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. (AYTU) is a Nasdaq-listed pharmaceutical company focused on advancing medicines for complex central nervous system diseases, with an emphasis on major depressive disorder (MDD) and attention deficit-hyperactivity disorder (ADHD). Its news flow reflects this focus, highlighting commercial progress, clinical positioning and corporate developments around its prescription portfolio.
A central theme in Aytu’s recent news is EXXUA (gepirone) extended-release tablets, a novel oral selective serotonin 5HT1a receptor agonist indicated for the treatment of MDD in adults. Company announcements have covered the commercial availability of EXXUA in the United States, its status as the first and only 5HT1a agonist approved by the U.S. Food and Drug Administration for MDD, and integration of EXXUA distribution into Aytu’s RxConnect patient access platform.
Investors following AYTU news will also see updates on the company’s ADHD Portfolio and Pediatric Portfolio performance, including revenue trends and commentary from management in quarterly operational and financial results. Aytu’s press releases discuss net revenue by portfolio, gross profit, adjusted EBITDA and investments related to the EXXUA launch.
In addition, Aytu regularly announces participation in investor conferences, healthcare summits and dedicated Investor Day events. These items often feature presentations by senior management and key opinion leaders in psychiatry, focusing on EXXUA’s clinical profile, market opportunity and the company’s broader CNS strategy. For investors and observers, the AYTU news page provides a centralized view of product launches, patent developments, financing updates and ongoing investor outreach activities.
Aytu (Nasdaq: AYTU) reported Q2 fiscal 2026 net revenue of $15.2M, adjusted EBITDA of $(0.8)M, and a $30.0M cash balance at December 31, 2025. The company launched EXXUA (gepirone) in mid-December 2025 as its commercial centerpiece targeting the >$22B U.S. MDD market.
Q2 results included a $10.6M net loss (driven by an $8.2M derivative warrant liability loss), initial EXXUA stocking revenue of $0.2M, and gross margin of 63%.
Aytu BioPharma (Nasdaq: AYTU) will report its fiscal 2026 second quarter operational and financial results after market close on Tuesday, February 3, 2026. The company will host a conference call and live webcast the same day at 4:30 p.m. Eastern time followed by a Q&A session.
Call-in numbers: (888) 506-0062 (U.S.) and +1 (973) 528-0011 (international) using participant access code 567381. The webcast will be available live and archived at the provided webcast link and on the Investors section of the company website under Events & Presentations. A teleconference replay will be available through February 17, 2026 at (877) 481-4010 (U.S.) or +1 (919) 882-2331 (international) using replay access code 53322.
Aytu BioPharma (Nasdaq:AYTU) held Investor Day on January 20, 2026 focused on EXXUA (gepirone) ER, the first FDA‑approved 5HT1a agonist for major depressive disorder (MDD) that launched commercially on December 15, 2025. Management reviewed pivotal Phase 3 results showing statistically significant HAM‑D17 improvement versus placebo (placebo‑subtracted differences of −2.47 and −2.45 at Week 8) and safety data from ~1,976 MDD patients. Company highlighted market opportunity (US MDD market > $22B), full national distribution, early prescription uptake, expected EXXUA gross margin of 66–68%, and key commercialization economics including a 28% base royalty and upfront payments tied to Fabre‑Kramer agreement.
Aytu BioPharma (Nasdaq:AYTU) launched EXXUA (gepirone) nationwide on January 20, 2026, following completion of launch training. EXXUA is the first FDA‑approved selective 5‑HT1A agonist for treatment of major depressive disorder in adults and is available through retail and participating Aytu RxConnect pharmacies.
The company positions EXXUA as a once‑daily monotherapy that selectively targets 5‑HT1A receptors while minimizing activity at serotonin receptors tied to sexual dysfunction and weight gain, side effects that the release says commonly drive treatment discontinuation.
Aytu BioPharma (Nasdaq: AYTU) announced that CEO Josh Disbrow will participate in a fireside chat at the Lytham Partners 2026 Investor Healthcare Summit on January 15, 2026 at 5:00 p.m. ET. The session is moderated by Thomas Flaten, senior research analyst at Lake Street Capital Markets.
The event will be available via webcast at https://lythampartners.com/hc2026/aytu and on the conference home page, with a replay accessible through the same links.
Aytu BioPharma (Nasdaq: AYTU) will hold an Investor Day on January 20, 2026 at 11:00 a.m. ET in New York City with a live webcast and archived replay available on the company's Investors site. The program will focus on EXXUA (gepirone) extended-release tablets, the first FDA-approved 5-HT1A agonist for major depressive disorder, and will feature presentations from KOLs and Aytu management followed by live Q&A.
In-person attendance requires advance registration via aytu@lythampartners.com.
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.