View Future GrowthThis 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 過去の業績過去 基準チェック /06主要情報-45.43%収益成長率75.70%EPS成長率Biotechs 業界の成長17.04%収益成長率n/a株主資本利益率-51.20%ネット・マージンn/a前回の決算情報30 Sep 2022最近の業績更新更新なしすべての更新を表示Recent updatesお知らせ • Dec 03Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite IndexAkouos, Inc. has been removed from NASDAQ Composite Index .お知らせ • 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.お知らせ • Dec 01Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology IndexAkouos, Inc. has been removed from NASDAQ Biotechnology Index .お知らせ • 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.分析記事 • 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...お知らせ • 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お知らせ • 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.お知らせ • Jun 26Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index分析記事 • 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...お知らせ • 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.分析記事 • 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...分析記事 • 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...お知らせ • Jun 28+ 2 more updatesAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth Index分析記事 • 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...お知らせ • 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.分析記事 • 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.お知らせ • 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.分析記事 • 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...分析記事 • 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.お知らせ • 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.収支内訳Akouos の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史NasdaqGS:AKUS 収益、費用、利益 ( )USD Millions日付収益収益G+A経費研究開発費30 Sep 220-93266730 Jun 220-96257131 Mar 220-98247431 Dec 210-87226530 Sep 210-74215330 Jun 210-64204531 Mar 210-54173831 Dec 200-49153430 Sep 200-46113530 Jun 200-4173131 Mar 200-3052531 Dec 190-26320質の高い収益: AKUSは現在利益が出ていません。利益率の向上: AKUSは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: AKUSは利益が出ておらず、過去 5 年間で損失は年間45.4%の割合で増加しています。成長の加速: AKUSの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: AKUSは利益が出ていないため、過去 1 年間の収益成長をBiotechs業界 ( 43% ) と比較することは困難です。株主資本利益率高いROE: AKUSは現在利益が出ていないため、自己資本利益率 ( -51.2% ) はマイナスです。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YPharmaceuticals-biotech 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2022/12/01 14:15終値2022/11/30 00:00収益2022/09/30年間収益2021/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Akouos, Inc. 4 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。6 アナリスト機関Tazeen AhmadBofA Global Researchnull nullBTIGJoseph PantginisH.C. Wainwright & Co.3 その他のアナリストを表示
お知らせ • Dec 03Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite IndexAkouos, Inc. has been removed from NASDAQ Composite Index .
お知らせ • 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.
お知らせ • Dec 01Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology IndexAkouos, Inc. has been removed from NASDAQ Biotechnology Index .
お知らせ • 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.
分析記事 • 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...
お知らせ • 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
お知らせ • 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.
お知らせ • Jun 26Akouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Index
分析記事 • 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...
お知らせ • 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.
分析記事 • 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...
分析記事 • 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...
お知らせ • Jun 28+ 2 more updatesAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth IndexAkouos, Inc.(NasdaqGS:AKUS) dropped from Russell 2500 Growth Index
分析記事 • 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...
お知らせ • 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.
分析記事 • 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.
お知らせ • 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.
分析記事 • 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...
分析記事 • 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.
お知らせ • 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.