Shares of Otonomy, Inc. (NASDAQ: OTIC) plummeted 81% to a new year-low of $3.80 this morning, a drastic fall below its previous low of $11.30, as investors reacted to news that the company reported negative results for its AVERTS-1 phase 3 clinical trial of OTIVIDEX in patients with Ménière’s disease. The clinical trial missed the primary endpoint and all key vertigo secondary endpoints. Shares of OTIC now trade in a 52-week range of $3.80-$21.15. “Based on these results, we are immediately suspending all development activities for OTIVIDEX including the ongoing AVERTS-2 trial. In addition, the company is undertaking a review of its product pipeline and commercial efforts to identify opportunities to extend its cash runway and build shareholder value,” Otonomy president and CEO David A. Weber, Ph.D., stated in the news release.
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Otonomy is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. OTIPRIO® (ciprofloxacin otic suspension) is approved in the United States for use during tympanostomy tube placement surgery in pediatric patients, an sNDA has been accepted for filing by the FDA for acute otitis externa (AOE) and a successful End-of-Phase 2 review has been completed with the FDA for acute otitis media with tympanostomy tubes (AOMT). OTO-311 is an NMDA receptor antagonist for the treatment of tinnitus that has completed a Phase 1 clinical safety trial. A program targeting sensorineural hearing loss including age-related hearing loss is in preclinical development. Otonomy’s proprietary formulation technology utilizes a thermosensitive gel and drug microparticles to enable single dose treatment by a physician. For additional information please visit www.otonomy.com.
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