Aytu Biopharma, Inc. is a specialty pharmaceutical company, which engages in identifying, acquiring, and commercializing novel products. It operates through the Rx and Consumer Health segments. The RX segment consists of various prescription pharmaceutical products sold through third parties. The Consumer Health segment includes various consumer health products sold directly to consumers. Its products include Adzenys ER, Adzenys XR-ODT, Cotempla XR-ODT, Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor, Generic Tussionex, Tuzistra XR, and ZolpiMist. The company was founded on August 9, 2002 and is headquartered in Englewood, CO.
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- Aytu BioPharma announced a five-year patent extension for EXXUA (gepirone) through September 2, 2030, expanding beyond the FDA's new chemical entity exclusivity period. - EXXUA represents the first-in-class selective serotonin 5HT1a receptor agonist approved for major depressive disorder treatment in adults. - The company plans to commercially launch EXXUA in 2025 to address unmet needs for the estimated 21 million Americans affected by major depressive disorder. - CEO Josh Disbrow highlighted EXXUA's potential to address treatment-related sexual dysfunction and weight gain challenges associated with many current MDD therapies.
- Aytu BioPharma has secured exclusive US commercialization rights for EXXUA (gepirone), the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder in adults. - EXXUA demonstrated significant improvement in depression symptoms across clinical trials involving over 5,000 patients, with sexual side effects comparable to placebo rather than typical antidepressants. - The company plans to launch EXXUA in Q4 2025 to compete in the over $22 billion US prescription MDD market, targeting 21 million affected Americans. - The transaction was financed by healthcare-focused institutional investors including Nantahala Capital Management and Stonepine Capital Management.
- Aytu BioPharma completed an upsized public offering raising $16.6 million to commercialize EXXUA, the first FDA-approved selective serotonin 5HT1a receptor agonist for major depressive disorder. - EXXUA represents a breakthrough in depression treatment as it demonstrates comparable sexual side effects to placebo, addressing a major limitation of current antidepressants. - The company plans to launch EXXUA in Q4 2025 to compete in the $22 billion U.S. prescription major depressive disorder market. - Clinical trials involving over 5,000 patients showed significant improvement in depression symptoms with EXXUA's novel mechanism of action.
