Congenital hearing loss

Otonomy Reports Third Quarter 2021 Financial Results and Provides Corporate Update

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수요일, 11월 10, 2021
Population, Compliance, Safety, Cisplatin, Private Securities Litigation Reform Act, Ear, Congenital hearing loss, Clinical trial, SG, R, Security (finance), Otorhinolaryngology, Ageing, CEO, Neurotology, GJB2, Applied Genetic Technologies Corporation, TFI, Technology, Food, Investment, Mutation, Growth, Hearing loss, Administration, Tinnitus, Research, Forward-looking statement, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Program, Noise, CIHL, Hearing, Cancer, Risk, File, Conference call, Patient, U.S. Securities and Exchange Commission, GLOBE, Development, Therapy, GAAP, SEC, General officer, Budget, Webcast, Investigational New Drug, Nasdaq, AAV, FDA, IND, Pharmaceutical industry, Lithium

SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2021 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

Key Points: 
  • ET
    SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc.(Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended September 30, 2021 and provided an update on its product pipeline and corporate activities.
  • OTO-313: Phase 2 trial in tinnitus is ongoing with top-line results expected in mid-2022; results of positive Phase 1/2 trial recently published in leading otolaryngology journal.
  • Operating Expenses: GAAP operating expenses were $12.5 million for the third quarter of 2021, compared to $10.4 million for the third quarter of 2020.
  • Non-GAAP operating expenses, which exclude stock-based compensation, were $10.7 million for the third quarter of 2021, compared to $8.8 million for the third quarter of 2020.

Decibel Therapeutics Reports Third Quarter 2021 Financial Results and Corporate Update

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수요일, 11월 10, 2021
CTA, Therapy, Birth defect, Security (finance), Terminology, Gene, Food, COVID-19, Treatment, Tinnitus, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Hearing, Regeneration, STRC, Cell, Prevalence, Karolinska Institute, USPTO, Cisplatin, Regeneron Pharmaceuticals, Congenital hearing loss, GJB2, Cell Reports, BVP, Research, University of Maryland School of Medicine, GLOBE, U.S. Securities and Exchange Commission, Noise-induced hearing loss, Cochlea, Program, United States Patent and Trademark Office, Patent, FDA, Bilateral vestibulopathy, Private Securities Litigation Reform Act, State Administrative Expenses, Medicine, Sale, Twitter, SEC, University, Ear, Maryland School, Hearing loss, Administration, Development, Company, IND, Pharmaceutical industry, Dentistry

BOSTON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.

Key Points: 
  • BOSTON, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the third quarter ended September 30, 2021 and provided a corporate update.
  • Third Quarter 2021 Financial Results:
    Cash Position: As of September 30, 2021, cash, cash equivalents and available-for-sale securities were $172.4 million.
  • Research and Development Expenses: Research and development expenses were $9.0 million for the third quarter of 2021, compared to $4.7 million for the third quarter of 2020.
  • However, while Decibel may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

Otonomy Announces Multiple Presentations at Neuroscience 2021 Meeting

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수요일, 10월 27, 2021
Research, University, SAN, Assistant, GJB2, Hearing, Tropomyosin receptor kinase B, Hearing loss, University of South Florida, BDNF, Patient, Neurotology, Society, Tropomyosin receptor kinase C, Review, M3, Ear, Tinnitus, EST, Â, Therapy, GLOBE, SFN, Congenital hearing loss, Applied Genetic Technologies Corporation, Pharmaceutical industry

SAN DIEGO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc.(Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Neuroscience 2021 meeting, which is the annual meeting of the Society for Neuroscience (SfN).

Key Points: 
  • SAN DIEGO, Oct. 27, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc.(Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today announced multiple presentations at the upcoming Neuroscience 2021 meeting, which is the annual meeting of the Society for Neuroscience (SfN).
  • This meeting will be held virtually November 8-11, 2021 with Preview Days taking place November 3-7 during which registered attendees can preview pre-recorded presentations.
  • Otonomys presentations include the previously disclosed positive top-line clinical results for OTO-313 in tinnitus and OTO-413 in hearing loss, and multiple presentations related to Otonomys preclinical programs.
  • All other Otonomy presentations are during interactive poster sessions occurring from 3:30 to 4:30 p.m. EST on November 10.

Decibel Therapeutics Receives Orphan Drug and Rare Pediatric Disease Designations for DB-OTO for the Treatment of Otoferlin-Related Congenital Hearing Loss

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목요일, 9월 9, 2021

Food and Drug Administration(FDA) has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for the companys lead gene therapy product candidate, DB-OTO, for the treatment of patients with otoferlin-related congenital hearing loss.

