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• SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDAFDA Extending PDUFA Date by Three Months to Allow More Time to Complete Their Review; New PDUFA Date Set to November 27, 2023

  6/5/2023

  SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, announced that the U.S. Food and Drug Administration has updated the Prescription Drug User Fee Act action date for the New Drug Application for nirogacestat for the treatment of adults with desmoid tumors.

• SpringWorks Therapeutics Announces Full Enrollment of Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors

  5/30/2023

  SpringWorks Therapeutics, Inc. 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.

• SpringWorks Therapeutics Announces Presentation of Additional Data from Phase 3 DeFi Trial of Nirogacestat in Adults with Desmoid Tumors at the 2023 ASCO Annual Meeting

  5/25/2023

  SpringWorks Therapeutics, Inc. announced that additional data from the Phase 3 DeFi trial assessing the impact of nirogacestat, an investigational gamma secretase inhibitor, on pain, tumor volume and T2 hypersensitivity in adults with desmoid tumors will be presented at the 2023 American Society of Clinical Oncology Annual Meeting, being held June 2-6, 2023.

• SpringWorks Therapeutics Announces Clinical Data Presentations of Nirogacestat in Combination with BCMA-Directed Therapies at the European Hematology Association 2023 Congress

  5/11/2023

  SpringWorks Therapeutics, Inc. 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.

• BeiGene Reports First Quarter 2023 Financial Results and Corporate Developments

  5/4/2023

  BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today reported financial results for the first quarter 2023, recent business highlights, and upcoming milestones.

• SpringWorks Therapeutics Reports First Quarter 2023 Financial Results and Recent Business Highlights

  5/3/2023

  SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported first quarter financial results for the period ended March 31, 2023 and provided an update on recent company developments.

• BeiGene & SpringWorks Present Clinical Data on Lifirafenib, in Combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023

  4/17/2023

  BeiGene, Ltd., and SpringWorks Therapeutics, Inc., 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.

• MapKure, BeiGene and SpringWorks Present Clinical Data on BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors at the American Association for Cancer Research Annual Meeting 2023

  4/17/2023

  MapKure, LLC, BeiGene, Ltd., and SpringWorks Therapeutics, Inc., 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.

• SpringWorks & BeiGene Present Clinical Data on Lifirafenib, in combination with Mirdametinib, in Patients with Advanced or Refractory Solid Tumors with MAPK Pathway Aberrations at the American Association for Cancer Research Annual Meeting 2023

  4/17/2023

  SpringWorks Therapeutics, Inc., and BeiGene, Ltd., 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.

• MapKure, SpringWorks and BeiGene Present Clinical Data on BGB-3245, a Selective Next-Generation B-RAF Inhibitor, in Adult Patients with Advanced or Refractory Solid Tumors at the American Association for Cancer Research Annual Meeting 2023

  4/17/2023

  MapKure, LLC, SpringWorks Therapeutics, Inc., and BeiGene, Ltd., 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.

• SpringWorks Therapeutics Announces New England Journal of Medicine Publication of Phase 3 DeFi Trial Evaluating Nirogacestat in Adults with Desmoid Tumors

  3/8/2023

  SpringWorks Therapeutics, Inc. announced today that data from the Phase 3 DeFi trial of nirogacestat, an investigational oral gamma secretase inhibitor, in adult patients with progressing desmoid tumors, were published in the New England Journal of Medicine (NEJM).

• SpringWorks Therapeutics to Participate in the Cowen 43rd Annual Health Care Conference

  3/1/2023

  SpringWorks Therapeutics, Inc. 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.

• SpringWorks Therapeutics Reports Fourth Quarter and Full-Year 2022 Financial Results and Recent Business Highlights

  2/28/2023

  SpringWorks Therapeutics, Inc. reported financial results for the fourth quarter and full-year periods ended December 31, 2022 and provided an update on recent company developments.

• SpringWorks Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Nirogacestat for the Treatment of Adults with Desmoid Tumors– PDUFA Action Date Set for August 27, 2023

  2/27/2023

  SpringWorks Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for nirogacestat.

• SpringWorks Therapeutics Highlights 2022 Accomplishments and Anticipated Milestones for 2023 at the 41st Annual J.P. Morgan Healthcare Conference

  1/9/2023

  SpringWorks Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, will present at the 41st Annual J.P. Morgan Healthcare Conference at 7:30 a.m. PT, and a live webcast will be available at ir.springworkstx.com.

• SpringWorks Therapeutics to Present at the 41st Annual J.P. Morgan Healthcare Conference

  1/3/2023

  SpringWorks Therapeutics, Inc. 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.

• SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Nirogacestat for the Treatment of Adults with Desmoid Tumors

  12/27/2022

  SpringWorks Therapeutics, Inc. announced that the Company has completed the submission of a New Drug Application to the United States Food and Drug Administration for nirogacestat, an investigational gamma secretase inhibitor, for the treatment of adults with desmoid tumors.

• SpringWorks Therapeutics to Participate in the Evercore ISI 5th Annual HealthCONx Conference

  11/22/2022

  SpringWorks Therapeutics, Inc. 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.

• ARS Pharmaceuticals Closes Merger with Silverback Therapeutics

  11/8/2022

  ARS Pharmaceuticals, Inc. announced the closing of its merger with Silverback Therapeutics, Inc.

• Precision BioSciences Reports Third Quarter 2022 Financial Results and Provides Business Update

  11/8/2022

  Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based ex vivo allogeneic CAR T and in vivo gene editing therapies, today announced financial results for the third quarter ended September 30, 2022 and provided a business update.