finance]Yahoo! Finance
- Nuvalent to Participate in the Piper Sandler 37th Annual Healthcare Conference [Yahoo! Finance]Yahoo! Finance
- Nuvalent to Participate in the Piper Sandler 37th Annual Healthcare ConferencePR Newswire
- Nuvalent Announces Closing of Public Offering of Common Stock and Full Exercise by Underwriters of Option to Purchase Additional Shares from Selling StockholdersPR Newswire
- Nuvalent (NASDAQ:NUVL) was given a new $140.00 price target on by analysts at Truist Financial Corporation.MarketBeat
NUVL
Earnings
- 5/8/25 - Miss
NUVL
Sec Filings
- 12/2/25 - Form 4
- 11/26/25 - Form 4
- 11/24/25 - Form 4
- NUVL's page on the SEC website