Aytu BioPharma

What Aytu BioPharma does

Aytu BioPharma is a specialty pharmaceutical company focused on central nervous system (CNS) therapeutics, serving patients with major depressive disorder (MDD), attention deficit hyperactivity disorder (ADHD), and pediatric allergic and fluoride-deficiency conditions. The company's flagship asset is EXXUA (gepirone), a first-in-class selective serotonin 5HT1a receptor agonist FDA-approved in September 2024 and commercially launched in mid-December 2025 to address the over $22 billion U.S. prescription MDD market. EXXUA is protected by a method-of-use patent extending through September 2030, and the company completed full field sales force deployment in mid-January 2026 to drive adoption.

The company's commercial portfolio also includes the ADHD franchise (Adzenys XR-ODT, Cotempla XR-ODT, METADATE CD) acquired via the 2021 merger with Neos Therapeutics, plus a legacy pediatric portfolio (Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor). Distribution is supported by Aytu RxConnect, a patient access program operating through approximately 1,000 pharmacies nationwide that reduces out-of-pocket costs and improves adherence. International ADHD rights are out-licensed to Medomie Pharma (Israel/Palestinian Authority) and Lupin Pharma Canada.

Aytu generates revenue primarily through prescription pharmaceutical product sales in the United States, supplemented by international licensing royalties. Q3 FY2026 net revenue was $12.4 million, with quarterly revenues of $13.9M (Q1) and $15.2M (Q2) indicating a transitional period as legacy ADHD declines under generic competition and EXXUA ramps. The company has reported 11 consecutive quarters of positive adjusted EBITDA excluding EXXUA launch investments, holds $30.0 million in cash as of December 31, 2025, and is publicly traded on NASDAQ under ticker AYTU, with stockholders' equity of $35.1 million following an April 2026 warrant reclassification.

Name

Aytu BioPharma

Legal name

Aytu BioPharma, Inc.

Website

https://aytubio.com

Company type

Public

Founded year

2000

Operating status

Operating

Headcount range

101–250 employees

Short description

Aytu BioPharma is a specialty pharmaceutical company developing and commercializing central nervous system therapeutics, including EXXUA for major depressive disorder and an ADHD franchise, serving patients in the U.S. through a specialty field sales force and a 1,000-pharmacy patient access network.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals (CNS Therapeutics)

NAICS

Pharmacies and Drug Retailers (456110)

SIC

Pharmaceutical Preparations (2834)

akta.pro industry

PRIMARYHLAIACAC

Neurology & CNS Specialty Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Specialty Pharmaceuticals

SECONDARYHLAIAAAF

Neurology & Psychiatry (CNS) Pharmaceuticals

Healthcare & Life Sciences/Pharmaceuticals/Branded (Innovator) Pharmaceuticals

SECONDARYHLACAKAG

Specialty Pharmacy & Complex Therapy Management Platforms

Healthcare & Life Sciences/Digital Health & Health IT/ePrescribing, Medication Management & Pharmacy IT

Keywords

• Specialty pharmaceuticals
• CNS therapeutics
• Depression treatment drugs
• ADHD medications
• Patient access programs

Headquarters

HQ city

Denver

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Operations, Personnel, Marketing or Sales, Technology or R&D, Supply Chain

Revenue model

1. Pharmaceutical product sales: Revenue generated from sales of proprietary pharmaceutical products including EXXUA for MDD, ADHD treatments (Adzenys XR-ODT, Cotempla XR-ODT, METADATE CD), pediatric products (Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor). Products are sold through prescription-based distribution channels.
2. Licensing revenue: Out-licensing of ADHD brands to partners in markets outside the United States, including Medomie Pharma (Israel and Palestinian Authority) and Lupin Pharma Canada.

Go-to-market motion1 record

Distribution channels3 records

Marketing channels4 records

Core offering

Aytu BioPharma develops, manufactures, and commercializes FDA-approved prescription central nervous system (CNS) pharmaceuticals, anchored by EXXUA (gepirone), a first-in-class 5HT1a receptor agonist for major depressive disorder, and a portfolio of extended-release ADHD stimulants (Adzenys XR-ODT, Cotempla XR-ODT, Metadate CD). The company also markets a legacy pediatric portfolio (Karbinal ER, Poly-Vi-Flor, Tri-Vi-Flor) and operates the Aytu RxConnect patient access program connecting patients to approximately 1,000 pharmacies nationwide.

Product overview

Aytu BioPharma is a specialty pharmaceutical company with a portfolio of central nervous system (CNS) products organized into three main categories: (1) EXXUA, a first-in-class FDA-approved treatment for major depressive disorder launched in December 2025; (2) an ADHD Portfolio comprising ADZENYS XR-ODT, COTEMPLA XR-ODT, and METADATE CD, which are CNS stimulants for ADHD patients across different age groups; and (3) a legacy Pediatric Portfolio including Karbinal ER for allergic conditions and Poly-Vi-Flor/Tri-Vi-Flor for fluoride deficiency. The company also operates Aytu RxConnect, a patient access program that provides affordable access to its products through approximately 1,000 pharmacies nationwide.

