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Atossa Therapeutics Announces Issuance of U.S. Patent Covering Enteric Oral (Z)-Endoxifen Formulations and Methods of Treating Patients Using (Z)-Endoxifen

1. Atossa received a new patent for (Z)-endoxifen formulations. 2. The patent reinforces Atossa's position in treating breast cancer. 3. Atossa is advancing (Z)-endoxifen in several clinical settings. 4. The patent includes 100 claims for various formulations and uses. 5. Strong IP portfolio crucial for late-stage trials and commercialization.

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FAQ

Why Bullish?

The patent strengthens Atossa's competitive position, similar to past successful drug approvals that boosted prices.

How important is it?

The patent enhances Atossa's market potential, directly influencing investor sentiment and future profits.

Why Long Term?

Long-term growth expected as patent exclusivity supports market position and clinical advancements.

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Atossa Therapeutics Strengthens Patent Portfolio with New Issuance

Atossa Therapeutics, Inc. (Nasdaq: ATOS), a biopharmaceutical company focused on innovative therapies for breast cancer, has announced a significant development in its intellectual property landscape. The United States Patent and Trademark Office (USPTO) has granted U.S. Patent No. 12,479,790 B2, which is dedicated to enteric oral formulations of (Z)-endoxifen and methods for treating hormone-dependent breast disorders.

Details of the New Patent

This newly issued patent comprises 100 claims that target highly pure formulations of (Z)-endoxifen. These claims cover:

  • Enteric oral formulations of (Z)-endoxifen free base
  • Specific solid oral dosage forms
  • Stable formulations ensuring sustained systemic exposure to (Z)-endoxifen

According to Dr. Steven Quay, President and CEO of Atossa, “This patent meaningfully extends and reinforces our already robust endoxifen patent estate. By covering both scalable manufacturing processes and key methods of use, this patent supports our long-term strategy to position (Z)-endoxifen as a differentiated therapy across the breast cancer spectrum.”

Strategic Implications for Atossa

The issuance of this patent is pivotal as Atossa prepares for late-stage clinical trials, reinforcing its commitment to developing (Z)-endoxifen for various breast cancer indications, including:

  • Metastatic Breast Cancer (MBC): A dose-ranging study is in preparation for registrational development.
  • Neoadjuvant ER+/HER2- Breast Cancer: Ongoing enrollment and data generation in the Phase 2 EVANGELINE trial.
  • Breast Cancer Risk-Reduction: A low-dose strategy aimed at reducing mammographic breast density and overall breast cancer risk.

About (Z)-Endoxifen

(Z)-endoxifen stands out as one of the most potent selective estrogen receptor modulators (SERMs). This compound not only inhibits estrogen receptors but also may promote their degradation. It has been effective in instances where tumors have resisted other hormonal therapies, demonstrating its versatility in treating various estrogen-related conditions.

Company Overview

Atossa Therapeutics, Inc. (Nasdaq: ATOS) is dedicated to addressing significant unmet needs in breast cancer treatment through innovative pharmacological interventions. The company's leading candidate, (Z)-endoxifen, represents a breakthrough in the breast cancer continuum, offering new hope for patients at different stages of the disease.

Forward-Looking Statements

This announcement includes "forward-looking statements" that are subject to risks and uncertainties affecting Atossa's future operations. Various factors could cause actual results or milestones to differ significantly from those anticipated, including the ability to implement effective clinical strategies and secure regulatory approvals for (Z)-endoxifen.

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