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) 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.
Milestone Pharmaceuticals (NASDAQ: MIST) received a Complete Response Letter (CRL) from the FDA regarding its New Drug Application for CARDAMYST™ (etripamil) nasal spray, a treatment for converting acute PSVT episodes to sinus rhythm in adults.
The CRL focused on two Chemistry, Manufacturing and Controls (CMC) issues: additional information needed on nitrosamine impurities based on new draft guidance, and a required inspection at a facility performing release testing that changed ownership during NDA review. Notably, the FDA raised no concerns about etripamil's clinical safety or efficacy data.
The company plans to request a Type A meeting to discuss addressing these issues in a resubmission. As of December 31, 2024, Milestone reported $69.7 million in cash, cash equivalents and short-term investments.
Milestone Pharmaceuticals (Nasdaq: MIST) announced it will present a moderated poster at the American College of Cardiology annual meeting (ACC25) in Chicago from March 29-31, 2025. The presentation will focus on clinical data for etripamil, showcasing its potential to convert multiple episodes of Paroxysmal Supraventricular Tachycardia (PSVT) to normal sinus rhythm.
According to Chief Medical Officer Dr. David Bharucha, the data demonstrates that successful conversion of earlier PSVT episodes predicts success in subsequent treatments. The findings support etripamil's potential use for successive PSVT episodes, pending approval, aiming to improve patient experience and quality of life.
Milestone Pharmaceuticals (NASDAQ: MIST) has reported its Q4 and full year 2024 financial results, highlighting the upcoming FDA PDUFA review date of March 27, 2025, for CARDAMYST™ nasal spray for PSVT treatment. The company plans a mid-2025 launch, pending approval.
Financial highlights include:
- Cash position of $69.7 million as of December 31, 2024
- Q4 2024 net loss of $12.4 million ($0.19 per share)
- Full-year 2024 net loss of $41.5 million ($0.67 per share)
Notable developments include a new Method of Use patent potentially extending CARDAMYST protection until 2042, and plans to initiate a Phase 3 trial for etripamil in AFib-RVR in 2025. The company's R&D expenses decreased to $14.4 million in 2024 from $31.1 million in 2023, while G&A expenses increased slightly to $16.7 million from $15.9 million.
Milestone Pharmaceuticals (Nasdaq: MIST) announced the granting of equity awards to four new employees on March 4, 2025. The compensation package includes 94,000 stock options with an exercise price of $1.65 per share, matching the company's closing share price on March 3, 2025.
The options were granted under the company's 2021 Inducement Plan and will vest over four years, with 25% vesting after one year and the remaining portion vesting in 36 equal monthly installments. These equity awards were approved by the Company's Compensation Committee and Board of Directors as inducement material for new employment, complying with Nasdaq Listing Rule 5635(c)(4).
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