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Akouos (NASDAQ: AKUS) announced that the FDA granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation (RPDD) for its gene therapy, AK-OTOF, aimed at treating otoferlin gene-mediated hearing loss. This condition, affecting approximately 20,000 individuals in the U.S. and Europe, results in severe-to-profound hearing loss. Akouos plans to submit an investigational new drug application in H1 2022. The designations may facilitate faster development and offer market exclusivity, tax credits, and potential priority review vouchers, enhancing AK-OTOF's clinical prospects.
Akouos (NASDAQ: AKUS), a precision genetic medicine company, announced that Dr. Manny Simons, its founder and CEO, will participate in a fireside chat at the 20th Annual Needham Virtual Healthcare Conference on April 14 at 4:30 p.m. ET. A live webcast will be available on the company's website. The replay will be accessible for 14 days post-conference. Akouos focuses on developing gene therapies aimed at restoring hearing for those with disabling hearing loss globally.
Akouos, a genetic medicine company, reported significant progress in 2020, including ongoing IND-enabling studies for its gene therapies AK-OTOF and AK-antiVEGF. Despite recent third-party manufacturing delays pushing the AK-OTOF IND submission to the first half of 2022, cash reserves of $308 million will fund operations for at least two years. R&D expenses rose to $34.3 million for the year, with a net loss of $48.6 million. The team expanded to 67 members, enhancing capabilities in gene therapies for hearing loss.
Akouos, a precision genetic medicine company, has launched the Resonate program in partnership with Blueprint Genetics to provide free genetic testing for individuals with auditory neuropathy. This initiative aims to identify the genetic causes of disabling hearing loss, enhancing understanding for affected individuals and healthcare providers. As genetic therapies are developed, accurate genetic diagnoses may improve eligibility for new treatments. The program is available in the US, offering a comprehensive testing approach with no cost to participants or their insurers.
Akouos (NASDAQ: AKUS) is a precision genetic medicine company focused on developing gene therapies for individuals with disabling hearing loss. On November 23, 2020, CEO Manny Simons participated in a pre-recorded fireside chat for the Piper Sandler 32nd Annual Virtual Healthcare Conference scheduled for December 1-3, 2020. The chat will be available for on-demand viewing on Akouos's website starting today and for 14 days following the conference.
Founded in 2016 and headquartered in Boston, Akouos aims to restore high-acuity hearing using its proprietary gene therapy platform.
Akouos, a precision genetic medicine company, reported Q3 2020 results and highlighted advancements towards a 2021 IND submission for its gene therapy AK-OTOF aimed at treating OTOF-mediated hearing loss. Notable leadership changes include the appointment of Sachiyo Minegishi as CFO and Jennifer Wellman as COO. The company has significantly improved its cash position to $320.1 million and is building internal manufacturing capabilities to support clinical trials. However, R&D and G&A expenses have increased substantially, contributing to a net loss of $13.1 million for the quarter.
Akouos, a precision genetic medicine company, announced that its CEO, Manny Simons, will present at two virtual investor conferences in October 2020. The first is the Jefferies Gene Therapy/Editing Summit on October 1, and the second is the Chardan Annual Genetic Medicines Conference on October 5. Both events will feature fireside chats. Live webcasts will be accessible via the company's website, with replays available for 14 days post-conference. Akouos focuses on gene therapies aimed at restoring hearing for individuals with disabling hearing loss.
Akouos, a genetic medicine company focused on hearing loss, reported Q2 2020 financial results, highlighting a strong cash position post-IPO. The company raised $244.4 million in gross proceeds in June, enhancing its capacity to advance its lead product candidate, AK-OTOF, targeting OTOF gene mutations. As of June 30, 2020, cash reserves totaled $333 million. R&D expenses rose to $9.9 million due to new studies and increased staffing. The net loss for the quarter was $12.5 million, up from $2 million a year prior. Akouos expects its cash reserves to sustain operations over the next two years.
Akouos, a precision genetic medicine company, closed its initial public offering of 14,375,000 shares at $17.00 per share, raising $244.4 million before underwriting discounts and commissions. The offering included 1,875,000 shares from underwriters' options. Trading on Nasdaq under the ticker AKUS began on June 26, 2020. BofA Securities, Cowen, and Piper Sandler managed the offering, with SEC registration effective June 25, 2020. Akouos focuses on gene therapies for high-acuity hearing restoration, leveraging a proprietary AAV vector library.
Akouos has priced its initial public offering of 12,500,000 shares at $17.00 per share, totaling gross proceeds of $212.5 million before fees. The offering is set to close around June 30, 2020, pending customary conditions. Additionally, the underwriters have an option to purchase 1,875,000 more shares. Trading on the Nasdaq under the ticker symbol AKUS begins on June 26, 2020. BofA Securities, Cowen, and Piper Sandler are leading the offering. Akouos focuses on gene therapies for disabling hearing loss, leveraging a proprietary adeno-associated viral vector platform.
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