Welcome to our dedicated page for Milestone Pharmaceuticals news (Ticker: MIST), a resource for investors and traders seeking the latest updates and insights on Milestone Pharmaceuticals stock.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) generates news primarily around its cardiovascular drug programs, regulatory milestones, and corporate developments. The company’s lead product, CARDAMYST™ (etripamil) nasal spray, is FDA approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults, and many of its announcements relate to this therapy and the broader etripamil clinical program.
News items for MIST often cover regulatory events, such as U.S. Food and Drug Administration actions on CARDAMYST, responses to Complete Response Letters, Prescription Drug User Fee Act (PDUFA) dates, and acceptance of a Marketing Authorization Application by the European Medicines Agency for etripamil nasal spray with the conditionally approved brand name TACHYMIST™ in Europe. These updates provide context on how the company’s PSVT program is progressing in major regulatory jurisdictions.
Another frequent category is clinical and scientific data. Milestone issues press releases on new analyses from its etripamil trials in PSVT and AFib-RVR, including pooled efficacy and safety results presented at medical meetings such as the American Heart Association Scientific Sessions. These articles describe conversion rates to sinus rhythm, time to conversion, and safety findings across randomized and open-label studies.
Investors and followers of MIST will also see corporate and financial news, including quarterly financial results, equity offerings, royalty purchase agreements, and inducement option grants under Nasdaq Listing Rule 5635(c)(4). Such releases outline how the company funds development and commercialization activities and how it prepares for the launch and distribution of CARDAMYST.
This news page aggregates these types of updates so readers can track Milestone’s regulatory progress, clinical data disclosures, and financing events in one place. Users interested in MIST can review past and recent headlines to understand how the company’s cardiovascular portfolio and commercial plans are evolving over time.
Milestone Pharmaceuticals (Nasdaq: MIST) announced a collaboration with Ji Xing Pharmaceuticals to develop and commercialize etripamil for paroxysmal supraventricular tachycardia (PSVT) in Greater China. The agreement includes a $15 million upfront payment, a $5 million equity investment, and potential milestone payments of up to $107.5 million. Etripamil, designed as a rapid-response therapy for PSVT, aims to transform treatment from emergency settings to home use. Ongoing Phase 3 trials for PSVT and a Phase 2 trial for atrial fibrillation are part of Milestone's comprehensive development program.
Milestone Pharmaceuticals (MIST) reported its financial results for Q4 and the full year of 2020, emphasizing progress in its etripamil development program for PSVT. The company has $142.3 million in cash, showing growth from $119.8 million in 2019. R&D expenses decreased to $5.8 million in Q4 from $14.1 million in the same period last year, aiding in narrowing the operating loss to $8.8 million. Milestone remains on track for topline data from the Phase 3 RAPID trial in late 2021 or early 2022 and has initiated a Phase 2 study for atrial fibrillation patients.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) has enrolled the first patient in its Phase 2 proof-of-concept study, known as the ReVeRA study, for etripamil nasal spray aimed at reducing ventricular rate in patients with atrial fibrillation and rapid ventricular rate (AFib-RVR). This double-blind, placebo-controlled trial in Canada will involve 50 participants, assessing both safety and efficacy. Currently, AFib impacts approximately 5 million Americans, projected to rise to 12 million in the next decade, presenting a significant market opportunity for etripamil if successful.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced that CEO Joseph Oliveto will present at several upcoming investor conferences. Key events include the Cowen 41st Annual Health Care Conference on March 4, 2021, the H.C. Wainwright Global Life Sciences Conference on March 9, 2021, and the Oppenheimer 31st Annual Healthcare Conference on March 16, 2021. A replay of the H.C. Wainwright presentation and a live webcast of the Oppenheimer presentation will be available on their website. Milestone focuses on developing etripamil for cardiovascular treatment.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced that its President and CEO, Joseph Oliveto, will present at two upcoming investor conferences. The events include the Piper Sandler 32nd Virtual Annual Healthcare Conference and the Evercore ISI 3rd Annual HealthCONx Conference on December 3, 2020, at 4:20 p.m. ET. A replay of the Piper Sandler fireside chat is available on the company's website, along with a live webcast of the Evercore presentation. Milestone is focused on developing etripamil for cardiovascular treatments.
Milestone Pharmaceuticals announced the enrollment of the first patient in the RAPID Phase 3 trial for etripamil, a treatment for paroxysmal supraventricular tachycardia (PSVT). The trial aims to assess the efficacy of a second dose of etripamil in patients who do not achieve symptom relief within 10 minutes. With a target of 500 patients and 180 confirmed SVT events, the data is expected by late 2021/early 2022. This trial follows the NODE-301 trial, which showed promising safety and efficacy results. Success in RAPID could support future FDA approvals for etripamil.
Milestone Pharmaceuticals (Nasdaq: MIST) reported its Q3 2020 financial results, highlighting plans to reopen enrollment in the pivotal Phase 3 RAPID trial for etripamil by year-end. The company raised $51.7 million through a public offering, reinforcing its financial position with $102.9 million in cash and equivalents. Q3 research and development expenses decreased to $8.2 million from $9.5 million last year, while general and administrative costs rose to $3.0 million. The company's operating loss narrowed to $12.1 million compared to $13.7 million in Q3 2019.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST) announced that CEO Joseph Oliveto will present at the Jefferies Virtual London Healthcare Conference on November 18, 2020, at 7:55 AM ET. The event will be held online, allowing broader access. A live webcast of the presentation can be viewed on Milestone's website, with a replay available for 30 days post-event. Milestone focuses on developing innovative cardiovascular treatments, particularly etripamil, currently in Phase 3 clinical trials.
Milestone Pharmaceuticals (Nasdaq: MIST) has priced a public offering of 3,810,097 common shares at $5.25 each, alongside pre-funded warrants to purchase 4,761,903 shares at $5.24 each. The offering aims to raise gross proceeds of $45 million to fund clinical development of etripamil and for general corporate purposes. The offering is set to close on October 27, 2020, pending customary closing conditions. Underwriters, Jefferies and Piper Sandler, also have a 30-day option to purchase an additional 1,285,800 shares.
Milestone Pharmaceuticals (Nasdaq: MIST) announced a proposed public offering of common shares and pre-funded warrants to certain investors. The offering, managed by Jefferies and Piper Sandler, is subject to market conditions. Milestone plans to use the net proceeds primarily for the clinical development of etripamil, its lead candidate for cardiovascular treatment, alongside capital expenditures and general corporate purposes. The underwriters will have a 30-day option to purchase an additional 15% of the offering. Details will be available in a prospectus supplement filed with the SEC.