$SWTX News
Last published 2mo ago
- 2mo agoSWTXApproval of Ogsiveo, Nda #217677 (Labeling)FDA Approved DrugsApproval Date: 08/20/2026; Drug Name: Ogsiveo, Nda #217677; Active Ingredients: NIROGACESTAT HYDROBROMIDE; Company: Springworks; Submission Status: Approval; Submission Classification: Labeling; Application Number: 217677
- 1y agoSWTXSpringWorks Therapeutics Announces Publication of Long-Term Efficacy and Safety Data from the Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors in the Journal of Clinical OncologyGlobeNewswireSTAMFORD, Conn., Oct. 21, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that long-term efficacy and safety data from the Phase 3 DeFi
- 1y agoSWTXEuropean Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with Desmoid TumorsGlobeNewswireSTAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted marketing
- 1y agoSWTXEuropean Commission Grants Conditional Approval of EZMEKLY® (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNGlobeNewswireSTAMFORD, Conn., July 18, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted conditional marketing
- 1y agoSWTXSpringWorks Therapeutics Receives Positive CHMP Opinion for Nirogacestat for the Treatment of Adults with Desmoid TumorsGlobeNewswire– If approved, nirogacestat will be the first and only therapy with marketing authorization in the EU for the treatment of desmoid tumors – – Decision from European Commission expected in the third quarter of 2025 –
- 1y agoSWTXSpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PNGlobeNewswire– If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN – – Decision from European Commission expected in the
- 1y agoSWTXMerck KGaA, Darmstadt, Germany to Acquire SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare BusinessGlobeNewswire– Purchase price of $47 per share in cash represents an equity value of approximately $3.9 billion, or an enterprise value of $3.4 billion (€3.0 billion) – – Planned acquisition will immediately add revenue and
- 1y agoSWTXMerck KGaA, Darmstadt, Germany, to Acquire US Biopharma Company SpringWorks Therapeutics to Accelerate Sustainable Growth of Healthcare BusinessBusiness WirePurchase price of $47 per share in cash represents an enterprise value of €3.0 billion ($3.4 billion), or an equity value of approximately $3.9 billion Planned acquisition will immediately add revenue and accelerate
- 1y agoSWTXSpringWorks Therapeutics Announces Expected CHMP Opinion in Q2 2025 for Nirogacestat for the Treatment of Adults with Desmoid Tumors in the European UnionGlobeNewswireSTAMFORD, Conn., April 27, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the
- 1y agoSWTXSpringWorks Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Highlights Recent Business UpdatesGlobeNewswire– 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
- 1y agoSWTXSpringWorks Therapeutics and Jewelry Designer Jennifer Fisher Team Up to Encourage People with Desmoid Tumors to Take Action Before Their Tumor Takes OverPR NewswireSpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, and Jennifer...
- 1y agoSWTXUPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNGlobeNewswire– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and
- 1y agoSWTXSpringWorks Therapeutics Announces FDA Approval of GOMEKLI™ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PNGlobeNewswire– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR,
- 1y agoSWTXApproval of Gomekli, Nda #219379 (Type 1 - New Molecular Entity)FDA Approved DrugsApproval Date: 02/11/2025; Drug Name: Gomekli, Nda #219379; Active Ingredients: MIRDAMETINIB; Company: Springworks Therapeutics Inc; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 219379
- 1y agoSWTXSpringWorks Therapeutics to Report Fourth Quarter and Full Year 2024 Financial Results on Thursday, February 20, 2025GlobeNewswireSTAMFORD, 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
- 1y agoSWTXSpringWorks Therapeutics Reports Preliminary Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates at 43rd Annual J.P. Morgan Healthcare ConferenceGlobeNewswire– Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively – – Ended 2024 with approximately $462 million in cash,
- 1y agoSWTXSpringWorks Therapeutics to Present at the 43rd Annual J.P. Morgan Healthcare ConferenceGlobeNewswireSTAMFORD, 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
- 1y agoSWTXSpringWorks Therapeutics to Participate in the 7th Annual Evercore ISI HealthCONx ConferenceGlobeNewswireSTAMFORD, 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
- 1y agoONCYIBRXIOVASNDX+1Biotech Companies' Q3 Updates: Promising Cancer Treatments on the HorizonPR NewswireUSA News Group News Commentary – As many biotech companies within the oncology space begin to roll out their end-of-quarter results, the American...
