财务表现 - 第二季度OGSIVEO(nirogacestat)净产品收入达4020万美元[2] - 公司2024年第二季度总收入为5,973.3万美元[21] - 2024年上半年总收入为8,073.9万美元[21] - 2024年第二季度和上半年研发费用分别为4,436.2万美元和9,798.4万美元[21,22] - 2024年第二季度和上半年销售、一般及管理费用分别为5,783.9万美元和11,795.2万美元[21,22] - 2024年第二季度和上半年每股基本和稀释亏损分别为0.54美元和1.72美元[23] - 2024年第二季度和上半年加权平均普通股数分别为7,412.1万股和7,394.5万股[23] - 截至2024年6月30日,现金、现金等价物和可流通证券为5.219亿美元[12] - 2024年6月30日公司营运资本为37,682.4万美元[26] - 2024年6月30日公司累计亏损为102,233.8万美元[26] - 2024年6月30日公司总股东权益为55,673.0万美元[26] 产品管线进展 - 已向FDA提交mirdametinib用于治疗NF1-PN患儿和成人的新药申请[3] - 在2024年ASCO年会上发表了ReNeu II期试验结果和DeFi III期试验的附加分析[4] - 启动了针对Hippo突变实体瘤患者的SW-682 I期a期试验[4] - 公司已向欧洲药品管理局提交了nirogacestat用于治疗成人患者desmoid肿瘤的上市申请[7] - 计划在2024年下半年发表ReNeu试验结果并在医学会议上报告DeFi试验的长期随访数据[7][8] - 计划在2024年下半年报告nirogacestat用于复发性卵巢颗粒细胞瘤患者的II期试验初始数据[7] 商业化进展 - OGSIVEO在美国上市持续强劲,公司正在推进mirdametinib在美国和欧洲的商业准备[6]

产品批准和商业化 - 公司于2023年11月获得FDA批准,OGSIVEO成为首个获批治疗成人进展性肌纤维瘤的药物[78] - OGSIVEO在2024年第一季度和上半年分别实现4020万美元和6120万美元的净产品收入[82] - 公司正在评估OGSIVEO在欧洲和其他地区的商业化机会[83] - 2023年11月公司获得FDA批准,OGSIVEO用于治疗成人进展性肌纤维瘤患者[106][117] - 2024年6月30日季度,公司产品收入为4,018.6万美元[106] - 2024年上半年,公司产品收入为6,119.2万美元[117] 临床试验和管线进展 - OGSIVEO在III期DeFi试验中显示了显著的疗效,包括无进展生存期延长71%、客观缓解率41%等[79] - 公司正在开展一项II期试验评估OGSIVEO治疗复发性卵巢颗粒细胞瘤,预计2024年下半年公布初步数据[84] - 公司的另一候选药物mirdametinib在III期ReNeu试验中显示了良好的疗效和安全性,已完成NDA提交[85,86] - 公司正在评估nirogacestat联合BCMA疗法治疗多发性骨髓瘤,与多家公司建立了合作关系[87,88] - 公司正在评估mirdametinib单药及联合疗法治疗MAPK通路异常的实体瘤[90] - 公司正在积极拓展管线,包括引入TEAD抑制剂等新机制的候选药物[91] 财务表现 - 2024年6月30日季度,公司其他收入为1,954.7万美元,主要来自终止GSK许可协议[95] - 2024年6月30日季度,销售、一般及管理费用增加1,084.5万美元至5,783.9万美元,主要用于支持OGSIVEO的商业化活动以及准备上市mirdametinib[107][108] - 2024年6月30日季度,研发费用增加850.4万美元至4,436.2万美元,主要用于nirogacestat、mirdametinib和其他项目的临床试验和药品生产[109][110][111][112] - 2024年上半年,销售、一般及管理费用增加2,678.3万美元至11,795.2万美元,主要用于支持OGSIVEO的商业化活动以及准备上市mirdametinib[118][119] - 2024年上半年,研发费用增加2,860.2万美元至9,798.4万美元,主要用于nirogacestat、mirdametinib和其他项目的临床试验和药品生产[120][121][122][123] - 公司在2024年6月30日和2023年12月31日分别有10亿美元和8.95亿美元的累计亏损[126] - 公司预计未来至少可以维持12个月的流动性[126] - 2024年上半年经营活动产生的净现金流出为1.207亿美元[128] - 2024年上半年投资活动产生的净现金流入为2.175亿美元[129] - 2024年上半年融资活动产生的净现金流入为282万美元[130] - 公司未来的资金需求将取决于多个因素,包括临床试验进展、商业化活动、研发费用等[131,132] - 公司预计未来将通过多种方式筹集资金,包括股权融资、债务融资、合作等[134] - 公司认为目前的通胀对其业务没有重大影响[135] - 公司在2024年上半年的合同义务和承诺与2023年年报中披露的一致[136] - 公司的关键会计政策和关键估计在2024年上半年未发生变化[137,138]

– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a ...

– Achieved $40.2 million in OGSIVEO® (nirogacestat) net product revenue in the second quarter – – Completed submission of NDA to the FDA for mirdametinib for the treatment of children and adults with NF1-PN – – Presented Phase 2b ReNeu trial results and additional analyses from Phase 3 DeFi trial at the 2024 ASCO Annual Meeting – – Initiated Phase 1a trial of SW-682 in patients with Hippo mutant solid tumors – STAMFORD, Conn., Aug. 07, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), ...

STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (NASDAQ:SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company's Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. "Martin is a proven ind ...

STAMFORD, Conn., July 29, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, today announced the appointment of Martin Mackay, Ph.D. to the Company’s Board of Directors. Dr. Mackay is a highly accomplished research and development (R&D) executive with more than 30 years of pharmaceutical and biotech R&D experience, including leadership roles at Pfizer, AstraZeneca and Alexion. “Martin is a proven in ...

STAMFORD, Conn., July 23, 2024 (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 Wednesday, August 7, 2024 to report its second quarter 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 conference call by pho ...

STAMFORD, Conn., July 23, 2024 (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 Wednesday, August 7, 2024 to report its second quarter 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 conference call by ph ...

Shares of SpringWorks Therapeutics, Inc. (SWTX) have rallied 45.8% in the past year against the industry’s decline of 6.7%.Earlier this month, the company completed the new drug application (NDA) submission for its investigational MEK inhibitor, mirdametinib, which is being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients.In March 2024, the company initiated the rolling submission of the NDA to the FDA for mirdametinib in N ...

SpringWorks Therapeutics, Inc. (SWTX) announced that it has completed the submission of a new drug application (“NDA”) for its investigational MEK inhibitor, mirdametinib, being developed for the treatment of neurofibromatosis type 1- associated plexiform neurofibromas (NF1-PN), in pediatric and adult patients. The NDA filing was based on data from the pivotal phase IIb ReNeu study, which evaluated mirdametinib in patients aged two years and above with NF1-associated PN causing significant morbidity. The pr ...