FDA approves SpringWorks’ Gomekli

The US Food and Drug Administration approved Gomekli (mirdametinib), from SpringWorks Therapeutics (Nasdaq: SWTX), a kinase inhibitor, for adult and pediatric patients two years of age and older with neurofibromatosis type 1 (NF1) – a type of tumor that forms on nerves, who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

The drug is the first and only FDA-approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN), said SpringWorks, which is currently the subject of advanced takeover talks with Germany’s Merck KGaA (MRK DE).

The company’s shares edged up 2% by close of trading and a further 5.9% to $58.37 in after-hours activity. SpringWorks was spun out of Pfizer (NYSE: PFE) in 2017 with two assets – mirdametinib and nirogacestat, with the later already marketed.