Welcome to our dedicated page for Aytu Biopharma news (Ticker: AYTU), a resource for investors and traders seeking the latest updates and insights on Aytu Biopharma stock.
Aytu BioPharma, Inc. develops and commercializes prescription medicines focused on complex central nervous system diseases. Its recurring company updates center on EXXUA (gepirone) extended-release tablets, an FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults, along with its ADHD products and legacy pediatric portfolio.
News from Aytu also covers operational and financial results, commercial launch activity, retail and Aytu RxConnect patient-access distribution, investor presentations, and product-level clinical and safety information for EXXUA. The company is a Nasdaq-listed specialty pharmaceutical issuer with prescription products sold through commercial distribution channels.
Aytu BioPharma (Nasdaq: AYTU) will host an Investor Day on January 20, 2026 at 11:00 a.m. ET in New York City, featuring presentations from senior leadership and discussions with Key Opinion Leaders (KOLs) about EXXUA (gepirone) extended-release tablets.
EXXUA is described as the first FDA-approved 5HT1a agonist for major depressive disorder (MDD). Commercial availability of EXXUA commenced earlier this week. The event includes a live Q&A and a webcast; the live and archived presentation will be available on Aytu's Investors website under Events & Presentations. In-person attendance requires advance registration via Aytu Investor Relations (aytu@lythampartners.com).
Aytu BioPharma (Nasdaq: AYTU) announced commercial availability of EXXUA (gepirone) extended-release tablets in the United States on December 15, 2025. EXXUA is described as the first and only 5HT1a agonist FDA-approved for the treatment of major depressive disorder (MDD) in adults.
The company says EXXUA showed significant improvement in depression symptoms across clinical trials involving more than 5,000 patients and reported no sexual dysfunction warnings and no clinically significant weight gain versus placebo. EXXUA is available through participating Aytu RxConnect pharmacies, with distribution through major U.S. wholesalers progressing to enable nationwide retail availability in the coming weeks.
Aytu BioPharma (Nasdaq: AYTU) announced management will present at NobleCon21 — Noble Capital Markets 21st Annual Emerging Growth Equity Conference in Boca Raton, FL.
The presentation is scheduled for Wednesday, December 3, 2025 at 10:30 AM ET. A high-definition webcast will be posted the following day on the company website and on Noble Conference and Channelchek, with the webcast archived for 90 days. Management will hold one-on-one investor meetings; scheduling via Noble representatives or aytu@lythampartners.com.
Aytu (Nasdaq:AYTU) reported Q1 fiscal 2026 results for the quarter ended September 30, 2025: total net revenue $13.9M, net income $2.0M (basic EPS $0.21), Adjusted EBITDA $(0.6)M, and $32.6M cash. The company said EXXUA (gepirone) extended-release tablets remain on track for a Q4 2025 commercial launch with initial shipments planned for December 2025 and sales force training and launch meeting scheduled through January 2026. A method-of-use patent for EXXUA was extended to Sept 2, 2030. Management highlighted ADHD portfolio stability and ongoing payer and KOL engagement ahead of launch.
Aytu BioPharma (Nasdaq: AYTU) will report its fiscal 2026 first quarter operational and financial results after market close on Thursday, November 13, 2025. A conference call and webcast to review results and host Q&A is scheduled the same day at 4:30 p.m. Eastern time. Interested parties can join by phone using US dial-in (888) 506-0062 or international +1 (973) 528-0011 with participant access code 240426. The live webcast and archived replay will be available at the provided webcaster link and on Aytu’s Investors site under Events & Presentations. A teleconference replay is available through November 27, 2025 via replay numbers and access code 53111.
Aytu BioPharma (Nasdaq: AYTU) announced that the U.S. method‑of‑use patent (U.S. Patent No. 7,538,116) for EXXUA (gepirone) extended‑release tablets was extended under 35 U.S.C. 156 through September 2, 2030. The extension supplements the NCE exclusivity previously granted by the FDA for gepirone, described as the first‑in‑class selective serotonin 5HT1a receptor agonist approved for treatment of major depressive disorder (MDD) in adults.
Management said EXXUA is on track for commercial launch in 2025 and that the company is discussing additional intellectual property and life‑cycle management options with its partner that may extend exclusivity beyond 2030. The release also cites an estimated 21 million Americans affected by MDD as the target patient population.
Aytu BioPharma (NASDAQ:AYTU) announced that management will participate in two investor conferences in October 2025.
Events: Maxim Growth Summit on October 22, 2025 in New York City, and Planet MicroCap Showcase: TORONTO 2025 on October 22–23, 2025 in Toronto. The Planet MicroCap presentation is scheduled for 2:30 p.m. ET and will be available via webcast.
Investor access: Investors may schedule one-on-one meetings by contacting their Maxim sales representative or Robert Blum of Lytham Partners at aytu@lythampartners.com. Registration is required to attend the Planet MicroCap Showcase and the webcast link is provided for remote viewing.
Aytu BioPharma (Nasdaq:AYTU), a pharmaceutical company specializing in innovative medicines for complex central nervous system diseases, has announced its participation in two upcoming investor conferences in September 2025.
Management will present at the MicroCap Rodeo Fall Conference in New York City on September 25, 2025, at 2:00 PM ET, and at the virtual Lytham Partners Fall 2025 Investor Conference on September 30, 2025, at 2:45 PM ET. Both presentations will be available via webcast, and management will conduct one-on-one meetings during both events.
Aytu BioPharma (NASDAQ:AYTU) reported its fiscal 2025 results with net revenue of $66.4 million, a 2% increase from fiscal 2024. The company posted a net loss of $13.6 million and adjusted EBITDA of $9.2 million, with a strong cash position of $31.0 million as of June 30, 2025.
The company's ADHD Portfolio generated $57.6 million in revenue, while the Pediatric Portfolio contributed $8.8 million. A significant highlight is Aytu's exclusive agreement to commercialize EXXUA, a novel first-in-class treatment for major depressive disorder (MDD), with launch planned for Q4 2025 targeting the $22 billion U.S. MDD market.
Aytu BioPharma (NASDAQ:AYTU), a pharmaceutical company specializing in innovative medicines for complex central nervous system diseases, has scheduled its fiscal 2025 full year and fourth quarter financial results announcement for September 23, 2025, after market close.
The company will host a conference call and webcast at 4:30 p.m. Eastern time on the same day, featuring a results review and Q&A session. The call will be accessible via phone and webcast, with replay available until October 7, 2025.