Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) shares have fallen 43% this morning after the company released disappointing top-line results from its phase 3 trials for FMX101 for patients with moderate-to-severe acne, Trial 04 and Trial 05. In the Trial 04, FMX101 did not demonstrate statistical significance on one of the two co-primary endpoints, specifically IGA success.
CEO Dov Tamarkin said:
“Whereas Trial 05 showed significance in both primary endpoints, Trial 04 did not meet significance for the IGA score endpoint. Our team has not yet received the full data set and we intend to provide an update on the program as soon as we complete our analysis. As we have previously announced, the safety extensions for trials 04 and 05 are fully enrolled and continue as planned.”
As of the end of 2016, Foamix had $131 million in cash and investments and the company expects its cash and investments to fund operations into mid-2019.
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Of the 742 elite funds we track, 15 funds owned $143.64 million of Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) and accounted for 35.30% of the float on December 31, versus 18 funds and $124.28 million respectively on September 30.
The Bottom Line
While acne treatment is a huge market (given that up to 50 million people in the U.S. suffer from the condition), there are also a lot of competitors, and Foamix has yet to crack the code, specifically as it relates to FMX101. Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) still has a lot of runway space, however, to try and right the ship.