Biotech Stocks Facing FDA Decision In March


The FDA decision on Otonomy Inc.’s (OTIC) supplemental New Drug Application seeking expanded approval of Otiprio for acute otitis externa is expected on March 2, 2018.

Acute otitis externa, also known as swimmer’s ear, is a common condition involving infection and inflammation of the ear canal typically caused by bacterial infection.

Otiprio, a single-dose form of the antibiotic ciprofloxacin, received its first FDA approval in December 2015 for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

The net sales of Otiprio for the fourth quarter of 2017 totaled $0.3 million, the same as that in the comparable year-ago quarter.

The Company is seeking to divest Otiprio, and discussions with multiple parties are underway.

OTIC closed Monday’s (Feb.26) trading at $6.00, up 1.69%.