FDA, Gomekli and SpringWorks

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.
US FDA approves SpringWorks' genetic disorder drug
The U.S. Food and Drug Administration said on Tuesday it has approved SpringWorks Therapeutics' drug to treat a type of rare genetic disorder, which causes tumors to grow in the tissue that covers 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.
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 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 SpringWorks Therapeutics’ Gomekli to treat neurofibromatosis type 1
The US Food and Drug Administration (FDA) has approved SpringWorks Therapeutics’ Gomekli (mirdametinib) to treat neurofibromatosis type 1 (NF1), a rare genetic disorder affecting approximately 100,000 people in the US.
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 ...
SpringWorks Therapeutics sets wholesale acquisition cost for GOMEKLI at $206.25
SpringWorks Therapeutics (SWTX) has announced that the U.S. Food and Drug Administration has approved GOMEKLI, a small molecule MEK inhibitor, for the treatment of adult and pediatric patients 2 years ...
FiercePharma1d
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 ...
Zacks.com on MSN5h
Biotech Stock Roundup: GILD Up on Q4 Results, BIIB, BMY Down on 2025 Guidance
It was a busy week for the biotech sector, as the fourth-quarter earnings season is in full swing. While Gilead Sciences, Inc ...
BioSpace1d
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 ...
Wedbush ups SpringWorks target to $81, expects Merck KGaA ‘official’ offer soon
Wedbush raised the firm’s price target on SpringWorks Therapeutics (SWTX) to $81 from $77 and keeps an Outperform rating on the shares following the Food and Drug Administration’s approval for Gomekli ...
SpringWorks Therapeutics price target raised to $66 from $63 at TD Cowen
TD Cowen raised the firm’s price target on SpringWorks Therapeutics (SWTX) to $66 from $63 and keeps a Buy rating on the shares. The firm says ...