SWTX - Earnings announcements

– Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively – – Received FDA approval of GOMEKLI™ (mirdametinib) for the treatment of adult and pediatric patients with symptomatic NF1-PN not amendable to complete resection – – Ended 2024 with $461.9 million in cash, cash equivalents and marketable securities – STAMFORD, Conn., Feb. 20, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the fourth quarter and full year periods ended December 31, 2024 and provi

STAMFORD, Conn., Jan. 30, 2025 (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 Thursday, February 20, 2025 to report its fourth quarter and full year financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcas

– 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 Application for mirdametinib for the treatment of adults and children with NF1-PN – – $498 million in cash, cash equivalents and marketable securities as of September 30, 2024; expected to fund the Company through profitability, which is anticipated in the first

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 corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcast will be availa

– 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, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported financial results for the second quarter of 2024 and provided an update

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 corresponding slides, please click here. To participate in the live conference call by phone, please click here to pre-register. Registered participants will then be provided with a dial-in number and conference code to access the call. A replay of the webcast will be availa

– 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 02, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today reported first quarter financial results for the period ended March 31, 2024 and

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 corresponding slides, please click here. To access the live call by phone, please pre-register for the call by clicking here. Once registration is complete, participants will be provided with a dial-in number and conference code to access the call. A replay of the webcast will

– 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 – A Media Snippet accompanying this announcement is available by clicking on this link. STAMFORD, Conn., Nov. 27, 2023 (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 approved OGSIVEO™ (nirogacestat), a

– 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 and NDA submission to the U.S. FDA planned in the first half of 2024 – – Company to host conference call today at 8:30 a.m. Eastern Time – STAMFORD, Conn., Nov. 16, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a clinical-st

STAMFORD, Conn., Aug. 19, 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, today announced that data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, will be presented as a late-breaking oral presentation at the European Society for Medical Oncology (ESMO) Congress 2022. The abstract is expected to be published online via the ESMO website on September 8, 2022 (12:05 a.m. CEST; 6:05 p.m. ET on September 7). "We are very pleased that t

-- NDA filing for Nirogacestat in Desmoid Tumors, Which Will Be Reviewed Under the FDA's Real-Time Oncology Review (RTOR) Program, Expected in Second Half of 2022 -- -- New Phase 2 Study Announced to Evaluate Nirogacestat in Patients with Ovarian Granulosa Cell Tumors -- -- Eight Clinical Collaborations Evaluating Nirogacestat as a Cornerstone of BCMA Combination Therapy Ongoing; Nirogacestat in Combination with Low Dose of GSK's BLENREP Being Evaluated in Phase 2 Trial and Advanced into Additional Sub-Studies with Standard of Care Agents -- -- Mirdametinib Being Evaluated in Monotherapy and Combination Studies in Rare Oncology Indications and Biomarker-Defined Solid Tumors -- -- BGB-324

-- Results Showed Statistically Significant Improvement in Progression-Free Survival (PFS) Compared to Placebo (Hazard Ratio (HR) = 0.29; P < 0.001) -- -- Statistical Significance Was Also Achieved on All Key Secondary Endpoints, Including Objective Response Rate (ORR) and Patient-Reported Outcomes (PROs) -- -- Nirogacestat Was Generally Well Tolerated with a Manageable Safety Profile -- -- Additional Data Expected to be Presented at Medical Conference in the Second Half of 2022 -- -- NDA Submission to the U.S. FDA Planned for Second Half of 2022 -- -- Company to Host Conference Call at 8:30 a.m. Eastern Time -- STAMFORD, Conn., May 24, 2022 (GLOBE NEWSWIRE) -- SpringWorks Therapeuti