Aytu Biopharma, Inc. (AYTU) stock plunged 3.57% in the current-market trading session at the price of $1.65 following the FDA clearance of IND application for AR101/Enzastaurin. 

AYTU is a specialty pharmaceutical firm with an emerging portfolio of prescription therapeutics and customer health products. Its primary pharmaceutical products treat attention deficit hyperactivity disorder and other pediatric diseases. 

FDA Clearance of IND Application for AR101/Enzastaurin 

On 13th December 2021, AYTU announced that FDA had cleared the Investigational New Drug application for AR101/enzastaurin. The clearance has enabled the company to initiate a clinical trial for AR101 to treat vascular Ehlers-Danlos Syndrome. Aytu BioPharma intends to start the PREVEnt Trial in VEDS by the first half of 2022. The PREVEnt Trial will evaluate the safety and effectiveness of enzastaurin in VEDS patients. Currently, there are no FDA-approved therapeutics for vascular Ehlers-Danlos Syndrome.  

Management Comments  

Chief executive officer of AYTU, Josh Disbrow, remarked that the FDA’s clearance of the AR101 IND is a significant initiative for VEDS patients. This clearance will be helpful in the clinical study in VEDS, a rare genetic disease with no approved treatment. The entire team will start working on this pivotal clinical trial as soon as possible, he added. 

Mr. Josh thanked the scientific advisory committee and regulatory advisors for their help and contribution. The company is now well-positioned to initiate the PREVEnt Trial by the first half of 2022. AYTU looks ahead to focus on next step of trial to help patients in their fight against this disease, he concluded.  

AYTU Acquired Orphan Drug Designation for AR101 

On 8th December 2021, AYTU announced that it had received Orphan Drug designation for AR101/enzastaurin to treat Ehlers-Danlos Syndrome. Aytu BioPharma expects to initiate the PREVEnt Trial of AR101 for VEDS patients by the first half of 2022. VEDS is a genetic disorder commonly diagnosed during childhood and characterized by bowel rupture, rupture of the gravid uterus, and arterial aneurysm. FDA grants Orphan Drug designation status to those medicines that provide safe and effective treatment of rare diseases that affect less than 200,000 people. 


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