Milestone Pharmaceuticals(MIST)

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Watch Milestone Pharmaceuticals For (Likely) Upcoming FDA Approval For Cardamyst
Seeking Alpha· 2025-07-07 22:01
Milestone Pharmaceuticals Inc. (NASDAQ: MIST ) is a microcap biotech company that was founded in 2003. It is based in Montreal, but also has a subsidiary in Charlotte, NC, with 30+ employees split fairly evenly between the two locations. Milestone IPO’d inI have been investing in the stock market since I was 17 years old, and over the 25+ years since I have learned the joy of compounding, the value of dividend reinvesting, and the principle that patient investing through good times and bad brings the greate ...
Milestone Pharmaceuticals to Present at the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 20:00
MONTREAL AND CHARLOTTE, N.C., May 28, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today announced that Amit Hasija, Chief Financial Officer, and Lorenz Muller, Chief Commercial Officer, will present at the Jefferies Healthcare Conference, to take place June 3 - 5, 2025, in New York. A webcast of the presentation will be available on June 5 at 8:10 AM EDT. The webcast will be available to watch live and there will be a replay for approximately 90-days following the presentation on ...
Milestone Pharmaceuticals (MIST) Upgraded to Buy: Here's Why
ZACKS· 2025-05-23 01:01
Milestone Pharmaceuticals (MIST) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Since a changing ...
Milestone Pharmaceuticals(MIST) - 2025 Q1 - Quarterly Results
2025-05-14 19:11
Exhibit 99.1 Etripamil for patients with atrial fibrillation with rapid ventricular rate (AFib-RVR) Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update Resolution of CRL Manufacturing issues in progress - Type A meeting requested No clinical safety or ef icacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ...
Milestone Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides Regulatory and Corporate Update
Globenewswire· 2025-05-14 19:04
Resolution of CRL Manufacturing issues in progress - Type A meeting requested No clinical safety or efficacy concerns raised by FDA MONTREAL and CHARLOTTE, N.C., May 14, 2025 (GLOBE NEWSWIRE) -- Milestone Pharmaceuticals Inc. (Nasdaq: MIST) today reported financial results for the first quarter ended March 31, 2025. The Company also announced the submission of a meeting request to the U.S. Food and Drug Administration (FDA) as the next step in the resolution of CRL issues. “Our immediate priority is to enga ...
Milestone Pharmaceuticals(MIST) - 2025 Q1 - Quarterly Report
2025-05-14 19:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 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, 2025 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: 001-38899 Milestone Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jur ...
MIST Stock Falls 66% Following Complete Response Letter for Cardamyst
ZACKS· 2025-04-03 04:00
Key Takeaways Shares of MIST plunged 66.2% since the CRL issuance, reflecting the delay in the launch of Cardamyst. The company's shares have lost 67.8% so far this year against the industry's 2.2% growth. Despite this regulatory roadblock, analysts remain cautiously optimistic about the drug's prospects. Milestone Pharmaceuticals (MIST) recently announced that the FDA has issued a Complete Response Letter (“CRL”) for its New Drug Application (“NDA”) seeking approval for CARDAMYST (etripamil) nasal spray. ...
FDA Issues Complete Response Letter for Etripamil for PSVT
Newsfilter· 2025-03-28 19:00
文章核心观点 公司宣布FDA针对CARDAMYST™(etripamil)鼻喷雾剂新药申请发布完整回复函,虽未对etripamil临床安全性或有效性数据提出担忧,但指出两个关键CMC问题待解决,公司将评估反馈并申请会议讨论以重新提交申请 [1][2] 公司情况 - 公司是一家开发和商业化创新心血管解决方案的生物制药公司,专注满足患者未被满足的需求,改善患者体验 [4] - 截至2024年12月31日,公司拥有6970万美元现金、现金等价物和短期投资 [1][2] 产品情况 - etripamil是公司主要研究产品,是一种新型钙通道阻滞剂鼻喷雾剂,用于治疗PSVT和AFib - RVR,若获批将为医疗保健提供者提供新治疗选择,让患者自我管理病情 [3][4] - CARDAMYST™是etripamil鼻喷雾剂有条件批准的品牌名,有完善临床试验项目,包括针对PSVT的3期临床和针对AFib - RVR的2期试验 [3] FDA提出的问题 - 公司需根据NDA提交后发布的新草案指南,提交有关亚硝胺杂质的额外信息 [6] - 需对进行etripamil放行测试的设施进行检查,确保其符合现行良好生产规范,该设施在NDA审查期间变更了所有权 [6] 公司计划 - 公司团队将评估FDA反馈,并打算申请A类会议讨论CRL中提出的问题,目标是在重新提交申请时解决这些问题 [2]
Milestone Pharmaceuticals: A Compelling Value Proposition For Patients And Payers
Seeking Alpha· 2025-03-22 03:18
文章核心观点 - 公司专注于小市值和微市值生物制药公司研究,希望改变临床阶段股票研究现状 [1] 公司投资目标 - 公司目标是小市值和微市值生物制药公司,这类年轻的临床阶段公司受机构关注少,券商研报常因利益相关导致市场波动,散户占公众持股多数,股价易受不重要信息影响 [1] 公司研究优势 - 公司重视临床信息,研究团队多为英国顶尖大学排名靠前的生命科学专业学生 [1] 公司持仓情况 - 公司及其附属机构持有Milestone Pharmaceuticals的多头头寸 [2]
Milestone Pharmaceuticals to Present Clinical Data on Etripamil at the American College of Cardiology
Globenewswire· 2025-03-20 20:00
文章核心观点 公司将在ACC25会议上展示海报介绍依曲帕米治疗阵发性室上性心动过速(PSVT)的潜力及相关数据 [1][2] 公司动态 - 公司将于2025年3月29 - 31日在芝加哥举行的美国心脏病学会年会(ACC25)上进行海报展示 [1] - 海报展示时间为2025年3月30日上午11:42 - 11:49(中部时间),地点在Moderated Poster Theater 1 [2] - 海报展示标题为“Consistency and Predictiveness of Conversion Among Multiple Episodes of Paroxysmal Supraventricular Tachycardia (PSVT) Treated with Etripamil: Outcomes from the NODE - 303 trial”,演讲者为James Ip医学博士 [2] 产品信息 - 公司主要研究产品依曲帕米是一种新型钙通道阻滞剂鼻喷雾剂,可让患者在无医疗监督下自我给药,用于治疗与PSVT和AFib - RVR相关的症状性发作 [3] - 数据显示依曲帕米有潜力成功将多次PSVT发作转为正常窦性心律,早期发作的转复可预测后续发作的转复情况,若获批可用于连续PSVT发作,有望改善患者体验和生活质量 [2] 公司介绍 - 公司是一家专注于开发和商业化创新心血管药物的生物制药公司,致力于满足患者未被满足的需求,改善患者体验 [3] 联系方式 - 公关副总裁Kim Fox,邮箱kfox@milestonepharma.com [6] - 投资者关系Kevin Gardner,邮箱kgardner@lifesciadvisors.com [6]