SpringWorks Therapeutics, Inc. (SWTX) stock surged 7.02% in after-hours trading on Tuesday, following a major regulatory approval and potential acquisition news.
The U.S. Food and Drug Administration (FDA) approved SpringWorks' drug Gomekli (mirdametinib) for the treatment of adult and pediatric patients with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas that cannot be completely removed surgically. NF1 is a rare genetic disorder that causes tumors to grow on nerves throughout the body.
"In addition to a capsule, we offer a tablet that dissolves in water, which is really important for patients unable to swallow, and those who couldn't previously receive therapy," said SpringWorks CEO Saqib Islam. The approval was based on a mid-stage trial where the drug showed significant reduction in tumor volume in both pediatric and adult patients.
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