Nuvalent Announces NDA Submission For Neladalkib

Apr 07, 2026 11:11 UTC

NUVL

Medium term

(RTTNews) - Nuvalent, Inc. (NUVL) announced the submission to the FDA of the company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC.

NDA submission to FDA for new drug candidate
Targeting advanced ALK-positive NSCLC patients

April 07, 2026 — 07:11 am EDT Written byRTTNews.comforRTTNews-> (RTTNews) - Nuvalent, Inc. (NUVL) announced the submission to the FDA of the company's NDA for neladalkib, an investigational ALK-selective inhibitor, in TKI pre-treated advanced ALK-positive NSCLC. The application is based on data in TKI pre-treated patients with advanced ALK-positive NSCLC treated with neladalkib in the ALKOVE-1 Phase 1/2 clinical trial. "The advancement of neladalkib from first clinical trial initiation to NDA submission in less than four years represents a remarkable pace in oncology drug development," said Da