View ValuationThis company has been acquiredThe company may no longer be operating, as it has been acquired. Find out why through their latest events.See Latest EventsAkouos 향후 성장Future 기준 점검 0/6핵심 정보32.1%이익 성장률34.86%EPS 성장률Biotechs 이익 성장25.2%매출 성장률93.0%향후 자기자본이익률n/a애널리스트 커버리지Low마지막 업데이트n/a최근 향후 성장 업데이트Price Target Changed • May 18Price target decreased to US$23.50Down from US$29.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.97. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$2.52 last year.모든 업데이트 보기Recent updates공시 • Dec 03Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite IndexAkouos, Inc. has been removed from NASDAQ Composite Index .공시 • Dec 02+ 2 more updatesAkouos, Inc. Announces Executive and Board ChangesAkouos, Inc. announced in accordance with the terms of the Merger Agreement, (i) each of Edward T. Mathers, Kush M. Parmar, Heather Preston, Saira Ramasastry, Vicki Sato, Emmanuel Simons and Arthur O. Tzianabos resigned from his or her respective position as a member of the Company's board of directors and all committees thereof, effective as of the Effective Time and (ii) Philip L. Johnson, Chris Anderson and Michael C. Thompson, each a director of Purchaser immediately prior to the Effective Time, became directors of the Company, in each case, effective as of the Effective Time. These resignations were tendered in connection with the Merger and not as a result of any disagreements between the Company and the resigning individuals on any matters related to the Company's operations, policies or practices. In accordance with the terms of the Merger Agreement, each officer of Purchaser immediately prior to the Effective Time became an officer of the Company effective as of the Effective Time. The officers of Purchaser immediately prior to the Effective Time were Philip L. Johnson as President, Chris Anderson as Secretary, Michael C. Thompson as Treasurer, Jonathan Groff as Assistant Secretary and Katie Lodato as Assistant Treasurer. Effective immediately following completion of the Merger, all of the incumbent officers of the Company, as of immediately prior to the effectiveness of the Merger, were removed as officers of the Company. Biographical and other information with respect to Philip L. Johnson, Chris Anderson, Michael C. Thompson, Jonathan Groff and Katie Lodato is set forth in Schedule I to the Offer to Purchase.공시 • Dec 01Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology IndexAkouos, Inc. has been removed from NASDAQ Biotechnology Index .공시 • Oct 20Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million.Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million on October 17, 2022. Lilly will commence a tender offer to acquire all outstanding shares of Akouos for $12.50 per share in cash, plus one contingent value right of up to $3.00 per share. In case of termination of the transaction under certain circumstances Akouos will be required to pay a termination fee of $17.5 million. The deal is subject to receipt of required antitrust clearance, expiration or termination of any applicable waiting period under the HSR Act and the tender of a majority of the outstanding shares of Akouos’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Akouos that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer. The transaction is not subject to any financing condition. The deal has been approved by the board of directors of Eli Lilly and Company. The board of directors of Akouos unanimously approved the transaction. The transaction is expected to close in the fourth quarter of 2022. For Lilly, Sarkis Jebejian and Keri Schick Norton of Kirkland & Ellis LLP are acting as legal counsel. For Akouos, Rosemary G. Reilly, Joseph B. Conahan and Andrew Bonnes of Wilmer Cutler Pickering Hale & Dorr LLP are acting as legal counsel and Centerview Partners LLC as financial advisor and fairness opinion provider.분석 기사 • Sep 19Is Akouos (NASDAQ:AKUS) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • Sep 14Akouos, Inc. Receives FDA Clearance of Its IND Application for AK-OTOF, A Gene Therapy Intended for the Treatment of OTOF-Mediated Hearing LossAkouos, Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2, first in human, pediatric clinical trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss. 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. OTOF-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the otoferlin gene, which 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. 