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Springworks Therapeutics Gains FDA Approval for GOMEKLI

Story Highlights
  • SpringWorks Therapeutics received FDA approval for GOMEKLI, a treatment for neurofibromatosis type 1.
  • GOMEKLI showed significant tumor reduction and manageable safety, impacting 40,000 in the US.
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Springworks Therapeutics Gains FDA Approval for GOMEKLI

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Springworks Therapeutics ( (SWTX) ) just unveiled an update.

On February 11, 2025, SpringWorks Therapeutics announced the FDA approval of GOMEKLI™ (mirdametinib), a treatment for neurofibromatosis type 1 with symptomatic plexiform neurofibromas, marking it as the first approved medicine for the condition. Based on Phase 2b trial results, GOMEKLI demonstrated significant tumor volume reduction and a manageable safety profile, offering a new therapeutic option for a condition affecting approximately 40,000 people in the US. This approval also granted SpringWorks a rare pediatric disease priority review voucher, further strengthening its market position in treating severe rare diseases.

More about Springworks Therapeutics

SpringWorks Therapeutics, Inc. is a commercial-stage biopharmaceutical company focused on developing treatments for severe rare diseases and cancer. The company recently received FDA approval for GOMEKLI™ (mirdametinib), a MEK inhibitor targeting neurofibromatosis type 1 with symptomatic plexiform neurofibromas.

YTD Price Performance: 52.80%

Average Trading Volume: 1,782,984

Technical Sentiment Consensus Rating: Sell

Current Market Cap: $4.02B

For detailed information about SWTX stock, go to TipRanks’ Stock Analysis page.

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