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BPMX

BioPharmX

$0.20

-0.0006 (-0.30%)

09:21
07/19/18
07/19
09:21
07/19/18
09:21

BioPharmX granted CARC waiver by FDA for acne candidate BPX-01

BioPharmX announced that the FDA has waived its requirement for a dermal carcinogenicity study for BPX-01, eliminating several years of non-clinical research normally required for FDA review. BPX-01, a novel topical gel formulation of minocycline for the treatment of inflammatory acne, received the waiver based on the results of a 39-week dermal minipig toxicity study conducted by BioPharmX and the extensive safety history of minocycline products including the clinical safety data from the BPX-01 Phase 2 acne studies. The 39-week minipig study with BPX-01 found no pre-neoplastic or hyperplastic changes that might be indicative of carcinogenic potential and the clinical studies were also negative in terms of cutaneous toxicity. The company also released a post hoc analysis of phase 2b data assessing the impact of BPX-01 on the treatment of acne vulgaris in women. It found that female subjects outperformed the overall study population in the Investigator Global Assessment outcomes. A higher proportion of subjects in the female subgroup demonstrated a clinically relevant improvement in acne severity.

BPMX BioPharmX
$0.20

-0.0006 (-0.30%)

09/13/17
HCWC
09/13/17
NO CHANGE
Target $3
HCWC
Buy
BioPharmX early rosacea study results promising, says H.C. Wainwright
H.C. Wainwright analyst Swayampakula Ramakanth views BioPharmX's early results from the BPX-01 rosacea study as promising. The results suggest that BPX-01 could become a "safe and highly effective therapy against rosacea," Ramakanth tells investors in a research note. The analyst reiterates a Buy rating on the shares with a $3 price target.

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STML

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BANR

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