Phase 3 Results Crush Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) Shares

Foamix Pharmaceuticals Ltd (NASDAQ:FOMX)

Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) shares cratered over 41% on topline results from its two Phase 3 clinical trials evaluating their lead product candidate FMX101 in the treatment of moderate to severe acne. FOMX shares ended Friday at $9.10 and closed today at $5.30. Volumes were very heavy. FOMX has an average daily trading volume figure of almost 135,000 but today over 3.8 million shares traded hands – over 28 times the average.

Dov Tamarkin, Ph.D., CEO of Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) reacted to the results by stating that Trial 05 exhibited statistical significance in both primary endpoints, Trial 04 did not meet the significance score endpoint. The full impact of the results are not yet complete and the team from Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) still has yet to complete their analysis.

The two double-blind, randomized, placebo-controlled Phase 3 trials (Trials No. 04 and 05) included a total of 961 subjects with moderate-to-severe acne. Subjects were randomized to receive either FMX101 (minocycline foam 4%) or vehicle foam once daily over 12 weeks.

The two co-primary endpoints were the absolute change in the number of inflammatory lesions (papules and pustules); and the proportion of patients achieving success at week 12, as defined by an IGA score of “clear” or “almost clear” and at least a two-grade improvement from baseline at week 12.

Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) develops and commercializes foam-based formulations for the treatment of skin ailments. Its lead product candidate is FMX101 but it is also developing FMX102, FMX103, and FMX 104. FMX102 has completed a Phase 2 trial for the treatment of impetigo caused by methicillin-resistant staphylococcus aureus. FMX 103 is in a Phase 2 trial for the treatment of Rosacea. FMX104 has completed a Phase 2 clinical trial for patients suffering from chemo-therapy induced rashes.

Foamix Pharmaceuticals Ltd (NASDAQ:FOMX) has licensing and development agreements with Bayer Healthcare, Sebela Pharmaceuticals Inc, Mylan N.V., and Actavis Laboratories. Two firms follow Foamix Pharmaceuticals Ltd (NASDAQ:FOMX). The listed ratings from both firms (released prior to today’s announcement) was a “Strong Buy”. Today’s price action established a new 52-week low for FOMX shares.

Ticker Symbol FOMX
Last Price a/o 4:00 PM EST  $                      5.30
Average Volume                    134,860
Market Cap (mlns)  $                  205.27
Sales (mlns) $5.50
Shares Outstanding (mlns) 38.73
Share Float (mlns) 30.51
Shortable Yes
Optionable Yes
Inside Ownership 0.00%
Short Float 4.75%
Short Interest Ratio 10.75
Quarterly Return -51.82%
YTD Return -52.25%
Year Return -10.92%

I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 96 hours. All information, or data, is provided with no guarantees of accuracy.

About the author: James Marion is a University of Houston student studying Business with a concentration in Finance.

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James Marion is a University of Houston student studying Business with a concentration in Finance. James has interned with several investment professionals and hopes to pursue a career as a professional stock analyst after graduation.

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