Aytu BioPharma stock soars 25% on FDA fast track status to AR101 for rare disease

Apr. 19, 2022 8:41 AM ETAytu BioPharma, Inc. (AYTU)By: Ravikash, SA News Editor1 Comment

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  • The U.S. Food and Drug Administration (FDA) granted fast track designation to Aytu BioPharma's (NASDAQ:AYTU) AR101 to treat patients with Vascular Ehlers-Danlos Syndrome (VEDS).
  • The company said it will evaluate AR101 (enzastaurin) in a trial called PREVEnt, which is expected to enroll ~260 COL3A1-positive patients with VEDS.
  • Ehlers-Danlos syndromes (EDS) are a group of rare inherited conditions which affect connective tissue. VEDS affects blood vessels and internal organs, that can cause them to split open and cause life-threatening bleeding.
  • The study will assess time to arterial events leading to intervention among patients treated with AR101 compared to patients treated with standard of care.
  • "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," said Aytu CEO Josh Disbrow.
  • The company noted that AR101 has already received orphan drug designation in the U.S. and Europe.
  • AYTU +24.82% to $1.14 premarket April 19
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