UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data from Phase 2b ReNeu
FDA approves Gomekli as first neurofibromatosis drug for adults
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat neurofibromatosis type 1 (NF1), a type of rare genetic disorder. Both adult and paediatric patients with NF1 who have symptomatic plexiform neurofibromas (PN) that cannot be surgically removed will be eligible for the treatment.
FDA Approves SpringWorks Therapeutics’ Gomekli for Neurofibromatosis Type 1, Symptomatic Plexiform Neurofibromas
Approval makes Gomekli the first treatment to be approved for both adults and pediatric patients for neurofibromatosis type 1, a genetic disorder that causes noncancerous tumors to grow on nerves throughout the body.
SpringWorks shares rise on FDA nod for GOMEKLI
Shares of SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) climbed 2.7%, building on a previous gain of 2%, following the FDA approval of their drug, GOMEKLI, for the treatment of neurofibromatosis type 1 (NF1) with symptomatic plexiform neurofibromas (PN) not amenable to complete resection.
1SWTX : SpringWorks Therapeutics Secures FDA Approval For Second Cancer Drug
SpringWorks' Gomekli wins FDA approval for NF1-related tumors, showing strong efficacy in trials. U.S. launch expected in two weeks, with EU review ongoing.
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of non-cancerous tumors on nerves throughout the body.  The federal agency said on Tuesday it
Spring Works shares rise on raised price target to $66
TD Cowen analysts increased their price target for Spring Works Therapeutics (NASDAQ:SWTX) shares to $66.00 from $63.00, while maintaining a "Buy" rating on the stock. The company's shares, currently trading at $57.
FDA approves SpringWorks’ Gomekli
The US Food and Drug Administration approved Gomekli (mirdametinib), from SpringWorks Therapeutics, 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,
SpringWorks Therapeutics confirms FDA approval of Gomekli
SpringWorks Therapeutics (SWTX) announced that the U.S. FDA has approved Gomekli, SpringWorks’ MEK inhibitor, for the treatment of adult and
SpringWorks sets wholesale acquisition cost for Gomekli at $206.25 per mg
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved Gomekli, a small molecule MEK inhibitor, ...
FiercePharma7h
Amid takeover talk, SpringWorks scores FDA nod for rare genetic disease treatment Gomekli
Tuesday, the agency signed off on SpringWorks’ Gomekli (mirdametinib) as a treatment for the rare genetic disorder ...
The American Journal of Managed Care3h
FDA Approves Mirdametinib for Neurofibromatosis Type 1 with Plexiform Neurofibromas
Adult and pediatric patients with neurofibromatosis type 1 who have symptomatic plexiform neurofibromas that are not amenable ...
BioSpace5h
SpringWorks Wins FDA Nod for Neurofibromatosis Drug, Tees Up Challenge to AstraZeneca
The FDA on Tuesday signed off on SpringWorks Therapeutics’ mirdametinib—now to carry the brand name Gomekli—for the treatment ...