The Commercial launch of neffy ® (epinephrine nasal spray) in the United States

Exciting News for ARS Pharma

ARS Pharma is thrilled to announce the commercial launch of neffy ® (epinephrine nasal spray) in the United States. This innovative product is set to revolutionize the way individuals with severe allergies manage their condition. The nasal spray offers a convenient and easy-to-use alternative to traditional epinephrine auto-injectors, providing quick relief in emergency situations.

FDA Approval and Priority Review

The Supplemental New Drug Application (NDA) for the neffy ® 1mg dose has been granted priority review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target date set for March 6, 2025. This expedited review process speaks to the significance and potential impact of this groundbreaking product on the healthcare industry.

Global Expansion

In addition to the commercial launch in the U.S., ARS Pharma has also secured an exclusive license agreement with ALK-Abelló to commercialize neffy ® in Europe, Canada, and certain other geographies. This strategic partnership will not only expand the reach of neffy ® but also solidify ARS Pharma’s presence in the global market.

Financial Stability

ARS Pharma is well-capitalized with $349.6 million in cash, cash equivalents, and short-term investments on a pro forma basis. This financial stability supports an operating runway of at least three years, ensuring the continued success and growth of the company.

Conference Call and Webcast

To celebrate this milestone achievement, ARS Pharma will be hosting a conference call and webcast today at 8:00 a.m. ET. Investors, healthcare professionals, and individuals with allergies are encouraged to tune in to learn more about neffy ® and its potential impact on the market.

How will this affect me?

Personal Impact

As an individual with severe allergies, the commercial launch of neffy ® represents a significant advancement in emergency treatment options. The convenience and ease of use offered by the nasal spray could potentially save lives and provide peace of mind for those at risk of anaphylaxis.

How will this affect the world?

Global Impact

The introduction of neffy ® into the market has the potential to make a substantial impact on a global scale. By offering a more accessible and user-friendly alternative to traditional epinephrine auto-injectors, neffy ® has the power to improve emergency treatment outcomes for individuals with severe allergies worldwide.

Conclusion

The commercial launch of neffy ® marks a significant milestone for ARS Pharma and the healthcare industry as a whole. With FDA approval, a strategic global partnership, and financial stability, ARS Pharma is well-positioned to lead the way in allergy management and emergency treatment solutions. The future looks bright for neffy ® and the individuals it aims to help.