On Wednesday, H.C. Wainwright increased the stock price target for Atossa Genetics (NASDAQ: NASDAQ:ATOS) to $7.00, up from the previous $6.00, while maintaining a Buy rating on the stock. This adjustment follows Atossa Genetics' announcement of its third-quarter earnings and a corporate update on Tuesday.
The company recently reported positive outcomes from its Phase 2 KARISMA-Endoxifen study, which is focused on assessing the efficacy of Z-endoxifen in reducing mammographic breast density (MBD) among premenopausal women. The study included 240 participants divided into three groups: two dosages of the medication, 1 mg and 2 mg daily, and a placebo group, with each group comprising 80 women.
The trial was designed to last six months, although assessments were made at earlier stages for participants who discontinued the treatment. While baseline characteristics were not disclosed, the company emphasized that the groups were well-balanced without significant differences in background factors.
The results indicated that the medication led to a reduction in MBD of -19.3% for the 1 mg dose and -26.5% for the 2 mg dose, both measured against the placebo. Notably, there was no significant difference in effectiveness between the two dosages of Z-endoxifen. The reductions in breast density are considered likely superior to those achieved by tamoxifen, a current treatment for MBD, which showed less reduction in a similar study.
The analyst from H.C. Wainwright highlighted that these findings suggest Z-endoxifen could potentially offer greater MBD reductions at lower doses compared to tamoxifen. In a separate study by Brentnall et al. in 2020, a 20 mg daily dose of tamoxifen resulted in a 17-25% reduction in breast density after one year, which is a higher dose over a longer period than the KARISMA-Endoxifen study.
In light of these positive results, H.C. Wainwright reiterated their Buy rating and raised the price target for Atossa Genetics, indicating confidence in the stock's potential performance.
In other recent news, Atossa Therapeutics has reported positive results from a Phase 2 study on Z-endoxifen, a treatment aimed at reducing mammographic breast density. The trial, conducted by H.C. Wainwright, saw significant reductions in density, with the 1 mg and 2 mg groups showing a 19.3% and 26.5% decrease respectively.
Furthermore, Atossa Genetics has secured a new patent from the United States Patent and Trademark Office (USPTO) for compositions including the active ingredient endoxifen, expanding the company's intellectual property portfolio.
Atossa Therapeutics has also begun a clinical trial in collaboration with Quantum (NASDAQ:QMCO) Leap Healthcare Collaborative. The trial will test a combination of Atossa's proprietary drug, (Z)-endoxifen, and Eli Lilly (NYSE:LLY)'s abemaciclib, aimed at high-risk women with newly diagnosed Estrogen Receptor positive (ER+) / Human Epidermal Growth Factor Receptor 2 negative (HER2-) breast cancer. The outcomes of this trial are expected in 2026.
Moreover, Atossa Therapeutics expressed support for the FDA's updated mammography regulations, which now require facilities to inform patients of their breast density, a key factor in breast cancer risk.
The company's ongoing projects include the development of (Z)-endoxifen in multiple phase 2 clinical trials and the support of the SMART study, a phase 2 trial using artificial intelligence to assess breast cancer risk. These are the recent developments at Atossa Therapeutics.
InvestingPro Insights
The recent positive results from Atossa Genetics' Phase 2 KARISMA-Endoxifen study and the subsequent price target increase by H.C. Wainwright are reflected in the company's recent market performance. According to InvestingPro data, Atossa has shown a strong return over the last three months, with a 15.38% price total return. Moreover, the company's year-to-date price total return stands at an impressive 70.45%, indicating significant investor confidence in the company's potential.
InvestingPro Tips highlight that Atossa holds more cash than debt on its balance sheet, which could provide the company with financial flexibility to further its research and development efforts. This strong financial position is particularly important for biotechnology companies like Atossa that are in the process of developing new treatments.
However, it's worth noting that Atossa is not currently profitable, as indicated by another InvestingPro Tip. This is not uncommon for biotech companies in the research and development phase, but it underscores the importance of the company's promising clinical results for its future prospects.
For investors seeking a more comprehensive analysis, InvestingPro offers 5 additional tips that could provide further insights into Atossa's financial health and market position.
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