Aytu BioPharma announced the commercial launch of EXXUA (gepirone) on December 15, 2025, making the drug the first FDA‑approved 5HT1a agonist for adults with major depressive disorder (MDD). The launch positions Aytu in a $22 billion U.S. MDD market, a significant expansion beyond its profitable ADHD portfolio.
EXXUA’s clinical data come from a 5,000‑patient program that demonstrated a clinically meaningful reduction in depressive symptoms without the sexual dysfunction or clinically significant weight gain that are common with SSRIs and SNRIs. The safety profile is a key differentiator that could attract prescribers and patients seeking alternatives to existing antidepressants.
The drug is distributed through Aytu’s proprietary RxConnect pharmacy network, a platform that has already proven effective for its ADHD products. By leveraging RxConnect, Aytu can accelerate market penetration and secure patient access while maintaining control over the supply chain. Nationwide retail availability is expected to roll out in the coming weeks as the company expands its distribution footprint.
Financially, Aytu’s Q3 2025 results underscored the company’s turnaround: net revenue rose 32% YoY to $18.5 million, driven by a 25% increase in the ADHD portfolio and a 77% jump in the pediatric segment. Net income reached $4.0 million ($0.21 per diluted share), a shift from a loss in the prior year, and adjusted EBITDA climbed to $3.9 million from $0.9 million. Cash and cash equivalents stood at $18.2 million as of March 31, 2025, providing a solid financial foundation for the new launch.
CEO Josh Disbrow highlighted the launch as a “significant milestone” and emphasized EXXUA’s novel mechanism and favorable side‑effect profile. He noted that the drug’s availability “opens a new growth avenue for Aytu in a large, underserved market.” Market reaction was positive, with analysts citing the product’s differentiation and the company’s proven distribution platform as key drivers of investor confidence.
The launch signals a strategic pivot toward CNS therapeutics and positions Aytu to capture a meaningful share of the MDD market. With a strong financial base, a differentiated product, and an established distribution network, the company is well‑placed to translate the launch into sustained revenue growth and further strengthen its competitive position in the mental health space.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.