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. Approximately 20,000 individuals are affected in the United States and Europe. In April 2021, FDA granted both Orphan Drug Designation and Rare Pediatric Disease Designation for AK-OTOF. AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea. A one-time, unilateral intracochlear administration of AK-OTOF is intended to result in the expression of normal full-length functional otoferlin protein in the IHCs, which has the potential to lead to recovery of auditory function. The advancement of AK-OTOF into clinical development is supported by nonclinical data demonstrating administration of AK-OTOF in Otof knockout mice results in durable expression of human otoferlin protein sufficient for sustained restoration of auditory function, as assessed by translationally relevant ABR assessments. In both mice and non-human primates, AK-OTOF was systemically and locally well tolerated, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function.? The Phase 1/2 clinical trial is designed to evaluate the safety and tolerability of escalating doses of AK-OTOF administered unilaterally to trial participants with OTOF-mediated hearing loss; it is also designed to assess efficacy through clinical measures such as ABR, which is an objective, clinically accepted endpoint. Given both the early onset of serious manifestations, as well as the need for timely intervention due to anatomical considerations and developmental considerations, eligible participants for the clinical trial will be pediatric. Based on interactions with FDA during the 30-day IND review period, the Company expects the first two participants will be as young as seven years of age, and that subsequent participants will be as young as two years of age at the time of administration. The Company plans to provide an update on clinical trial initiation activities for AK-OTOF later this year.Seeking Alpha • Sep 13Akouos stock rises 11% on FDA nod to start gene therapy trial for hearing lossThe U.S. Food and Drug Administration (FDA) cleared Akouos' (NASDAQ:AKUS) investigational new drug application (IND) seeking to start a phase 1/2 trial of gene therapy therapy AK-OTOF to treat pediatric patients with otoferlin gene (OTOF)-mediated hearing loss. The company said it plans to begin a pediatric phase 1/2 study, which includes children as young as two years of age in the dose-escalation phase (Part A), to evaluate AK-OTOF. "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," said Akouos Co-Founder, President and CEO Manny Simons. Based on auditory brainstem response data from nonclinical studies, a one-time administration of AK-OTOF has the potential to deliver durable restoration of auditory function, the company said in a Sept. 13 press release. AKUS +11.14% to $3.89 premarket Sept. 13공시 • Jul 28Akouos, Inc. Announces Resignation of Chris Smith as Member of the Board of Directors, Effective August 15, 2022On July 21, 2022, Chris Smith notified Akouos, Inc. that he has been appointed as Chief Executive Officer of NeoGenomics, Inc. effective August 15, 2022, and as a result of his new appointment, concurrently notified the Company of his resignation as a member of the Board of Directors of the Company, effective August 15, 2022. With the resignation, Mr. Smith also resigned as a member of the Company’s Nominating and Corporate Governance Committee.공시 • Jun 26Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index분석 기사 • Jun 04We Think Akouos (NASDAQ:AKUS) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...공시 • May 20Akouos, Inc. 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 MeetingAkouos, Inc. presented nonclinical data at the American Society of Gene and Cell Therapy 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 in adeno-associated viral vectors for regulated gene expression in the inner ear. Nonclinical In Vivo Expression, Durability of Effect, Biodistribution/Shedding, and Safety Evaluations Support Clinical Development of AK-OTOF for OTOF-mediated Hearing Loss. Presenting Author: Ann E. Hickox, Ph.D. Session Title and Room: Ophthalmic and Auditory Diseases; Salon G AK-OTOF is an AAV vector-based gene therapy intended for the treatment of patients with otoferlin gene-mediated hearing loss by delivering transgenes encoding OTOF to inner hair cells. Following intracochlear delivery, and subsequent co-transduction of IHCs by each component vector, the two transgene products recombine to generate a full-length otoferlin mRNA transcript