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Positive FDA Feedback and Promising Phase 2 Results Justify Buy Rating for Atossa Therapeutics

Positive FDA Feedback and Promising Phase 2 Results Justify Buy Rating for Atossa Therapeutics

Analyst Emily Bodnar from H.C. Wainwright maintained a Buy rating on Atossa Therapeutics and keeping the price target at $7.00.

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Emily Bodnar has given her Buy rating due to a combination of factors surrounding Atossa Therapeutics’ progress with their Z-endoxifen drug. The company has received positive feedback from the FDA, which supports their clinical development plans for Z-endoxifen in treating metastatic ER+/HER2- breast cancer. This endorsement from the FDA not only validates Atossa’s strategy but also eliminates the need for further preliminary meetings, indicating a strong alignment with regulatory expectations.
Additionally, Atossa has reported promising results from their Phase 2 pilot study, showing significant reductions in the Ki-67 biomarker and tumor volume, alongside a well-tolerated safety profile with no serious adverse events. The granting of a new US patent for Z-endoxifen’s oral formulations further strengthens the drug’s market potential by enhancing its purity, stability, and bioavailability. These developments, coupled with plans to file an IND by 4Q25 and commence patient dosing shortly thereafter, underpin the positive outlook and justify the Buy rating.

In another report released on July 30, Craig-Hallum also maintained a Buy rating on the stock with a $4.00 price target.

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