Otonomy

Otonomy, Inc. operates as a biopharmaceutical company. engages in the development of therapeutics for neurotology. The firm’s product pipeline includes OTIVIDEX (dexamethasone) Meniere's disease, OTIPRIO (ciprofloxacin otic suspension) acute otitis media with tubes (AOMT), OTO-313 (gacyclidine) tinnitus, OTO-413 (BDNF) hidden hearing Loss, OTO-510 (otoprotectant) prevent CIHL, OTO-6XX (hair cell regeneration) severe hearing loss. It operates under the Otiprio brand. The company was founded by Jay B. Lichter, Jeffrey Harris, Rick Friedman, and Allen F. Ryan on May 6, 2008 and is headquartered in San Diego, CA.

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Otonomy is an expert in the otology field in order to build the premier company dedicated to the treatment of otic disorders via localized drug delivery. This approach has already been widely adopted for the delivery of short-acting antibiotics to treat otitis media through a tympanostomy tube. In addition, otolaryngologists have demonstrated that the injection of steroids into the middle ear cavity can provide a therapeutic effect for patients with acute inner ear disorders such as Ménière’s disease and sudden sensorineural hearing loss. Expansion of this effort holds great promise for the treatment of chronic hearing loss, severe vertigo, and even tinnitus. The key to Otonomy's leading position in this nascent field is the development of a proprietary formulation platform that provides sustained drug exposure from a single administration. Broad application of this technology has already been established across a number of therapeutic classes, and from these, three product candidates have been advanced into development.

SAN DIEGO, April 06, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced its participation in the 20th Annual Needham Virtual Healthcare Conference. David A. Weber, Ph.D., president and CEO of Otonomy, will present a company overview on Tuesday, April 13, 2021 at 4:30 p.m. ET (1:30 p.m. PT).

Otonomy to Present at the Needham Virtual Healthcare Conference

SAN DIEGO, April 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the presentation of previously disclosed clinical results from the successful OTO-313 Phase 1/2 trial at the upcoming American Neurotology Society's 56th Annual Spring Meeting, which is part of the Combined Otolaryngology Spring Meeting (COSM), to be held virtually April 7-11, 2021. The oral presentation will be delivered on April 10, 2021 at 5:07 p.m. EDT by Kenneth Maxwell, M.D., a Neurotologist at Piedmont Ear Nose & Throat Associates in Winston-Salem, North Carolina. Dr. Maxwell was an investigator in the trial.

Otonomy Announces Presentation of OTO-313 Clinical Results at American Neurotology Society Annual Meeting

Investors need to pay close attention to Otonomy (OTIC) stock based on the movements in the options market lately.

Are Options Traders Betting on a Big Move in Otonomy (OTIC) Stock?

SAN DIEGO, Feb. 25, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management will participate in three upcoming virtual conferences:

Otonomy to Participate in Three Upcoming Investor Conferences

Shares of Otonomy Inc. plunged 50.1% to pace all premarket decliners, after the biopharmaceutical company said Phase 3 trial of its Ménière's disease (vertigo) treatment failed to meet its primary endpoint. "We are disappointed by the top-line results for the primary intent-to-treat population and are undertaking an assessment to understand the difference observed with the per protocol analysis," said Chief Executive David Weber.

Otonomy stock loses half its value after disappointing trial results of vertigo treatment

Otonomy Inc (NASDAQ: OTIC) has reported topline data from Phase 3 trial evaluating OTIVIDEX in patients with Ménière's disease. It is an inner ear disorder that causes episodes of vertigo (spinning) and hearing loss.

Otonomy's OTIVIDEX Fails To Separate From Placebo In Inner Ear Disorder Study

SAN DIEGO, Feb. 22, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that the Phase 3 clinical trial of OTIVIDEX in patients with Ménière's disease did not achieve the primary endpoint, which was the count of definitive vertigo days (DVD) in Month 3 for OTIVIDEX vs. placebo for the intent-to-treat (ITT) population (n = 148; p value = 0.312) using the Negative Binomial Model. This analysis did achieve statistical significance for the per protocol (PP) population (n = 136; p value = 0.031). These results were similar using the Generalized Poisson model (p value = 0.340 for ITT and p value = 0.030 for PP).

