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SpringWorks Therapeutics(SWTX) - 2024 Q1 - Quarterly Results
2024-05-02 10:29
– Achieved $21.0 million in OGSIVEO (nirogacestat) net product revenue in the first quarter – ® – Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors – Exhibit 99.1 SpringWorks Therapeutics Reports First Quarter 2024 Financial Results and Highlights Recent Business Updates – Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Phase 2b ReNeu trial results accepted for oral presentation at ...
SpringWorks Therapeutics(SWTX) - 2023 Q4 - Annual Report
2024-02-27 11:51
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State of Other Jurisdiction of incorporation o ...
SpringWorks Therapeutics(SWTX) - 2023 Q4 - Annual Results
2024-02-27 11:44
SpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business Updates – Reported OGSIVEO™ (nirogacestat) net product revenue of $5.4 million in first partial quarter of launch following FDA approval on November 27, 2023 – – Submitted Marketing Authorization Application to the European Medicines Agency for nirogacestat for the treatment of desmoid tumors – – Presented positive topline data from Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN; ...
SpringWorks Therapeutics(SWTX) - 2023 Q3 - Quarterly Report
2023-11-02 10:38
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2023 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _ ...
SpringWorks Therapeutics(SWTX) - 2023 Q2 - Quarterly Report
2023-08-02 10:36
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2023 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ (Exact name of registrant as specified ...
SpringWorks Therapeutics(SWTX) - 2023 Q1 - Quarterly Report
2023-05-03 10:32
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2023 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _____ ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2023-03-02 18:19
Nirogacestat in Desmoid Tumors - The FDA accepted the NDA submission for Nirogacestat in desmoid tumors in Q1 2023 with Priority Review, with a PDUFA date of August 27, 2023 [61] - Desmoid tumor recurrence can be up to 77% following surgery [67] - In the Phase 3 DeFi trial, the objective response rate (ORR) for Nirogacestat was 41%, compared to 8% for placebo (p<0001) [90] - The Phase 3 DeFi trial demonstrated a 71% reduction in the risk of disease progression with Nirogacestat (hazard ratio: 029, p<0001) [140] - Among women of childbearing potential, ovarian dysfunction (OD) was observed in 75% receiving nirogacestat [119] Mirdametinib in NF1-PN - Topline data from the Phase 2b ReNeu trial in NF1-PN is expected in 2H 2023 [163] - NF1 patients have a ~30-50% lifetime risk of developing NF1-PN [151] - In the ReNeu trial, 50% of adult patients achieved an objective response by BICR [170] MAPK Portfolio - Approximately 25% of ER+ mBC patients progress on endocrine therapy [2] - Class 1 and 2 MEK mutants are sensitive to Mirdametinib in vitro [3] - BGB-3245 is active against resistance mutations that arise in BRAF V600 patients treated with approved BRAF inhibitors [270]
SpringWorks Therapeutics(SWTX) - 2022 Q4 - Annual Report
2023-02-28 11:39
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State of Other Jurisdiction of incorporation o ...
SpringWorks Therapeutics (SWTX) Investor Presentation - Slideshow
2022-11-04 18:07
Corporate Presentation November 2022 六 SpringW Forward-Looking Statements 2 Note: Unless otherwise indicated, the information presented herein is as of November 2022 and made publicly available on November 3, 2022. This presentation may contain "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, including but not limited to current beliefs, expectations and assumptions regarding t ...
SpringWorks Therapeutics(SWTX) - 2022 Q3 - Quarterly Report
2022-11-03 10:34
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2022 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (203) 883-9490 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUM ...