SpringWorks's NDA For Mirdametinib Granted Priority Review For Treatment Of NF1-PN

(RTTNews) - Wednesday, SpringWorks Therapeutics, Inc. (SWTX) announced that the FDA has accepted its New Drug Application or NDA for Mirdametinib for Priority Review for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas or NF1-PN, in both adult and pediatric populations. Following this news, the stock rose 2% in the pre-market trade.

The target action date under the Prescription Drug User Fee Act is scheduled for February 28, 2025.

In addition, the company reported that the European Medicines Agency has validated the Marketing Authorization Application for Mirdametinib.

The application includes data from the Phase 2b ReNeu trial, which tested Mirdametinib in patients aged two years and older with NF1-associated PN that causes significant health issues. The trial showed strong response rates, lasting effects, and improvements in pain and overall quality of life.

Moreover, the FDA has previously granted Mirdametinib several designations, including Orphan Drug, Fast Track, and Rare Pediatric Disease.

In pre-market activity on the Nasdaq, the shares are trading at $41.95, up 2.14%.