Otonomy Announces Top-Line Results for the Phase 3 Clinical Trial of OTIVIDEX® in Patients with Ménière's Disease

Otonomy, Inc. (OTIC) CEO David Weber on Q4 2020 Results - Earnings Call Transcript

Conference call and webcast today at 4:30 p.m. ET

Otonomy Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Corporate Update

SAN DIEGO, Feb. 04, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the fourth quarter and full year 2020 and provide a corporate update at 4:30 p.m. ET on February 11, 2021.

Otonomy to Report Fourth Quarter and Full Year 2020 Financial Results and Provide Corporate Update

OTIC failed a phase 3 trial and fell from $20 to $5, and hasn't recovered since despite succeeding in another phase 3. A tiebreaker third phase 3 is ongoing with data by 1Q2021.

Otonomy And Its Efforts At Resurrecting Itself

SAN DIEGO, Jan. 05, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in a fireside chat at the virtual H.C. Wainwright BioConnect 2021 Conference to be held January 11-14, 2021.

Otonomy to Participate in the H.C. Wainwright BioConnect 2021 Virtual Conference

SAN DIEGO, Dec. 17, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced positive top-line results from the Phase 1/2 clinical trial of OTO-413 in subjects with speech-in-noise hearing difficulty. The randomized, double-blind, placebo-controlled trial demonstrated that a single intratympanic injection of OTO-413, a sustained exposure formulation of brain-derived neurotrophic factor (BDNF), was well-tolerated across all dose cohorts. Furthermore, there was demonstration of therapeutic activity of OTO-413 versus placebo across multiple clinically-validated speech-in-noise hearing tests at consecutive time points (Days 57 and 85). Based on these results, the company plans to continue development of OTO-413 for the treatment of hearing loss.

Otonomy Reports Positive Top-Line Results from Phase 1/2 Clinical Trial of OTO-413 in Patients with Hearing Loss

Otonomy (OTIC) saw a big move last session, as its shares jumped more than 5% on the day, amid huge volumes.

Otonomy (OTIC) Looks Good: Stock Adds 5% in Session

SAN DIEGO, Nov. 30, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today provided updates regarding the statistical analysis plan for the ongoing Phase 3 trial of OTIVIDEX in Ménière's disease, and outlined plans for a Phase 2 trial of OTO-313 in tinnitus.

Otonomy Provides Update on OTIVIDEX® and OTO-313 Programs

Otonomy, Inc. (OTIC) CEO David Weber on Q3 2020 Results - Earnings Call Transcript

Otonomy (OTIC) delivered earnings and revenue surprises of 12.00% and -54.55%, respectively, for the quarter ended September 2020. Do the numbers hold clues to what lies ahead for the stock?

Otonomy (OTIC) Reports Q3 Loss, Misses Revenue Estimates

Otonomy, Inc. (OTIC) CEO David Weber On Q3 2020 Results - Quick Version Earnings Call Transcript

Shares of Otonomy (NASDAQ:OTIC) were flat after the company reported Q3 results. Quarterly Results Earnings per share were up 33.33% over the past year to ($0.22), which beat the estimate of ($0.24).

Otonomy: Q3 Earnings Insights

Otonomy Reports Third Quarter 2020 Financial Results and Provides Corporate Update

SAN DIEGO, Oct. 28, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced it will report financial results for the third quarter of 2020 and provide a corporate update at 4:30 p.m. ET on November 4, 2020.

Otonomy to Report Third Quarter 2020 Financial Results and Provide Corporate Update

SAN DIEGO, Oct. 02, 2020 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced the completion of patient enrollment in the Phase 3 clinical trial of OTIVIDEX in Ménière’s disease. A total of 149 patients have been enrolled in the trial, exceeding the target of 142 patients. Following randomization to treatment with a single intratympanic injection of OTIVIDEX or placebo, patients are followed for three months.

Otonomy Completes Patient Enrollment for Phase 3 Trial of OTIVIDEX® in Ménière’s Disease

SAN DIEGO, Sept.  02, 2020  (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced that management is scheduled to participate in four upcoming virtual investor conferences.

Otonomy to Participate in Four Upcoming Investor Conferences

Otonomy, Inc. (OTIC) CEO David Weber on Q2 2020 Results - Earnings Call Transcript

Compound has potential to benefit patients with severe hearing loss Compound has potential to benefit patients with severe hearing loss

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