Foamix Shares Ripping Higher: What You Need To Know

Foamix Pharmaceuticals Ltd FOMX shares were solidly higher Wednesday on positive trial results for its acne treatment candidate.

Biopharmx Corp BPMX, which also has an acne product candidate in development, moved in sympathy, although it was trading down at the time of publication Wednesday. 

Foamix shares were trading higher by more than 5 percent at $6.22 Wednesday afternoon, while the penny stock Biopharmx was down 4.59 percent at 21 cents.  

What Happened

Foamix announced positive top-line results for its third Phase 3 clinical trial that evaluated FMX101 for treating moderate-to-severe acne.

FMX101 is a topical minocycline foam.

The company said the pipeline candidate met both co-primary endpoints of absolute change from the baseline in inflammatory lesion count at Week 12 and investigator global assessment treatment success at Week 12.

FMX101's safety profile was consistent with the one determined from the previous two Phase 3 studies.

Why It's Important

Foamix said if approved, FMX101 would be the first minocycline product available for patients in the U.S.

"This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psychosocial effects of acne," said Foamix CEO David Domzalski.

Biopharmx's inflammatory acne treatment candidate BPX-01 is being evaluated in a Phase 2 trial. In mid-July, the company said the FDA waived its requirement for a dermal carcinogenicity study for the candidate, eliminating several years of non-clinical research.

What's Next

Foamix said it will continue to share data as it becomes available over the remainder of 2018.

With the conclusion of this third study, Foamix said it's in a position to finalize its efforts to submit its first NDA.

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