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 Therapeutics Inc (NASDAQ: SWTX) has announced positive topline results from the DeFi Phase 3 trial evaluating nirogacestat in adult patients with progressing desmoid tumors. Desmoid tumors are noncancerous growths occurring in the connective tissue, most often in the abdomen, arms.

Why SpringWorks Shares Are Soaring Today Premarket

Shares of SpringWorks Therapeutics Inc. SWTX, +2.18% were up 14.9% in premarket trading on Tuesday after the company said a late-stage clinical trial evaluating its treatment for patients with progressing desmoid tumors met its primary endpoint. A desmoid tumor is a rare disease.

SpringWorks shares jump 14%; company plans to seek FDA approval for desmoid tumor therapy this year

STAMFORD, Conn., May 16, 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 it will host a virtual R&D Day for investors and analysts on Friday, June 10, 2022 at 10:00 am ET. The program will include presentations by members of the SpringWorks executive leadership team as well as external thought leaders in the Company's core development areas. A Q&A session will follow the presentations.

SpringWorks Therapeutics to Host Virtual R&D Day on June 10, 2022

– Activities to Enable the Topline Analysis from Phase 3 DeFi Trial Underway with Data Expected in the Second Quarter –

SpringWorks Therapeutics Reports First Quarter 2022 Financial Results and Recent Business Highlights

Data from Phase 3 trial for Nirogacestat in treating desmoid tumors and Phase 2 combination trial with anti-BCMA antibody Blenrep in relapsed/refractory multiple myeloma is expected in mid-year. The company has multiple partnerships (including with Pfizer, GlaxoSmithKline, Janssen, Seattle Biosciences, Allogene, etc.) to combine Nirogacestat with their anti-BCMA therapies.

SpringWorks Therapeutics: Rating Buy Ahead Of Mid-Year Data Releases

-- Collaboration Represents SpringWorks' Eighth Clinical Collaboration and Highlights Continued Execution on Strategy to Advance Nirogacestat in Combination with BCMA Therapies -- -- Collaboration Represents SpringWorks' Eighth Clinical Collaboration and Highlights Continued Execution on Strategy to Advance Nirogacestat in Combination with BCMA Therapies --

SpringWorks Therapeutics Announces Clinical Trial Collaboration and Supply Agreement with Regeneron to Evaluate Nirogacestat in Combination with REGN5458 in Patients with Relapsed or Refractory Multiple Myeloma

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Since the coronavirus pandemic began in early 2020, the FDA's plate has been full with reviews of COVID-19 vaccines and treatments. That has put the approval of many other drugs and therapies on the back burner.

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– Topline Analysis from Phase 3 DeFi Trial Expected to be Triggered in the First Quarter of 2022; Topline Data Expected to be Reported During the First Half of 2022 –

SpringWorks Therapeutics Reports Fourth Quarter and Full-Year 2021 Financial Results and Recent Business Highlights

STAMFORD, Conn., Jan. 04, 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 Saqib Islam, Chief Executive Officer, will present at the 40th Annual J.P. Morgan Healthcare Conference on Tuesday, January 11, 2022 at 8:15 am ET.

SpringWorks Therapeutics to Present at the 40th Annual J.P. Morgan Healthcare Conference

Results from the phase 3 DeFi study using Nirogacestat as a monotherapy for patients with desmoid tumors are expected to be released end of 2021 or early 2022. Nirogacestat is being explored in 7 combinations trials for the treatment of patients with multiple myeloma.

SpringWorks Is A Biotech To Watch With Several Partnerships And Solid Drug Pipeline

AbbVie

SpringWorks Therapeutics Inc (NASDAQ: SWTX) entered into a clinical trial collaboration agreement with AbbVie Inc (NYSE: ABBV) to evaluate SpringWorks' nirogacestat combination with ABBV-383 in relapsed or refractory multiple myeloma. Gamma secretase inhibition helps prevent the cleavage and shedding of BCMA from the surface of myeloma cells.

AbbVie, SpringWorks Join Forces To Conduct Multiple Myeloma Combo Therapy Trial

– Seventh Clinical Collaboration Represents Continued Execution on Strategy to Advance Nirogacestat in Combination with BCMA Therapies –

SpringWorks Therapeutics Announces Clinical Collaboration with AbbVie to Evaluate Nirogacestat in Combination with ABBV-383 in Patients with Relapsed or Refractory Multiple Myeloma

STAMFORD, Conn., Dec. 06, 2021 (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 1b/2 trial evaluating nirogacestat, SpringWorks' investigational gamma secretase inhibitor (GSI), in combination with elranatamab (PF-06863135) Pfizer's investigational B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody, in patients with relapsed or refractory multiple myeloma.

SpringWorks Therapeutics Announces Dosing of First Patient in Phase 1b/2 Trial Evaluating Nirogacestat in Combination with Elranatamab (PF-06863135) in Patients with Relapsed or Refractory Multiple Myeloma

STAMFORD, Conn., Nov. 29, 2021 (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 2b ReNeu trial evaluating mirdametinib, an investigational MEK inhibitor, in adult and pediatric patients with NF1-associated plexiform neurofibromas (NF1-PN). The study enrolled over 50 adults and over 50 pediatric patients with NF1-PN. SpringWorks expects to provide an update on anticipated ReNeu trial timelines and milestones at an upcoming company-sponsored R&D Day.

