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Otonomy Inc (OTIC.OQ)

OTIC.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Otonomy Inc Immediately Discontinuing Commercial Support For Otiprio
Monday, 27 Nov 2017 04:30pm EST 

Nov 27 (Reuters) - Otonomy Inc ::OTONOMY INC - ‍ IS IMMEDIATELY DISCONTINUING COMMERCIAL SUPPORT FOR OTIPRIO WHICH IS EXPECTED TO SIGNIFICANTLY REDUCE FUTURE OPERATING EXPENSES​.OTONOMY INC - ‍ DISCONTINUING COMMERCIAL SUPPORT FOR OTIPRIO EXPECTED TO RESULT IN ESTIMATED CASH SAVINGS OF MORE THAN $20 MILLION IN 2018​.OTONOMY INC - ‍ DISCUSSIONS ARE UNDERWAY TO DIVEST OTIPRIO​.OTONOMY INC - ‍IS ELIMINATING EMPLOYMENT POSITIONS AND CEASING PROGRAMS RELATED TO COMMERCIALIZATION AND MARKET SUPPORT OF OTIPRIO​.OTONOMY INC - ‍ELIMINATING COMMERCIAL PERSONNEL REDUCES OTONOMY'S HEADCOUNT TO APPROXIMATELY 50​.OTONOMY INC - ‍OTONOMY IS NOT PREPARED TO PROVIDE OPERATING EXPENSE GUIDANCE FOR 2018 AT THIS TIME​.OTONOMY - ‍INCLUDING SEVERANCE PAYMENTS, COMMERCIAL PROGRAM WIND-DOWN COSTS, TOTAL GAAP OPERATING EXPENSES FOR 2017 EXPECTED TO BE ABOUT $95-$100 MILLION​.OTONOMY INC - NON-GAAP EXPENSES FOR 2017 ARE EXPECTED TO TOTAL IN RANGE OF $73 MILLION-$78 MILLION​.OTONOMY INC - ‍EXPECTS ITS CASH BALANCE INCLUDING CASH, CASH EQUIVALENTS, AND SHORT-TERM INVESTMENTS TO TOTAL $118 MILLION-$123 MILLION AT END OF 2017​.OTONOMY INC - ‍ INTENDS TO COMPLETE CLINICAL DEVELOPMENT TO SUPPORT REGISTRATION OF OTIVIDEX IN UNITED STATES FOR PATIENTS WITH MÉNIÈRE'S DISEASE.  Full Article

Otonomy reports third quarter loss of $0.69 per share
Wednesday, 8 Nov 2017 04:12pm EST 

Nov 8 (Reuters) - Otonomy Inc :Otonomy reports third quarter 2017 financial results and provides corporate update.Cash, cash equivalents, and short-term investments totaled $134.3 million as of Sept 30, 2017, compared to $196.4 million as of Dec 31, 2016​.Qtrly net loss per share , basic and diluted $0.69‍​.  Full Article

Otonomy reports positive results from averts-2 phase 3 trial of otividex™ in patients with ménière's disease
Wednesday, 8 Nov 2017 04:05pm EST 

Nov 8 (Reuters) - Otonomy Inc :Otonomy reports positive results from Averts-2 Phase 3 trial of Otividex™ in patients with Ménière's disease.Otonomy reports positive results from Averts-2 Phase 3 trial of Otividex™ in patients with Ménière's disease.Otonomy Inc - ‍achieved primary endpoint in study​.Otonomy Inc - ‍company plans to meet with FDA to discuss results of study and clinical requirements for registration​.Otonomy Inc - ‍otividex was generally well-tolerated with no drug-related serious adverse events observed​.  Full Article

Otonomy Inc says ‍non-commercial workforce reduced by one-third​
Wednesday, 13 Sep 2017 07:30am EDT 

Sept 13 (Reuters) - Otonomy Inc :Otonomy provides business and financial update.Otonomy Inc - ‍* non-commercial workforce reduced by one-third​.Otonomy Inc - ‍current cash balance expected to fund company into 2020​.Otonomy Inc - ‍non-commercial workforce reduced by one-third​.Otonomy Inc - ‍review underway to prioritize company's pipeline which includes multiple clinical and preclinical stage assets​.Otonomy Inc - ‍ additionally, no clinical trials will be initiated during remainder of 2017​.Otonomy Inc - ‍cost savings from actions are expected to total approximately $7 million for remainder of 2017​.Otonomy Inc - ‍total non-GAAP operating expenses are now expected to total $73-$78 million for 2017​.Otonomy Inc - ‍ total GAAP operating expenses for 2017 are expected to total $95-$100 million for 2017​.Otonomy Inc - company expects its cash balance to total $120-$125 million at end of 2017.Otonomy Inc - co expects cash burn to total less than $45 million in 2018, current cash balance will fund company into 2020.  Full Article

