Springworks Therapeutics, Inc. Stock Price, News & Analysis

SpringWorks Therapeutics (NYSE:SWTX) has received conditional marketing authorization from the European Commission for EZMEKLY® (mirdametinib) to treat NF1-PN in both adult and pediatric patients aged 2 years and above. This marks a significant milestone as EZMEKLY becomes the first and only therapy approved in the EU for this rare genetic disorder.

The approval is based on the Phase 2b ReNeu trial results involving 114 patients, which demonstrated impressive efficacy with an objective response rate of 41% in adults and 52% in children. The median tumor volume reduction was approximately 41-42% across both groups, with response durability of at least 12 months in nearly 90% of responders.

NF1 affects approximately 3 in 10,000 people in the EU, with 30-50% developing plexiform neurofibromas. EZMEKLY will be available in both capsule and dispersible tablet forms, offering a new treatment option for this previously underserved patient population.

SpringWorks Therapeutics (SWTX) received a positive CHMP opinion recommending approval of nirogacestat for treating adults with progressing desmoid tumors requiring systemic treatment in the EU. The oral gamma secretase inhibitor demonstrated significant benefits in the Phase 3 DeFi trial, showing a 71% lower risk of disease progression versus placebo. The drug improved objective response rate and patient-reported outcomes including pain and quality of life. The European Commission's final approval decision is expected in Q3 2025. If approved, nirogacestat would become the first authorized therapy for desmoid tumors in the EU. The drug previously received Orphan Drug designation and is already approved in the U.S. Common side effects include diarrhea, ovarian toxicity, rash, and nausea.

SpringWorks Therapeutics (SWTX) has received a positive CHMP opinion recommending conditional marketing authorization for mirdametinib in the European Union for treating NF1-PN in patients aged 2 years and above. The Phase 2b ReNeu trial demonstrated significant efficacy with 41% objective response rate in adults and 52% in children. The median best percentage change in target PN volume was -41% in adults and -42% in children, with most responses lasting at least 12 months. If approved, mirdametinib would be the first therapy in the EU for both adults and children with NF1-PN, a genetic disorder affecting approximately 135,000 people in the EU. The European Commission's final decision is expected in Q3 2025.

The drug showed a manageable safety profile, with common side effects including rash, diarrhea, and musculoskeletal pain. Mirdametinib is already approved in the U.S. for similar indications.

Merck KGaA, Darmstadt, Germany has announced plans to acquire SpringWorks Therapeutics for $47 per share in cash, representing an equity value of approximately $3.9 billion. The purchase price offers a 26% premium over SpringWorks' unaffected 20-day volume-weighted average price.

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 acquisition will immediately contribute to Merck's revenues and is expected to be earnings accretive by 2027.

The transaction, funded through available cash and new debt, is expected to close in the second half of 2025, subject to shareholder and regulatory approvals. This strategic move will strengthen Merck's presence in the U.S. market and expand SpringWorks' therapeutic reach globally.

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.