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Aytu Biopharma Inc Stock Price, News & Analysis

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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) delivers innovative therapeutics addressing critical needs in urology and neurobehavioral health. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's prescription drug developments, regulatory milestones, and strategic initiatives.

Access timely announcements including FDA approvals, clinical trial results, financial disclosures, and partnership agreements. Our curated collection ensures you stay informed about AYTU's advancements in prostate cancer diagnostics, ADHD treatments, and operational efficiency programs.

Key updates cover prescription drug pipeline progress, market expansion efforts, and expert analyses of corporate developments. Bookmark this page for direct access to primary source materials and objective reporting on Aytu BioPharma's position in the specialty pharmaceuticals sector.

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Aytu BioPharma (NASDAQ:AYTU) announced the launch of the Phase 3 PREVEnt trial for enzastaurin (AR101), targeting patients with Vascular Ehlers-Danlos Syndrome (VEDS), a rare genetic condition. The trial, with over 30 sites across the US and Europe, aims to evaluate enzastaurin's efficacy in reducing serious arterial events. The FDA has granted a Safe to Proceed Letter, and approvals have been obtained in several European countries. Patient recruitment is underway, with the goal of dosing the first patient by early 2023.

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Aytu BioPharma announces the appointment of Vivian Liu to its board of directors, effective July 1, 2022. Liu, with extensive experience in biotechnology, is expected to bolster the company's focus on growth, particularly in developing therapeutics for rare diseases. CEO Josh Disbrow expressed confidence in Liu's ability to drive the company's strategic plans. Currently, Liu is Head of Corporate Affairs for PREMIA Holdings and has held leadership roles in several pharmaceutical companies. Aytu is focused on enhancing its therapeutic pipeline and expanding commercial operations.

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Aytu BioPharma (NASDAQ:AYTU) will participate in the Lytham Partners Summer 2022 Investor Conference on June 21-22, 2022. Aytu's webcast presentation is scheduled for 9:00 am ET on June 21 and will be available for replay on the company’s website. Management will also engage in virtual one-on-one meetings during the conference. Aytu focuses on developing novel therapeutics, including treatments for rare pediatric disorders and conditions like ADHD. Their pipeline includes AR101, aimed at Vascular Ehlers-Danlos Syndrome, which has received FDA Orphan Drug designation.

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Aytu BioPharma reported a 79% increase in quarterly net revenue, reaching $24.2 million, the highest in its history. Prescription revenue surged 170% year-over-year to $13.9 million. The company is focusing on enhancing financial performance, with plans to improve gross margins through manufacturing efficiencies. However, it recorded a net loss of $53.1 million primarily due to a $45.2 million impairment related to goodwill from the Neos acquisition. Cash reserves stand at $27.6 million as of March 31, 2022.

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Aytu BioPharma, Inc. (NASDAQ:AYTU) announced positive results from a preclinical study demonstrating the effectiveness of its Healight™ ultraviolet light endotracheal catheter in delaying ventilator-associated pneumonia (VAP) development in a porcine model. The study observed a 46% reduction in multidrug-resistant Pseudomonas aeruginosa after two treatments. Given that VAP carries a high mortality rate, this development addresses a significant clinical need. Aytu plans to pursue further studies to advance Healight’s potential treatment applications and report more data later in 2022.

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Aytu BioPharma, Inc. (NASDAQ:AYTU) announced that the FDA has granted Fast Track designation to AR101 (enzastaurin) for treating Vascular Ehlers-Danlos Syndrome (VEDS). This designation allows for expedited development and review, highlighting the need for treatments in this serious condition. The planned PREVEnt Trial will enroll approximately 260 patients to assess AR101's efficacy compared to standard care. With Orphan Drug designations in the US and Europe, Aytu aims to initiate patient dosing by late 2022 or early 2023.

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Aytu BioPharma announced the listing of its newly issued US patent No. 11,166,947 for Cotempla XR-ODT in the FDA's Orange Book, effective March 23, 2022. This patent covers pediatric dosing methods for treating ADHD with methylphenidate and extends the product's exclusivity through at least 2038. Cotempla XR-ODT, approved by the FDA in June 2017, serves children ages 6-17, offering a unique orally disintegrating tablet form. The CEO emphasized the importance of this patent in protecting the product as the ADHD medication market grows.

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Aytu BioPharma (NASDAQ:AYTU) announced its participation in the Cantor Fitzgerald Virtual Rare Orphan Disease Summit on March 29, 2022, at 11:00 a.m. ET. The panel will focus on managing clinical trials for rare diseases during and after COVID-19. Aytu is a pharmaceutical company dedicated to developing treatments for rare, pediatric-onset disorders. Their product line includes medications for ADHD and allergy treatment, and they are advancing their therapeutic pipeline, including AR101 for Vascular Ehlers-Danlos Syndrome, a condition with no existing treatments.

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Aytu BioPharma (NASDAQ:AYTU) announced that CFO Mark Oki and CCO Greg Pyszczymuka will participate in a fireside chat at the 34th Annual Roth Conference on March 15, 2022, at 2:00 p.m. PT in Dana Point, California. The conference runs from March 13-15. A live webcast will be accessible on the company’s website and archived for 90 days.

Aytu BioPharma specializes in developing therapeutics for rare pediatric disorders and offers prescription products for ADHD and allergy treatment, along with a pipeline drug, AR101, for vascular Ehlers-Danlos Syndrome.

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Aytu BioPharma announced the closing of an underwritten offering, raising $7.6 million through the sale of 3,030,000 shares of common stock and associated warrants. Each share and pre-funded warrant was priced at $1.25, with warrants exercisable for 1.1 shares at $1.30. The proceeds will support growth initiatives, including the PREVEnt Trial for AR101, aimed at treating vascular Ehlers-Danlos Syndrome. There is no public market for the pre-funded and common warrants. Canaccord Genuity and Roth Capital Partners facilitated the offering.

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FAQ

What is the current stock price of Aytu Biopharma (AYTU)?

The current stock price of Aytu Biopharma (AYTU) is $2.35 as of September 2, 2025.

What is the market cap of Aytu Biopharma (AYTU)?

The market cap of Aytu Biopharma (AYTU) is approximately 21.1M.
Aytu Biopharma Inc

Nasdaq:AYTU

AYTU Rankings

AYTU Stock Data

21.10M
8.21M
7.58%
38.09%
6.52%
Drug Manufacturers - Specialty & Generic
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