Otonomy reports results for Averts-1 phase 3 trial for Otividex
Wednesday, 30 Aug 2017 07:00am EDT 

Aug 30 (Reuters) - Otonomy Inc ::Says ‍company is withdrawing spending guidance for year pending review of product pipeline plans.Otonomy reports results for Averts-1 phase 3 trial for Otividex in patients with Ménière's disease.Says ‍company to immediately suspend all development activities for Otividex​.Says clinical trial missed its primary endpoint.Says ‍clinical trial missed its primary endpoint which was count of definitive vertigo days by Poisson Regression analysis​.Says ‍trial also failed to achieve statistical significance for any of key secondary vertigo endpoints at month 3​.Says ‍undertaking a review of its product pipeline plans and commercial efforts in order to identify "opportunities" to extend its cash runway​.  Full Article

Otonomy ‍reaffirms qtrly ‍net loss per share $0.77​
Thursday, 3 Aug 2017 04:12pm EDT 

Aug 3 (Reuters) - Otonomy Inc :Otonomy reports second quarter 2017 financial results and provides corporate update.Otonomy Inc - ‍reaffirms its expectations that GAAP operating expenses will be in range of $103-$108 million for 2017​.Otonomy Inc - ‍reaffirms its expectations that non-GAAP operating expenses will be in range of $80-$85 million for 2017​.Otonomy Inc - qtrly ‍net loss per share, basic and diluted $0.77​.  Full Article

FDA accepts Otonomy's expanded label application for Otiprio
Tuesday, 18 Jul 2017 07:30am EDT 

July 18 (Reuters) - Otonomy Inc -:Otonomy announces FDA acceptance of Otiprio supplemental new drug application filing for acute otitis externa.Otonomy Inc - Otiprio been assigned a prescription drug user fee act (pdufa) action date of March 2, 2018 ​.Otonomy-If approved within standard review period,co anticipates commercial launch of otiprio for second indication,prior to peak summer season for aoe.  Full Article

Otonomy Inc reports Q1 loss per share $0.89
Thursday, 4 May 2017 04:27pm EDT 

May 4 (Reuters) - Otonomy Inc :Otonomy reports first quarter 2017 financial results and provides corporate update.Otonomy Inc - Otonomy reaffirms its expectations that GAAP operating expenses will be in range of $103-$108 million for 2017.Otonomy Inc - reaffirms non-GAAP operating expenses will be in range of $80-$85 million for 2017.Otonomy Inc - qtrly loss per share $0.89.Q1 earnings per share view $-0.86 -- Thomson Reuters I/B/E/S.  Full Article

Otonomy loss per share $0.88
Thursday, 2 Mar 2017 04:18pm EST 

Otonomy Inc : Otonomy reports fourth quarter and full year 2016 financial results and provides corporate update .Qtrly loss per share $0.88.  Full Article

Otonomy initiates patient enrollment in phase 2 clinical trial of oto-104 as protectant against cisplatin-induced hearing loss
Thursday, 19 Jan 2017 07:30am EST 

Otonomy Inc : Otonomy initiates patient enrollment in phase 2 clinical trial of oto-104 as protectant against cisplatin-induced hearing loss . Otonomy initiates patient enrollment in phase 2 clinical trial of oto-104 as protectant against cisplatin-induced hearing loss .Otonomy Inc says is also conducting two phase 3 clinical trials for oto-104 in ménière's disease patients, with results expected in second half of 2017.  Full Article

BRIEF-Otonomy Inc Immediately Discontinuing Commercial Support For Otiprio

* OTONOMY INC - ‍ IS IMMEDIATELY DISCONTINUING COMMERCIAL SUPPORT FOR OTIPRIO WHICH IS EXPECTED TO SIGNIFICANTLY REDUCE FUTURE OPERATING EXPENSES​