and subsequently a full-length otoferlin protein. Results from this presentation show: Intracochlear administration of AK-OTOF in otoferlin knockout mice, or its tagged version (AAVAnc80-FLAG.hOTOF) in non-human primates (NHPs), leads to full-length human otoferlin protein expression only in the target IHCs; human otoferlin expression in IHCs of Ofof -/- mice restores auditory function as early as two weeks post-administration and restoration was durable through at least six months. AK-OTOF was systemically and locally well tolerated in both mice and NHPs, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function. Limited systemic exposure of AK-OTOF following intracochlear administration was observed, and no otoferlin protein expression was detected in any non-target tissue types evaluated, including those with detectable levels of vector sequences and otoferlin mRNA expression. 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. Ubiquitous promoters can drive strong widespread expression in the inner ear in mice and NHPs. This expression can be well tolerated across the inner ear, as is the case for Akouos’s first two programs, AK-OTOF and AK-antiVEGF. Addition of selective cis-regulatory elements may be needed for some transgenes, such as GJB2, where expression in a portion of nontarget cells is not well tolerated. This nonclinical study explored the potential use of miR-TS incorporation in AAV vectors for de-targeting transgene expression in different cell types of the cochlea. Using an in vitro model, expression of transgene mRNA and protein in the presence or absence of the target sites was evaluated. Akouos identified multiple microRNA target sites to drive various differential expression patterns demonstrating that a combination of AAVAnc80 and miR-TS can drive expression in supporting cells, while limiting expression in hair cells in cochlear explants. Future work will focus on evaluating miR-TS regulation in vivo and identifying combinations of different miR-TSs to enhance de-targeting in specific cell types where, for example, expression driven by ubiquitous promoters is not well tolerated.Price Target Changed • May 18Price target decreased to US$23.50Down from US$29.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.97. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$2.52 last year.분석 기사 • Feb 19We Think Akouos (NASDAQ:AKUS) Can Afford To Drive Business GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...분석 기사 • Oct 28Companies Like Akouos (NASDAQ:AKUS) Are In A Position To Invest In GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...공시 • Jun 28+ 2 more updatesAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth Index분석 기사 • Jun 26Here's Why We're Not Too Worried About Akouos' (NASDAQ:AKUS) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...공시 • May 12Akouos, Inc. Presents Nonclinical Data Supporting Future Clinical Development of Ak-Otof and Ak-Antivegf At the American Society of Gene and Cell Therapy 24Th Annual MeetingAkouos, Inc. presented nonclinical data supporting the future clinical development of both 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, in three digital presentation sessions at the virtual American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting. Otoferlin plays a critical role in exocytosis of synaptic vesicles at the inner hair cell synapse, and mutations in OTOF, the gene encoding otoferlin, are associated with autosomal recessive sensorineural hearing loss. AK-OTOF is designed to deliver normal OTOF by utilizing a dual vector approach, which encodes the 5’ and the 3’ components of OTOF. Multiple analyses demonstrate in vitro transduction with dual AK-OTOF vector results in full-length human otoferlin (RNA and protein), with no detection of truncated proteins from either AK-OTOF or its component vectors (5’hOTOF and 3’hOTOF). A one-to-one ratio of the AK-OTOF component vectors appears to be optimal for efficient reconstitution of full-length human otoferlin. In cynomolgus macaques, full-length human otoferlin protein expression is detected in inner hair cells of non-human primate (NHP) cochleae by both immunohistochemistry and immunodetection one month following intracochlear administration of AAVAnc80-FLAG.hOTOF.분석 기사 • Mar 04We Think Akouos (NASDAQ:AKUS) Can Afford To Drive Business GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...Is New 90 Day High Low • Jan 14New 90-day low: US$17.45The company is down 5.0% from its price of US$18.42 on 15 October 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 17% over the same period.