Key Points: 
  • Food and Drug Administration(FDA) has granted both Orphan Drug Designation and Rare Pediatric Disease Designation for the companys lead gene therapy product candidate, DB-OTO, for the treatment of patients with otoferlin-related congenital hearing loss.
  • We are pleased to receive these important designations from the FDA, which support our conviction that innovative treatments for congenital hearing loss are urgently needed, said Heather Wolff, Vice President, Clinical Development Operations ofDecibel.
  • Preclinical studies support the potential of DB-OTO to provide hearing to children born with profound hearing loss due to a mutation of the otoferlin gene.
  • Orphan Drug Designation is granted to drugs and biologics intended for the treatment, diagnosis or prevention of rare diseases, or conditions affecting fewer than 200,000 people in the United States.

Decibel Therapeutics Reports Second Quarter 2021 Financial Results and Corporate Update

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화요일, 8월 10, 2021
Bilateral vestibulopathy, IPO, IND, Coronavirus Scientific Advisory Board (Turkey), Administration, Therapy, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Food, U.S. Securities and Exchange Commission, CTA, Hearing, Security (finance), Program, Medicine, Gene, Toxicology, Private Securities Litigation Reform Act, Sale, BVP, COVID-19, Hearing loss, Research, Twitter, Terminology, Board, Congenital hearing loss, Board of directors, FDA, SEC, GLOBE, Regeneration, SAB, Development, Treatment, Pharmaceutical industry, Management, Lithium

BOSTON, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.

Key Points: 
  • BOSTON, Aug. 10, 2021 (GLOBE NEWSWIRE) -- Decibel Therapeutics (Nasdaq: DBTX), a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today reported financial results for the second quarter ended June 30, 2021 and provided a corporate update.
  • The second quarter of 2021 has been a time of continued progress across the business as we gear up for meaningful milestones expected in 2022.
  • Second Quarter 2021 Financial Results:
    Cash Position: As of June 30, 2021, cash, cash equivalents and available-for-sale securities were $184.6 million, compared to $54.3 million as of December 31, 2020.
  • Research and Development Expenses: Research and development expenses were $6.8 million for the second quarter of 2021, compared to $5.3 million for the second quarter of 2020.

Otonomy Reports Second Quarter 2021 Financial Results and Provides Corporate Update

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수요일, 8월 4, 2021
Accounting, BAS

SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended June 30, 2021 and provided an update on its product pipeline and corporate activities. The company will host a conference call and webcast today at 4:30 p.m. ET to discuss recent highlights and financial results.

Key Points: 
  • ET
    SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Otonomy, Inc.(Nasdaq: OTIC), a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology, today reported financial results for the quarter ended June 30, 2021 and provided an update on its product pipeline and corporate activities.
  • Operating Expenses: GAAP operating expenses were $12.0 million for the second quarter of 2021, compared to $10.6 million for the second quarter of 2020.
  • Non-GAAP operating expenses, which exclude stock-based compensation, were $10.2 million for the second quarter of 2021, compared to $9.1 million for the second quarter of 2020.
  • Research and Development Expenses: GAAP research and development (R&D) expenses were $8.4 million for the second quarter of 2021, compared to $6.9 million for the second quarter of 2020.

Global Hearing-Aid Devices (Hearing Aid Devices v/s Hearing Implants) Market, Competition Forecast & Opportunities, 2026 - ResearchAndMarkets.com

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화요일, 8월 3, 2021
Medical devices, Health, Audiology, Nervous system, Hearing loss, Otorhinolaryngology, Otology, Hearing, Deafness, Hearing aid, Sensorineural hearing loss, SoundBite Hearing System, Congenital hearing loss

The "Global Hearing-Aid Devices Market, By Type (Hearing Aid Devices v/s Hearing Implants), By Type of Hearing Loss (Sensorineural v/s Conductive), By Product Type, By Technology Type, By Patient Type, By Distribution Channel, By Region, Competition Forecast & Opportunities, 2026" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Global Hearing-Aid Devices Market, By Type (Hearing Aid Devices v/s Hearing Implants), By Type of Hearing Loss (Sensorineural v/s Conductive), By Product Type, By Technology Type, By Patient Type, By Distribution Channel, By Region, Competition Forecast & Opportunities, 2026" report has been added to ResearchAndMarkets.com's offering.
  • The Global Hearing-aid Devices Market stood at USD15.86 billion in value terms in 2020 and is forecast to grow at CAGR of 5.49% to reach USD21.61 billion by 2026.
  • Moreover, growing trend for customized implants is also a major factor that is driving the hearing-aid devices market.
  • The Global Hearing-aid Devices Market is categorized by type, type of hearing loss, product type, technology type, patient type, distribution channel, and regional distribution.

