The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

Shots:The CHMP has recommended conditional approval of mirdametinib for pts (≥2yrs.) with unresectable neurofibromatosis type 1 associated symptomatic plexiform neurofibromas (NF1-PN) based on P-IIb (ReNeu) trial; EC’s decision expected in Q3’25The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…

ByRidhi RastogiMay 26, 2025

NEWS

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

Shots:Merck KGaA has entered into a definitive agreement to acquire SpringWorks Therapeutics to strengthen its rare disease portfolio & expand SpringWorks’ reach to markets beyond the USAs per the agreement, Merck KGaA will acquire SpringWorks for $47/share (~26% premium), with an equity value of ~$3.9B or an enterprise value of ~$3.4B, funded by…

ByRidhi RastogiApril 28, 2025

NEWS

SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)

Shots:The US FDA has approved Gomekli for pts (≥2 years) with unresectable NF1-PN based on P-IIb (ReNeu) trial & has also granted RPD PRV to SpringWorks; availability in US market is expected within 2wks; MAA is under EMA review with decision expected in 2025The P-IIb (ReNeu) study assessed Gomekli(2mg/m^2, BID) in 2 Arms…

ByRidhi RastogiFebruary 12, 2025

The CHMP Adopts Positive Opinion for SpringWorks Therapeutics’ Mirdametinib to Treat NF1-PN

Merck KGaA to Acquire SpringWorks Therapeutics for ~$3.9B

SpringWorks Therapeutics Receives US FDA Approval for Gomekli to Treat Neurofibromatosis Type 1 Associated Symptomatic Plexiform Neurofibromas (NF1-PN)

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