Springworks Therapeutics, Inc. Stock Price, News & Analysis

Merck KGaA has announced plans to acquire SpringWorks Therapeutics (SWTX) for $47 per share in cash, representing an equity value of $3.9 billion and enterprise value of $3.4 billion. The purchase price offers a 26% premium to SpringWorks' 20-day volume-weighted average price.

The acquisition will strengthen Merck's Healthcare business in rare tumors and expand its U.S. presence. SpringWorks brings two FDA-approved therapies: OGSIVEO® for adult desmoid tumors and GOMEKLI™, the first approved treatment for neurofibromatosis type 1-associated plexiform neurofibromas in adults and children.

The transaction is expected to close in H2 2025, subject to shareholder and regulatory approvals. It will immediately contribute to Merck's revenues and is expected to be earnings accretive by 2027. The acquisition will be funded through available cash and new debt while maintaining Merck's strong investment grade credit rating.

SpringWorks Therapeutics (SWTX) has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is expected to provide its opinion on the marketing authorization application for nirogacestat in Q2 2025. The application seeks approval for nirogacestat, an oral gamma secretase inhibitor, for treating adults with desmoid tumors in the European Union.

SpringWorks Therapeutics (SWTX) reported strong financial results for Q4 and full-year 2024. The company achieved $61.5 million in Q4 and $172.0 million in full-year 2024 OGSIVEO® U.S. net product revenues. A significant milestone was reached with FDA approval of GOMEKLI™ for treating adult and pediatric patients with NF1-PN.

The company ended 2024 with $461.9 million in cash and equivalents. Q4 2024 net loss was $77.3 million ($1.04 per share), compared to $94.3 million ($1.44 per share) in Q4 2023. Full-year 2024 net loss was $258.1 million ($3.48 per share), an improvement from $325.1 million ($5.15 per share) in 2023.

R&D expenses increased to $60.2 million in Q4 2024, while SG&A expenses rose to $77.1 million, primarily due to commercial activities supporting GOMEKLI and OGSIVEO launches.

SpringWorks Therapeutics (SWTX) has partnered with jewelry designer Jennifer Fisher for an educational campaign about desmoid tumors. The initiative aims to raise awareness and encourage patients to seek specialist care for these aggressive tumors that can arise anywhere in the body.

Desmoid tumors can cause severe chronic pain, reduced mobility, and significantly impact quality of life. They are most common in patients aged 20-44, with a higher prevalence in females. The campaign emphasizes the importance of tracking symptoms and consulting oncologists experienced in treating desmoid tumors, as these tumors have high recurrence rates after surgery.

Jennifer Fisher shares her personal experience with a chest wall desmoid tumor diagnosed at age 30, highlighting the emotional journey and the importance of expert care. Dr. Alessandra Maleddu, a Sarcoma Specialist, notes that treatment guidelines now recommend systemic therapies over surgery for most growing or symptomatic desmoid tumors.

SpringWorks Therapeutics (SWTX) has received FDA approval for GOMEKLI™ (mirdametinib), the first medicine approved for both adults and children with NF1-PN (neurofibromatosis type 1 with plexiform neurofibromas). The approval is based on the Phase 2b ReNeu trial results, which demonstrated significant efficacy with a 41% objective response rate in adults and 52% in children.

The trial showed deep and durable tumor volume reductions, with median best percentage changes of -41% in adults and -42% in children. The responses were long-lasting, with approximately 90% of patients maintaining responses for at least 12 months. GOMEKLI will be available in the US within two weeks through specialty pharmacies.

SpringWorks received a rare pediatric disease priority review voucher from the FDA. The company's Marketing Authorization Application is currently under review by the European Medicines Agency, with a decision expected in 2025.

SpringWorks Therapeutics (SWTX) has received FDA approval for GOMEKLI™ (mirdametinib), the first medicine approved for both adults and children with NF1-PN (neurofibromatosis type 1 with plexiform neurofibromas). The approval is based on the Phase 2b ReNeu trial results, which showed significant efficacy with a 41% objective response rate in adults and 52% in children.

The trial demonstrated deep and durable tumor volume reductions, with median best percentage changes of -41% in adults and -42% in children. The responses were long-lasting, with approximately 90% of patients maintaining responses for at least 12 months. GOMEKLI showed a manageable safety profile, with common side effects including rash, diarrhea, and nausea.

SpringWorks received a rare pediatric disease priority review voucher from the FDA. The drug is expected to be available in the US within two weeks through specialty pharmacies.

SpringWorks Therapeutics (SWTX) has announced it will host a conference call and webcast on Thursday, February 20, 2025, at 8:30 a.m. ET to discuss its fourth quarter and full year 2024 financial results along with recent business updates. The commercial-stage biopharmaceutical company, which focuses on severe rare diseases and cancer, will provide access to the live webcast with accompanying slides. Participants wishing to join the conference call need to pre-register to receive dial-in details. A replay of the webcast will be temporarily available on the company's investor relations website.

SpringWorks Therapeutics (SWTX) reported preliminary Q4 and full-year 2024 results, with OGSIVEO® achieving $61.5 million in Q4 and $172.0 million in full-year U.S. net product revenues. The company ended 2024 with $461.9 million in cash, cash equivalents, and marketable securities, expecting to fund operations through profitability anticipated in H1 2026.

Long-term follow-up data from the Phase 3 DeFi trial showed improved outcomes with nirogacestat, including further tumor size reductions and increased response rates. The company secured a global license from Rappta Therapeutics for SW-3431, a PP2A molecular glue, for $13 million upfront.

Key 2025 priorities include continuing OGSIVEO's U.S. launch, securing EU approval, launching mirdametinib for NF1-PN treatment (PDUFA: February 28, 2025), and advancing pipeline programs including SW-682 and SW-3431.

SpringWorks Therapeutics (SWTX), a commercial-stage biopharmaceutical company specializing in severe rare diseases and cancer, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Chief Executive Officer Saqib Islam will deliver a presentation on Monday, January 13, 2025, at 11:15 a.m. PT.

The presentation will be accessible via live webcast through the Events & Presentations page in the Investors & Media section of SpringWorks' website. Interested parties can view a replay of the presentation for a time following the conference through the company's website at ir.springworkstx.com.