공시 • Jan 12Akouos and Blueprint Genetics Announce the Resonate Program to Improve Access to Genetic Testing for Individuals with Auditory NeuropathyAkouos, Inc. and Blueprint Genetics announced the Resonate program. The program offers genetic testing to eligible individuals with auditory neuropathy at no cost to participants, their insurance, or their healthcare providers. The Resonate program is available in the United States and plans to expand to additional geographic regions throughout 2021. To be eligible for the program, individuals can be any age, and must have a current or prior clinical diagnosis of auditory neuropathy, or a medical history consistent with auditory neuropathy. Auditory neuropathy is a hearing disorder in which the inner ear successfully detects sound, but has a problem with sending sound from the ear to the brain. In many cases, genetic mutations cause auditory neuropathy. The Resonate program provides access to the Blueprint Genetics Comprehensive Hearing Loss and Deafness Panel that includes more than 230 genes associated with genetic forms of hearing loss. To help understand their results, participants in the United States also have access to genetic counseling provided by the program at no cost to participants, their insurance, or their healthcare providers.분석 기사 • Jan 10Did Akouos, Inc. (NASDAQ:AKUS) Insiders Buy Up More Shares?We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. On...분석 기사 • Nov 18Akouos (NASDAQ:AKUS) Is In A Good Position To Deliver On Growth PlansWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...Is New 90 Day High Low • Oct 08New 90-day low: US$17.99The company is down 19% from its price of US$22.30 on 10 July 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.공시 • Oct 02+ 1 more updateAkouos, Inc. Appoints Sachiyo Minegishi as Chief Financial OfficerEffective October 1, 2020, the board of directors of Akouos, Inc. appointed Sachiyo Minegishi as the Company’s Chief Financial Officer, Treasurer and Assistant Secretary. Upon commencement of her appointment, Ms. Minegishi assumed the duties of the Company’s principal financial officer and principal accounting officer and Emmanuel Simons, the Company’s Chief Executive Officer, ceased to serve as principal financial officer and principal accounting officer. There are no reportable family relationships or related party transactions involving the Company and Ms. Minegishi. Ms. Minegishi, age 43, served from April 2016 to September 2020 in various roles of increasing responsibility at bluebird bio, Inc., a biotechnology company, including, most recently, as vice president, global program lead for sickle cell disease (SCD) and previously as vice president, global brand lead, SCD and oncology portfolio. From September 2012 to April 2016, Ms. Minegishi served in various roles at Aegerion Pharmaceuticals Inc., a biopharmaceutical company, including as senior director, U.S. cardiology rare disease marketing and as senior director, global business development.이익 및 매출 성장 예측NasdaqGS:AKUS - 애널리스트 향후 추정치 및 과거 재무 데이터 (USD Millions)날짜매출이익자유현금흐름영업현금흐름평균 애널리스트 수12/31/202410-137N/A-87312/31/2023N/A-117N/A-73412/31/2022N/A-98N/A-7749/30/2022N/A-93-87-74N/A6/30/2022N/A-96-85-73N/A3/31/2022N/A-98-76-68N/A12/31/2021N/A-87-73-64N/A9/30/2021N/A-74-68-58N/A6/30/2021N/A-64-58-49N/A3/31/2021N/A-54-56-48N/A12/31/2020N/A-49-45-41N/A9/30/2020N/A-46-44-38N/A6/30/2020N/A-41-37-33N/A3/31/2020N/A-30-29-25N/A12/31/2019N/A-26-23-20N/A더 보기애널리스트 향후 성장 전망수입 대 저축률: AKUS 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 vs 시장: AKUS 향후 3년 동안 수익성이 없을 것으로 예상됩니다.고성장 수익: AKUS 향후 3년 동안 수익성이 없을 것으로 예상됩니다.수익 대 시장: AKUS 은(는) 내년에 수익이 없을 것으로 예상됩니다.고성장 매출: AKUS 은(는) 내년에 수익이 없을 것으로 예상됩니다.주당순이익 성장 예측향후 자기자본이익률미래 ROE: AKUS의 자본 수익률이 3년 후 높을 것으로 예상되는지 판단하기에 데이터가 부족합니다.성장 기업 찾아보기7D1Y7D1Y7D1YPharmaceuticals-biotech 산업의 고성장 기업.View Past Performance기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2022/12/01 04:15종가2022/11/30 00:00수익2022/09/30연간 수익2021/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Akouos, Inc.는 6명의 분석가가 다루고 있습니다. 이 중 4명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Tazeen AhmadBofA Global Researchnull nullBTIGJoseph PantginisH.C. Wainwright & Co.3명의 분석가 더 보기
Price Target Changed • May 18Price target decreased to US$23.50Down from US$29.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.97. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$2.52 last year.
