SpringWorks Therapeutics Inc

Springworks Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in applying a precision medicine approach to acquiring, developing and commercializing medicines. It focuses on developing drugs for underserved patient populations suffering from devastating rare diseases and cancer. Its pipeline include Nirogacestat, Mirdametinib and BGB-3245. The company was founded in August 2017 and is headquartered in Stamford, CT.

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SpringWorks reports robust Q1 revenue, poised for patient-centric growth

SpringWorks Therapeutics demonstrated strong financial performance and market acceptance for OGSIVEO in Q1 2024.
The company's focus on patient-centric care and pipeline advancement positions them well for future growth and innovation.
While facing challenges in market competition and regulatory landscape, SpringWorks has opportunities for expansion and diversification.

SpringWorks reports robust Q2 earnings, focuses on expanding treatments

SpringWorks Therapeutics delivered strong financial performance in Q2 2024, driven by $40.2 million in net product revenue for OGSIVEO.
The company's focus on expanding OGSIVEO reach, advancing mirdametinib, and developing its emerging portfolio underscores its commitment to innovation.
While facing challenges such as rising operating expenses, SpringWorks remains well-positioned with a healthy cash reserve to pursue growth opportunities.
Strategically navigating challenges and capitalizing on opportunities will be crucial for SpringWorks to sustain its momentum and drive future success.

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Springworks Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which engages in the application of a medicine approach to acquiring, developing, and commercializing medicines. Its pipeline includes Nirogacestat, Mirdametinib, Brimarafenib, SW-682, and EGFR Inhibitor. The company was founded in August 2017 and is headquartered in Stamford, CT.

SpringWorks (SWTX) posts encouraging data from phase IIb study on its MEK inhibitor, mirdametinib for treating neurofibromatosis type 1-associated plexiform neurofibromas. Stock falls.

SpringWorks (SWTX) Falls Despite Positive Mirdametinib Study Data

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

SpringWorks Therapeutics Announces Positive Topline Results from the Phase 2b ReNeu Trial of Mirdametinib in NF1-PN

SpringWorks Therapeutics' lead candidate, Nirogacestat, for treating Desmoid tumors, is coming up for an FDA decision - PDUFA date - on 27 November. I believe that an FDA approval for Nirogacestat in Desmoid tumors is more likely than not and discuss why I think so. I discuss Nirogacestat in detail because I think the value of this asset alone exceeds the current market value of the company.

SpringWorks Therapeutics: How A Likely FDA Approval Can Kickstart The Stock's Repricing Potential

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

SpringWorks Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights

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

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

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.

SpringWorks Therapeutics Appoints Dr. Tai-An Lin as Chief Scientific Officer

– 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 –

SpringWorks Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Today we revisit SpringWorks Therapeutics, Inc. for the first time in nearly a year. The company's primary drug asset is on the cusp of garnering SpringWorks' first FDA approval for a rare affliction. An updated investment analysis follows in the paragraphs below.

SpringWorks Therapeutics: FDA Decision Date Ahead

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.

SpringWorks Therapeutics to Participate in the Goldman Sachs 44th Annual Global Healthcare Conference

The U.S. Food and Drug Administration (FDA) has extended its decision for SpringWorks Therapeutics Inc's tumor treatment by three months as the health regulator needs more time to review additional data, the company said on Monday.

US FDA delays decision on SpringWorks Therapeutics' tumor treatment

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

SpringWorks Therapeutics Announces PDUFA Date Extension for Nirogacestat NDA

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.

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

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

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

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.

SpringWorks Therapeutics to Participate in the TD Cowen 4th Annual Oncology Innovation Summit

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.

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

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

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

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).

SpringWorks Therapeutics to Participate in the Bank of America Securities 2023 Health Care Conference

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 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.

SpringWorks and 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

BeiGene

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. & STAMFORD, Conn.--(BUSINESS WIRE)--BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), and SpringWorks Therapeutics, Inc.

BeiGene and 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

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 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.

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

BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. & SAN MATEO, Calif. & STAMFORD, Conn.--(BUSINESS WIRE)--MapKure, LLC, BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), and SpringWorks Therapeutics, Inc. (NASDAQ: SWTX), 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.

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

SpringWorks Therapeutics: Pfizer Offshoot With Interesting Pipeline

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

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

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.

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