Latest news with #SpringWorks
Yahoo
27-05-2025
- Business
- Yahoo
SpringWorks Therapeutics (SWTX) Surged on Acquisition News
Carillon Tower Advisers, an investment management company, released its 'Carillon Eagle Small Cap Growth Fund' first quarter 2025 investor letter. A copy of the letter can be downloaded here. Small-cap stocks experienced a significant drop in Q1, with the Russell 2000 Growth Index (down 11.12%) trailing the Russell 2000 Value Index (down 7.74%). In the Russell 2000 Growth Index, real estate, which increased by 1.76%, outperformed all sectors both absolutely and relatively. The only other sector delivering positive returns was consumer staples, which rose by 0.67%. In addition, please check the fund's top five holdings to know its best picks in 2025. In its first-quarter 2025 investor letter, Carillon Eagle Small Cap Growth Fund highlighted stocks such as SpringWorks Therapeutics, Inc. (NASDAQ:SWTX). Headquartered in Stamford, Connecticut, SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) is a biopharmaceutical company. The one-month return of SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) was 0.65%, and its shares gained 9.67% of their value over the last 52 weeks. On May 23, 2025, SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) stock closed at $46.48 per share with a market capitalization of $3.5 billion. Carillon Eagle Small Cap Growth Fund stated the following regarding SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) in its Q1 2025 investor letter: "SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) is a commercial-stage biopharmaceutical company that develops treatments for various diseases and cancers. During the first quarter, a major pharmaceutical company announced that it was in talks to acquire SpringWorks. In response, SpringWorks cancelled all meetings and its earnings call, reflecting the significance of the potential deal. Although no agreement has been finalized, the stock performed well last quarter." A closeup of a scientist in a lab coat, mixing two liquids for a compound to treat rare diseases. SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) is not on our list of 30 Most Popular Stocks Among Hedge Funds. As per our database, 71 hedge fund portfolios held SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) at the end of the first quarter, which was 40 in the previous quarter. While we acknowledge the potential of SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) as an investment, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is as promising as NVIDIA but that trades at less than 5 times its earnings, check out our report about the undervalued AI stock set for massive gains. In another article, we covered SpringWorks Therapeutics, Inc. (NASDAQ:SWTX) and shared the list of best immunology stocks to buy. In addition, please check out our hedge fund investor letters Q1 2025 page for more investor letters from hedge funds and other leading investors. READ NEXT: Michael Burry Is Selling These Stocks and A New Dawn Is Coming to US Stocks. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
23-05-2025
- Business
- Yahoo
SpringWorks Therapeutics Receives Positive CHMP Opinion for Mirdametinib for the Treatment of Adult and Pediatric Patients with NF1-PN
– If approved, mirdametinib is expected to be the first and only therapy in the European Union with marketing authorization for both adults and children with NF1-PN – – Decision from European Commission expected in the third quarter of 2025 – STAMFORD, Conn., May 23, 2025 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a conditional marketing authorization for mirdametinib, a MEK inhibitor, for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in pediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above. The European Commission (EC) will review the CHMP opinion and is expected to make a final decision regarding the approval in the third quarter of 2025. If approved, mirdametinib will be available in 1 and 2 mg capsules and in a 1 mg dispersible tablet, which dissolves easily in water. 'The positive opinion from the CHMP brings us one step closer to delivering our medicine to both children and adults with NF1-PN in Europe, who we believe are in need of new therapeutic advances,' said Saqib Islam, Chief Executive Officer of SpringWorks. 'Upon approval, we look forward to bringing mirdametinib to appropriate patients in Europe as quickly as possible.' NF1 is a genetic disorder that affects approximately 3 in 10,000 people in the EU, or an estimated 135,000 people.1,2 Patients with NF1 have approximately a 30 to 50% lifetime risk of developing plexiform neurofibromas, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment.3,4 Plexiform neurofibromas can transform into malignant peripheral nerve sheath tumors, an aggressive and potentially fatal disease.5 Surgical removal can be challenging due to the infiltrative tumor growth pattern of plexiform neurofibromas along nerves, and up to approximately 85% of plexiform neurofibromas are considered not amenable to complete resection.6,7,8 'NF1-PN is a genetic disorder that can be highly morbid and unpredictable. It takes a significant physical and emotional toll on patients and their caregivers, and there have been limited treatment options available,' said Ignacio Blanco, MD, PhD, Chairman of the National Reference Center for Adult Patients with Neurofibromatosis at Hospital Universitari Germans Trias i Pujol, Spain. 