FDA, GOMEKLI and SpringWorks

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.
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,
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.
Springworks’ Gomekli wins priority FDA nod for NF1 neurofibromas
Snagging its second U.S. FDA approval since being spun out of Pfizer Inc. in 2017, Springworks Therapeutics Inc. is aiming to position Gomekli (mirdametinib), cleared for neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN) not amenable to complete resection,
FDA approves new genetic disorder drug
The Food and Drug Administration (FDA) approved a new drug to treat a disorder causing the growth of noncancerous tumors on nerves throughout the body.  The federal agency said on Tuesday it
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
UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (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 ...
FiercePharma23h
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 ...
Pharm Exec18h
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 ...
BioSpace21h
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 ...
SpringWorks Therapeutics' chief people officer sells $1.6 million in stock
Daniel Pichl, Chief People Officer at SpringWorks Therapeutics (NASDAQ:SWTX), has recently sold a significant portion of his holdings in the company. According to a Form 4 filing with the SEC, Pichl ...
SpringWorks Therapeutics may be worth around $77 a share in a takeover - analyst
SpringWorks Therapeutics (SWTX) may be acquired by Merck KGaA for $77 per share, representing a potential premium of 92% ...
Merck KGaA in Talks to Buy SpringWorks Therapeutics
Merck KGaA said it’s in advanced talks to purchase SpringWorks Therapeutics Inc., sending shares of the US cancer and rare ...