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Investing.com - H.C. Wainwright reiterated a Buy rating and $7.00 price target on Atossa Genetics (NASDAQ:ATOS) following the company’s update on its Z-endoxifen development plans. Trading at $0.76, ATOS shares currently sit significantly below the analyst’s target, which represents over 820% potential upside. InvestingPro data shows analysts maintain a strong buy consensus with price targets ranging from $4.00 to $7.75.
Atossa recently provided an overview of its strategy to advance Z-endoxifen across the breast cancer treatment spectrum after completing a Type C meeting with the FDA on November 17. The FDA offered feedback on clinical trial design, endpoint strategy, and potential expedited regulatory pathways for Z-endoxifen in three breast cancer settings: metastatic disease, neoadjuvant, and risk-reduction.
The company is pursuing multiple parallel development tracks, including an ongoing Phase 2 neoadjuvant trial (EVANGELINE), a metastatic breast cancer dose-ranging study with an IND already filed, and a low-dose risk-reduction strategy with an NDA expected in 2026. Atossa also plans to submit INDs in 2026 for Z-endoxifen as a combination therapy for metastatic breast cancer and potentially for other indications like Duchenne muscular dystrophy and glioblastoma. With a current ratio of 6.77, InvestingPro data indicates ATOS has liquid assets exceeding short-term obligations, providing runway for these development programs despite its current cash burn rate.
Z-endoxifen is currently being evaluated in the I-SPY 2 trial in combination with CDK4/6 inhibitor abemaciclib, with data expected in 2026. The company awaits FDA feedback on its IND submission for metastatic breast cancer, which H.C. Wainwright anticipates will clear before year-end 2025.
Approximately 800 patients have been treated with Z-endoxifen to date across various breast cancer settings, demonstrating what H.C. Wainwright describes as a favorable safety and tolerability profile. With a market capitalization of just $98.11 million and EBITDA of -$32.84 million in the last twelve months, InvestingPro’s Financial Health Score of 2.09 (FAIR) reflects the company’s development-stage status. Discover comprehensive analysis of ATOS and 1,400+ other stocks through InvestingPro’s Research Reports, which transform complex data into actionable investment intelligence.
In other recent news, Atossa Therapeutics has completed a Type C meeting with the FDA to discuss the regulatory strategy for its investigational drug, (Z)-endoxifen, in various breast cancer settings. The FDA provided feedback on potential expedited pathways for the drug’s use in metastatic breast cancer, neoadjuvant treatment, and breast cancer risk-reduction. Additionally, a joint study by Insilico Medicine and Atossa identified (Z)-endoxifen as a potential treatment for glioblastoma multiforme, one of the deadliest adult brain tumors, using AI-powered analysis. Atossa also announced that (Z)-endoxifen may have applications in treating Duchenne Muscular Dystrophy and related conditions. In corporate developments, Atossa appointed Mark Daniel as Chief Financial Officer, bringing over 25 years of life-sciences finance experience to prepare for potential commercialization of (Z)-endoxifen. Furthermore, H.C. Wainwright has reiterated its Buy rating on Atossa’s stock, maintaining a $7.00 price target after the company amended the design of its Phase 2 EVANGELINE trial. The trial’s patient count will be reduced from 214 to between 40-65 patients, focusing on premenopausal women with early-stage ER+/HER2- breast cancer.
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