FDA accepted Nuvalent’s NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC with Priority Review and set a PDUFA target action date of November 27, 2026. Nuvalent appointed Georg Pirmin Meyer, M.D., as Chief International Officer to drive global expansion and launch strategies based on ALKOVE-1 trial data.
The FDA has accepted Nuvalent’s NDA for neladalkib in TKI pre-treated advanced ALK-positive NSCLC, granting Priority Review and setting a PDUFA target action date of November 27, 2026. This submission is based on efficacy and safety data from the global ALKOVE-1 Phase 1/2 trial, reflecting strong clinical support for regulatory approval.
Nuvalent has appointed veteran biopharmaceutical executive Georg Pirmin Meyer, M.D., as Chief International Officer to spearhead its global expansion strategy. Meyer’s track record includes leading international launches and P&L responsibilities at Blueprint Medicines and Vertex Pharmaceuticals, positioning Nuvalent for market entry outside the U.S.
The ALKOVE-1 trial evaluated neladalkib in TKI pre-treated patients and generated preliminary data in TKI-naïve NSCLC cohorts, demonstrating tumor responses and central nervous system penetration. Data will be presented at the ASCO Annual Meeting from May 29 to June 2, 2026, supporting both current filings and upcoming TKI-naïve expansion strategies.
