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Milestone Pharmaceuticals Inc. (Symbol: MIST) is a biopharmaceutical company headquartered at 6100 Royalmount Ave, Montreal, QC, Canada. The company specializes in developing and commercializing innovative treatments for cardiovascular conditions, with a key focus on its lead investigational product, etripamil.
Milestone's primary product, etripamil, is a calcium channel blocker designed for rapid onset as a nasal spray. This unique formulation allows patients to self-administer the medication to terminate episodes of paroxysmal supraventricular tachycardia (PSVT). PSVT is a condition characterized by an abnormally fast heart rate, which can be both sudden and recurrent.
The company is also conducting a Phase 2 clinical trial to evaluate the efficacy of etripamil for patients with atrial fibrillation experiencing a rapid ventricular rate (AFib-RVR). This trial marks another significant step in expanding the usage of etripamil to address additional cardiovascular indications.
Recent Achievements and Current Projects:
- Milestone intends to use the proceeds from its latest offering to further the development of etripamil for PSVT and AFib-RVR, along with other general corporate purposes.
- The company has secured a shelf registration statement on Form S-3, effective as of February 2, 2022, allowing for streamlined securities offering.
- Milestone actively participates in educational initiatives, such as partnering with the Arrhythmia Alliance for SVT Awareness Day, aimed at raising awareness about heart rhythm disorders.
Financial Condition and Partnerships: Milestone maintains a strong financial position, supported by recent offerings and strategic partnerships. The company's collaborations with healthcare organizations and participation in global awareness campaigns underline its commitment to improving cardiovascular health.
Key Highlights:
- Innovative treatment for PSVT with a patient-administered nasal spray.
- Ongoing Phase 2 trial for AFib-RVR.
- Effective use of proceeds for development and expansion.
- Active involvement in cardiovascular health awareness initiatives.
With a robust pipeline and strategic initiatives, Milestone Pharmaceuticals Inc. is dedicated to addressing unmet needs in cardiovascular care, making significant strides in the biopharmaceutical industry.
Milestone Pharmaceuticals (MIST) reported its financial results for Q4 and FY 2022, highlighting significant corporate developments. Following a strategic financing of $125 million in March 2023, the company expects sufficient cash resources to fund operations into mid-2025. A New Drug Application (NDA) for etripamil, aimed at treating paroxysmal supraventricular tachycardia (PSVT), is expected to be submitted in Q3 2023. The Phase 3 RAPID trial showed positive topline results, with 64.3% of patients converting to sinus rhythm with etripamil compared to 31.2% on placebo. However, the company's operating loss increased to $58.4 million in FY 2022 from $42.9 million in FY 2021.
Milestone Pharmaceuticals (Nasdaq: MIST) announced a strategic financing of $125 million with RTW Investments to bolster the development of its investigational drug etripamil for treating paroxysmal supraventricular tachycardia (PSVT). Funds, including $64.6 million in cash resources, are allocated to support operations until mid-2025, including a New Drug Application (NDA) submission planned for Q3 2023. Etripamil aims to empower patients to manage PSVT outside hospital settings. The investment comprises $50 million in convertible notes and $75 million in royalty financing, subject to FDA approval.
Milestone Pharmaceuticals has announced significant progress in the development of etripamil, an investigational treatment for paroxysmal supraventricular tachycardia (PSVT). The completion of NODE-303 and RAPID-extension studies paves the way for a New Drug Application (NDA) submission expected in Q3 2023, following positive feedback from the FDA. Etripamil aims to be the first fast-acting, patient-administered therapy for PSVT, potentially reducing reliance on emergency services. Recent Phase 3 trial results show 64.3% of patients converted to sinus rhythm within 30 minutes of self-administering etripamil, significantly higher than placebo (31.2%).
On February 28, 2023, Milestone Pharmaceuticals (Nasdaq: MIST) announced its management team will present at two upcoming investor conferences. The events include the Cowen 43rd Annual Health Care Conference on March 7 at 1:30 p.m. ET and the Oppenheimer 33rd Annual Healthcare Conference on March 14 at 2:40 p.m. ET. Live webcasts of the presentations can be accessed on Milestone's website, with archived replays available for approximately 90 days. Milestone focuses on cardiovascular medicines, with its lead candidate, etripamil, having completed Phase 3 trials for paroxysmal supraventricular tachycardia and a Phase 2 trial for atrial fibrillation.
Milestone Pharmaceuticals (Nasdaq: MIST) will host a virtual deep-dive event on December 6, 2022 at 1:00 p.m. ET to discuss the commercial prospects of etripamil, its lead investigational product for treating paroxysmal supraventricular tachycardia (PSVT). This condition affects around two million Americans and is characterized by sudden episodes of rapid heartbeat. Etripamil is a self-administered nasal spray aimed at improving treatment accessibility, shifting care from emergency settings. For more information, visit Milestone's website.
Milestone Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical firm dedicated to cardiovascular medicine, announced management participation in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, at 1:30 p.m. ET in New York, NY. Investors can access a live webcast via Milestone's website, with an archived replay available for 90 days post-event. Milestone's lead product, etripamil, is in Phase 3 trials for treating paroxysmal supraventricular tachycardia and Phase 2 for atrial fibrillation with rapid ventricular rate.
Milestone Pharmaceuticals reported significant progress with its lead product, etripamil, in treating paroxysmal supraventricular tachycardia (PSVT). The Phase 3 RAPID trial achieved its primary efficacy endpoint with 64.3% of patients converting to sinus rhythm compared to 31.2% on placebo. Safety data remains consistent with previous studies. The company plans to submit a New Drug Application to the FDA in mid-2023. Financially, Milestone had $77.2 million in cash and reported an operating loss of $14.6 million for Q3 2022, slightly higher than the prior year.
Milestone Pharmaceuticals (MIST) reported positive results from its Phase 3 RAPID trial of etripamil, a nasal spray for paroxysmal supraventricular tachycardia (PSVT). The trial achieved its primary endpoint, with 64.3% of etripamil patients converting to sinus rhythm within 30 minutes compared to 31.2% with placebo (HR = 2.62, p<0.001). Median conversion time was 17 minutes for etripamil users. Additionally, fewer medical interventions and emergency visits were noted. Safety data supported its self-administration potential. Milestone plans to submit a New Drug Application for etripamil in mid-2023.
Milestone Pharmaceuticals (Nasdaq: MIST) has announced a late-breaking presentation of data from the Phase 3 RAPID clinical trial focusing on etripamil for paroxysmal supraventricular tachycardia (PSVT). This presentation will occur at the American Heart Association Scientific Sessions 2022 from November 5-7, 2022. The trial data highlights etripamil's potential as a self-administered treatment, aiming to enhance patient convenience by shifting care from emergency settings to home use.
Milestone Pharmaceuticals (Nasdaq: MIST) announced successful results from the Phase 3 RAPID trial of etripamil, a nasal spray for treating paroxysmal supraventricular tachycardia (PSVT). The trial achieved its primary endpoint, with 64.3% of patients converting to sinus rhythm within 30 minutes compared to 31.2% on placebo (HR = 2.62, p<0.001). Safety data indicated tolerability, with no serious adverse events reported. Milestone plans to file a New Drug Application (NDA) with the U.S. FDA in mid-2023, further supporting the potential for etripamil as a self-administered treatment.
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