Differentiator

Problem solved

Functional benefit

Brands

• EXXUA: First-in-class medication approved by FDA for treating major depressive disorder in adults; a selective serotonin 5HT1a receptor agonist
• Adzenys XR-ODT
• Cotempla XR-ODT
• Metadate CD
• Aytu RxConnect
• Karbinal ER
• Poly-Vi-Flor
• Tri-Vi-Flor

Products and services

• EXXUA™ (gepirone) extended-release tablets First-in-class FDA-approved selective serotonin 5HT1a receptor agonist for the treatment of major depressive disorder (MDD) in adults; gepirone extended-release tablet.
• ADZENYS XR-ODT® Central nervous system (amphetamine) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older; extended-release orally disintegrating tablet.
• COTEMPLA XR-ODT® Central nervous system (methylphenidate) stimulant indicated for the treatment of ADHD in patients 6 to 17 years of age; extended-release orally disintegrating tablet.
• METADATE® CD Central nervous system (methylphenidate) stimulant indicated for the treatment of ADHD in patients 6 to 15 years of age; extended-release capsule.
• Karbinal™ ER Prescription medication indicated to treat various allergic conditions including seasonal and perennial allergic rhinitis, vasomotor rhinitis, and other common allergic conditions.
• Poly-Vi-Flor® Prescription fluoride-based supplement product line containing combinations of vitamins and fluoride in various oral formulations, prescribed for infants and children to treat or prevent fluoride deficiency.
• Tri-Vi-Flor® Complementary prescription fluoride-based supplement product line containing combinations of vitamins and fluoride in various oral formulations, prescribed for infants and children to treat or prevent fluoride deficiency.
• Aytu RxConnect Patient access program that enables affordable, predictable patient access to Aytu's portfolio of products through approximately 1,000 pharmacies nationwide, supporting patients through their complex treatment journey.

Quantifiable outcome

• Over 1,300 prescriptions written by more than 450 unique prescribers within initial EXXUA launch period
• +2 more outcomes

Segments3 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Two partnerships are on record, tiered minor.

• Medomie PharmaminorChannel Partner/ Reseller/ DistributorLicensed rights to Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) to commercialize these ADHD products in Israel and the Palestinian Authority.
• Lupin Pharma CanadaminorChannel Partner/ Reseller/ DistributorLicensed rights to Adzenys XR-ODT (amphetamine) and Cotempla XR-ODT (methylphenidate) to commercialize these ADHD products in Canada.

Scale indicators10 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Axsome Therapeutics: Commercial-stage CNS specialty pharma with Auvelity, an FDA-approved novel-mechanism treatment for MDD. Directly comparable to Aytu given similar size, MDD focus, and novel-mechanism strategy targeting the same prescriber base.
• Sage Therapeutics: CNS-focused specialty pharma with FDA-approved treatments for major depressive disorder (Zurzuvae) and postpartum depression. Directly comparable given overlapping MDD therapeutic area and similar specialty pharma commercial model.
• Supernus Pharmaceuticals: Specialty pharma focused on CNS disorders including ADHD and epilepsy. Directly comparable product overlap in ADHD (Qelbree) and similar specialty pharma commercial model targeting psychiatrists and pediatricians.
• Corcept Therapeutics: Specialty pharma commercializing Korlym for Cushing's syndrome with pipeline in psychiatry. Comparable small-cap CNS-focused commercial model with single-asset revenue concentration and similar prescriber targeting.
• Intra-Cellular Therapies: Specialty pharma commercializing Caplyta for schizophrenia and bipolar depression. Directly comparable given CNS focus, novel-mechanism therapies, and overlap in depression/psychiatry prescriber base.
• Acadia Pharmaceuticals: CNS specialty pharma commercializing Nuplazid for Parkinson's disease psychosis with growing psychiatry franchise. Comparable mid-cap CNS specialty commercial model targeting overlapping physician specialties.

Broad incumbents

• ANI Pharmaceuticals: Specialty pharma with generics, brands, and rare disease portfolio. Comparable as a small-cap specialty pharma with mixed legacy and growth franchises, though broader therapeutic focus than Aytu.
• Jazz Pharmaceuticals: Large specialty pharma with significant CNS franchise (Xywav, Epidiolex, Sunosi). Comparable CNS commercial infrastructure and target prescriber base, though much larger scale and broader portfolio than Aytu.

Emerging players

• Tris Pharma: Private specialty pharma with ADHD and CNS pipeline including novel extended-release stimulant formulations. Comparable as a niche CNS/ADHD-focused company, though privately held and pre-IPO relative to Aytu.
• Cerevel Therapeutics: CNS-focused biotech with pipeline in schizophrenia, Parkinson's, and epilepsy. Comparable CNS therapeutic focus and novel-mechanism strategy, though still in earlier commercial stages than Aytu.

Market position

Competitive moat4 records

Key risks1 record

Key highlights7 records

Customer concentration

• Xtwitter.com/AytuBioPharma_
• Facebookfacebook.com/Aytu-BioPharma-1879831055582584
• LinkedInlinkedin.com/company/aytu-bioscience-inc-

Revenue estimate

Valuation estimate

Number of profiles

Profiles11 records

Subsidiaries2 records

Funding overview

Funding rounds7 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A3 records

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Aytu BioPharma