공시 • Dec 03Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite IndexAkouos, Inc. has been removed from NASDAQ Composite Index .
공시 • Dec 02+ 2 more updatesAkouos, Inc. Announces Executive and Board ChangesAkouos, Inc. announced in accordance with the terms of the Merger Agreement, (i) each of Edward T. Mathers, Kush M. Parmar, Heather Preston, Saira Ramasastry, Vicki Sato, Emmanuel Simons and Arthur O. Tzianabos resigned from his or her respective position as a member of the Company's board of directors and all committees thereof, effective as of the Effective Time and (ii) Philip L. Johnson, Chris Anderson and Michael C. Thompson, each a director of Purchaser immediately prior to the Effective Time, became directors of the Company, in each case, effective as of the Effective Time. These resignations were tendered in connection with the Merger and not as a result of any disagreements between the Company and the resigning individuals on any matters related to the Company's operations, policies or practices. In accordance with the terms of the Merger Agreement, each officer of Purchaser immediately prior to the Effective Time became an officer of the Company effective as of the Effective Time. The officers of Purchaser immediately prior to the Effective Time were Philip L. Johnson as President, Chris Anderson as Secretary, Michael C. Thompson as Treasurer, Jonathan Groff as Assistant Secretary and Katie Lodato as Assistant Treasurer. Effective immediately following completion of the Merger, all of the incumbent officers of the Company, as of immediately prior to the effectiveness of the Merger, were removed as officers of the Company. Biographical and other information with respect to Philip L. Johnson, Chris Anderson, Michael C. Thompson, Jonathan Groff and Katie Lodato is set forth in Schedule I to the Offer to Purchase.
공시 • Dec 01Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology IndexAkouos, Inc. has been removed from NASDAQ Biotechnology Index .
공시 • Oct 20Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million.Eli Lilly and Company (NYSE:LLY) entered into a definitive agreement to acquire Akouos, Inc. (NasdaqGS:AKUS) from 5AM Venture Management, LLC, New Enterprise Associates, Inc. and others for approximately $460 million on October 17, 2022. Lilly will commence a tender offer to acquire all outstanding shares of Akouos for $12.50 per share in cash, plus one contingent value right of up to $3.00 per share. In case of termination of the transaction under certain circumstances Akouos will be required to pay a termination fee of $17.5 million. The deal is subject to receipt of required antitrust clearance, expiration or termination of any applicable waiting period under the HSR Act and the tender of a majority of the outstanding shares of Akouos’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Akouos that are not tendered in the tender offer through a second-step merger at the same consideration as paid in the tender offer. The transaction is not subject to any financing condition. The deal has been approved by the board of directors of Eli Lilly and Company. The board of directors of Akouos unanimously approved the transaction. The transaction is expected to close in the fourth quarter of 2022. For Lilly, Sarkis Jebejian and Keri Schick Norton of Kirkland & Ellis LLP are acting as legal counsel. For Akouos, Rosemary G. Reilly, Joseph B. Conahan and Andrew Bonnes of Wilmer Cutler Pickering Hale & Dorr LLP are acting as legal counsel and Centerview Partners LLC as financial advisor and fairness opinion provider.
