ARS Pharmaceuticals (SPRY) said Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use issued a "positive opinion" on the company's application for marketing authorization for its adrenaline nasal spray, EURneffy, to treat allergic reactions.
The committee's recommendation will be submitted to the European Commission for the formal marketing authorization process, expected in Q3, ARS said.
If approved, EURneffy will be made available in Europe in Q4, according to ARS.
In the US, the company said the Food and Drug Administration is expected to decide by Oct. 2 on its new drug application for neffy, the company said.
The company's shares were 5.6% higher in recent premarket activity.
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