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SpringWorks Therapeutics, Inc. (Nasdaq: SWTX) is a dynamic, mission-driven biopharmaceutical company dedicated to creating transformative medicines for underserved patient populations facing severe rare diseases and cancer. Initially conceived by Pfizer, SpringWorks exemplifies a novel model of collaboration by connecting scientists, biopharmaceutical partners, patient groups, funders, and philanthropists to propel cutting-edge science into clinical reality. Founded in 2017, the company's name reflects its proactive approach to drug development, focusing on addressing unmet medical needs promptly.
SpringWorks employs a precision medicine approach to acquiring, developing, and commercializing life-changing therapies. The company's portfolio includes a range of small molecule targeted oncology product candidates, with a focus on debilitating conditions such as desmoid tumors, neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), hereditary xerocytosis, and post-traumatic stress disorder. Among its significant achievements, SpringWorks recently launched OGSIVEO™ (nirogacestat), the first U.S. Food and Drug Administration (FDA)-approved therapy for adults with progressing desmoid tumors.
In December 2023, SpringWorks successfully priced an underwritten public offering, raising approximately $275 million to further its development initiatives. This financial boost supports ongoing and future clinical trials, such as the Phase 2 trial evaluating nirogacestat in recurrent ovarian granulosa cell tumors and multiple BCMA-directed therapies in collaboration with industry leaders.
SpringWorks' strategic collaborations extend to both industry and academia, enhancing its ability to deliver innovative treatment options. The company’s precision medicine strategy has facilitated rapid advancements in clinical trials for rare tumor types and genetically defined cancers. For instance, the Phase 2b ReNeu trial for mirdametinib, an investigational MEK inhibitor for NF1-PN, has shown promising results and is soon to be submitted for FDA approval.
The company’s approach to clinical development is underscored by its diversified oncology pipeline. This includes efforts to address highly prevalent, genetically defined cancers and solid tumors. SpringWorks continues to expand its reach with ongoing trials and upcoming regulatory submissions, aiming to bring more life-altering therapies to patients.
SpringWorks remains focused on its mission to improve the lives of patients with severe and rare diseases while demonstrating robust operational excellence and strategic growth. For more detailed and updated information, please visit www.springworkstx.com and follow SpringWorks on X, LinkedIn, and YouTube.
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.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced its participation in the 7th Annual Evercore ISI HealthCONx Conference. The company's management will engage in a fireside chat on Tuesday, December 3, 2024, at 12:30 p.m. ET in Coral Gables, Florida.
The event will be accessible via live webcast through the Events & Presentations page on SpringWorks' investor website. A replay will be available for a time after the conference. SpringWorks is a commercial-stage biopharmaceutical company specializing in severe rare diseases and cancer treatments.
SpringWorks Therapeutics (Nasdaq: SWTX) has announced its participation in the upcoming Jefferies London Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, November 19, 2024, at 10:30 a.m. ET in London, UK. The event will be accessible via live webcast through the Events & Presentations page on SpringWorks' investor website. A replay will be available for a time after the conference.
SpringWorks Therapeutics (SWTX) reported Q3 2024 financial results with $49.3 million in OGSIVEO® net product revenue, a 23% increase from Q2. The company posted a net loss of $53.5 million ($0.72 per share). Long-term follow-up data from Phase 3 DeFi trial showed improved tumor reduction and safety profile. The FDA granted Priority Review for mirdametinib NDA with PDUFA date of February 28, 2025. With $498.1 million in cash and equivalents, SpringWorks expects to achieve profitability by first half of 2026.
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