분석 기사 • Sep 19Is Akouos (NASDAQ:AKUS) In A Good Position To Deliver On Growth Plans?Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • Sep 14Akouos, Inc. Receives FDA Clearance of Its IND Application for AK-OTOF, A Gene Therapy Intended for the Treatment of OTOF-Mediated Hearing LossAkouos, Inc. announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to initiate a Phase 1/2, first in human, pediatric clinical trial of AK-OTOF, a gene therapy intended for the treatment of patients with otoferlin gene (OTOF)-mediated hearing loss. 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. OTOF-mediated hearing loss is a form of sensorineural hearing loss caused by mutations in the otoferlin gene, which 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. 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. Approximately 20,000 individuals are affected in the United States and Europe. In April 2021, FDA granted both Orphan Drug Designation and Rare Pediatric Disease Designation for AK-OTOF. AK-OTOF is a dual adeno-associated viral (AAV) vector-based gene therapy intended to treat patients with OTOF-mediated hearing loss by delivering transgenes encoding OTOF to the inner hair cells (IHCs) of the cochlea. A one-time, unilateral intracochlear administration of AK-OTOF is intended to result in the expression of normal full-length functional otoferlin protein in the IHCs, which has the potential to lead to recovery of auditory function. The advancement of AK-OTOF into clinical development is supported by nonclinical data demonstrating administration of AK-OTOF in Otof knockout mice results in durable expression of human otoferlin protein sufficient for sustained restoration of auditory function, as assessed by translationally relevant ABR assessments. In both mice and non-human primates, AK-OTOF was systemically and locally well tolerated, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function.? The Phase 1/2 clinical trial is designed to evaluate the safety and tolerability of escalating doses of AK-OTOF administered unilaterally to trial participants with OTOF-mediated hearing loss; it is also designed to assess efficacy through clinical measures such as ABR, which is an objective, clinically accepted endpoint. Given both the early onset of serious manifestations, as well as the need for timely intervention due to anatomical considerations and developmental considerations, eligible participants for the clinical trial will be pediatric. Based on interactions with FDA during the 30-day IND review period, the Company expects the first two participants will be as young as seven years of age, and that subsequent participants will be as young as two years of age at the time of administration. The Company plans to provide an update on clinical trial initiation activities for AK-OTOF later this year.
Seeking Alpha • Sep 13Akouos stock rises 11% on FDA nod to start gene therapy trial for hearing lossThe U.S. Food and Drug Administration (FDA) cleared Akouos' (NASDAQ:AKUS) investigational new drug application (IND) seeking to start a phase 1/2 trial of gene therapy therapy AK-OTOF to treat pediatric patients with otoferlin gene (OTOF)-mediated hearing loss. The company said it plans to begin a pediatric phase 1/2 study, which includes children as young as two years of age in the dose-escalation phase (Part A), to evaluate AK-OTOF. "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," said Akouos Co-Founder, President and CEO Manny Simons. Based on auditory brainstem response data from nonclinical studies, a one-time administration of AK-OTOF has the potential to deliver durable restoration of auditory function, the company said in a Sept. 13 press release. AKUS +11.14% to $3.89 premarket Sept. 13
공시 • Jul 28Akouos, Inc. Announces Resignation of Chris Smith as Member of the Board of Directors, Effective August 15, 2022On July 21, 2022, Chris Smith notified Akouos, Inc. that he has been appointed as Chief Executive Officer of NeoGenomics, Inc. effective August 15, 2022, and as a result of his new appointment, concurrently notified the Company of his resignation as a member of the Board of Directors of the Company, effective August 15, 2022. With the resignation, Mr. Smith also resigned as a member of the Company’s Nominating and Corporate Governance Committee.
공시 • Jun 26Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index
분석 기사 • Jun 04We Think Akouos (NASDAQ:AKUS) Needs To Drive Business Growth CarefullyJust because a business does not make any money, does not mean that the stock will go down. For example, biotech and...
