ARS Pharmaceuticals announces NMPA approval for neffy 2 mg

ARS Pharmaceuticals (SPRY) announced that the National Medical Products Administration in China has granted approval for neffy 2 mg for the emergency treatment of Type 1 allergic reactions in adults and children who weigh 30 kg or more. ARS Pharma and Pediatrix Therapeutics anticipate filing for approval of neffy 1 mg dose for children greater than 15 kg and less than 30 kg in the coming months. ARS Pharma entered into an exclusive licensing agreement with Pediatrix Therapeutics in 2021, providing them with exclusive rights to commercialize neffy in China for severe allergic reactions as well as certain other diseases such as chronic spontaneous urticaria. ARS Pharma will receive a final regulatory milestone of $4M and is eligible to receive up to $80M in sales milestones, as well as tiered royalties in the low double digits on annual net sales. ARS Pharma will be responsible for manufacturing and supplying neffy to Pediatrix Therapeutics in China at cost of goods and expects neffy to be available in the spring of 2026.