NEW YORK, July 2, 2024 /PRNewswire/ -- Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of SpringWorks Therapeutics, Inc. (NASDAQ: SWTX) breached their fiduciary duties to shareholders. The investigation concerns potential self-dealing. Shareholders may be entitled to damages and corporate governance reforms. If you own SWTX please contact Justin Kuehn, Esq. by email at [email protected] or call (833) 672-0814. The consultation and case are free wit ...

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN). "We are ...

STAMFORD, Conn., July 01, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the Company has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for mirdametinib, an investigational MEK inhibitor, for the treatment of pediatric and adult patients with neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN). "We are ...

STAMFORD, Conn., June 05, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced that management will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference, taking place in Miami, Florida on Tuesday, June 11, 2024 at 2:00 p.m. ET. To access the live webcast, please visit the Events & Presentations page within the Investors & Media section of the comp ...

– Results from pivotal Phase 2b ReNeu trial of mirdametinib in patients with NF1-PN to be presented in an oral presentation – – Additional data and analyses from Phase 3 DeFi trial of OGSIVEO® (nirogacestat) highlighting consistent safety and efficacy across subgroups of adults with desmoid tumors also being presented in oral and poster sessions – STAMFORD, Conn., May 23, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe ra ...

财务数据和关键指标变化 - 公司在第一季度实现了2100万美元的OGSIVEO净产品收入 [12] - 公司维持了强劲的财务状况,截至第一季度末现金、现金等价物和可流通证券余额为5.73亿美元 [40] 各条业务线数据和关键指标变化 - OGSIVEO在上市初期就取得了强劲的商业执行力和高需求,体现了该药物在治疗成人型肌纤维瘤患者中的巨大未满足需求 [12] - OGSIVEO在肿瘤中心和社区医疗机构中的采用率都很高,77%的肿瘤中心已经开始给患者开具OGSIVEO处方 [13] - 患者对OGSIVEO治疗的反馈很积极,尤其是在缓解疼痛症状方面 [14] 各个市场数据和关键指标变化 - 公司预计美国有5500-7000名活跃管理的肌纤维瘤患者,OGSIVEO有机会惠及这一广泛的患者群体 [45] - OGSIVEO获得了广泛的保险报销,代表98%商业保险人群的保险公司都已经报销该药物 [20] 公司战略和发展方向及行业竞争 - 公司将继续推动OGSIVEO在肿瘤中心和社区医疗机构的深度和广度应用,维持良好的患者准入 [17] - 公司正在推进mirdametinib用于治疗神经纤维瘤1型相关的神经纤维瘤的NDA申报,预计2025年获批 [8][24][26] - 公司正在拓展nirogacestat在卵巢颗粒细胞瘤和多发性骨髓瘤等适应症的应用,并推进brimarafenib和SW-682等新药的临床开发 [32][33][35][37] 管理层对经营环境和未来前景的评论 - 公司对OGSIVEO在成人肌纤维瘤治疗中的长期成功充满信心,认为目前只触及了很小一部分可受益患者 [22][44][45] - 公司认为mirdametinib有望成为治疗神经纤维瘤1型相关神经纤维瘤的最佳-in-class疗法,能为大量患者带来显著益处 [27][28][31][46][47][48] - 公司对广泛的管线产品组合充满信心,未来一年将有多个重要临床进展 [32][33][35][37][38] 其他重要信息 - 公司获批推出新的OGSIVEO150mg和100mg片剂及新型铝塑泡罩包装,有助于提高患者依从性 [21] - 公司拥有21项OGSIVEO相关专利,可保护至2043年 [22] 问答环节重要的提问和回答 问题1 **Anupam Rama 提问** 询问OGSIVEO的库存动态情况 [55] **Bhavesh Ashar 回答** 分销商只持有最低库存,公司第一季度收入主要由新患者需求和续订处方带动 [57] 问题2 **Yaron Werber 提问** 询问OGSIVEO在新诊断患者和既往治疗患者中的销售占比 [59] **Saqib Islam 回答** 公司看到两类患者都有采用,预计新诊断患者将是短期主要增长动力,但长期来看,既往接受其他治疗的患者转换也会是重要来源 [60] 问题3 **Michael Schmidt 提问** 询问是否存在季节性因素影响第一季度的报销情况 [71] **Bhavesh Ashar 回答** 公司在4个月内已经实现了广泛的保险报销覆盖,包括商业保险、Medicare和Medicaid,与预期的患者人群结构相符 [73]

Q1 2024 Financial Results and Business Update May 2, 2024 Today’s Speakers and Agenda Sections Presenter Saqib Islam Opening Remarks Chief Executive Officer Bhavesh Ashar Commercial Highlights Chief Commercial Officer ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ____________________________________________________ FORM 10-Q ____________________________________________________ x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2024 OR ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _ COMMISSION FILE NUMBER 001-39044 _____ ...

Exhibit 99.1 SpringWorks Therapeutics Reports First Quarter 2024 Financial Results and Highlights Recent Business Updates – Achieved $21.0 million in OGSIVEO® (nirogacestat) net product revenue in the first quarter – – Received validation from the EMA for MAA of nirogacestat for the treatment of adults with desmoid tumors – – Initiated rolling submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Phase 2b ReNeu trial results accepted for oral presentation at ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number: 001-39044 SPRINGWORKS THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 83-4066827 (State of Other Jurisdiction of incorporation o ...