Don't Forget About Your Hearing Health This Summer

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화요일, 5월 18, 2021
Audiology, Hearing loss, Medical specialties, Health sciences, Nervous system, Occupational safety and health, Hearing aid, Otology, Hearing, Accessibility, Management of hearing loss, Congenital hearing loss

Join us to learn the latest about hearing health, communication access and the technologies and strategies that help people with hearing loss live well.

Key Points: 
  • Join us to learn the latest about hearing health, communication access and the technologies and strategies that help people with hearing loss live well.
  • This three-day event includes a research symposium on Hearing Care for All , and robust workshops on advances in hearing aids, accessibility through mobile devices, hearing access in the workplace and more.
  • "Through our convention, you will learn more about how you can use hearing screenings and technology to stay connected to the hearing world.
  • Health experts and those living with hearing loss will share how they stay vital.

Decibel Therapeutics and Invitae Announce Launch of Amplify™ Genetic Testing Program

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금요일, 1월 29, 2021
Health, Genetics, Other Science, Clinical trials, Science, Pharmaceutical, Biotechnology, Medicine, Clinical medicine, Health sciences, Audiology, Deafness, Auditory neuropathy, Communication disorders, Genetic testing, Hearing loss, Medical genetics, Congenital hearing loss, Sensorineural hearing loss, DB-OTO, Invitae, Decibel Therapeutics

Decibel Therapeutics , a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced a partnership with Invitae, a leading medical genetics company, to launch AmplifyTM, a no-charge genetic testing program to screen for the genetic cause of congenital hearing loss in children diagnosed with auditory neuropathy.

Key Points: 
  • Decibel Therapeutics , a clinical-stage biotechnology company dedicated to discovering and developing transformative treatments to restore and improve hearing and balance, today announced a partnership with Invitae, a leading medical genetics company, to launch AmplifyTM, a no-charge genetic testing program to screen for the genetic cause of congenital hearing loss in children diagnosed with auditory neuropathy.
  • This program seeks to provide much-needed answers to patients and families of patients who experience congenital, monogenic hearing loss.
  • AmplifyTM is available to individuals who meet the following criteria:
    AmplifyTM is a no-charge program that offers genetic testing for those who qualify.
  • Although genetic testing can confirm a potential diagnosis, the absence of a genetic alteration does not preclude a diagnosis of genetic hearing loss.

Decibel Therapeutics Announces Exclusive Licensing Agreements for Hearing Loss Gene Therapy Technology

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월요일, 11월 2, 2020
Health, FDA, Medical devices, Genetics, Clinical trials, Pharmaceutical, Biotechnology, Branches of biology, Biology, Life sciences, Applied genetics, Emerging technologies, Gene delivery, Medical genetics, Molecular biology, Hearing loss, Congenital hearing loss, Adeno-associated virus, Gene therapy

Decibel Therapeutics , a clinical-stage biotechnology company developing novel restorative gene therapeutics to treat hearing loss and balance disorders, today announced exclusive license agreements with the University of Florida (UF) and the University of California, San Francisco (UCSF) for an adeno-associated virus (AAV) gene therapy technology designed to restore hearing to individuals with profound, congenital hearing loss caused by mutations in the otoferlin gene.

Key Points: 
  • Decibel Therapeutics , a clinical-stage biotechnology company developing novel restorative gene therapeutics to treat hearing loss and balance disorders, today announced exclusive license agreements with the University of Florida (UF) and the University of California, San Francisco (UCSF) for an adeno-associated virus (AAV) gene therapy technology designed to restore hearing to individuals with profound, congenital hearing loss caused by mutations in the otoferlin gene.
  • People born with biallelic mutations in the otoferlin gene have profound hearing loss because this signal between the ear and the brain is lost.
  • The AAV-mediated gene therapy technology is jointly owned by UF and UCSF, and Decibel has secured exclusive licenses to the rights of the two universities in the intellectual property.
  • There is a significant unmet need for therapeutics that can restore hearing in individuals with congenital, profound hearing loss.