– Achieved $61.5 million and $172.0 million in fourth quarter and full year 2024 OGSIVEO® (nirogacestat) U.S. net product revenues, respectively – – Received FDA approval of GOMEKLI™ (mirdametinib) for the treatment of adult and pediatric patients with symptomatic NF1-PN not amendable to complete resection – – Ended 2024 with $461.9 million in cash, cash equivalents and marketable securities – STAMFORD, Conn., Feb. 20, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stag ...

– 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-d3e6dfa9c ...

GOMEKLI™ (mirdametinib) capsules and tablets for oral suspension GOMEKLI™ (mirdametinib) capsules and tablets for oral suspension Saqib Islam, SpringWorks Therapeutics CEO Saqib Islam, SpringWorks Therapeutics CEO SpringWorks Therapeutics, Inc SpringWorks Therapeutics, Inc. GOMEKLI™ (mirdametinib) logo GOMEKLI™ (mirdametinib) logo – 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 sho ...

– 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 ...

SpringWorks Therapeutics (SWTX) shares ended the last trading session 6% higher at $41.20. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 7.2% loss over the past four weeks.The company’s sole marketed drug, Ogsiveo, which is approved for treating adult patients with progressing desmoid tumors, has been witnessing a strong initial uptake. The growing optimism surrounding Ogsiveo might have driven the recent share p ...

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]