Earlier this month, the company completed the new drug application (NDA) submission for its investigational MEK inhibitor, mirdametinib, which is being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients. SWTX plans to file a marketing application with the European Medicines Agency seeking approval for mirdametinib for the treatment of children and adults with NF1-PN later in the second half of 2024. Following the FDA nod, not ...

The NDA filing was based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity. SpringWorks Therapeutics, Inc. (SWTX) announced that it has completed the submission of a new drug application ("NDA") for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients. The pr ...

NEW YORK, July 2, 2024 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. Why Your Participation Matters: For additional information, please visit Shareholder Derivative Litigation - Kuehn Law. Contacts: Kuehn Law, P ...

"We are pleased to be one step closer towards our goal of bringing mirdametinib to patients with NF1-PN in the U.S. and believe that our ReNeu data support the potential for mirdametinib to be a differentiated and best-inclass therapy for both children and adults living with this devastating disease," said Saqib Islam, Chief Executive Officer of SpringWorks. "We look forward to working closely with the FDA throughout the review process and also plan to file for regulatory approval in the European Union late ...

The NDA submission includes data from the pivotal Phase 2b ReNeu trial, which evaluated mirdametinib in patients ≥ 2 years of age with NF1-associated PN causing significant morbidity. Results were presented in an oral presentation at the 2024 American Society of Clinical Oncology Annual Meeting and demonstrated that mirdametinib treatment resulted in significant objective response rates confirmed by blinded independent central review, deep and durable responses, improvement in pain and health-related qualit ...

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. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the comp ...

– 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) highlighting consistent safety and efficacy across subgroups of adults with desmoid tumors also being presented in oral and poster sessions – STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe ra ...

Start Time: 08:30 January 1, 0000 9:06 AM ET SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) Q1 2024 Earnings Conference Call May 02, 2024, 08:30 AM ET Company Participants Saqib Islam - CEO Francis Perier - CFO Bhavesh Ashar - Chief Commercial Officer Jim Cassidy - CMO Samantha Sandler - Senior Director of IR Conference Call Participants Anupam Rama - JPMorgan Yaron Werber - TD Cowen Corinne Johnson - Goldman Sachs Peter Lawson - Barclays Alec Stranahan - Bank of America Michael Schmidt - Guggenheim Operator ...

Q1 2024 Financial Results and Business Update May 2, 2024 3 Note: Unless otherwise indicated, the information presented herein is as of May 2024 and made publicly available on May 2, 2024. This presentation may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _____ ...