Key Takeaways:
- FDA accepted Nuvalent's NDA for neladalkib with Priority Review
- PDUFA target action date set for Nov 27, 2026
- Second NDA under review after zidesamtinib's Sept 18 PDUFA date
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Nuvalent gains FDA priority review for neladalkib with Nov 27 PDUFA date
Key Takeaways:
- FDA accepted Nuvalent's NDA for neladalkib with Priority Review
- PDUFA target action date set for Nov 27, 2026
- Second NDA under review after zidesamtinib's Sept 18 PDUFA date
The US Food and Drug Administration accepted Nuvalent Inc.'s New Drug Application for neladalkib in TKI pre-treated advanced ALK-positive non-small cell lung cancer, granting Priority Review with a PDUFA target action date of Nov 27, 2026.
"The submission is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the global, registration-directed ALKOVE-1 Phase 1/2 clinical trial," James Porter, Ph.D., Chief Executive Officer of Nuvalent, said in a statement. The company plans to share those results, along with preliminary data for TKI-naive patients, during an oral presentation at the 2026 American Society of Clinical Oncology annual meeting in Chicago from May 29 to June 2.
Neladalkib is an investigational, brain-penetrant ALK-selective inhibitor designed to overcome resistance to first-, second-, and third-generation ALK inhibitors, including tumors with single or compound treatment-emergent ALK mutations such as G1202R. The drug has received breakthrough therapy designation from the FDA for patients with locally advanced or metastatic ALK-positive NSCLC previously treated with two or more ALK tyrosine kinase inhibitors, as well as orphan drug designation for ALK-positive NSCLC.
The acceptance marks Nuvalent's second NDA under FDA review. The agency accepted the company's application for zidesamtinib, a ROS1-selective inhibitor, in TKI pre-treated advanced ROS1-positive NSCLC with a PDUFA date of Sept 18, 2026. Nuvalent also announced the appointment of Georg Pirmin Meyer, M.D., as Chief International Officer to lead the company's global expansion strategy. Meyer previously served as Senior Vice President and General Manager, International at Blueprint Medicines, where he led European launches of Ayvakit (avapritinib) across three indications.
The dual NDA filings position Nuvalent for potential back-to-back approvals in biomarker-driven NSCLC, a market where treatment options remain limited for patients who develop resistance to existing therapies. Investors will watch the ASCO data presentation next week for updated efficacy and safety data that could inform the drug's commercial prospects. The company's US commercial and medical affairs teams are already in place, Porter said.
This article is for informational purposes only and does not constitute investment advice.
[1] Nuvalent Announces Key Program and Business Updates, Strengthening Foundation for Global Leadership in ROS1- and ALK-positive NSCLC[2] FDA approves 1st chronic HDV treatment[3] FDA Accepts sBLA for Anktiva in Papillary-Only NMIBC[4] FDA grants priority review to Nuvalent lung cancer drug, new global chief joins - Stock Titan
