DENVER- Aytu BioPharma, Inc. (NASDAQ:AYTU) announced Monday the commercial availability of EXXUA in the United States for the treatment of major depressive disorder (MDD). The small-cap biotech, with a market capitalization of just $23.43 million, has seen its shares surge 59.72% over the past year according to InvestingPro data.
EXXUA is the first and only 5HT1a agonist approved by the FDA for MDD treatment, representing a new approach to treating the condition that affects an estimated 21 million Americans.
The medication is immediately available through participating Aytu RxConnect pharmacies, with distribution through major U.S. wholesalers underway to enable nationwide availability across pharmacy retailers in the coming weeks.
According to the company, EXXUA demonstrated significant improvement in depression symptoms in clinical trials involving more than 5,000 patients. The drug notably has no warnings or adverse events related to sexual dysfunction and no clinically significant weight gain compared to placebo.
“EXXUA represents a truly unique approach to treating MDD, offering a novel mechanism of action and distinctive clinical profile – including the absence of reported sexual side effects in clinical trials,” said Josh Disbrow, Chief Executive Officer of Aytu.
The medication carries a boxed warning, as do other antidepressants, regarding increased risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. EXXUA is not approved for use in pediatric patients.
Other serious side effects may include QT prolongation, which can cause irregular heartbeats, serotonin syndrome when taken with certain other medicines, and manic episodes in people with bipolar disorder.
The company stated that ensuring patient access to EXXUA remains a top priority, with efforts focused on making the therapy both affordable and widely available through its patient access program.
This announcement is based on a press release statement from Aytu BioPharma.
In other recent news, Aytu BioPharma reported its first-quarter earnings for 2025, revealing a net revenue of $13.9 million, a decrease from $16.6 million year-over-year. Despite this decline, the revenue exceeded both Ascendiant Capital’s estimate of $12.6 million and the consensus expectation of $12.4 million.
The company’s pro forma earnings per share were $(0.08), surpassing the consensus estimate of $(0.23) but falling short of Ascendiant’s estimate of $(0.06). Following these results, Ascendiant Capital raised its price target for Aytu BioPharma from $12.50 to $13.00, maintaining a Buy rating. Additionally, Aytu BioPharma highlighted the upcoming launch of Exxua, a new antidepressant, as part of its strategic focus on operational efficiency. These developments reflect the company’s efforts to navigate financial challenges while pursuing growth opportunities.
