SWTX's NDA for Rare Tumor Drug Gets Priority Review From FDA

SpringWorks Therapeutics, Inc. (SWTX) announced that the FDA had accepted its new drug application ("NDA") seeking approval for the company's investigational MEK inhibitor, mirdametinib, which is being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients. With the FDA granting a priority review to the NDA, a decision from the regulatory body is expected on Feb. 28, 2025. At present, the FDA is not planning to hold an advisory c ...