OTOF

Sensorion Reports 2022 First Half Results

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Thursday, September 22, 2022
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Sensorion (FR0012596468 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces its half-year results as of June 30, 2022, alongside its outlook for the remainder of 2022.

Key Points: 
  • Sensorion (FR0012596468 ALSEN) a pioneering clinical-stage biotechnology company which specializes in the development of novel therapies to restore, treat and prevent within the field of hearing loss disorders, announces its half-year results as of June 30, 2022, alongside its outlook for the remainder of 2022.
  • Nawal Ouzren, CEO of Sensorion, said: Sensorion has made good progress across our pipeline of small molecule and gene therapy programs in the first half of this year.
  • In late 2021, Sensorion filed a proof-of-concept clinical trial application in CIO to evaluate the potential of SENS-401 treatment.
  • Following further analysis of the AUDIBLE-S study earlier in 2022, Sensorion has adapted the NOTOXIS trial design to focus SENS-401 in the prevention arm only.

Akouos Receives FDA Clearance of its IND Application for AK-OTOF, a Gene Therapy Intended for the Treatment of OTOF-mediated Hearing Loss

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Tuesday, September 13, 2022
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“The AK-OTOF IND clearance from FDA is an important step toward achieving our mission of making healthy hearing available to all,” said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos. “This first in human clinical trial for AK-OTOF is groundbreaking and highlights Akouos’s leadership in the field -- we expect this to be the first clinical trial for a genetic inner ear condition, the first in which an AAV gene therapy is administered to the inner ear, and the first for any inner ear condition to begin in a pediatric population.”

Key Points: 
  • Currently, there are no approved pharmacologic treatment options for individuals with OTOF-mediated hearing loss, a form of sensorineural hearing loss caused by mutations in the OTOF gene.
  • The AK-OTOF IND clearance from FDA is an important step toward achieving our mission of making healthy hearing available to all, said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos.
  • There is a significant unmet need in OTOF-mediated hearing loss, as individuals typically have Severe to Profound sensorineural hearing loss from birth, and there are currently no approved pharmacologic options, said Jen Wellman, chief operating officer of Akouos.
  • Individuals with OTOF-mediated hearing loss have bilateral hearing loss that is typically Severe to Profound and congenital, exhibiting absent or highly abnormal auditory brainstem response (ABR) from birth.

Sensorion Receives Positive Opinion for Orphan Drug Designation for OTOF-GT for the Treatment of Otoferlin Gene-Mediated Hearing Loss From the European Medicine Agency

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Monday, September 12, 2022
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OTOF-GT meeting the criteria for ODD, the European Commission will issue a decision within 30 days of receipt of the COMP positive opinion.

Key Points: 
  • OTOF-GT meeting the criteria for ODD, the European Commission will issue a decision within 30 days of receipt of the COMP positive opinion.
  • Sensorions OTOF-GT gene therapy development program aims to restore hearing in people living with otoferlin deficiency.
  • Patients with mutations in OTOF suffer from severe to profound sensorineural prelingual non syndromic hearing loss.
  • Otoferlin deficiency could be responsible for up to 8% of all cases of congenital hearing loss, around 20,000 people are affected in the US and Europe.

Akouos Reports Second Quarter 2022 Financial Results and Provides Business Highlights

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Monday, August 15, 2022
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Received a notice of allowance from USPTO for claims covering compositions, including AK-OTOF, and methods of treatment useful for OTOF-mediated hearing loss

Key Points: 
  • Received a notice of allowance from USPTO for claims covering compositions, including AK-OTOF, and methods of treatment useful for OTOF-mediated hearing loss
    BOSTON, Aug. 15, 2022 (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 reports financial results for the second quarter ended June 30, 2022 and provides business highlights.
  • We look forward to providing updates later this year on both product candidates, said Manny Simons, Ph.D., M.B.A., co-founder, president, and chief executive officer of Akouos.
  • Research and Development (R&D) Expenses R&D expenses were $14.3 million for the second quarter ended June 30, 2022, compared to $17.1 million for the same period in 2021.
  • General and Administrative (G&A) Expenses G&A expenses were $6.7 million for the second quarter ended June 30, 2022, compared to $5.7 million for the same period in 2021.

