Aytu BioPharma (AYTU) Rises and Falls on News
Early today, Aytu BioPharma announced Fast Track Designation to AR101 for the treatment of Vascular Ehlers-Danlos Syndrome. As the news released, the stock surged around 25%. But, the stock fell throughout the day, and closed at $0.80, down 9.38%.
Aytu BioPharma is a pharmaceutical company focused on developing and commercializing novel therapeutics and is located in the PRISM MedDiagnostics Index, which is up 1.3% for the day.
Josh Disbrow, the CEO of Aytu stated “We are pleased that AR101 has received FDA Fast Track designation as it highlights the significant need for new treatment options for patients diagnosed with VEDS, a serious, life-shortening condition for which there are no approved treatments today. Receipt of Fast Track designation enables more frequent interaction with the FDA throughout the AR101 development process, along with a shorter review timeframe. With this important designation now in hand, we are focused on getting the operational elements of the pivotal PREVEnt study of AR101 in place such that we can initiate it as quickly as possible, with plans to begin patient dosing by late 2022 or early 2023.”
About Aytu BioPharma, Inc.
Aytu BioPharma is a pharmaceutical company with a portfolio of commercial prescription therapeutics and consumer health products, and a growing therapeutics pipeline focused on treating rare, pediatric-onset disorders. The company’s prescription products include Adzenys XR-ODT® (amphetamine) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) and Cotempla XR-ODT® (methylphenidate) extended-release orally disintegrating tablets (see Full Prescribing Information, including Boxed WARNING) for the treatment of attention deficit hyperactivity disorder (ADHD), as well as Karbinal® ER (carbinoxamine maleate), an extended-release carbinoxamine (antihistamine) suspension indicated to treat numerous allergic conditions, and Poly-Vi-Flor® and Tri-Vi-Flor®, two complementary fluoride-based prescription vitamin product lines containing combinations of fluoride and vitamins in various formulations for infants and children with fluoride deficiency. Aytu is also building a therapeutic pipeline, which includes AR101 (enzastaurin), a PKCβ inhibitor in development for the treatment of vascular Ehlers-Danlos Syndrome (VEDS). VEDS is a rare genetic disease typically diagnosed in childhood resulting in high morbidity and a significantly shortened lifespan, and for which there are no currently approved treatments. AR101 has received Orphan Drug designation and Fast Track designation from the U.S. Food and Drug Administration and has received Orphan Drug designation from the European Medicines Agency. To learn more, please visit aytubio.com.