SpringWorks TherapeuticsNASDAQ: SWTX

Since we last visited with SpringWorks Therapeutics, Inc. in the summer of 2023, the company has garnered its first FDA approval. That drug has seen encouraging initial sales, and management recently submitted a marketing application for a second candidate. The stock has pulled back recently, even as SpringWorks has funding in place to get the company to profitability in the years ahead.

SpringWorks Therapeutics (SWTX) reported earnings 30 days ago. What's next for the stock?

The FDA accepts and grants priority review to SpringWorks' NDA for mirdametinib for treating neurofibromatosis type 1-associated plexiform neurofibromas.

– PDUFA target action date of February 28, 2025 – – EU Marketing Authorization Application also validated by European Medicines Agency – STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of adult and pediatric patients with neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN).

Here, we are discussing some reasons why investing in SpringWorks (SWTX) stock now may turn out to be a prudent move.

SWTX's market confidence has increased post-launch, with $40.2 million in product revenue and $19.5 million in collaboration revenue in the first quarter. Nirogacestat approval for desmoid tumors and potential approval for mirdametinib in 2025 position SWTX well for growth. SWTX's strong commercial execution and expanding product portfolio indicate the potential for profitability and market appreciation.

SpringWorks Therapeutics (SWTX) came out with a quarterly loss of $0.54 per share versus the Zacks Consensus Estimate of a loss of $1.12. This compares to loss of $1.25 per share a year ago.

– Achieved $40.2 million in OGSIVEO ® (nirogacestat) net product revenue in the second quarter –

STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company's Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion.