SpringWorks Therapeutics Q4 2022 Earnings Report
Key Takeaways
SpringWorks Therapeutics reported positive data from their Phase 3 DeFi trial of nirogacestat in desmoid tumors, which led to the FDA accepting their New Drug Application and granting Priority Review. They are also encouraged by the potential for mirdametinib as a therapy for children and adults with NF1-PN.
NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review with a PDUFA Action Date Set for August 27, 2023.
Topline Data from Phase 2b ReNeu Trial Evaluating Mirdametinib in Adult and Pediatric Patients with NF1-Associated Plexiform Neurofibromas Expected in the Second Half of 2023.
Dosed First Patient in Phase 1/2a Combination Study of BGB-3245 and Mirdametinib.
Expanded Intellectual Property Portfolio, Strengthening Protection for Nirogacestat into 2042 and for Mirdametinib into 2041.
SpringWorks Therapeutics
SpringWorks Therapeutics
Forward Guidance
This presentation contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions