Core Insights - SpringWorks Therapeutics reported strong financial results for the fourth quarter and full year 2024, achieving U.S. net product revenues of $61.5 million and $172.0 million for OGSIVEO® (nirogacestat) respectively [1][6] - The company received FDA approval for GOMEKLI™ (mirdametinib) for treating symptomatic NF1-PN in both adults and pediatric patients, marking a significant milestone in its product offerings [1][6] - As of December 31, 2024, SpringWorks had a cash position of $461.9 million, indicating a solid financial foundation for future growth [1][6] Financial Performance - OGSIVEO net product revenues were $61.5 million in Q4 2024 and $172.0 million for the full year 2024, a substantial increase compared to previous periods [6][19] - Selling, General and Administrative (SG&A) expenses rose to $77.1 million for Q4 2024 and $256.7 million for the full year, up from $59.8 million and $197.6 million in 2023, primarily due to commercial readiness activities for GOMEKLI and OGSIVEO [7][19] - Research and Development (R&D) expenses increased to $60.2 million in Q4 2024 and $200.5 million for the full year, compared to $43.7 million and $150.5 million in 2023, driven by higher external costs related to clinical trials and drug manufacturing [7][19] - The net loss attributable to common stockholders was $77.3 million, or $1.04 per share, for Q4 2024, and $258.1 million, or $3.48 per share, for the full year, showing improvement from the previous year's losses [7][19] Product Development and Pipeline - The company is advancing a diversified pipeline, including ongoing studies for nirogacestat in various indications, with initial data from a Phase 2 trial expected in the first half of 2025 [2][6] - A Marketing Authorization Application (MAA) for nirogacestat is under review with the European Medicines Agency (EMA), with potential launch in Germany anticipated in mid-2025 [6][19] - GOMEKLI is now available through a specialty pharmacy network in the U.S., and an MAA for mirdametinib is also under review with the EMA [6][19] Strategic Outlook - The CEO expressed confidence in the company's ability to serve the desmoid tumor community and emphasized the importance of the recent FDA approval of GOMEKLI for expanding treatment options [2][6] - SpringWorks is committed to global expansion of its medicines and aims to develop important therapeutic advances for underserved patient populations [2][6]

Core Insights - SpringWorks Therapeutics has received FDA approval for GOMEKLI™ (mirdametinib), the first and only treatment for both adults and children with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) [1][2][11] - The approval is based on positive results from the Phase 2b ReNeu trial, which demonstrated significant tumor volume reductions and a manageable safety profile [3][4][5] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, with GOMEKLI being its second FDA approval in less than 18 months [2][21] - The company is also advancing a diverse portfolio of novel targeted therapy product candidates for solid tumors and hematological cancers [21] Product Details - GOMEKLI is an oral MEK inhibitor approved for patients aged 2 years and older with symptomatic NF1-PN not amenable to complete resection [11][21] - The drug is available in 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension, and is expected to be available through specialty pharmacies within two weeks [7][21] Clinical Trial Results - The ReNeu trial enrolled 114 patients (58 adults and 56 pediatric patients) and achieved a confirmed objective response rate (ORR) of 41% in adults and 52% in children [3][4] - The median best percentage change in target PN volume was -41% in adults and -42% in children, with 88% of adults and 90% of children showing a response lasting at least 12 months [3][5] Market Need - NF1 affects approximately 100,000 individuals in the U.S., with about 40,000 living with NF1-PN, highlighting a significant unmet need for effective treatment options [2][9] - Prior to GOMEKLI, there were no approved medications for NF1-PN, making this approval a critical advancement for patients [2][5] Regulatory Status - GOMEKLI was granted a rare pediatric disease priority review voucher by the FDA and has previously received Orphan Drug and Fast Track designations [4][5] - The Marketing Authorization Application for GOMEKLI is under review by the European Medicines Agency (EMA), with a decision expected in 2025 [8]

Core Insights - SpringWorks Therapeutics has received FDA approval for GOMEKLI™ (mirdametinib), the first and only treatment for both adults and children with neurofibromatosis type 1 (NF1) associated plexiform neurofibromas (PN) [3][5][17] - The approval is based on positive results from the Phase 2b ReNeu trial, demonstrating significant efficacy and a manageable safety profile [6][8][9] - The company has been granted a rare pediatric disease priority review voucher by the FDA, highlighting the importance of this treatment for the NF1-PN patient community [3][6] Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer [27] - The company has developed GOMEKLI as the first FDA-approved medicine for NF1-PN, and it also markets OGSIVEO (nirogacestat) for adults with desmoid tumors [27] - SpringWorks is advancing a diverse portfolio of targeted therapy candidates for solid tumors and hematological cancers [27] Product Details - GOMEKLI is an oral MEK inhibitor approved for patients aged 2 years and older with symptomatic plexiform neurofibromas not amenable to complete resection [17][12] - The product is available in 1 mg and 2 mg capsules, as well as a 1 mg tablet for oral suspension [12] - GOMEKLI is expected to be available through specialty pharmacies and distributors in the U.S. within two weeks of approval [12] Clinical Trial Insights - The Phase 2b ReNeu trial enrolled 114 patients (58 adults and 56 pediatric patients) and met its primary endpoint with a confirmed objective response rate (ORR) of 41% in adults and 52% in children [7][8] - Tumor volume reductions were significant, with a median best percentage change of -41% in adults and -42% in children [8] - The trial also reported improvements in pain and quality of life for patients, indicating the treatment's potential to enhance overall well-being [8] Market Context - NF1 is a genetic disorder affecting approximately 100,000 individuals in the U.S., with a 30-50% lifetime risk of developing plexiform neurofibromas [5][14] - Prior to GOMEKLI, there were no approved treatments for NF1-PN, making this approval a significant advancement for the patient community [5][6] - The approval of GOMEKLI represents a critical new option for NF patients and their families, addressing a substantial unmet medical need [10][5]

– GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN – – Approval based on positive data from Phase 2b ReNeu trial, which showed GOMEKLI treatment resulted in robust ORR, deep and durable reductions in tumor volume, and a manageable safety profile – – SpringWorks granted rare pediatric disease priority review voucher by the FDA – Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/8eb8effc-49a5-4b24-911f-d3e6dfa9c8 ...

STAMFORD, Conn., Jan. 30, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that it will host a live conference call and webcast at 8:30 a.m. ET on Thursday, February 20, 2025 to report its fourth quarter and full year financial results and discuss recent business updates. To join the live webcast and view the corresponding slides, please click here. To participate in the live confe ...

SpringWorks Therapeutics (SWTX) announced preliminary net product revenues for fourth-quarter and full-year 2024 for its sole marketed drug, Ogsiveo (nirogacestat). The drug is approved for treating adult patients with progressing desmoid tumors who require systemic treatment.The company also outlined some expected milestones related to its commercial portfolio and other pipeline candidates for 2025.Shares of SWTX were down 13.9% on Jan. 13 following the news announcement.In the past year, shares of SpringW ...

– Achieved $61.5 million and $172.0 million in preliminary fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively – – Ended 2024 with approximately $462 million in cash, cash equivalents, and marketable securities – – Additional updates across Company's commercial portfolio and investigational pipeline to be provided during J.P. Morgan Healthcare conference presentation today at 11:15 a.m. PT – STAMFORD, Conn., Jan. 13, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeu ...

Company Overview - SpringWorks Therapeutics (SWTX) shares increased by 6% to $41.20 in the last trading session, following a higher-than-average trading volume, contrasting with a 7.2% loss over the past four weeks [1] - The company's only marketed drug, Ogsiveo, approved for treating adult patients with progressing desmoid tumors, is experiencing strong initial uptake, contributing to the recent share price rally [2] Financial Performance - SpringWorks Therapeutics is expected to report a quarterly loss of $0.66 per share, reflecting a year-over-year increase of 54.2% [2] - Revenue projections for the upcoming quarter are $56.23 million, representing a significant increase of 931.8% compared to the same quarter last year [2] Market Trends - Trends in earnings estimate revisions are closely linked to near-term stock price movements, indicating potential strength in the stock [3] - The consensus EPS estimate for SpringWorks Therapeutics has remained unchanged over the last 30 days, suggesting that the stock's price may not sustain its upward movement without changes in earnings estimates [4] Industry Context - SpringWorks Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where Nurix Therapeutics, another company in the same sector, has seen a 1.7% decline in its stock price [4] - Nurix Therapeutics has a consensus EPS estimate of -$0.67 for its upcoming report, which is a 13% improvement from the previous year [5]

Company Overview - SpringWorks Therapeutics is a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer [3] - The company applies a precision medicine approach to develop and deliver life-changing medicines [3] - OGSIVEO® (nirogacestat) is the company's first FDA-approved therapy for adult patients with progressing desmoid tumors requiring systemic treatment [3] - SpringWorks has a diversified targeted therapy pipeline spanning solid tumors and hematological cancers, with programs from preclinical development to advanced clinical trials [3] - The company has entered into multiple collaborations with industry and academia to unlock the full potential of its portfolio [3] Upcoming Event - SpringWorks Therapeutics CEO Saqib Islam will present at the 43rd Annual J P Morgan Healthcare Conference on January 13, 2025 at 11:15 a m PT [1] - The live webcast can be accessed on the company's website, with a replay available for a limited time [2] Additional Information - More information about SpringWorks Therapeutics is available on their website and social media channels [4]

Core Insights - Jonathan Faison highlights Tarsus Pharmaceuticals and SpringWorks Therapeutics as key investment opportunities in the biotech sector, with Tarsus's XDEMVY showing strong performance and SpringWorks's Ogsiveo gaining traction in the market [1][2] Tarsus Pharmaceuticals - Tarsus Pharmaceuticals has a market cap of $1.8 billion and an enterprise value of approximately $1.5 billion, with a valuation of 1x to 1.5x peak sales [2] - The lead drug, XDEMVY, targets Demodex blepharitis and has seen a price increase from $15 to the mid-$40s, indicating strong market performance [1][2] SpringWorks Therapeutics - SpringWorks Therapeutics is currently the number one holding in the portfolio, representing around 13% of it, with Ogsiveo launched for desmoid tumors [2] - Ogsiveo has achieved a 70% market share for new prescriptions in its category and is projected to have an annualized run rate of $200 million to $250 million, with only 10% market penetration so far [2] - The company anticipates three launches next year, including the European Union launch for Ogsiveo and the U.S. launch for Mirdametinib, which has a priority review with a PDUFA date in February [2] Market Dynamics - Over 90% of doctors have indicated they will use Ogsiveo again, with 90% stating they will use it as a frontline treatment [2] - The addressable market for Ogsiveo is larger than previously anticipated, strengthening the investment thesis for SpringWorks Therapeutics [2] - The competitive landscape includes AstraZeneca's Koselugo, which is currently approved only for pediatric indications, presenting an opportunity for SpringWorks to capture a larger market share [2]