Aytu Biopharma Inc Stock Price, News & Analysis

Denovo Biopharma announced that its partner Aytu BioPharma (Nasdaq: AYTU) has received FDA clearance for its IND application for enzastaurin and Orphan Drug Designation (ODD) for treating Vascular Ehlers-Danlos Syndrome (VEDS). The IND clearance allows Aytu to initiate the PREVEnt Trial in VEDS in 2022, evaluating enzastaurin's safety and efficacy. ODD status provides financial incentives and potential market exclusivity for the drug. VEDS is a severe condition affecting 1 in 50,000 people worldwide, with no FDA-approved therapies available.

Aytu BioPharma (NASDAQ:AYTU) announced FDA clearance of the IND application for AR101 (enzastaurin), allowing the initiation of the pivotal PREVEnt Trial for treating vascular Ehlers-Danlos Syndrome (VEDS). The trial aims to assess the safety and efficacy of enzastaurin in patients with confirmed COL3A1 mutations. Currently, there are no FDA-approved therapies for VEDS, affecting 1 in 50,000 individuals. The trial, set to begin in the first half of 2022, expects to enroll about 260 patients and will focus on reducing fatal and non-fatal arterial events.

Aytu BioPharma (NASDAQ:AYTU) announced the U.S. FDA has granted Orphan Drug designation to AR101 (enzastaurin) for treating vascular Ehlers-Danlos Syndrome (VEDS), a rare genetic disorder with no FDA-approved treatments. This designation allows for financial incentives and potential market exclusivity. The company plans to initiate the pivotal PREVEnt Trial for AR101 in early 2022, aimed at addressing the unmet medical needs of VEDS patients. CEO Josh Disbrow emphasized the significance of this milestone for future therapeutic developments.

Aytu BioPharma has received a U.S. patent for its Healight ultraviolet-A light-based respiratory catheter, enabling treatment of infectious conditions via a UV-light-emitting delivery tube. Patent Number 11,179,575, extending to August 2040, covers innovative methods of internal treatment. CEO Josh Disbrow highlighted the patent's broad implications, allowing applications beyond endotracheal use. The Healight device aims to treat severe respiratory infections, specifically targeting SARS-CoV-2, and shows promising results in small clinical studies.

Aytu BioPharma, Inc. (NASDAQ:AYTU) announced its recognition as the 178th fastest-growing company in North America by the Deloitte Technology Fast 500, demonstrating a remarkable 758% growth from 2017 to 2020. This accolade reflects Aytu's evolution into a fully integrated pediatric-focused specialty pharmaceutical company. CEO Josh Disbrow highlighted the company's strategic milestones and ongoing commitment to developing innovative therapeutic solutions. Aytu's commercial portfolio includes treatment for ADHD and other pediatric conditions, along with a developing pipeline for rare diseases.

Aytu BioPharma reported a strong fiscal Q1 2022, with net revenues of $21.9 million, a 62% increase year-over-year. The company experienced a significant rise in prescription revenues, particularly in its ADHD product line, which grew 140%. Despite this growth, Aytu posted a net loss of $27.9 million, largely due to a $19.5 million impairment expense. Aytu ended the quarter with $40.6 million in cash and plans a pivotal study for AR101 in VEDS, expected to start in early 2022.

Aytu BioPharma (NASDAQ:AYTU) announced a conference call on November 15, 2021, at 4:30 p.m. ET for reviewing its first quarter fiscal 2022 results and discussing its business strategy. The company will also file its Form 10-K after market close on the same day. The call can be accessed via toll-free and international numbers, with a replay available for fourteen days. Aytu specializes in therapeutics for ADHD and has a growing product portfolio, including treatments for pediatric conditions.

Aytu BioPharma reported a 74% sequential increase in net revenue to $23.5M for the fourth quarter and 138% year-over-year growth to $65.6M for fiscal 2021. The company ended the quarter with approximately $50M in cash. A pivotal study for AR101, targeting Vascular Ehlers-Danlos Syndrome, is set to begin in early 2022. The merger with Neos Therapeutics is expected to generate $15M in annual synergies. However, the company reported a net loss of $19M in Q4 and $58.3M for the year due to acquisition-related expenses and impairment charges.