Investors love biotech stocks for the lottery ticket-like returns they can offer if a company strikes medical gold. Case in point: Atossa Genetics (ATOS), whose shares skyrocketed nearly 30% Wednesday. The reason? The biotech company announced that the positive preliminary results reported in 3Q18 in the P1 study of topical Endoxifen in male healthy subjects are now final.
All objectives were successfully met:
- Safety: There were no clinically significant safety signals and no clinically significant adverse events in participants receiving topical Endoxifen.
- Tolerability: Topical Endoxifen was well tolerated at each dose level and for the dosing duration utilized in the study.
Atossa CEO Dr. Steven C. Quay commented, “These positive final results support the further development of topical Endoxifen to treat breast health conditions in men, including a condition called gynecomastia, or breast enlargement and pain, which frequently occurs in men taking androgen deprivation therapy for prostate cancer […] We are also conducting a Phase 2 study using our topical Endoxifen in women with mammographic breast density (MBD) which we anticipate completing in the second quarter 2019. Once we have the results from the MBD study, we will determine next steps using topical Endoxifen to treat male breast conditions including gynecomastia.”
Gynecomastia is a condition characterized by male breast enlargement that’s accompanied by pain, which occurs through a hormonal imbalance of testosterone and estrogen. The condition is often caused by androgen deprivation therapy for prostate cancer (affecting up to 90% of patients), but can also be caused by anti-anxiety medications, chemotherapy and some heart medications. The embarrassing (and often painful) nature of gynecomastia can lead to compliance issues with the therapies causing it. The condition is common, affecting 25% of men between 50 and 69, a total of 10M per year in the US. While radiation can be used as a prophylactic, there are no approved therapeutics on the market for gynecomastia. SERMs, such as tamoxifen, are sometimes used off-label.
In reaction to the news, Maxim analyst Jason McCarthy reiterated a Buy rating on ATOS shares, with price target of $5.00, which implies a huge upside of nearly 225% from current levels. (To watch McCarthy’s track record, click here)