Milestone Pharmaceuticals Stock Price, News & Analysis

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) has submitted its response to the FDA's Complete Response Letter (CRL) regarding the New Drug Application for CARDAMYST (etripamil) nasal spray. The submission follows a productive Type A meeting with the FDA. CARDAMYST is being developed as a self-administered therapy for converting acute episodes of paroxysmal supraventricular tachycardia (PSVT) to normal heart rhythm in adults. The FDA will determine the acceptance of the response and new PDUFA date within 30 days, with an expected review period of 2-6 months. If approved, CARDAMYST would become the first and only self-administered treatment for rapid PSVT episode termination.

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 (MIST) reported Q1 2025 financial results and provided updates on CARDAMYST, its lead product for paroxysmal supraventricular tachycardia (PSVT). The company received a Complete Response Letter (CRL) from the FDA in March 2025 citing two CMC-related issues: additional information needed on nitrosamine impurities and a new facility inspection requirement. Milestone has requested a Type A meeting with the FDA to address these issues. Financial highlights include cash position of $56.0 million as of March 31, 2025, and a net loss of $20.8 million for Q1 2025. The company also announced a new patent extending CARDAMYST's protection until July 2042 and has paused the Phase 3 study for atrial fibrillation with rapid ventricular rate (AFib-RVR) to focus on resolving the CRL issues.

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).