공시 • May 20Akouos, Inc. 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 MeetingAkouos, Inc. presented nonclinical data at the American Society of Gene and Cell Therapy 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 in adeno-associated viral vectors for regulated gene expression in the inner ear. Nonclinical In Vivo Expression, Durability of Effect, Biodistribution/Shedding, and Safety Evaluations Support Clinical Development of AK-OTOF for OTOF-mediated Hearing Loss. Presenting Author: Ann E. Hickox, Ph.D. Session Title and Room: Ophthalmic and Auditory Diseases; Salon G AK-OTOF is an AAV vector-based gene therapy intended for the treatment of patients with otoferlin gene-mediated hearing loss by delivering transgenes encoding OTOF to inner hair cells. Following intracochlear delivery, and subsequent co-transduction of IHCs by each component vector, the two transgene products recombine to generate a full-length otoferlin mRNA transcript and subsequently a full-length otoferlin protein. Results from this presentation show: Intracochlear administration of AK-OTOF in otoferlin knockout mice, or its tagged version (AAVAnc80-FLAG.hOTOF) in non-human primates (NHPs), leads to full-length human otoferlin protein expression only in the target IHCs; human otoferlin expression in IHCs of Ofof -/- mice restores auditory function as early as two weeks post-administration and restoration was durable through at least six months. AK-OTOF was systemically and locally well tolerated in both mice and NHPs, and no adverse effects were observed in clinical pathology, otic pathology, systemic histopathology, or auditory or cochlear function. Limited systemic exposure of AK-OTOF following intracochlear administration was observed, and no otoferlin protein expression was detected in any non-target tissue types evaluated, including those with detectable levels of vector sequences and otoferlin mRNA expression. 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. Ubiquitous promoters can drive strong widespread expression in the inner ear in mice and NHPs. This expression can be well tolerated across the inner ear, as is the case for Akouos’s first two programs, AK-OTOF and AK-antiVEGF. Addition of selective cis-regulatory elements may be needed for some transgenes, such as GJB2, where expression in a portion of nontarget cells is not well tolerated. This nonclinical study explored the potential use of miR-TS incorporation in AAV vectors for de-targeting transgene expression in different cell types of the cochlea. Using an in vitro model, expression of transgene mRNA and protein in the presence or absence of the target sites was evaluated. Akouos identified multiple microRNA target sites to drive various differential expression patterns demonstrating that a combination of AAVAnc80 and miR-TS can drive expression in supporting cells, while limiting expression in hair cells in cochlear explants. Future work will focus on evaluating miR-TS regulation in vivo and identifying combinations of different miR-TSs to enhance de-targeting in specific cell types where, for example, expression driven by ubiquitous promoters is not well tolerated.
Price Target Changed • May 18Price target decreased to US$23.50Down from US$29.00, the current price target is an average from 4 analysts. New target price is 691% above last closing price of US$2.97. Stock is down 78% over the past year. The company is forecast to post a net loss per share of US$3.22 next year compared to a net loss per share of US$2.52 last year.
분석 기사 • Feb 19We Think Akouos (NASDAQ:AKUS) Can Afford To Drive Business GrowthEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
분석 기사 • Oct 28Companies Like Akouos (NASDAQ:AKUS) Are In A Position To Invest In GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...
공시 • Jun 28+ 2 more updatesAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth Index
분석 기사 • Jun 26Here's Why We're Not Too Worried About Akouos' (NASDAQ:AKUS) Cash Burn SituationEven when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...
