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. develops and commercializes cardiovascular medicines, centered on CARDAMYST (etripamil) nasal spray. CARDAMYST is FDA-approved for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia, or PSVT, to sinus rhythm in adults. Etripamil is also being developed for symptomatic episodic attacks associated with AFib-RVR.
Company news commonly covers CARDAMYST commercialization, payer formulary access, real-world evidence work such as the RESET-PSVT registry, cardiovascular conference presentations, regulatory updates, financial results and business updates. Milestone also reports equity inducement grants and other corporate actions tied to its Nasdaq-listed common shares.
Milestone (Nasdaq: MIST) announced pooled analyses showing consistent efficacy, tolerability, and safety for investigational etripamil nasal spray in self‑administered treatment of PSVT.
Key pooled results: 622 enrolled patients across trials; median time to conversion 18.5 minutes (95% CI: 15.7–21.0); Kaplan‑Meier conversion by 30 minutes 59.6% (range 53.6%–64.3%); conversion by 60 minutes 63.2%–75.1%. Safety from >1,050 treated patients was described as predominantly mild, transient, and nasal‑site localized; test‑dose failure rate was 1.4% among >1,100 dosed in sinus rhythm.
Data will be presented Nov 10, 2025 at AHA Scientific Sessions by James Ip, M.D. The FDA PDUFA date for the CARDAMYST NDA is Dec 13, 2025.
Milestone Pharmaceuticals (Nasdaq: MIST) will present a poster at the American Heart Association Scientific Sessions 2025 in New Orleans on November 10, 2025. The poster reports combined data on the efficacy, safety, and test-dose tolerability of self-administered etripamil for acute paroxysmal supraventricular tachycardia (PSVT) across multiple clinical trials.
The presentation is by James Ip, M.D. and is scheduled for Monday, November 10, 2025, 10:30–11:30 AM CST. The data describe patient-administered use of etripamil focusing on acute PSVT episodes.
Milestone Pharmaceuticals (NASDAQ: MIST) announced its participation in two upcoming healthcare conferences. CEO Joe Oliveto will conduct one-on-one meetings at the Wells Fargo Healthcare Conference in Boston (September 3-5, 2025) and deliver a corporate presentation at the H.C. Wainwright 27th Annual Global Investment Conference in New York (September 8-10, 2025).
The H.C. Wainwright presentation will be webcast live on September 9 at 12:00 PM EDT, with a replay available for approximately 90 days on the company's website.
Milestone Pharmaceuticals (Nasdaq: MIST) reported Q2 2025 financial results and significant regulatory progress for CARDAMYST™. The FDA accepted the company's Complete Response Letter (CRL) response, setting a new PDUFA date of December 13, 2025 for their PSVT treatment.
The company substantially strengthened its financial position through a public offering raising up to $170 million in gross proceeds if all warrants are exercised, with immediate net proceeds of $48.7 million. Additionally, Milestone extended its $75 million royalty agreement with RTW Investments through December 2025.
Q2 2025 financial results showed a net loss of $13.0 million, compared to $9.4 million in Q2 2024. The company ended the quarter with $43.4 million in cash and equivalents, while commercial expenses increased to $5.1 million as they prepare for CARDAMYST's potential launch.
Milestone Pharmaceuticals (NASDAQ:MIST) has announced the pricing of its public offering to raise approximately $52.5 million. The offering includes 31.5 million common shares and pre-funded warrants for an additional 3.5 million shares, along with accompanying Series A and Series B Common Warrants, priced at $1.50 per share combination.
The offering is expected to close around July 14, 2025. The proceeds will fund the clinical development and commercial launch of etripamil for paroxysmal supraventricular tachycardia (PSVT), along with working capital and general corporate purposes. TD Cowen, Piper Sandler & Co., and Wells Fargo Securities are serving as joint book-running managers.
Milestone Pharmaceuticals (NASDAQ: MIST) has announced a proposed public offering of common shares along with Series A and Series B warrants. The company is also offering pre-funded warrants as an alternative to common shares for certain investors.
The proceeds will be used to fund the clinical development and commercial launch of etripamil for paroxysmal supraventricular tachycardia (PSVT), along with working capital and general corporate purposes. The offering is being managed by TD Cowen, Piper Sandler & Co., and Wells Fargo Securities as joint book-running managers, with H.C. Wainwright & Co. as lead manager.
Milestone Pharmaceuticals (Nasdaq: MIST) announced that the FDA has accepted its response to the Complete Response Letter (CRL) for CARDAMYST™ (etripamil) nasal spray, setting a new PDUFA date of December 13, 2025. The drug is being developed for paroxysmal supraventricular tachycardia (PSVT) treatment.
Additionally, the company extended its $75 million Royalty Purchase Agreement with RTW Investments through December 31, 2025. The agreement will provide funding for CARDAMYST's commercial launch upon FDA approval. The company's CRL response included additional nitrosamine studies and changes to manufacturing testing facilities, with no clinical concerns raised by the FDA.
Milestone Pharmaceuticals (NASDAQ: MIST) announced its participation in the upcoming Jefferies Healthcare Conference, scheduled for June 3-5, 2025, in New York. The company will be represented by Chief Financial Officer Amit Hasija and Chief Commercial Officer Lorenz Muller. Their presentation is set for June 5th at 8:10 AM EDT.
The presentation will be accessible via webcast and will remain available for replay on Milestone's website for approximately 90 days. Interested parties can find the webcast in the News & Events section at www.milestonepharma.com. Investors seeking meetings with the Milestone team during the conference should contact their Jefferies representative.