Maxim Group downgraded Atossa Genetics (NASDAQ:ATOS) to “hold” from “buy” and removed its previous price target of $9 after the company reported results from its Phase 2 study evaluating topical endoxifen in patients with mammographic breast density (MBD). The stock was quoted at $2.57 in afternoon trading on June 27.
“Though the study achieved its primary endpoint, safety issues that led to high attrition rates (80%) raises questions and leaves doubt, in our view, for the topical endoxifen program,” writes analyst Jason McCarthy. “As such, we have removed topical endoxifen from our model.”
Mr. McCarthy said the 80% discontinuation rate reflected skin rashes and local irritation. Although the study protocol included patient assessments at three and six months, 72 of the participants did not complete a full six months of dosing.
While the data looks positive, and perhaps there may be a way to use topical endoxifen for short-term use, “we await clarity from the FDA as to whether there remains any potential for topical endoxifen in MBD,” he added.