SpringWorks Therapeutics Announces Full Enrollment of Phase 2b ReNeu Trial Evaluating Mirdametinib in Adult and Pediatric Patients with NF1-Associated Plexiform Neurofibromas

STAMFORD, Conn., Nov. 23, 2021 (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 4th Annual Evercore ISI HealthCONx Conference, taking place virtually on Tuesday, November 30, 2021, at 3:30 pm ET.

SpringWorks Therapeutics to Participate in the 4th Annual Evercore ISI HealthCONx Conference

– Announced Advancement into Randomized Phase 2 Expansion and Addition of New Sub-studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refractory Multiple Myeloma –

SpringWorks Therapeutics Reports Third Quarter 2021 Financial Results and Recent Business Highlights

-- Based on Encouraging Preliminary Data Observed with the First Dose Exploration Cohort (0.95 mg/kg BLENREP Q3W + Nirogacestat) a Randomized Phase 2 Cohort Expansion to Compare Against 2.5 mg/kg Q3W BLENREP Monotherapy Has Been Initiated -- -- Two New Sub-Studies of BLENREP + Nirogacestat Combined with Standard-of-Care Therapies Now Planned --

SpringWorks Therapeutics Announces the Initiation of an Expanded Phase 2 Cohort and Addition of New Sub-Studies to Existing Clinical Collaboration with GlaxoSmithKline Evaluating Nirogacestat in Combination with BLENREP in Patients with Relapsed or Refrac

– SpringWorks to Utilize Pioneering Computational Modeling Approaches Developed by Yibing Shan, Ph.D., Previously Founding Member of DE Shaw Research and Leading Computational Structural Biologist –

SpringWorks Therapeutics to Collaborate with Ab Magnitude on Target Identification and Discovery of Next-Generation Targeted Oncology Therapeutics

- Portfolio is Currently in Lead Optimization and Includes Several Novel Approaches for Targeting Mutant EGFR that are Designed to Address Both De Novo Oncogenic Drivers and Emerging Resistance Mutations -

SpringWorks Therapeutics to Collaborate with Leading Academic Institutions to Advance Portfolio of Next-Generation Mutation-Selective EGFR Inhibitors

STAMFORD, Conn., Sept. 07, 2021 (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 the H.C. Wainwright 23rd Annual Global Investment Conference. A webcast of the company presentation will be available on-demand starting Monday, September 13, 2021 at 7:00 am ET.

SpringWorks Therapeutics to Present at the H.C. Wainwright 23rd Annual Global Investment Conference

-- Research to be Led by Constantine Mitsiades, M.D., Ph.D., at Dana-Farber Cancer Institute -- -- Research to be Led by Constantine Mitsiades, M.D., Ph.D., at Dana-Farber Cancer Institute --

SpringWorks Therapeutics Enters into Research Collaboration with Leading Cancer Institute to Further Evaluate Nirogacestat as a BCMA Potentiator in Multiple Myeloma

– Entered into Clinical Collaboration with Seagen to Evaluate Nirogacestat in Combination with SEA-BCMA and Dosed First Patients in Three Phase 1 Clinical Trials Evaluating Nirogacestat in Combination with BCMA Therapies Across Modalities in Patients with Relapsed or Refractory Multiple Myeloma –

SpringWorks Therapeutics Reports Second Quarter 2021 Financial Results and Recent Business Highlights

Platform Study to Evaluate Mirdametinib as a Combination Therapy with Fulvestrant in Patients with ER+ Metastatic Breast Cancer and as a Monotherapy in Patients with Advanced Solid Tumors Harboring Activating Mutations in MEK1 or MEK2 Platform Study to Evaluate Mirdametinib as a Combination Therapy with Fulvestrant in Patients with ER+ Metastatic Breast Cancer and as a Monotherapy in Patients with Advanced Solid Tumors Harboring Activating Mutations in MEK1 or MEK2

SpringWorks Therapeutics Announces Phase 1b/2a Clinical Trial of Mirdametinib in Patients with Advanced Solid Cancers Harboring MAPK-Activating Mutations

STAMFORD, Conn., July 20, 2021 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,066,358 (the ‘358 patent), directed to mirdametinib, the Company's product candidate in development for several oncology indications, including as a monotherapy for patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN). The ‘358 patent, assigned to Warner-Lambert Company LLC (a subsidiary of Pfizer), expires in 2041. The ‘358 patent is a composition of matter patent that covers the polymorphic form of mirdametinib that is currently in clinical development. SpringWorks has exclusive rights to the ‘358 patent pursuant to an existing worldwide license with Pfizer.

SpringWorks Therapeutics Announces Issuance of New U.S. Composition of Matter Patent to Polymorphic Form of Mirdametinib, Extending Patent Protection Into 2041

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