Foamix Pharmaceuticals Ltd. FOMX announced that it has completed patient enrollment in two phase III studies that will evaluate the efficacy and safety of one of its pipeline candidates, FMX101 (topical 4% minocycline foam), for the treatment of moderate-to-severe acne.
In the study, patients will be randomized in a 12-week double-blind phase, when they will be treated topically once daily with either FMX101 or the respective foam vehicle. The two co-primary efficacy endpoints of both the studies include the absolute change from baseline in inflammatory lesion counts in each treatment group at week 12, the proportion of patients achieving success at week 12, and at least a 2-grade improvement (decrease) from baseline at week 12.
Patients who complete the entire 12 weeks of the double-blind portion will have the option to continue in a long-term open-label safety extension, which will evaluate the safety of intermittent use of FMX101 for up to nine more months.
The two studies are being conducted simultaneously and the company expects to report top-line data in the first half of 2017. Foamix intends to file for FMX101 approval under the 505(b)(2) regulatory pathway.
We are encouraged by the company’s progress with the candidate. Upon approved, FMX101 will be the first FDA-approved topical antibiotic treatment for moderate-to-severe acne, a skin disorder that affects millions of people every year with potentially significant psychological and social implications.
Note that post Trump’s victory in the presidential race, shares of Foamix have gained a significant 72% compared to the Zacks categorized Medical-Drugs industry's 21.8% drop.
Foamix currently carries a Zacks Rank #3 (Hold).
FOAMIX PHARMA Price
Stocks to Consider
Some better-ranked stocks in the healthcare sector include Anika Therapeutics ANIK, Athersys, Inc. ATHX and Arbutus Biopharma Corporation ABUS. Athersys sports a Zacks Rank #1 (Strong Buy), while both Anika and Arbutus carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates increased from $1.96 to $2.06 for 2016 and from $2.03 to $2.09 for 2017 over the last 60 days. The company posted a positive surprise in the four trailing quarters with an average beat of 33.14%. Its share price has gained 21% year to date.
Athersys’ loss estimates narrowed from 24 cents to 18 cents in 2016 and from 38 cents to 28 cents for 2017 over the last 60 days. The company posted positive surprises in all the four trailing quarters with an average beat of 110.52%. Its share price has gained 61% year to date.
Arbutus’ loss estimates narrowed from $2.15 to $1.74 for 2016 and from $1.96 to $1.51 for 2017 over the last 60 days. The company posted a positive surprise thrice in the four trailing quarters with an average beat of 59.31%.
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