Bet_Noire Shares of ARS Pharmaceuticals ( NASDAQ: SPRY ) rose 13% Friday after the company announced it had received FDA approval for its epinephrine nasal spray for the treatment of severe allergic reactions. ARS said the product, which will be marketed under the name neffy, was approved for the treatment of Type 1 allergic reactions, including anaphylaxis, in adults and children who weigh 66 lbs. or more.
The company plans to make the product available in the U.S. within eight weeks, according to a statement .
ARS plans to file by the end of Q3 for FDA approval of the product for the treatment of children who weigh between 15 kg and 30 kg. The company expects to launch the product in Europe in Q4 after it receives authorization from the European Commission. Also on Friday, Oppenheimer said it saw FDA approval of neffy de-risking the regulatory path for a sublingual oral formulation of epinephrine being developed by Aquestive Therapeutics ( AQST ).
(Updates with information about a potential rival product being developed by Aquestive Therapeutics.) More on ARS Pharmaceuticals ARS Pharmaceuticals On Track With Neffy Despite Regulatory Hurdles ARS Pharmaceuticals nasal spray for anaphylaxis endorsed in EU Seeking Alpha’s Quant Rating on ARS Pharmaceuticals Historical earnings data for ARS Pharmaceuticals Financial information for ARS Pharmaceuticals.