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FOMX

Foamix

$4.36 /

-0.05 (-1.13%)

16:12
02/18/20
02/18
16:12
02/18/20
16:12

Foamix announces results from two pivotal Phase 3 clinical trials for FMX103

Foamix Pharmaceuticals announced results from an integrated efficacy analysis on the two pivotal Phase 3 clinical trials for FMX103, or minocycline, 1.5% foam, currently under review by the FDA for the treatment of moderate to severe papulopustular rosacea in adults. The new data have been presented at the 17th Annual South Beach Symposium in Dermatology held on February 6-9, in Miami, Florida. Foamix previously announced that the FDA has accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for June 2nd, 2020 under the Prescription Drug User Fee Act. Integrated Summary of Efficacy Highlights includes: the integrated efficacy analysis compared FMX103 to vehicle from 2 identical Phase 3 studies with 1,522 subjects after 12 weeks of once daily application. In the combined analysis of both pivotal Phase 3 studies, FMX103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints.

  • 02

    Jun

FOMX Foamix
$4.36 /

-0.05 (-1.13%)

10/21/19 H.C. Wainwright
Foamix price target raised to $11 from $10 at H.C. Wainwright
10/16/19 Barclays
Barclays likes Foamix setup into October 20 FDA action date
10/08/19 Cantor Fitzgerald
Cantor reiterates Overweight on Foamix ahead of FMX101 PDUFA
06/11/19 Barclays
Foamix initiated with an Overweight at Barclays

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