(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 Darlene Noci, Chief Development Officer at Nuvalent.
In pre-market trading on NasdaqGS, Nuvalent shares are up 0.38 percent to $104.10.
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