SpringWorks (SWTX) Completes NDA Submission for Mirdametinib

The NDA filing was based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity. SpringWorks Therapeutics, Inc. (SWTX) announced that it has completed the submission of a new drug application ("NDA") for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients. The pr ...