ARS Pharma Submits Response For Neffy MAA To EMA's CHMP, Signs License Deal With CSL Seqirus

(RTTNews) - ARS Pharmaceuticals (SPRY), Tuesday announced the submission of Day 180 response for Neffy's Marketing Authorization Application to the Committee for Medicinal Products for Human Use of the European Medicines Agency, expecting to receive the opinion on the drug in the second quarter of 2024.

Neffy or epinephrine nasal spray is an investigational drug proposed for the treatment of Type I allergic reactions including anaphylaxis.

The response covers all concerns previously raised by the Committee for Medicinal Products for Human Use (CHMP), incorporating findings from a repeat dose PK/PD study of Neffy under nasal allergen challenge (NAC) conditions and updated testing concerning nitrosamine levels.

Simultaneously, the biopharmaceutical company also signed an exclusive license and distribution agreement with CSL Seqirus, a subsidiary of CSL Ltd. to commercialize Neffy across Australia and New Zealand.

Under the agreement, ARS will receive an upfront payment as well as event-driven milestone payments.

Currently, ARS Pharma's stock is up 0.12 percent at $8.61 on the Nasdaq.