Nuvalent Highlights Pipeline Progress, Anticipates 2029 Operating Runway.
ByAinvest
Monday, Jan 12, 2026 6:34 am ET1min read
NUVL--
Nuvalent, a biopharmaceutical company, has announced FDA acceptance of its NDA for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with a PDUFA target action date of September 18, 2026. The company plans NDA submissions for neladalkib in TKI pre-treated ALK-positive NSCLC and zidesamtinib expansion in TKI-naïve ROS1-positive NSCLC populations in 2026. Nuvalent remains well capitalized with an operating runway into 2029.
Stay ahead of the market.
Get curated U.S. market news, insights and key dates delivered to your inbox.
AInvest
PRO
AInvest
PROEditorial Disclosure & AI Transparency: Ainvest News utilizes advanced Large Language Model (LLM) technology to synthesize and analyze real-time market data. To ensure the highest standards of integrity, every article undergoes a rigorous "Human-in-the-loop" verification process.
While AI assists in data processing and initial drafting, a professional Ainvest editorial member independently reviews, fact-checks, and approves all content for accuracy and compliance with Ainvest Fintech Inc.’s editorial standards. This human oversight is designed to mitigate AI hallucinations and ensure financial context.
Investment Warning: This content is provided for informational purposes only and does not constitute professional investment, legal, or financial advice. Markets involve inherent risks. Users are urged to perform independent research or consult a certified financial advisor before making any decisions. Ainvest Fintech Inc. disclaims all liability for actions taken based on this information. Found an error?Report an Issue
Comments
No comments yet