AKUS Akouos Inc.

13.17
+0.19  (+1%)
Previous Close 12.98
Open 13
52 Week Low 12.25
52 Week High 30.67
Market Cap $453,697,307
Shares 34,449,302
Float 21,389,400
Enterprise Value $158,829,307
Volume 57,305
Av. Daily Volume 230,338
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Drug Pipeline

Drug Stage Notes
AK-OTOF
Hearing loss
Phase 1/2
Phase 1/2
Phase 1/2 IND filing to be submitted 1H 2022.

Latest News

  1. BOSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced the appointment of Dr. Kathy Reape as chief development officer. Dr. Reape brings over 20 years of experience in the pharmaceutical industry, including significant gene therapy translational and development expertise, to Akouos.

    "We welcome Dr. Reape to the Akouos team at this exciting time in the company's growth, as we continue to advance the AK-OTOF and AK-antiVEGF programs towards our planned IND submissions in 2022," said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer. "As…

    BOSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced the appointment of Dr. Kathy Reape as chief development officer. Dr. Reape brings over 20 years of experience in the pharmaceutical industry, including significant gene therapy translational and development expertise, to Akouos.

    "We welcome Dr. Reape to the Akouos team at this exciting time in the company's growth, as we continue to advance the AK-OTOF and AK-antiVEGF programs towards our planned IND submissions in 2022," said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer. "As we continue to forge a path for development of genetic medicines for individuals living with disabling hearing loss, Dr. Reape's broad clinical development expertise and notable recent experience in preparing the marketing application and securing approval for the first FDA-approved in vivo gene therapy for the treatment of a rare inherited retinal disorder will prove invaluable."

    Dr. Reape was most recently Chief Medical Officer at Spark Therapeutics where she oversaw clinical development, pharmacovigilance, and medical affairs activities and was a key member of the team responsible for the development and commercialization of the first FDA-approved in vivo gene therapy, LUXTURNA®, for an inherited retinal disease caused by mutations in both copies of the RPE65 gene. She also oversaw the development of Spark's pipeline of gene therapies addressing CNS disease, hemophilia, metabolic disorders, and inherited retinal dystrophies. Prior to Spark, Dr. Reape was senior vice president of clinical development focusing on global brands research and development at Allergan and Actavis. She holds both her undergraduate and M.D. degrees from the University of Pennsylvania and completed her internship and residency at the University of Florida and the University of Medicine and Dentistry of New Jersey.

    "I am excited to work alongside a team of experts in neurotology, genetics, inner ear drug delivery, and AAV gene therapy who have the unique combination of expertise to progress our shared mission, healthy hearing available to all," said Dr. Reape. "Akouos is positioned to be a leader in genetic medicines for inner ear conditions, an area for which there are no pharmacologic treatment options and is generally underserved. I look forward to working with the Akouos team and the deaf and hard-of-hearing community to evaluate whether gene therapies, such as AK-OTOF and AK-OTOF, could address the needs of individuals and families affected by disabling hearing loss."

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.



    Contacts




    Media:

    Katie Engleman, 1AB

    Investors:

    Courtney Turiano, Stern Investor Relations



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  2. BOSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will participate in a fireside chat at the Bank of America 2021 Virtual Healthcare Conference on Wednesday, May 12 at 2:00 p.m. EDT.

    A live webcast of the fireside chat will be available on the investors section of the company's website at www.akouos.com. To access the webcast, please go to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads…

    BOSTON, May 07, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos, will participate in a fireside chat at the Bank of America 2021 Virtual Healthcare Conference on Wednesday, May 12 at 2:00 p.m. EDT.

    A live webcast of the fireside chat will be available on the investors section of the company's website at www.akouos.com. To access the webcast, please go to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Akouos's website for 30 days following the conference.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Contacts

    Media:

    Katie Engleman, 1AB

    Investors:

    Courtney Turiano, Stern Investor Relations



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  3. BOSTON, April 27, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that new nonclinical data will be presented at the American Society of Gene and Cell Therapy 24th Annual Meeting, which is being held virtually from May 11 to 14, 2021.

    Three digital presentations will highlight nonclinical data that support future clinical development of AK-OTOF, a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss, and AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma. These digital presentations will occur on Tuesday, May 11…

    BOSTON, April 27, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that new nonclinical data will be presented at the American Society of Gene and Cell Therapy 24th Annual Meeting, which is being held virtually from May 11 to 14, 2021.

    Three digital presentations will highlight nonclinical data that support future clinical development of AK-OTOF, a gene therapy intended for the treatment of otoferlin gene (OTOF)-mediated hearing loss, and AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma. These digital presentations will occur on Tuesday, May 11, 2021 from 8:00 to 10:00 a.m. EDT.

    Details are as follows:

    Digital Presentation Title: In Vitro and In Vivo Analyses of Dual Vector Otoferlin Expression to Support the Clinical Development of AK-OTOF (AAVAnc80-hOTOF Vector)

    Presenting Author: Eva Andres-Mateos

    Session Title: AAV Vectors - Preclinical and Proof-of-Concept Studies

    Abstract Number: 355

    Digital Presentation Title: Durable Recovery of Auditory Function Following Intracochlear Delivery of AK-OTOF (AAVAnc80-hOTOF Vector) in a Translationally Relevant Mouse Model of Otoferlin Gene (OTOF)-Mediated Hearing Loss

    Presenting Author: Ann Hickox

    Session Title: Neurologic Diseases

    Abstract Number: 569

    Digital Presentation Title: Demonstration of Tolerability of a Novel Delivery Approach and Secreted Protein Expression Following Intracochlear Delivery of AK-antiVEGF (AAVAnc80-antiVEGF Vector) in Non-Human Primates

    Presenting Author: John Connelly

    Session Title: AAV Vectors - Preclinical and Proof-of-Concept Studies

    Abstract Number: 358

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Contacts



    Media:

    Katie Engleman, 1AB

    Investors:

    Courtney Turiano, Stern Investor Relations



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  4. BOSTON, April 13, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. Akouos anticipates that it will submit an investigational new drug application (IND) for AK-OTOF in the first half of 2022.

