Milestone Pharmaceuticals reports positive results and updates on FDA approval for new products.

From GlobeNewswire: 2024-11-12 09:03:00

Milestone Pharmaceuticals Inc. reported financial results for Q3 2024 and provided updates on the potential FDA approval of CARDAMYST nasal spray for PSVT management. Milestone is also preparing for a Phase 3 study in AFib-RVR set to commence in H1 2025. Positive results were announced from a Phase 3 trial of etripamil conducted in China.

The FDA has accepted the NDA for CARDAMYST for PSVT, with a PDUFA target date of March 27, 2025. Positive results from a Phase 3 trial of etripamil conducted in China showed statistically significant efficacy in converting PSVT to sinus rhythm. Milestone also hosted a KOL webinar and presented PRO data at the ESC Congress.

Milestone is on track to initiate a Phase 3 trial for etripamil in AFib-RVR in H1 2025. Joseph Papa was appointed to the board of directors in September. Financially, as of September 30, 2024, Milestone had cash, cash equivalents, and short-term investments of $76.4 million. Research and development expenses have decreased compared to the same period in 2023. Milestone Pharmaceuticals reported a net loss of $29.2 million for the nine months ending September 30, 2024, an improvement from the $46.1 million loss in the previous year. Refer to the quarterly report on Form 10-Q filed with the SEC on November 12, 2024 for more financial details.

Etripamil, Milestone’s lead investigational product, is a novel calcium channel blocker nasal spray aimed at treating symptomatic episodes of PSVT and AFib-RVR. This self-administered therapy bypasses the need for immediate medical oversight, empowering patients with active management. Etripamil, under the brand name CARDAMYST™, has undergone extensive clinical trials for these conditions.

Milestone Pharmaceuticals Inc. (Nasdaq: MIST) focuses on developing cardiovascular solutions to enhance the lives of individuals with heart conditions. Etripamil, their lead product, offers patients the ability to self-administer treatment for PSVT and AFib-RVR without medical supervision. The company prioritizes patient needs and self-management in their innovative approaches.

This press release includes forward-looking statements regarding interactions with regulatory bodies, the commercial launch of etripamil, and the outcomes of clinical trials. Milestone Pharmaceuticals emphasizes the importance of FDA approval for etripamil and the potential impact on patient care. Risks, including regulatory approval uncertainty and market conditions, are highlighted in the company’s filings with the SEC. 1. In a recent study, it was found that 75% of Americans believe climate change is a major threat to the country. This marks a significant increase from previous years, indicating a growing concern among the public.

2. The stock market saw a sharp decline today, with the Dow Jones Industrial Average dropping by over 500 points. This comes amidst fears of an economic slowdown and uncertainty surrounding global trade tensions.

3. A new report revealed that over 1 million species are at risk of extinction due to human activities. The findings highlight the urgent need for conservation efforts to protect biodiversity and ecosystems around the world.

4. Researchers have discovered a new potential treatment for Alzheimer’s disease that targets toxic proteins in the brain. The experimental drug has shown promising results in early studies and could offer hope for patients suffering from this devastating condition.

5. A major tech company announced plans to invest $1 billion in renewable energy projects to reduce its carbon footprint. The initiative aims to transition to 100% renewable energy by 2030, setting a new standard for sustainability in the industry.



Read more at GlobeNewswire:: Milestone Pharmaceuticals Reports Third Quarter 2024