In its Thursday trading session, Akouos Inc. (NASDAQ: AKUS) rose by 8.08%, or $1.16, compared with its previous market close price. The lowest price the Akouos stock touched during the day was $14.37, while the day’s peak was $15.95.
Based on Barchart’s data, AKUS closed at $14.36 during the previous trading session, while the volume traded was 88075.0. The AKUS stock has soared as this week the company announced a couple of positive developments with respect to its leading candidate.
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What were the recent moves?
Acouos is committed to bringing the benefits of genomic medicine to people around the world who suffer from hearing loss by developing gene therapies which could be used to restore, improve, and preserve high-acuity physiologic hearing.
AKUS has developed a precise genetic therapy platform that integrates a proprietary AAV vector library and a novel delivery strategy that allow it to develop precision therapies for various forms of sensory-nerve degeneration.
This week AKUS announced that its lead product, AK-OTOF was granted Orphan Drug Designation (ODD) as well as Rare Pediatric Disease Designation (RPDD) by the U.S. Food and Drug Administration (FDA).
AK-OTOF is a gene therapy meant for patients who already have otoferlin gene-mediated hearing loss. An investigational new drug application (IND) for AK-OTOF is expected to be submitted during the first half of 2022 by AKUS.
What does this mean for AKUS?
Being designated an ODD allows AKUS to qualify for a number of benefits, including seven years of post-approval market exclusivity, assistance in the drug development process, tax credits for clinical testing, and exemptions from FDA fees.
Under the Priority Review Voucher program, Akouos (AKUS) may be eligible to receive a voucher in case FDA approves AK-OTOF to treat OTOF-mediated hearing loss. By redeeming the voucher, AKUS may request priority review for a new marketing application for another product or it may sell the voucher to another sponsor.