공시 • May 12Akouos, Inc. Presents Nonclinical Data Supporting Future Clinical Development of Ak-Otof and Ak-Antivegf At the American Society of Gene and Cell Therapy 24Th Annual MeetingAkouos, Inc. presented nonclinical data supporting the future clinical development of both 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, in three digital presentation sessions at the virtual American Society of Gene and Cell Therapy (ASGCT) 24th Annual Meeting. Otoferlin plays a critical role in exocytosis of synaptic vesicles at the inner hair cell synapse, and mutations in OTOF, the gene encoding otoferlin, are associated with autosomal recessive sensorineural hearing loss. AK-OTOF is designed to deliver normal OTOF by utilizing a dual vector approach, which encodes the 5’ and the 3’ components of OTOF. Multiple analyses demonstrate in vitro transduction with dual AK-OTOF vector results in full-length human otoferlin (RNA and protein), with no detection of truncated proteins from either AK-OTOF or its component vectors (5’hOTOF and 3’hOTOF). A one-to-one ratio of the AK-OTOF component vectors appears to be optimal for efficient reconstitution of full-length human otoferlin. In cynomolgus macaques, full-length human otoferlin protein expression is detected in inner hair cells of non-human primate (NHP) cochleae by both immunohistochemistry and immunodetection one month following intracochlear administration of AAVAnc80-FLAG.hOTOF.
분석 기사 • Mar 04We Think Akouos (NASDAQ:AKUS) Can Afford To Drive Business GrowthJust because a business does not make any money, does not mean that the stock will go down. For example, although...
Is New 90 Day High Low • Jan 14New 90-day low: US$17.45The company is down 5.0% from its price of US$18.42 on 15 October 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 17% over the same period.
공시 • Jan 12Akouos and Blueprint Genetics Announce the Resonate Program to Improve Access to Genetic Testing for Individuals with Auditory NeuropathyAkouos, Inc. and Blueprint Genetics announced the Resonate program. The program offers genetic testing to eligible individuals with auditory neuropathy at no cost to participants, their insurance, or their healthcare providers. The Resonate program is available in the United States and plans to expand to additional geographic regions throughout 2021. To be eligible for the program, individuals can be any age, and must have a current or prior clinical diagnosis of auditory neuropathy, or a medical history consistent with auditory neuropathy. Auditory neuropathy is a hearing disorder in which the inner ear successfully detects sound, but has a problem with sending sound from the ear to the brain. In many cases, genetic mutations cause auditory neuropathy. The Resonate program provides access to the Blueprint Genetics Comprehensive Hearing Loss and Deafness Panel that includes more than 230 genes associated with genetic forms of hearing loss. To help understand their results, participants in the United States also have access to genetic counseling provided by the program at no cost to participants, their insurance, or their healthcare providers.
분석 기사 • Jan 10Did Akouos, Inc. (NASDAQ:AKUS) Insiders Buy Up More Shares?We've lost count of how many times insiders have accumulated shares in a company that goes on to improve markedly. On...
분석 기사 • Nov 18Akouos (NASDAQ:AKUS) Is In A Good Position To Deliver On Growth PlansWe can readily understand why investors are attracted to unprofitable companies. For example, biotech and mining...
Is New 90 Day High Low • Oct 08New 90-day low: US$17.99The company is down 19% from its price of US$22.30 on 10 July 2020. The American market is up 7.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share.
공시 • Oct 02+ 1 more updateAkouos, Inc. Appoints Sachiyo Minegishi as Chief Financial OfficerEffective October 1, 2020, the board of directors of Akouos, Inc. appointed Sachiyo Minegishi as the Company’s Chief Financial Officer, Treasurer and Assistant Secretary. Upon commencement of her appointment, Ms. Minegishi assumed the duties of the Company’s principal financial officer and principal accounting officer and Emmanuel Simons, the Company’s Chief Executive Officer, ceased to serve as principal financial officer and principal accounting officer. There are no reportable family relationships or related party transactions involving the Company and Ms. Minegishi. Ms. Minegishi, age 43, served from April 2016 to September 2020 in various roles of increasing responsibility at bluebird bio, Inc., a biotechnology company, including, most recently, as vice president, global program lead for sickle cell disease (SCD) and previously as vice president, global brand lead, SCD and oncology portfolio. From September 2012 to April 2016, Ms. Minegishi served in various roles at Aegerion Pharmaceuticals Inc., a biopharmaceutical company, including as senior director, U.S. cardiology rare disease marketing and as senior director, global business development.