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Jun 30, 2022
SpringWorks Therapeutics Q2 2022 Earnings Report
Reported positive data across core focus areas and prepared for potential product launch.
Key Takeaways
SpringWorks Therapeutics reported positive data from the Phase 3 DeFi trial and encouraging preliminary data from the study evaluating nirogacestat with low-dose belantamab mafodotin in patients with multiple myeloma. The company is focused on preparing for its first potential product launch and advancing its diversified targeted oncology pipeline.
Phase 3 DeFi trial evaluating nirogacestat in adult patients with progressing desmoid tumors met its primary and all key secondary endpoints.
Encouraging preliminary data from Phase 1/2 study evaluating nirogacestat in combination with low dose belantamab mafodotin in patients with relapsed or refractory multiple myeloma was presented at ASCO.
Mirdametinib monotherapy and combination therapy studies in rare oncology indications and biomarker-defined solid tumors continue to progress.
BGB-3245 monotherapy to advance into cohort expansion studies and combination study of BGB-3245 and mirdametinib planned to initiate in 2H 2022.
SpringWorks Therapeutics
SpringWorks Therapeutics
Forward Guidance
The second half of 2022 will be focused on continued preparation for our first potential product launch, including submitting our NDA for nirogacestat in desmoid tumors and progressing the commercial preparations to serve patients with desmoid tumors while continuing to advance our diversified targeted oncology pipeline.
Positive Outlook
- Plans to report additional data from the Phase 3 DeFi clinical trial at an upcoming medical conference
- The potential for the results of the Phase 3 DeFi clinical trial to support an NDA submission
- The timing of our planned NDA submission for nirogacestat
- Plans for seeking regulatory approval for and making nirogacestat available to desmoid tumor patients, if approved
- Plans to report additional data from the dose escalation portion of the Phase 1b/2 trial evaluating mirdametinib with lifirafenib at an upcoming medical conference
Challenges Ahead
- The success and timing of our product development activities, including the initiation and completion of SpringWorks’ clinical trials
- The fact that topline data from the Phase 3 DeFi trial or topline or interim data from other clinical studies may not be predictive of the final or more detailed results of such study, or the results of other ongoing or future studies
- The success and timing of our collaboration partners’ ongoing and planned clinical trials
- The timing of our planned regulatory submissions and interactions, including the NDA for nirogacestat planned for the second half of 2022 and the timing and outcome of decisions made by the U.S. Food and Drug Administration (FDA) and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies
- Whether FDA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our drug candidates, including nirogacestat and mirdametinib