H.C. Wainwright Reiterates Buy Rating on Atossa Genetics (ATOS)

H.C. Wainwright analyst Emily Bodnar reiterated a Buy rating and $7.00 price target on Atossa Genetics (NASDAQ: ATOS).

The analyst commented: "This morning, Atossa provided a high level overview of its plans to advance Z-endoxifen (Z-endox) across the breast cancer (BC) treatment continuum following the completion of a Type C meeting with the FDA on November 17. During the meeting, the FDA provided constructive feedback on clinical trial design, including endpoint strategy, and potential expedited regulatory pathways for Z-endox across 3 distinct BC settings: metastatic disease (mBC), neoadjuvant, and risk-reduction. Management believes that this interaction with the agency provided meaningful clarification that will support a capital efficient, streamlined, registrational approach and shortened regulatory timeline, which we view favorably. Atossa is well-positioned to implement this feedback with multiple parallel development tracks including an ongoing, recently optimized, Phase 2 neoadjuvant trial (EVANGELINE), an mBC dose-ranging study in preparation with an IND already filed, and a low-dose risk-reduction strategy (NDA expected 2026; Figure 1). The company also anticipates submitting INDs in 2026 to evaluate Z-endox as a combo therapy for mBC and potentially in other indications where Z-endox has shown potential efficacy such as Duchenne muscular dystrophy (DMD) (see here) and glioblastoma (see here). Z-endox is currently being evaluated in the neoadjuvant setting in the I-SPY 2 trial in combo with CDK4/6 inhibitor abemaciclib, which we believe represents a logical combo approach for future development, including 2L+ ER+/HER2- mBC. Data from this trial are expected in 2026. Atossa awaits FDA feedback regarding Z-endox's IND submission in mBC, which we anticipate will clear before YE25 given the FDA's 30-day IND review period. We are confident that the IND will clear as ~800 patients have been treated with Z-endox to date, across various BC settings, demonstrating a favorable safety and tolerability profile. Reiterate Buy rating and $7 PT."

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Shares of Atossa Genetics closed at $0.76 yesterday.

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