Cannot view this video? Visit: https://www.youtube.com/watch?v=AmXw89EJ_80 Brown Bagging for Calgary's Kids (BB4CK) is a non-profit organization that has worked for over 30 years to ensure kids in Calgary have access to food. The BB4CK community includes dedicated volunteers, parents, school staff and donors who help to connect kids to food. With community kitchens and hundreds of volunteers assembling lunches for thousands of kids every day, the team is committed to removing barriers to food in a dignified ...

巴西IBOVESPA指数短线波动不大，现跌0.6%。特朗普称他们对巴西前总统Bolsonaro非常不公平。 ...

纪要涉及的行业和公司 - 行业：生物制药行业，聚焦杜氏肌营养不良症（Duchenne muscular dystrophy，DMD）治疗领域 [4] - 公司：Capricor Therapeutics（CAPR），一家专注于细胞疗法的生物制药公司 [1] 纪要提到的核心观点和论据 核心观点 1. Capricor公司的Daramyacel生物制品许可申请（BLA）未获FDA批准，公司将积极应对以推动产品获批 [4][5] 2. HOPE - 3临床试验数据有望为BLA重新获批提供关键支持 [10] 3. 公司认为现有数据能证明Daramyacel的疗效和安全性，FDA的决定出乎意料 [4][6] 论据 1. **BLA未获批情况** - FDA发出完整回复信（CRL），指出BLA未满足有效性的法定要求，需要更多临床数据，还提及化学、制造控制（CMC）部分存在未解决问题 [4][5] - 公司遵循FDA各阶段指导，完成预许可检查、中期审查无重大缺陷，回复超50个信息请求，但咨询委员会会议被取消，且临近后期会议时收到CRL [6] 2. **Daramyacel疗效和安全性数据** - HOPE - 2试验中，Daramyacel达到主要疗效终点，次要和探索性心脏终点内部一致性高，复合p值为0.0066 [7][8] - HOPE - 2开放标签扩展研究显示，与倾向匹配外部对照相比，左心室射血分数有统计学显著结果，p值为0.0079；两年时多个关键心脏参数的全球统计测试p值为0.0086 [9] - Daramyacel已在超250名患者中进行超700次输注，各临床研究中显示出一致且良好的安全性 [9] 3. **HOPE - 3临床试验情况** - 已完成12个月时间点评估，104名DMD患者参与随机双盲安慰剂对照研究，预计第三季度出一年数据 [10] - 研究最初评估上肢功能和关键心脏结局，若心脏功能终点结果积极，可加强当前BLA，符合FDA对充分且良好控制研究的指导 [10] - HOPE - 3是充分且良好控制的研究，随机双盲安慰剂对照，患者招募完成，功率分析适当，对上肢功能和射血分数有高功率 [31] 4. **其他支持情况** - 美国领先的DMD医师科学家提交联合信支持Daramyacel临床项目和BLA提交的数据 [12] - 公司与NS Pharma合作，对方知晓CRL情况，仍完全致力于商业化 [58] 其他重要但可能被忽略的内容 1. **统计分析问题**：HOPE - 2原模型基于84名患者试验，因早期揭盲分布失衡，需用非参数分析，公司统计学家与FDA详细沟通，FDA曾接受该分析，但现又回到传统观点 [30][31] 2. **HOPE - 3研究设计**：最初设计为队列A，后根据FDA建议增加队列B，两队列独立功率分析，各臂独立达到80%功率，p值为0.05，合并后功率更高 [32] 3. **CMC情况**：FDA推迟审查CMC部分，公司认为可及时解决剩余问题，相信CMC包在重置PDUFA时钟时能按计划进行 [5][11][57] 4. **监管途径**：公司希望此次为BLA的重大修订，而非新的BLA申请，因HOPE - 3数据未包含在原BLA中，可提供额外数据满足FDA要求 [48] 5. **国际临床开发**：公司将继续与欧洲药品管理局（EMA）和日本药品医疗器械局（PMDA）合作，原认为HOPE - 3数据可能适用于美国以外地区，策略未变 [66]

 July 11, 2025 – TheNewswire - Vancouver, British Columbia – Blue Lagoon Resources Inc. (the “Company”) (CSE: BLLG; OTCQB: BLAGF; FSE: 7BL) is pleased to announce the official opening of its wholly owned Dome Mountain Gold Mine Project, that recently received its mining permit – making it one of only nine mining permits granted in British Columbia in the past decade - and one of just a few high-grade, road-accessible gold projects to reach production-ready status in recent years.The celebration, held on Ju ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Altria (MO) , which belongs to the Zacks Tobacco industry.This owner of Philip Morris USA, the nation's largest cigarette maker has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 3.35%.For the last reported quarter, Altria came out with earnings of $1.23 ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering NextEra Energy (NEE) , which belongs to the Zacks Utility - Electric Power industry.When looking at the last two reports, this parent company of Florida Power & Light Co. has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 2.99%, on average, in the last two quarters.For the last reported quarter, NextEra came out ...

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? Truist Financial Corporation (TFC) , which belongs to the Zacks Banks - Major Regional industry, could be a great candidate to consider.This company has seen a nice streak of beating earnings estimates, especially when looking at the previous two reports. The average surprise for the last two quarters was 2.88%.For the last reported quarter, Truist Fin ...

Have you been searching for a stock that might be well-positioned to maintain its earnings-beat streak in its upcoming report? It is worth considering Bright Horizons Family Solutions (BFAM) , which belongs to the Zacks Business - Services industry.This child care and early education services provider has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 14.96%.For the most recent quar ...

If you are looking for a stock that has a solid history of beating earnings estimates and is in a good position to maintain the trend in its next quarterly report, you should consider The Bank of New York Mellon Corporation (BK) . This company, which is in the Zacks Banks - Major Regional industry, shows potential for another earnings beat.When looking at the last two reports, this company has recorded a strong streak of surpassing earnings estimates. The company has topped estimates by 8.15%, on average, i ...

公司业绩表现 - 博格华纳(BWA)在过去两个季度中平均超出盈利预期11.52% [1] - 最近季度每股收益(EPS)实际为0.98美元，超出预期13.27%(预期1.11美元) [2] - 前一季度EPS实际为1.01美元，超出预期9.78%(预期0.92美元) [2] 盈利预测指标 - 当前盈利ESP(预期惊喜预测)为+11.20%，显示分析师近期对公司盈利前景持乐观态度 [8] - 盈利ESP与Zacks排名3(持有)结合时，未来盈利超预期的可能性较高 [5][8] - 历史数据显示，具备正盈利ESP和Zacks排名3及以上组合的股票，近70%概率会超预期 [6] 盈利预测方法 - Zacks盈利ESP通过比较"最准确预估"与"共识预估"来衡量潜在盈利惊喜 [7] - 分析师在财报发布前修正的预估通常包含最新信息，可能比早期预测更准确 [7] - 下一次财报预计将于2025年7月31日发布 [8] 行业背景 - 公司属于Zacks汽车-原装设备行业 [1]