'Surgical removal of plexiform neurofibromas can be challenging and is often not possible, so if approved, mirdametinib could be an important treatment option for children and adult patients in Europe.' The CHMP opinion was based on the Marketing Authorization Application (MAA) for mirdametinib, which was validated by the EMA in August 2024. The MAA centered on the primary results from the Phase 2b ReNeu trial, which enrolled 114 patients with NF1-PN age 2 years or older (58 adults and 56 pediatric patients). The study met the primary endpoint of confirmed objective response rate (ORR), as assessed by blinded independent central review, demonstrating an ORR of 41% (N= 24/58) in adults and 52% in children (N=29/56). The median best percentage change in target PN volume was -41% (range: -90 to 13%) in adults and -42% (range: -91 to 48%) in children. Among those with a confirmed response, 88% percent of adults and 90% of children had a response of at least 12 months duration, and 50% and 48%, respectively, had a response of at least 24 months duration. Both adults and children also experienced early and sustained significant improvements from baseline in pain and quality of life as assessed across multiple patient-reported outcome tools.9 Mirdametinib demonstrated a manageable safety and tolerability profile. The most common adverse events (>25%) reported in adults receiving mirdametinib were rash, diarrhea, nausea, musculoskeletal pain, vomiting and fatigue. The most common adverse events (>25%) occurring in children were rash, diarrhea, musculoskeletal pain, abdominal pain, vomiting, headache, paronychia, left ventricular dysfunction and nausea.9 Mirdametinib is approved in the U.S. for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. About the ReNeu TrialReNeu (NCT03962543) is an ongoing, multi-center, open-label, single arm, Phase 2b trial evaluating the efficacy, safety and tolerability of mirdametinib in patients ≥2 years of age with an inoperable NF1-associated PN causing significant morbidity. The study enrolled 114 patients to receive mirdametinib at a dose of 2 mg/m2 twice daily (maximum dose of 4 mg twice daily) without regard to food. Mirdametinib was administered orally in a 3-week on, 1-week off dosing schedule as either a capsule or dispersible tablet. The primary endpoint is confirmed objective response rate (ORR) defined as the proportion of patients with a ≥20% reduction in target tumor volume on consecutive scans during the 24-cycle treatment phase, as measured by MRI and assessed by blinded independent central review. Secondary endpoints include safety and tolerability, duration of response, and changes in patient-reported outcomes from baseline to Cycle 13. The treatment phase of the trial is complete, and results were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Patients who completed the treatment phase were eligible to continue receiving treatment in the optional long-term follow-up portion of the study, which is ongoing. About NF1-PNNeurofibromatosis type 1 (NF1) is a rare genetic disorder that arises from mutations in the NF1 gene, which encodes for neurofibromin, a key suppressor of the MAPK pathway.10,11 NF1 is the most common form of neurofibromatosis, with an estimated global birth incidence of approximately 1 in 2,500 individuals.3,12 In the EU, NF1 affects approximately 3 in 10,000 people, or an estimated 135,000 people.1,2 The clinical course of NF1 is heterogeneous and manifests in a variety of symptoms across numerous organ systems, including abnormal pigmentation, skeletal deformities, tumor growth and neurological complications, such as cognitive impairment.13 Patients with NF1 have an 8 to 15-year mean reduction in their life expectancy compared to the general population.1 NF patients have approximately a 30%-50% lifetime risk of developing plexiform neurofibromas, or PN, which are tumors that grow in an infiltrative pattern along the peripheral nerve sheath and that can cause severe disfigurement, pain and functional impairment; in rare cases, NF1-PN may be fatal.3,4,5 NF1-PNs are most often diagnosed in the first two decades of life.3 These tumors can be aggressive and are associated with clinically significant morbidities; typically, they grow more rapidly during childhood.14,15 Surgical removal of these tumors can be challenging due to the infiltrative tumor growth pattern along nerves and can lead to permanent nerve damage and disfigurement.5 Up to approximately 85% of plexiform neurofibromas are considered not amenable to complete resection.6,7,8 About MirdametinibMirdametinib is an oral, small molecule MEK inhibitor approved in the United States for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection. The FDA and the European Commission have granted Orphan Drug designation for mirdametinib for the treatment of NF1. About SpringWorks TherapeuticsSpringWorks is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with severe rare diseases and cancer. We developed and are commercializing the first and only FDA-approved medicine for adults with desmoid tumors and the first and only FDA-approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). We are also advancing a diverse portfolio of novel targeted therapy product candidates for patients with both solid tumors and hematological cancers. For more information, visit and follow @SpringWorksTx on X, LinkedIn, Facebook, Instagram and YouTube. Forward-Looking Statements This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, relating to our business, operations, and financial conditions, including but not limited to current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, our development and commercialization plans, our preclinical and clinical results, our expectations regarding the timing and results of the EMA's review of our MAA for mirdametinib and our plans to begin its initial launch in the European Union in 2025, our plans to continue to study mirdametinib in pediatric and young adult patients with low-grade gliomas in a Phase 2 study, as well as relating to other future conditions. Words such as, but not limited to, 'look forward to,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'intend,' 'plan,' 'would,' 'should' and 'could,' and similar expressions or words, identify forward-looking statements. