SpringWorks Therapeutics Announces Positive Topline Results from the Phase 2b ReNeu Trial of Mirdametinib in NF1-PN
The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
- The ReNeu trial enrolled 114 patients in two cohorts (pediatric and adult) across 50 sites in the U.S.
- Mirdametinib was generally well tolerated in the ReNeu trial, with the majority of adverse events (AEs) being Grade 1 or Grade 2.
- “We are extremely pleased that the results of our ReNeu trial demonstrate a compelling clinical profile across measures of both safety and efficacy.
- SpringWorks plans to submit a New Drug Application (NDA) for mirdametinib to the FDA in the first half of 2024.