ARS Pharma's Neffy Shakes Up Japanese Market with Major NDA Acceptance

In a significant stride for pharmaceutical innovation and patient care, ARS Pharmaceuticals (NASDAQ: ARSP) witnessed its stock skyrocket by an impressive 17% in premarket trading. This surge was catalyzed by the thrilling news that Japan's Ministry of Health, Labour and Welfare (MHLW) has officially accepted the New Drug Application (NDA) for Neffy, ARS Pharma's groundbreaking epinephrine nasal spray.

Neffy is poised to revolutionize the treatment of severe allergic reactions, commonly known as Type I reactions, including life-threatening anaphylaxis.

This needle-free alternative to traditional epinephrine auto-injectors offers a much-needed solution for individuals who may struggle with or fear injections, or those who require immediate and discreet administration during an allergic emergency.

The NDA submission in Japan was spearheaded by ARS Pharma's esteemed partner, Sumitomo Pharma.

This collaboration highlights a strategic global effort to expand access to this vital medication. The acceptance of the NDA by the MHLW is not just a regulatory milestone; it also triggers a substantial $10 million milestone payment from Sumitomo Pharma to ARS Pharma, underscoring the confidence and commitment within their partnership.

Sumitomo Pharma holds the exclusive rights to develop and commercialize Neffy throughout Japan, positioning them to address a significant unmet medical need within the country.

The Japanese market represents a substantial opportunity for Neffy, potentially offering a safer, more convenient, and less intimidating option for managing severe allergic reactions.

This positive development in Japan follows ARS Pharma's ongoing efforts to secure approval in other major markets.

Neffy is currently under review with the U.S. Food and Drug Administration (FDA), with a PDUFA target action date of July 28, 2024. This date marks a critical juncture after the company's diligent resubmission following an initial Complete Response Letter (CRL). The global momentum building around Neffy reflects its potential to significantly improve the lives of millions worldwide who live with the constant threat of anaphylaxis.

The MHLW's acceptance of the NDA for Neffy in Japan is a pivotal moment for ARS Pharma, validating their innovative approach and strengthening their position in the global pharmaceutical landscape.

It brings the company one step closer to making Neffy available to patients, offering a new era of confidence and accessibility in managing severe allergic emergencies.