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, risks relating to: (i) the fact that topline or interim data from clinical studies may not be predictive of the final or more detailed results of such study or the results of other ongoing or future studies, (ii) the success and timing of our collaboration partners' ongoing and planned clinical trials, (iii) the timing of our planned regulatory submissions and interactions, including the timing and outcome of decisions made by the FDA, EMA, and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies, (iv) whether EMA or other regulatory authorities will require additional information or further studies, or may fail or refuse to approve or may delay approval of our product candidates, including mirdametinib, (v) our ability to obtain regulatory approval of any of our product candidates or maintain regulatory approvals granted for our products, (vi) our plans to research, discover and develop additional product candidates, (vii) our ability to enter into collaborations for the development of new product candidates and our ability to realize the benefits expected from such collaborations, (viii) our ability to maintain adequate patent protection and successfully enforce patent claims against third parties, (ix) the adequacy of our cash position to fund our operations through any time period indicated herein, (x) our ability to establish manufacturing capabilities, and our collaboration partners' abilities to manufacture our product candidates and scale production, and (xi) our ability to meet any specific milestones set forth herein. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. Accordingly, readers are cautioned not to place undue reliance on these forward-looking statements. For further information regarding the risks, uncertainties and other factors that may cause differences between SpringWorks' expectations and actual results, you should review the 'Risk Factors' in Item 1A of Part II of SpringWorks' Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 as well as discussions of potential risks, uncertainties and other important factors in SpringWorks' subsequent filings. Contacts: MediaMedia@ InvestorsInvestors@ References Lee TJ, et al. Incidence and prevalence of neurofibromatosis type 1 and 2: a systematic review and meta-analysis. Orphanet J Rare Dis. 2023;18(1):292. doi:10.1186/s13023-023-02911-2. Eurostat. Population and population change statistics. Eurostat Statistics Explained. 2024. Available at: Accessed May 8, 2025. Prada C, Rangwala F, Martin L, et al. Pediatric Plexiform Neurofibromas: Impact on Morbidity and Mortality in Neurofibromatosis Type 1. J Pediatr. 2012;160(3):461-467. doi:10.1016/ Miller DT, et al. Health supervision for children with neurofibromatosis Type 1. Pediatrics. 2019;143(5):e20190660. Kamaludin, Siti Nurhazwani, et al. 'Plexiform neurofibromatosis with peripheral malignant nerve sheath tumor and scoliosis - more surveillance imaging needed?' Radiology case reports vol. 17,7 2388-2393. 6 May. 2022, doi:10.1016/ Needle M, Cnaan A, Dattilo J, et al. Prognostic signs in the surgical management of plexiform neurofibroma: The Children's Hospital of Philadelphia experience, 1974-1994. J Pediatr. 1997;131(5):678-682. doi:10.1016/s0022-3476(97)70092-1. Ejerskov, C., Farholt, S., Nielsen, F.S.K. et al. Clinical Characteristics and Management of Children and Adults with Neurofibromatosis Type 1 and Plexiform Neurofibromas in Denmark: A Nationwide Study. Oncol Ther 11, 97–110 (2023). doi:10.1007/s40487-022-00213-4. Wolkenstein, P. et al. (2023) 'French cohort of children and adolescents with neurofibromatosis type 1 and symptomatic inoperable plexiform neurofibromas: Cassiopea study', European Journal of Medical Genetics, 66(5), p. 104734. doi:10.1016/ Moertel CL, Fisher MJ, Weiss BD, et al. ReNeu: A pivotal, Phase IIb trial of mirdametinib in adults and children with symptomatic neurofibromatosis type 1-associated plexiform neurofibroma. J Clin Oncol. 2024;JCO.24.01034. doi:10.1200/JCO.24.01034. Yap YS, McPherson JR, Ong CK, et al. The NF1 gene revisited - from bench to bedside. Oncotarget. 2014;5(15):5873-5892. doi:10.18632/oncotarget.2194. Rasmussen S, Friedman J. NF1 Gene and Neurofibromatosis 1. Am J Epidemiol. 2000;151(1):33-40. doi:10.1093/ Ferner R. Neurofibromatosis 1 and neurofibromatosis 2: a twenty first century perspective. The Lancet Neurology. 2007;6(4):340-351. doi:10.1016/s1474-4422(07)70075-3. Weiss, Brian D et al. 'NF106: A Neurofibromatosis Clinical Trials Consortium Phase II Trial of the MEK Inhibitor Mirdametinib (PD-0325901) in Adolescents and Adults with NF1-Related Plexiform Neurofibromas.' Journal of clinical oncology: official journal of the American Society of Clinical Oncology vol. 39,7 (2021):797-806. doi:10.1200/JCO.20.02220. Gross A, Singh G, Akshintala S, et al. Association of plexiform neurofibroma volume changes and development of clinical morbidities in neurofibromatosis 1. Neuro Oncol. 2018;20(12):1643-1651. doi:10.1093/neuonc/noy067. Nguyen R, Dombi E, Widemann B, et al. Growth dynamics of plexiform neurofibromas: a retrospective cohort study of 201 patients with neurofibromatosis 1. Orphanet J Rare Dis. 2012;7(1):75. doi:10.1186/ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Wire
30-04-2025
- Business
- Business Wire
SPRINGWORKS INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of SpringWorks Therapeutics, Inc.
