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

ARS Pharmaceuticals recently announced the submission of its Day 180 response to the European Medicines Agency's Committee for Medicinal Products for Human Use, in relation to the Marketing Authorization Application for Neffy. The company anticipates a verdict on the medication within the second quarter of 2024.

Neffy, also known as the epinephrine nasal spray, is a potentially groundbreaking treatment for Type I allergic reactions, specifically cases of anaphylaxis. The response includes all the aspects earlier questioned by the Committee for Medicinal Products for Human Use. This includes findings from a repeated dose PK/PD study of Neffy under particular allergen challenges, as well as updated tests concerning the presence of nitrosamines.

In addition to this, ARS Pharmaceuticals has entered into an exclusive licensing and distribution agreement with CSL Seqirus, the subsidiary of CSL Ltd., to market Neffy in Australia and New Zealand.

According to the terms of the agreement, ARS Pharmaceuticals will receive an initial payment, followed by potential milestone payments that will be determined by future developments.

At the time of this report, ARS Pharma's stock has a slight increase of 0.12 percent on the Nasdaq, positioning it at $8.61.