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A Foamix acne drug PhIII bombs, sending shares into a tailspin

Dov Tamarkin, CEO of Foamix

While Allergan was pulling into the final regulatory lap this morning with its experimental acne drug, rivals at Foamix tripped over a Phase III hurdle for another contestant in the field.

Shares of Foamix Pharmaceuticals were crushed in pre-market trading on Monday after the biotech reported that its acne drug came up with a split decision in two Phase III studies.

FMX101, which was used to sell its lackluster 2014 IPO, hit the co-primaries for a reduction in lesions and an IGA score for success in trial 05. Trial 04, though, proved a flop. And investors were routed on the mixed results.

The stock $FOMX plunged 48% on the news.

The drug is a minocycline foam. Foamix also has three other clinical-stage products in development: FMX103 for moderate-to-severe rosacea, FMX102 for impetigo, and FDX104, a doxycycline foam for the management of acne-like rash induced by EGFRI anticancer drugs.

“Whereas Trial 05 showed significance in both primary endpoints, Trial 04 did not meet significance for the IGA score endpoint,” said Dov Tamarkin, PhD, CEO of Foamix. “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.”



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