NEW YORK CITY & NEW ORLEANS--(BUSINESS WIRE)--Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC ('KSF') are investigating the proposed sale of SpringWorks Therapeutics, Inc. (NasdaqGS: SWTX) to Merck KGaA, Darmstadt, Germany. Under the terms of the proposed transaction, shareholders of SpringWorks will receive $47.00 in cash for each share of SpringWorks that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company. If you believe that this transaction undervalues the Company and/or if you would like to discuss your legal rights regarding the proposed sale, you may, without obligation or cost to you, e-mail or call KSF Managing Partner Lewis S. Kahn ( toll free at any time at 855-768-1857, or visit to learn more. To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit
Yahoo
30-04-2025
- Business
- Yahoo
Merck KGaA to Buy Springworks for $3.9B
German pharma company Merck is buying US biotech SpringWorks Therapeutics for $3.9B. SpringWorks makes medicines for cancer and rare diseases and is expected to give a boost to Merck's health-care division. Belen Garijo, Merck KGaA CEO joined Bloomberg Open Interest to talk about the deal. Sign in to access your portfolio
Yahoo
29-04-2025
- Business
- Yahoo
Merck KGaA to buy biotech SpringWorks for $3.9B
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Merck KGaA has agreed to buy biotechnology company SpringWorks Therapeutics, announcing Monday a $3.9 billion deal after months of negotiations over an acquisition. The German pharmaceutical firm will pay $47 per SpringWorks share, a small premium to the stock's closing price Friday but 17% higher than the $40.28 it closed at on Feb. 7, the last trading day before reports emerged of the companies' discussions. SpringWorks has developed two drugs that are approved in the U.S. to treat rare tumors. Ogsiveo is cleared for adults with desmoid tumors, while Gomekli won the Food and Drug Administration's OK in February for adults and children with neurofibromatosis type 1 who experience symptoms from a type of benign tumor. Merck KGaA's proposed acquisition of SpringWorks is the first biotech buyout worth more than $1 billion to be announced since mid-January, when Johnson & Johnson agreed to purchase Intra-Cellular Therapies for $14.6 billion. The deals in between have been smaller and more opportunistic, reflecting a negotiating environment that's been frozen by uncertainty over tariffs and a gyrating stock market. Some of that turmoil may have played a role in drawing out discussions between German Merck and SpringWorks, which in February confirmed the two companies were in 'advanced talks.' While sizable in dollar terms, the deal that emerged nearly two months later values SpringWorks at a relatively low premium, even after adjusting for the share price run-up that followed reports on the companies' negotiations. Shares in SpringWorks were trading as high as $93.59 in early 2021, when the market for biotech stocks was booming. Merck KGaA, which provides bioprocessing services in addition to developing new drugs, has been hunting for deals as part of a strategy it rolled out last fall. The buyout is 'a major step in our active portfolio strategy' to position the company 'as a globally diversified, innovation and technology powerhouse,' CEO Belén Garijo said in a statement. 'Beyond this planned transaction, we will continue to explore M&A opportunities across our three complementary business sectors.' Once the deal is complete, Merck KGaA expects the addition of SpringWorks to immediately contribute to revenue via sales of the biotech's two approved drugs. The company said it will fund the acquisition via available cash and new debt, while retaining 'the ability to pursue larger transactions.' Merck KGaA also touted the buyout as a way to expand its presence in the U.S. The companies expect the transaction to close this quarter, contingent on their receipt of required regulatory sign-offs.
