US FDA approves SpringWorks' genetic disorder drug (updated)

SpringWorks Therapeutics

11/02/2025 21:35

(Adds details on the drug and the trial in paragraphs 2,3;
background in paragraph 5)
       Feb 11 (Reuters) - The U.S. Food and Drug Administration
said on Tuesday it has approved SpringWorks Therapeutics'
 SWTX.O  drug to treat a type of rare genetic disorder, which
causes tumors to grow on nerves throughout the body.
    The drug, branded as Gomekli, was approved for adults and
children 2 years of age and older suffering from
neurofibromatosis type 1, with symptomatic plexiform
neurofibromas in which the tumor cannot be surgically removed.
    The approval was based on a mid-stage trial, where the drug
showed 20% or more reduction in tumor volume in 52% of pediatric
patients and 41% of adult patients.
    Shares of the company gained 2% in extended trading.
SpringWorks did not immediately respond to a Reuters request for
comment seeking details on pricing.
    Earlier this week, Merck KGaA  MRCG.DE , the German
healthcare and technology group, said it was in advanced talks
to acquire SpringWorks.
    

 (Reporting by Christy Santhosh, Kamal Choudhury and Sriparna
Roy in Bengaluru; Editing by Mohammed Safi Shamsi and Shilpi
Majumdar)
 ((Christy.Santhosh@thomsonreuters.com))