- 1y agoSWTXSpringWorks Therapeutics, Inc. (SWTX) Q3 2024 Earnings Call TranscriptEarnings Call Transcripts
- 1y agoSWTXSpringWorks Therapeutics to Participate in the Jefferies London Healthcare ConferenceGlobeNewswireSTAMFORD, 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
- 1y agoSWTXSpringWorks Therapeutics Reports Third Quarter 2024 Financial Results and Recent Business HighlightsGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics Announces Mirdametinib Data to be Presented at the 2024 Society for Neuro-Oncology (SNO) Annual MeetingGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics Announces Publication of the Pivotal Phase 2b ReNeu Trial Evaluating Mirdametinib in Adults and Children with NF1-PN in the Journal of Clinical OncologyGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics Announces Long-Term Efficacy and Safety Data from Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors to be Presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual MeetingGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics to Participate in Guggenheim's Inaugural Healthcare Innovation ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics to Report Third Quarter 2024 Financial Results on Tuesday, November 12, 2024GlobeNewswireSTAMFORD, 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
- 2y agoSWTXFDA Grants Priority Review to SpringWorks Therapeutics' New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PNGlobeNewswire– 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,
- 2y agoSWTXSpringWorks Therapeutics, Inc. (SWTX) Q2 2024 Earnings Call TranscriptEarnings Call Transcripts
- 2y agoSWTXSpringWorks Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business HighlightsGlobeNewswire– 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 –
- 2y agoSWTXSpringWorks Therapeutics Appoints Dr. Martin Mackay to its Board of DirectorsGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics to Report Second Quarter 2024 Financial Results on Wednesday, August 7, 2024GlobeNewswireSTAMFORD, 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
- 2y agoSWTXKuehn Law Encourages Investors of SpringWorks, Therapeutics Inc. to Contact Law FirmPR NewswireKuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of SpringWorks Therapeutics, Inc....
- 2y agoSWTXSpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PNGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics Announces Data to be Presented at the 2024 American Society of Clinical Oncology (ASCO) Annual MeetingGlobeNewswire– 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)
- 2y agoSWTXSpringWorks Therapeutics to Participate in the BofA Securities 2024 Health Care ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics, Inc. (SWTX) Q1 2024 Earnings Call TranscriptEarnings Call Transcripts
- 2y agoSWTXSpringWorks Therapeutics Reports First Quarter 2024 Financial Results and Highlights Recent Business UpdatesGlobeNewswire– 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 – –
- 2y agoSWTXSpringWorks Therapeutics Announces Abstracts Accepted for Presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual MeetingGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics to Report First Quarter 2024 Financial Results Thursday, May 2, 2024GlobeNewswireSTAMFORD, 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
- 2y agoSWTXApproval of Ogsiveo, Nda #217677 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 04/04/2024; Drug Name: Ogsiveo, Nda #217677; Active Ingredients: NIROGACESTAT HYDROBROMIDE; Company: Springworks; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 217677
- 2y agoSWTXSpringWorks Therapeutics Initiates Rolling Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PNGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics Announces European Medicines Agency Validation for Marketing Authorization Application of Nirogacestat for the Treatment of Adults with Desmoid TumorsGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Highlights Recent Business UpdatesGlobeNewswire– 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
- 2y agoSWTXSpringWorks Therapeutics to Present at Upcoming Investor ConferencesGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics to Participate in the Guggenheim Healthcare Talks 6th Annual Biotechnology ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics Highlights 2023 Accomplishments and Anticipated Milestones for 2024 at the 42nd Annual J.P. Morgan Healthcare ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics to Present at the 42nd Annual J.P. Morgan Healthcare ConferenceGlobeNewswireSTAMFORD, 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
- 2y agoSWTXSpringWorks Therapeutics Announces Closing of Upsized Public Offering of Common Stock and Full Exercise of Underwriters' Option to Purchase Additional SharesGlobeNewswireSTAMFORD, 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