    Otoferlin gene (OTOF)-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the OTOF gene. The OTOF gene encodes otoferlin…

    BOSTON, April 13, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that the U.S. Food and Drug Administration (FDA) has granted both Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for AK-OTOF, a gene therapy intended for the treatment of otoferlin gene-mediated hearing loss. Akouos anticipates that it will submit an investigational new drug application (IND) for AK-OTOF in the first half of 2022.

    Otoferlin gene (OTOF)-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the OTOF gene. The OTOF gene encodes otoferlin, a protein that enables the inner hair cells of the cochlea to release neurotransmitter vesicles in response to stimulation by sound to activate auditory neurons. Most individuals with OTOF-mediated hearing loss have Severe-to-Profound sensorineural hearing loss from birth and approximately 20,000 individuals are affected in the United States and Europe. AK-OTOF is designed to treat the underlying cause of OTOF-mediated hearing loss through delivery of a transgene using a dual vector technology that results in expression of normal, functional otoferlin protein in the affected cells, namely inner hair cells, in the cochlea.

    "There are currently no pharmacologic treatment options for individuals with OTOF-mediated hearing loss, or for any other form of sensorineural hearing loss. The nonclinical data reported to date for AK-OTOF demonstrate durable recovery of auditory function and support future clinical development." said Jen Wellman, chief operating officer of Akouos. "We believe these are the first Orphan Drug and Rare Pediatric Disease designations granted by FDA for a genetic form of hearing loss, and represent an important milestone for the field of inner ear genetic medicines. The receipt of both designations could help us accelerate development of AK-OTOF, a therapy that we believe has the potential to restore physiologic hearing and provide long-lasting benefits to these individuals and their families."

    The Office of Orphan Products Development of FDA grants ODD 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. The designation affords Akouos the potential for certain benefits, including up to seven years of post-approval market exclusivity, assistance in the drug development process, tax credits for clinical development, and exemptions from certain FDA fees.

    Rare pediatric disease designation is granted by FDA to encourage development of treatments for serious or life-threatening rare diseases in which the disease manifestations primarily affect individuals aged from birth to 18 years. Under the Priority Review Voucher program, and subject to FDA approval of AK-OTOF for the treatment of OTOF-mediated hearing loss, Akouos may be eligible to receive one priority review voucher, which could then be redeemed to receive priority review for a subsequent marketing application for a different product or sold or transferred to another sponsor.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Forward-Looking Statements

    Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the timing of our IND submission for AK-OTOF and the potential receipt of a priority review voucher and other benefits from the ODD and RPDD. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: our limited operating history; uncertainties inherent in the development of product candidates, including the initiation and completion of nonclinical studies and clinical trials; whether results from nonclinical studies will be predictive of results or success of clinical trials; the timing of and our ability to submit applications for, and obtain and maintain regulatory approvals for, our product candidates; our expectations regarding our regulatory strategy; our ability to realize the expected benefits of ODD and RPDD; the potential for changes in regulatory requirements; our ability to fund our operating expenses and capital expenditure requirements with our cash, cash equivalents, and marketable securities; the potential advantages of our product candidates; the rate and degree of market acceptance and clinical utility of our product candidates; our estimates regarding the potential addressable patient population for our product candidates; our commercialization, marketing, and manufacturing capabilities and strategy; our ability to obtain and maintain intellectual property protection for our product candidates; our ability to identify additional products, product candidates, or technologies with significant commercial potential that are consistent with our commercial objectives; the impact of government laws and regulations; risks related to competitive programs; the potential that our internal manufacturing capabilities and/or external manufacturing supply may experience delays; the impact of the COVID-19 pandemic on our business, results of operations, and financial condition; our ability to maintain and establish collaborations or obtain additional funding; and other factors discussed in the "Risk Factors" section included in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the Securities and Exchange Commission, and in other filings that the Company makes with the Securities and Exchange Commission in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

    Contacts

    Media:

    Katie Engleman, 1AB

    Investors:

    Courtney Turiano, Stern Investor Relations



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  5. BOSTON, April 08, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., founder, president, and CEO of Akouos, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14 at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the investors section of the company's website at www.akouos.com. To access the webcast, please go on to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A…

    BOSTON, April 08, 2021 (GLOBE NEWSWIRE) -- Akouos, Inc. ("Akouos") (NASDAQ:AKUS), a precision genetic medicine company dedicated to developing potential gene therapies for individuals living with disabling hearing loss worldwide, today announced that Manny Simons, Ph.D., founder, president, and CEO of Akouos, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Wednesday, April 14 at 4:30 p.m. ET.

    A live webcast of the fireside chat will be available on the investors section of the company's website at www.akouos.com. To access the webcast, please go on to the Akouos website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Akouos's website for 14 days following the conference.

    About Akouos

    Akouos is a precision genetic medicine company dedicated to developing gene therapies with the potential to restore, improve, and preserve high-acuity physiologic hearing for individuals living with disabling hearing loss worldwide. Leveraging its precision genetic medicine platform that incorporates a proprietary adeno-associated viral (AAV) vector library and a novel delivery approach, Akouos is focused on developing precision therapies for forms of sensorineural hearing loss. Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

    Contacts

    Media:

    Katie Engleman, 1AB

    Investors:

    Courtney Turiano, Stern Investor Relations



    Primary Logo

    View Full Article Hide Full Article
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