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SpringWorks Therapeutics
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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 Q3’25 The P-IIb (ReNeu) study assessed mirdametinib (2mg/m^2, BID) in 2 Arms (N=114: 56 pediatric & 58 adults) & met its 1EP of cORR…
May 26, 2025

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SpringWorks Therapeutics
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 2025 The P-IIb (ReNeu) study assessed Gomekli(2mg/m^2, BID) in 2 Arms…
February 12, 2025

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Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas
INSIGHTS+

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Shots: The 41st Annual J.P. Morgan Healthcare Conference took place on 09 – 12 January 2023 in San Francisco, CA, USA. It is the largest and most informative healthcare investment symposium in the industry, bringing together a cohort of industry leaders, emerging fast-growing companies, innovative technology creators, and members of the investment community  The major announcement…
January 19, 2023

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