Edgewise Therapeutics NASDAQ: EWTX is up 50% in a single session and 450% from recent lows for a reason. Its novel, oral, selective treatment for obstructive hypertrophic cardiomyopathy did remarkably well in early trials. The news is important because hypertrophic cardiomyopathy or HCM for short, is the leading cause of sudden cardiac-related death in people under 35. HCM is a genetic disease causing thickening in the heart muscle, an industry worth more than $1.25 billion today and growing. There are no c ...

Shares of Edgewise Therapeutics (EWTX) soared 30% in the pre-market trading on Thursday after it reported positive top-line data of EDG-7500 from an early-stage study in healthy subjects and Part A (single-dose arm) of a mid-stage study in patients with obstructive hypertrophic cardiomyopathy (HCM).EWTX’s EDG-7500 Shows Superior Efficacy in Both StudiesPer the data readout from the phase I study in healthy adults, no meaningful changes in left ventricle ejection fraction (LVEF), an important predictor of mo ...

One of the biopharma company's heart drugs performs as well as initially hoped.Shares of biopharma outfit Edgewise Therapeutics (EWTX 46.88%) soared more than 50% today, reaching a three-year high following an update on the clinical testing of its cardiac drug EDG-7500. The treatment shows promise in two related but distinct trials as a treatment for certain patients with improper bloodflow within the heart.Heart drug EDG-7500 works as hopedOn Thursday, Edgewise Therapeutics published data regarding the pha ...

On Thursday, Edgewise Therapeutics Inc. EWTX released announced topline data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial for obstructive hypertrophic cardiomyopathy.Obstructive hypertrophic cardiomyopathy is a heart condition that occurs when the wall between the left and right ventricles of the heart thickens, blocking blood flow from the left ventricle to the body’s main artery. In the Phase 1 single ascending dose (SAD) trial (n=48), heal ...

公司概况 - 公司自2017年成立以来一直专注于肌肉生理学和小分子药物发现,推进首创治疗肌肉疾病的新一代疗法[105] - 公司目前有两个临床阶段项目,分别针对肌肉营养不良和严重心脏疾病[105] - 公司正在推进临床三期试验的sevasemten(EDG-5506)以及正在进行2期试验的EDG-7500[105,106] - 公司还在持续推进临床前管线,包括新的心血管代谢靶点的表征[105] 财务状况 - 公司自成立以来一直亏损,预计未来一段时间内仍将持续亏损,主要用于推进产品候选药的临床开发[107] - 公司目前现金及现金等价物和可供出售证券为5.118亿美元,预计可支持未来至少12个月的运营[108] - 公司自成立以来通过私募和公开发行筹集资金7.67亿美元,截至2024年6月30日现金及可转让证券余额为5.12亿美元[139] - 2024年上半年经营活动现金流出5.47亿美元,主要由于净亏损和营运资本变动[140,141,142] - 公司预计未来将继续需要大量资本支持研发和运营[147,148,149,150] - 公司预计现有现金及可转让证券足以支持未来至少12个月的计划运营和资本支出[155,156,157] 费用情况 - 公司2024年第二季度研发费用为3068万美元,较2023年同期增加1112万美元,主要是sevasemten和EDG-7500临床试验费用增加[128,129] - 公司2024年第二季度管理费用为742.7万美元,较2023年同期增加164.7万美元,主要是人员成本和股份支付增加[130] - 研发费用同比增加18.9百万美元,主要由于Sevasemten临床项目费用增加10.1百万美元[136] - EDG-7500临床项目费用为9.1百万美元[136] - 内部成本增加5.1百万美元,主要是人员成本增加[136] - 一般及行政费用同比增加2.9百万美元,主要是人员相关成本和专业咨询费用增加[137] - 利息收入同比增加6.1百万美元,主要是由于可转让证券余额和利率上升[138] 其他 - 公司正在密切关注宏观经济和地缘政治形势的发展,如通胀、银行业动荡、信贷市场收紧等,做好应对准备[109] - 公司是一家较小的报告公司,不需要提供此项目下的信息[164]

临床试验进展 - 完成了EDG-7500的I期单剂量和多剂量试验，正在进行CIRRUS-HCM II期试验[6][7] - 继续推进GRAND CANYON全球关键性试验以评估sevasemten治疗贝克尔肌营养不良的疗效[10] - 推进LYNX和FOX II期试验以评估sevasemten治疗杜氏肌营养不良的安全性和疗效[11][12][13] 财务状况 - 现金、现金等价物和可流动证券为5.118亿美元[15] - 研发费用为3,070万美元，较上一季度增加300万美元[16] - 一般及管理费用为740万美元，较上一季度增加30万美元[17] - 净亏损为3,150万美元，每股亏损0.34美元[18]

Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the 'long' context, investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades.Whil ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ 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: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1725586 ...

Exhibit 99.1 News Release Edgewise Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights – Announced positive two-year topline results of sevasemten ARCH open label trial and advanced GRAND CANYON pivotal cohort in Becker – –Positive interim topline data for DUNE trial of sevasemten in Becker – – Expanded Phase 2 LYNX trial of sevasemten in Duchenne – – Anticipated to overenroll Phase 2 FOX trial in Duchenne boys previously treated with gene therapy – – Initiated Phase 2 C ...

Shares of Edgewise Therapeutics, Inc. (EWTX) have gained 4.6% over the past four weeks to close the last trading session at $17.28, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $26.40 indicates a potential upside of 52.8%. The mean estimate comprises five short-term price targets with a standard deviation of $3.65. While the lowest estimate of $23 indicates a 33.1% increase f ...