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FOMX

Foamix

$3.85

0.33 (9.38%)

08:21
11/04/19
11/04
08:21
11/04/19
08:21

Foamix announces publication of AMZEEQ topical foam long-term safety data

Foamix Pharmaceuticals announced the peer review publication of the long term open label safety portions of studies FX2014-04 and FX2014-05 in the Journal of Clinical and Aesthetic Dermatology. Studies 04 and 05 were conducted by Foamix to support the New Drug Application submission of AMZEEQ topical foam, which was approved by the U.S. Food and Drug Administration for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older. Highlights from the Long-Term Safety Program: The open-label safety portions of Studies 04 and 05 enrolled a total of 657 patients, all of whom had completed 12 weeks of AMZEEQ topical foam, 4% or vehicle treatment in the preceding double-blind phases of these studies. Patients continued for up to an additional 40 weeks of open-label treatment with AMZEEQ. Of those enrolled in this safety study, 291 completed a total of 52 weeks of therapy. The key findings from the study are as follows: Subject satisfaction with AMZEEQ treatment remained high when re-assessed at Week 52 which was consistent with scores obtained at Week 12. Application site adverse events occurred in less than 2% of patients during the additional 40 weeks of open-label treatment with AMZEEQ. In the assessment of facial dermal tolerability at Week 52, more than 95% of patients had "none" or "mild" signs and symptoms, and no severe local tolerability scores were recorded. Non-dermal adverse events were comparable in type and frequency with those reported during the double-blinded portions of each study. The most frequently reported treatment-emergent adverse event was nasopharyngitis. No serious drug-related adverse events were reported.

FOMX Foamix
$3.85

0.33 (9.38%)

06/11/19
LEHM
06/11/19
INITIATION
Target $10
LEHM
Overweight
Foamix initiated with an Overweight at Barclays
Barclays analyst Balaji Prasad started Foamix Pharmaceuticals with an Overweight rating and $10 price target. The analyst launched coverage of 20 U.S. Specialty Pharmaceuticals with a Neutral industry view. He placed importance on cash flows and companies' ability to manage leverage and improve balance sheets.
10/08/19
CANT
10/08/19
NO CHANGE
Target $15
CANT
Overweight
Cantor reiterates Overweight on Foamix ahead of FMX101 PDUFA
Cantor Fitzgerald analyst Louise Chen says her 25 physician survey supports her positive view on the market opportunity for Foamix's FMX10. If approved, FMX101 has the potential to address a significant unmet need in the treatment of moderate-to-severe acne, which remains a difficult condition, Chen tells investors in a research note. She reiterates an Overweight rating on Foamix shares with a $15 price target ahead of the upcoming FDA action date for FMX101 on October 20. The analyst thinks the Street is underestimating the uptake of acne drugs.
10/16/19
LEHM
10/16/19
NO CHANGE
Target $10
LEHM
Overweight
Barclays likes Foamix setup into October 20 FDA action date
Barclays analyst Balaji Prasad highlights Foamix Pharmaceuticals' key upcoming FDA action date of October 20 for FMX-101 in acne. The analyst says ~75% of his $10 price target is derived from FMX-101, and that approval could add another $2, or 320% potential upside from current share levels. The analyst sees a 90% probability of success and forecasts 2025 risk adjusted sales of $202M. Prasad continues to like Foamix's risk/reward setup going into the October 20 PDUFA and he reiterates an Overweight rating on the shares.
10/21/19
HCWC
10/21/19
NO CHANGE
Target $11
HCWC
Buy
Foamix price target raised to $11 from $10 at H.C. Wainwright
Foamix Pharmaceuticals last week arguably the most successful week in its history as a public company, with FMX101 being approved by the FDA for treatment of moderate-to-severe acne vulgaris and FMX103 being accepted for review by the agency as a treatment for moderate-to-severe papulopustular rosacea, H.C. Wainwright analyst Raghuram Selvaraju tells investors in a research note. The analyst reiterates a Buy rating on the shares and boosted his price target to $11 from $10.

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AMRN

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