Articles from SpringWorks Therapeutics, Inc.

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.

– Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively –

STAMFORD, Conn., Jan. 03, 2025 (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 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 11:15 a.m. PT.

STAMFORD, Conn., Nov. 26, 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 7th Annual Evercore ISI HealthCONx Conference, taking place in Coral Gables, Florida on Tuesday, December 3, 2024 at 12:30 p.m. ET.

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.

– Achieved $49.3 million in OGSIVEO® (nirogacestat) net product revenue in the third quarter –

– 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 –

– Mirdametinib treatment demonstrated significant confirmed objective response rates and a manageable safety profile in adults and children with NF1-PN –

– 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. 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.

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.

– PDUFA target action date of February 28, 2025 –

– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter –

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, including leadership roles at Pfizer, AstraZeneca and Alexion.

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.

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 patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN).

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 45th Annual Global Healthcare Conference, taking place in Miami, Florida on Tuesday, June 11, 2024 at 2:00 p.m. ET.

– Results from pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN to be presented in an oral presentation –

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.

– Achieved $21.0 million in OGSIVEO® (nirogacestat) net product revenue in the first quarter –

– Results from Phase 2b ReNeu trial of mirdametinib in NF1-PN accepted for oral presentation –

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.

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 neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Application based on Phase 3 DeFi trial in which nirogacestat significantly improved progression-free survival and objective response rate compared to placebo, with rapid and sustained improvements in symptom burden including pain, physical and role functioning, and quality of life

– Reported OGSIVEO™ (nirogacestat) net product revenue of $5.4 million in first partial quarter of launch following FDA approval on November 27, 2023 –

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:

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.

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 42nd 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 accomplishments and announced its anticipated key milestones for 2024.

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.

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 option to purchase up to an additional 1,422,413 shares of common stock in this offering. The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $316.25 million.

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 the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $275.0 million. The offering is expected to close on or about December 7, 2023, subject to the satisfaction of customary closing conditions. In addition, SpringWorks has granted the underwriters a 30-day option to purchase up to an additional 1,422,413 shares of its common stock at the public offering price, less underwriting discounts and commissions.

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 a 30-day option to purchase up to an additional $37.5 million of shares of its common stock in the offering.

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.

– 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 –

– Confirmed objective response rate of 52% in pediatric patients and 41% in adult patients, as assessed by Blinded Independent Central Review –

– PDUFA target action date for nirogacestat NDA in adults with desmoid tumors remains set for November 27, 2023 –

- Nirogacestat Treatment Demonstrated Rapid and Sustained Improvements in Functional Status Compared to Placebo Across Multiple Assessment Tools -

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 drug discovery programs from target identification through early clinical trials across the therapeutic areas of oncology, immuno-oncology, and immunology.

– 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 –

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 44th Annual Global Healthcare Conference in Dana Point, CA on Monday, June 12, 2023 beginning at 11:20 a.m. PT / 2:20 p.m. ET.

FDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023

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 ovarian granulosa cell tumors (OvGCT). SpringWorks expects to report initial data from the trial in 2024.

- Nirogacestat Treatment Demonstrated Rapid, Sustained and Consistent Reductions in Pain Compared to Placebo Using Multiple Assessment Tools -

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 4th Annual Oncology Innovation Summit on Wednesday, May 31, 2023 beginning at 1:00 p.m. ET.

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 agent (BCMA) therapies in patients with relapsed or refractory multiple myeloma (RRMM) will be presented at the European Hematology Association (EHA) 2023 Congress, taking place in Frankfurt, Germany from June 8-11, 2023. Updated clinical data from the Phase 1/2 study sponsored by GSK plc (LSE/NYSE: GSK) evaluating nirogacestat in combination with low-dose belamaf (belantamab mafodotin-blmf), GSK’s antibody-drug conjugate targeting BCMA, in patients with RRMM will be presented in a poster presentation. In addition, new data from the Phase 1b clinical trial sponsored by Janssen Research & Development, LLC (Janssen) evaluating nirogacestat in combination with teclistamab, Janssen’s bispecific antibody targeting BCMA and CD3, will be presented in an oral presentation.

– NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review; PDUFA Action Date Set for August 27, 2023 –

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. ET).

STAMFORD, Conn. and BASEL, Switzerland and BEIJING and CAMBRIDGE, Mass., April 17, 2023 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQSWTX), 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 advanced or refractory solid tumors with RAS mutations, RAF mutations and other MAPK pathway aberrations. The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

STAMFORD, Conn. and BASEL, Switzerland and BEIJING and CAMBRIDGE, Mass. and SAN MATEO, Calif., April 17, 2023 (GLOBE NEWSWIRE) -- MapKure, LLC, SpringWorks Therapeutics, Inc. (NASDAQSWTX), 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 advanced or refractory solid tumors harboring MAPK pathway aberrations. The data are being presented today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023, taking place in Orlando, Florida.

– Nirogacestat Treatment Significantly Improved Progression-Free Survival, Objective Response Rate and Key Patient Reported Outcomes –

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 43rd Annual Health Care Conference on Tuesday, March 7, 2023 at 12:50 p.m. ET.

– NDA for Nirogacestat in Adults with Desmoid Tumors Accepted by the FDA and Granted Priority Review; PDUFA Action Date Set for August 27, 2023 –

– PDUFA Action Date Set for August 27, 2023 –

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 41st 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 2022 accomplishments and announced its anticipated key milestones for 2023.

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.

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 gamma secretase inhibitor, for the treatment of adults with desmoid tumors.  

STAMFORD, Conn., Nov. 22, 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 management will participate in a fireside chat at the Evercore ISI 5th Annual HealthCONx Conference, taking place virtually on Tuesday, November 29, 2022 at 4:20 p.m. ET.

– Presented Positive Data from Phase 3 DeFi Trial Evaluating Nirogacestat in Adult Patients with Progressing Desmoid Tumors at the European Society for Medical Oncology (ESMO) Congress 2022 –

STAMFORD, Conn., Sept. 29, 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 the first patient has been dosed in a Phase 2 trial evaluating nirogacestat, SpringWorks’ investigational gamma secretase inhibitor, as a monotherapy in patients with recurrent ovarian granulosa cell tumors.