공시 • Dec 03
Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Composite Index Akouos, Inc. has been removed from NASDAQ Composite Index . 공시 • Dec 01
Akouos, Inc.(NasdaqGS:AKUS) dropped from NASDAQ Biotechnology Index Akouos, Inc. has been removed from NASDAQ Biotechnology Index . 공시 • Oct 20
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. 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. 공시 • Sep 14
Akouos, Inc. Receives FDA Clearance of Its IND Application for AK-OTOF, A Gene Therapy Intended for the Treatment of OTOF-Mediated Hearing Loss Akouos, 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. 
