SWTX

Will SpringWorks' Mirdametinib For A Rare Genetic Disorder Pass FDA Muster?

(RTTNews) - SpringWorks Therapeutics, Inc. (SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025, at 11:15 a.m. PT / 2:15 p.m. ET.

SpringWorks continues to make substantial progress in developing its pipeline of therapies, particularly in the areas of rare diseases and oncology.

The company's New Drug Application for Mirdametinib proposed for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), is under priority review by the FDA, with a decision due on February 28, 2025.

Neurofibromatosis type 1 (NF1) is a rare genetic disorder, with affected individuals experiencing a reduction in life expectancy of 8 to 15 years compared to the general population.

The company's first FDA-approved therapy, OGSIVEO (nirogacestat) is a gamma-secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. The drug was approved in the U.S. on November 27, 2023.

The financial results for the third quarter ended September 30, 2024, were reported recently.

SpringWorks reported a net loss of $53.5 million, or $0.72 per share, for the third quarter of 2024, an improvement from the net loss of $79.4 million, or $1.27 per share, in the third quarter of 2023.

Revenue for the quarter totaled $49.3 million, primarily driven by the strong performance of OGSIVEO.

The company's selling, general, and administrative (SG&A) expenses were $61.6 million, up from $46.5 million in the same quarter of 2023, reflecting increased commercial readiness activities to support the U.S. launch of Mirdametinib, the drug under regulatory review.

Research and development (R&D) expenses increased to $42.3 million for the quarter, compared to $37.5 million in the same period of 2023, driven by higher drug manufacturing and clinical trial costs.

SpringWorks' cash, cash equivalents, and marketable securities totaled $498 million as of September 30, 2024.

SWTX shares debuted on the Nasdaqglobal marketon September 13, 2019, under the ticker symbol "SWTX", priced at $18.00 per share.

SWTX closed Thursday's (Jan. 02, 2025) trading at $36.08, down 0.14%. In Premarket trading, the stock is down 2.69% at $35.11.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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