Galderma's failure to secure U.S. approval for its Relfydess product, a rival to AbbVie's Botox, doesn't shift the competitive landscape as rivals might face similar hurdles, Jefferies analysts say in a research note. The U.S. Food and Drug Administration's decision illustrates the challenges of producing neurotoxins like Relfydess, which are highly complex biologic drugs produced via fermentation and sensitive to subtle product variation, the analysts say. Daxxify--which competes with Relfydess and Botox in this market--also received multiple FDA rejection letters, they add. The decision doesn't reduce the likelihood that Relfydess will get U.S. approval, according to Jefferies. Shares in Galderma fall 5.3%. (adria.calatayud@wsj.com)
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Galderma's Relfydess Setback Doesn't Shift Competitive Landscape — Market Talk
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Galderma's failure to secure U.S. approval for its Relfydess product, a rival to AbbVie's Botox, doesn't shift the competitive landscape as rivals might face similar hurdles, Jefferies analysts say in a research note. The U.S. Food and Drug Administration's decision illustrates the challenges of pr…