STAMFORD, Conn., Nov. 12, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Jefferies London Healthcare Conference, taking place in London, United Kingdom on Tuesday, November 19, 2024 at 10:30 a.m. ET. To access the live webcast, please... Read More

Achieved $49.3 million in OGSIVEO ® (nirogacestat) net product revenue in the third quarter Long-term follow-up data from the Phase 3 DeFi trial of nirogacestat in adults with desmoid tumors highlight further reductions in tumor size, increase in ORR, sustained improvement in desmoid tumor symptoms, and consistent safety profile Granted FDA Priority Review on NDA and received validation of EU Marketing Authorization... Read More

Data from the pivotal Phase 2b ReNeu trial demonstrate that patients with NF1-PN achieved deep responses and improvements in health-related quality of life over the course of mirdametinib treatment Encouraging results from Phase 1/2 study of mirdametinib in pediatric patients with low-grade glioma also to be presented in oral session at SNO STAMFORD, Conn., Nov. 11, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc.... Read More

Mirdametinib treatment demonstrated significant confirmed objective response rates and a manageable safety profile in adults and children with NF1-PN Patients achieved deep and durable reductions in tumor volume and early, sustained and clinically meaningful improvements in pain and health-related quality of life New Drug and Marketing Authorization Applications under review; U.S. PDUFA action date set for February 28, 2025... Read More

Long-term follow-up data highlight further reductions in tumor size, increase in ORR with additional CRs, sustained improvement in desmoid tumor symptoms, and consistent safety profile, now with a median duration of therapy of approximately 3 years STAMFORD, Conn., Nov. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and... Read More

STAMFORD, Conn., Nov. 05, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at Guggenheim’s Inaugural Healthcare Innovation Conference, taking place in Boston, Massachusetts on Wednesday, November 13, 2024 at 1:00 p.m. ET. To access the live... Read More

STAMFORD, Conn., Oct. 22, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Tuesday, November 12, 2024 to report its third quarter financial results and discuss recent business updates. To join the live webcast and view the... Read More

PDUFA target action date of February 28, 2025 EU Marketing Authorization Application also validated by European Medicines Agency STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application... Read More

Achieved $40.2 million in OGSIVEO ® (nirogacestat) net product revenue in the second quarter Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors STAMFORD, Conn., Aug. 07,... Read More

STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company’s Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience,... Read More

STAMFORD, Conn., July 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Wednesday, August 7, 2024 to report its second quarter financial results and discuss recent business updates. To join the live webcast and view the... Read More

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult... Read More

STAMFORD, Conn., June 05, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc . (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Goldman Sachs 45 th Annual Global Healthcare Conference, taking place in Miami, Florida on Tuesday, June 11, 2024 at 2:00 p.m. ET. To access the live webcast, please... Read More

Results from pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN to be presented in an oral presentation Additional data and analyses from Phase 3 DeFi trial of OGSIVEO ® (nirogacestat) highlighting consistent safety and efficacy across subgroups of adults with desmoid tumors also being presented in oral and poster sessions STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc.... Read More

STAMFORD, Conn., May 08, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the BofA Securities 2024 Health Care Conference, taking place in Las Vegas, Nevada on Tuesday, May 14, 2024 at 3:40 p.m. PT / 6:40 p.m. ET. To access the live webcast,... Read More

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 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 the 2024 ASCO Annual Meeting STAMFORD, Conn., May... Read More

Results from Phase 2b ReNeu trial of mirdametinib in NF1-PN accepted for oral presentation Additional data from the Phase 3 DeFi trial of OGSIVEO® (nirogacestat) in adults with desmoid tumors also accepted for presentations at ASCO STAMFORD, Conn., April 24, 2024 (GLOBE NEWSWIRE) - - SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today... Read More

STAMFORD, Conn., April 18, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. E.T. on Thursday, May 2, 2024 to report its first quarter financial results and discuss recent business updates. To join the live webcast and view the... Read More

STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has initiated a rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, in pediatric and adult patients with... Read More

STAMFORD, Conn., Feb. 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for nirogacestat, an oral gamma secretase inhibitor, for the treatment of adults with desmoid tumors. If approved,... Read More

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; on track to submit New Drug Application in first... Read More

STAMFORD, Conn., Feb. 22, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will present at the following investor conferences: TD Cowen 44th Annual Health Care Conference on Monday, March 4 at 2:50 p.m. E.T. Barclays 26th Annual Global Healthcare Conference on Tuesday, March 12 at... Read More

STAMFORD, Conn., Jan. 31, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference, taking place in New York, New York on Thursday, February 8, 2024 at 2:00 p.m. ET. To access the live... Read More

STAMFORD, Conn., Jan. 08, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, will present today at the 42 nd Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at ir.springworkstx.com . Ahead of the presentation, the Company highlighted its 2023... Read More

STAMFORD, Conn., Dec. 21, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that Saqib Islam, Chief Executive Officer, will present at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 7:30 a.m. PT. To access the live webcast, please visit the Events & Presentations page... Read More

STAMFORD, Conn., Dec. 08, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today the closing of its previously announced underwritten public offering of 10,905,171 shares of its common stock at a public offering price of $29.00 per share, which includes the exercise in full by the underwriters of their... Read More

STAMFORD, Conn., Dec. 05, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today the pricing of an underwritten public offering of 9,482,758 shares of its common stock at a public offering price of $29.00 per share. All of the shares in the offering are being sold by SpringWorks. The gross proceeds from... Read More

STAMFORD, Conn., Dec. 04, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock. All of the shares in the offering will be sold by SpringWorks. In addition, SpringWorks expects to grant the underwriters... Read More

