SpringWorks (SWTX) Completes NDA Submission for Mirdametinib
SWTXSpringWorks Therapeutics(SWTX) ZACKS·2024-07-03 01:16

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 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. The pr ...