Akouos Presents Nonclinical Data Supporting the Planned Clinical Development of AK-OTOF and Strategies for Regulated Gene Expression in the Inner Ear at the American Society of Gene and Cell Therapy 25th Annual Meeting

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Thursday, May 19, 2022
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BOSTON, May 19, 2022 (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, presented nonclinical data at the American Society of Gene and Cell Therapy (ASGCT) 25th Annual Meeting. The company gave two nonclinical presentations at the meeting: one that supports the planned clinical development of AK-OTOF, a gene therapy intended for the treatment of OTOF-mediated hearing loss; and another that supports the potential use of microRNA target site (miR-TS) in adeno-associated viral (AAV) vectors for regulated gene expression in the inner ear.

Key Points: 
  • AK-OTOF is an AAV vector-based gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss by delivering transgenes encoding OTOF to inner hair cells (IHCs).
  • Together, these nonclinical studies further support the planned clinical development of AK-OTOF for the treatment of OTOF-mediated hearing loss.
  • In the development of AAV gene therapy vectors, a goal is to generate safe and effective product candidates that deliver targeted transgene expression.
  • Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

Akouos Reports First Quarter 2022 Financial Results and Provides Business Highlights

Retrieved on: 
Thursday, May 12, 2022
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BOSTON, May 12, 2022 (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 reports financial results for the first quarter ended March 31, 2022 and provides business highlights.

Key Points: 
  • BOSTON, May 12, 2022 (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 reports financial results for the first quarter ended March 31, 2022 and provides business highlights.
  • The year is off to a strong start for us as we continue to progress toward planned IND submissions for AK-OTOF and for AK-antiVEGF in 2022.
  • Building on this momentum, we are presenting new, nonclinical data at ASGCT that support the clinical development of AK-OTOF.
  • Additionally, Akouos is on track to submit an IND in 2022 for AK-antiVEGF, a gene therapy intended for the treatment of patients with vestibular schwannoma.

Akouos to Present at the American Society of Gene and Cell Therapy 25th Annual Meeting

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Tuesday, May 3, 2022
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BOSTON, May 03, 2022 (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 (ASGCT) 25th Annual Meeting, which will take place in Washington, D.C. (both in-person and virtually) from May 16 to 19, 2022.

Key Points: 
  • BOSTON, May 03, 2022 (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 (ASGCT) 25th Annual Meeting, which will take place in Washington, D.C. (both in-person and virtually) from May 16 to 19, 2022.
  • Details are as follows:
    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.

Akouos Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Business Highlights

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Tuesday, March 29, 2022
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BOSTON, March 29, 2022 (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 reports financial results for the fourth quarter and full year ended December 31, 2021 and provides business highlights.

Key Points: 
  • Additionally, Akouos continues to plan for an IND submission in 2022 for AK-antiVEGF, a gene therapy candidate in preclinical development for the potential treatment of patients with vestibular schwannoma.
  • Two nonclinical studies in non-human primates evaluating protein expression and tolerability support future clinical development of AK-antiVEGF for the treatment of vestibular schwannoma.
  • Cash Position Cash, cash equivalents, and marketable securities were $232.5 million as of December31, 2021, as compared to $308.0 million as of December 31, 2020.
  • Headquartered in Boston, Akouos was founded in 2016 by leaders in the fields of neurotology, genetics, inner ear drug delivery, and AAV gene therapy.

Akouos Reports Third Quarter 2021 Financial Results and Provides Business Highlights

Retrieved on: 
Friday, November 12, 2021
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BOSTON, Nov. 12, 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 reports financial results for the third quarter ended September 30, 2021, and provides business highlights.

Key Points: 
  • BOSTON, Nov. 12, 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 reports financial results for the third quarter ended September 30, 2021, and provides business highlights.
  • Additionally, Akouos continues to plan for IND submission in 2022 for AK-antiVEGF, a gene therapy intended for the treatment of vestibular schwannoma.
  • Chief technical officer joins leadership team In November 2021, Akouos announced the appointment of Stacy Price as chief technical officer.
  • At Akouos, she will be responsible for the strategy and operations of vector manufacturing and device development and manufacturing.

Sensorion Reports 2021 First Half Results

Retrieved on: 
Monday, September 27, 2021
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Many elements of Sensorions strategic planning came together in a successful first half of 2021.

Key Points: 
  • Many elements of Sensorions strategic planning came together in a successful first half of 2021.
  • Since not all of the patients have yet completed their 28-day end of treatment visit, Sensorion will continue the recruitment until the end of October 2021.
  • Following this initial success, Sensorion and Cochlear announced the initiation of a Phase 1 clinical trial of SENS-401 (Arazasetron) in patients scheduled for cochlear implantation on September 8, 2021.
  • The study will be sponsored by Sensorion and the proposed design is expected to be submitted to regulatory authorities during H2 2021 (see post-closing events).