AURIS MEDICAL (EARS)

[Vintage1776]

An FDA panel on Friday voted 10-3 in favor of recommending approval of AcelRx Pharmaceuticals Inc.'s (ACRX) DSUVIA for the management of moderate-to-severe acute pain in medically supervised settings for adult patients.

DSUVIA is a 30 mcg sufentanil tablet in a pre-filled applicator for sublingual administration by a healthcare professional, and is designed to provide an easy-to-administer dosage form for rapid relief as early as 15 minutes.

The FDA usually follows the recommendations of its advisory panels, although it is not required to do so. The regulatory agency's final decision is set for November 3, 2018.

Trading in ACRX was halted on Friday. The stock closed Thursday's trading at $3.98, up 10.71%.

Auris Medical Holding AG (EARS) is slated to provide an update on its intranasal betahistine program on Wednesday, October 17, 2018.

The intranasal betahistine program includes AM-125 for the treatment of vertigo, and AM-201 for the treatment of antipsychotic-induced weight gain and somnolence.

The key results from the second phase I trial of AM-125 in healthy volunteers will also be presented on Wednesday.

EARS closed Friday's trading at $0.98, up 44.12%.