Cassiopea Wins With Winlevi Acne Phase III Data
The Italian-headquartered, Swiss-listed company spun out of Cosmo Pharmaceuticals has moved a step closer to having the first topical anti-androgen drug approved for acne.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Italy-based Cassiopea says “very positive results” from Breezula's 12-month Phase II alopecia trial support progressing it to Phase III, particularly given the clean safety profile.
FDA approval for DRM04 in hyperhidrosis is expected at the end of June, but Phase III data for DRM01 in acne was the main event for investors. CEO Tom Wiggans said Dermira will try to understand what went wrong, while staying focused on DRM04 commercialization and lebrikizumab in Phase IIb.