STAMFORD, Conn., Nov. 29, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference, taking place in Miami, Florida on Thursday, November 30, 2023 at 8:45 a.m. ET. To access the live webcast please visit... Read More

Approval based on positive data from Phase 3 DeFi trial, in which OGSIVEO significantly improved progression-free survival and objective response rate, with rapid and sustained improvements in pain, physical functioning and overall quality of life SpringWorks to host conference call tomorrow at 8:00 a.m. ET STAMFORD, Conn.,... Read More

Confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review Mirdametinib treatment resulted in deep and durable responses and significant improvements in key secondary patient-reported outcome measures Mirdametinib was generally well tolerated with low rates of Grade 3+ adverse events Additional data expected to be presented at medical conference... Read More

PDUFA target action date for nirogacestat NDA in adults with desmoid tumors remains set for November 27, 2023 On track to report topline data from the Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN in the fourth quarter of 2023 Presented additional Phase 3 DeFi data at CTOS demonstrating statistically significant and clinically meaningful improvements in functional status in desmoid tumor patients treated with... Read More

Nirogacestat Treatment Demonstrated Rapid and Sustained Improvements in Functional Status Compared to Placebo Across Multiple Assessment Tools STAMFORD, Conn., Nov. 01, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the presentation of additional... Read More

STAMFORD, Conn., Sept. 11, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced the appointment of Tai-An Lin, Ph.D., as its Chief Scientific Officer. Dr. Lin brings more than 25 years of biotechnology and global pharmaceutical experience in advancing... Read More

Presented additional Phase 3 DeFi data at ASCO demonstrating clinically significant reductions in pain and substantial reductions in tumor volume and T2 hyperintensity with nirogacestat treatment Completed enrollment of Phase 2 trial evaluating nirogacestat in patients with ovarian granulosa cell tumors Highlighted encouraging Phase 1 and 2 clinical data from emerging pipeline programs at AACR and EHA STAMFORD, Conn., Aug.... Read More

STAMFORD, Conn., June 07, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Goldman Sachs 44 th Annual Global Healthcare Conference in Dana Point, CA on Monday, June 12, 2023 beginning at... Read More

STAMFORD, Conn., June 05, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has updated the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for nirogacestat for... Read More

STAMFORD, Conn., May 30, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that it has achieved full enrollment in its Phase 2 trial evaluating nirogacestat, an investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent... Read More

Nirogacestat Treatment Demonstrated Rapid, Sustained and Consistent Reductions in Pain Compared to Placebo Using Multiple Assessment Tools Substantial Reductions in MRI-Assessed Tumor Volume and T2 Hyperintensity Observed with Nirogacestat Compared to Placebo STAMFORD, Conn., May 25, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing... Read More

STAMFORD, Conn., May 24, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that management will participate in a fireside chat at the virtual TD Cowen 4 th Annual Oncology Innovation Summit on Wednesday, May 31, 2023 beginning at 1:00 p.m. ET. To... Read More

STAMFORD, Conn., May 11, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that data from two collaborator-sponsored clinical studies evaluating nirogacestat, an investigational oral gamma secretase inhibitor, in combination with B-cell maturation... Read More

NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review; PDUFA Action Date Set for August 27, 2023 Phase 3 DeFi Trial Evaluating Nirogacestat in Adults with Desmoid Tumors Published in the New England Journal of Medicine Encouraging Clinical Data on MAPK Solid Tumor Programs Presented at the American Association for Cancer Research Annual Meeting 2023 STAMFORD, Conn., May 03, 2023... Read More

STAMFORD, Conn., May 02, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Bank of America Securities 2023 Health Care Conference on Tuesday, May 9, 2023 beginning at 11:20 a.m. PT (2:20 p.m.... Read More

STAMFORD, Conn. and BASEL, Switzerland and BEIJING and CAMBRIDGE, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), today announced that they will present updated clinical data from the Phase 1b trial of BeiGene’s RAF dimer inhibitor, lifirafenib, in combination with SpringWorks’ MEK inhibitor, mirdametinib, in patients with... Read More

STAMFORD, Conn. and BASEL, Switzerland and BEIJING and CAMBRIDGE, Mass. and SAN MATEO, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- MapKure, LLC, SpringWorks Therapeutics, Inc. ( NASDAQ: SWTX), and BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), today announced that they will present updated clinical data from the Phase 1a/1b study of BGB-3245, an investigational, selective RAF dimer inhibitor, in adult patients with... Read More

Nirogacestat Treatment Significantly Improved Progression-Free Survival, Objective Response Rate and Key Patient Reported Outcomes New Drug Application Under Review by the FDA with PDUFA Action Date of August 27, 2023 STAMFORD, Conn., March 08, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with... Read More

STAMFORD, Conn., March 01, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Cowen 43 rd Annual Health Care Conference on Tuesday, March 7, 2023 at 12:50 p.m. ET. To access the live webcast,... Read More

NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review; 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... Read More

STAMFORD, Conn., Feb. 27, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for nirogacestat, an investigational gamma secretase inhibitor, for the... Read More

STAMFORD, Conn., Jan. 09, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, will present today at the 41 st Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at ir.springworkstx.com . Ahead of the... Read More

STAMFORD, Conn., Jan. 03, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, today announced that Saqib Islam, Chief Executive Officer, will present at the 41st Annual J.P. Morgan Healthcare Conference on Monday, January 9, 2023 at 7:30 a.m. PT. To access the live... Read More

STAMFORD, Conn., Dec. 27, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for nirogacestat, an investigational... Read More