AYTU News & Events

Reports Q2 revenue $15.2M vs. $16.2M last year. Revenue was impacted by a deemphasis in marketing for the ADHD and pediatric portfolios as the company shifted focus to the launch of EXXUA. Reports ADHD portfolio net revenue $13.2M vs. $13.8M last year. "This is a truly momentous time for Aytu as we commercially launched EXXUA, the first and only 5HT1a agonist approved by the FDA for the treatment of MDD, representing a new way to treat MDD," said CEO Josh Disbrow.

Aytu BioPharma announced the nationwide commercial launch of EXXUA and completion of its launch meeting last week that finalized sales training and launch preparations for EXXUA, the first and only selective 5-HT1A agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder in adults, representing a new way to treat MDD. EXXUA is a once-daily monotherapy with a unique mechanism of action that selectively targets 5-HT1A receptors, important regulators of mood and emotion while minimizing activity at serotonin receptors linked to side effects such as sexual dysfunction and weight gain that are common with many first-line antidepressants. EXXUA is only approved for use in adults. Antidepressants increase the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies.

Aytu BioPharma announced the commercial availability of EXXUA in the United States. EXXUA is the first and only 5HT1a agonist approved by the United States Food and Drug Administration for the treatment of major depressive disorder, representing a new way to treat MDD. The immediate availability of EXXUA through participating Aytu RxConnect pharmacies enables patients and prescribers the ability to access EXXUA through Aytu's best-in-class patient access program, Aytu RxConnect. In parallel, distribution through all major United States wholesalers is progressing to enable nationwide availability across all pharmacy retailers in the coming weeks.

Aytu BioPharma announced that the method of use patent for EXXUA extended-release tablets has been extended through September 2, 2030 under 35 U.S.C. 156. The patent extension further expands upon the new chemical entity exclusivity period granted by the United States Food and Drug Administration. Gepirone is an NCE, and EXXUA is the first-in-class selective serotonin 5HT1a receptor agonist approved by the FDA for the treatment of major depressive disorder in adults.