| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | November 22, 2024 4:00 P.M. |
| Form: | S-3 | ||||||
| |||||||
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| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 8/22/2024 | $9.00 | Buy | Rodman & Renshaw |
| 6/20/2023 | $8.00 → $4.00 | Buy → Hold | Jefferies |
| 4/22/2022 | $8.00 → $10.00 | Neutral → Overweight | Piper Sandler |
CRL focused on CMC; no clinical issues relating to etripamil raised $69.7M in cash, cash equivalents and short-term investments as of December 31, 2024 MONTREAL and CHARLOTTE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) today announced the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA) for CARDAMYST™ (etripamil) nasal spray, a prescription medication in development for the conversion of acute episodes of PSVT to sinus rhythm in adults. The FDA did not raise any concerns regarding etripamil clinical safety or efficacy data and highlighted two key Chemistry, Manufact
MONTREAL and CHARLOTTE, N.C., March 20, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present a moderated poster presentation at the American College of Cardiology annual meeting (ACC25), to be held March 29th to 31st, 2025 in Chicago, Illinois. "This presentation highlights the potential ability of etripamil to successfully convert multiple episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to restore normal sinus rhythm. Further, the data showed that conversion of earlier episodes was predictive of conversion
FDA PDUFA review goal date of March 27, 2025 for CARDAMYST™ (etripamil) nasal spray for Paroxysmal Supraventricular Tachycardia (PSVT) Assuming FDA approval, proposed launch in PSVT targeted for mid-2025 Milestone well-capitalized to commercialize upon approval with royalty financing MONTREAL and CHARLOTTE, N.C., March 13, 2025 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST) today reported financial results for the fourth quarter and full year ended December 31, 2024 and provided a regulatory and corporate update. "We are focused on the potential FDA approval for CARDAMYST and the opportunity to help the millions of patients suffering from PSVT," said Joseph Oliveto,
SC 13G/A - Milestone Pharmaceuticals Inc. (0001408443) (Subject)
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SC 13G/A - Milestone Pharmaceuticals Inc. (0001408443) (Subject)
Rodman & Renshaw initiated coverage of Milestone Pharmaceuticals with a rating of Buy and set a new price target of $9.00
Jefferies downgraded Milestone Pharmaceuticals from Buy to Hold and set a new price target of $4.00 from $8.00 previously
Piper Sandler upgraded Milestone Pharmaceuticals from Neutral to Overweight and set a new price target of $10.00 from $8.00 previously
New Drug Application submitted to the U.S. Food and Drug Administration for CARDAMYST™, the conditionally approved brand name for etripamil nasal spray, for patients with PSVT Positive Phase 2 data evaluating etripamil in AFib-RVR were a Featured Science Presentation at 2023 AHA Scientific Sessions; Phase 3 program expected to begin enrollment in mid-2024Company to host Investor and Analyst Webcast to review data from ReVeRA Phase 2 study of etripamil in atrial fibrillation with rapid ventricular rate today at 8:00 a.m. ETMONTREAL and CHARLOTTE, N.C., Nov. 13, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST) today reported financial results for the third quarter ended Septem
- Self-administration of etripamil in patients experiencing AFib-RVR episodes resulted in a substantial reduction in ventricular rate which was sustained over 60 minutes - Data featured in an oral session at the Heart Rhythm 2023 Annual Meeting - Company to host virtual KOL conference call and webcast to discuss etripamil development for the treatment of AFib-RVR today at 8:00 a.m. ET MONTREAL and CHARLOTTE, N.C., May 22, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced promising data from an ad hoc analysis of a subset of patients experien
- Cardiac Electrophysiology Key Opinions Leaders to include Paul Dorian, MD, and Jonathan Piccini, MD - Conference call and webcast on Monday, May 22, 2023 at 8:00 a.m. ET MONTREAL and CHARLOTTE, N.C., May 8, 2023 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that the Company will host a virtual Key Opinion Leader (KOL) event on Monday, May 22, 2023 at 8:00 a.m. ET. The event will focus on etripamil, the Company's lead investigational product, for the potential treatment of patients with atrial fibrillation (AFib) and rapid ventricular rate (A
8-K - Milestone Pharmaceuticals Inc. (0001408443) (Filer)
8-K - Milestone Pharmaceuticals Inc. (0001408443) (Filer)
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MONTREAL and CHARLOTTE, N.C., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the appointment of Joseph Papa to its Board of Directors ("Board"), effective September 3, 2024. Mr. Papa is a renowned pharmaceutical and healthcare leader, with more than 35 years of experience navigating companies through periods of rapid growth, transformation, and strategic M&A transactions, including as former Chairman and CEO of Bausch + Lomb, Bausch Health and Perrigo and as a director of SparingVision and Candel Therapeutics. He brings bro
- RAPID topline data readout remains on track for mid-second half 2022 - Results from NODE-302 study highlights etripamil safety and reduced need for ED interventions MONTREAL and CHARLOTTE, N.C., May 12, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the first quarter ended March 31, 2022, and provided a clinical and corporate update. "The beginning of 2022 has been a productive time for Milestone, marked by continued progress advancing our lead Phase 3 program, etripamil, for patients with PSVT," said Josep
- RAPID topline data readout expected mid-second half 2022 MONTREAL and CHARLOTTE, N.C., March 24, 2022 /PRNewswire/ -- Milestone Pharmaceuticals Inc. (NASDAQ:MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today reported financial results for the fourth quarter and year ended December 31, 2021 and provided a clinical and corporate update. "2021 was a year of focused execution across our ongoing clinical programs which are evaluating etripamil in patients with PSVT and AFib-RVR," said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. "We are well-positioned for a transformat