By Adria Calatayud
Galderma shares fell after the Swiss skincare specialist failed to obtain approval from the U.S. Food and Drug Administration for its latest product to rival AbbVie's Botox for the second time.
Shares in Galderma were down 5.6% in European morning trading Wednesday, leaving the stock up 7% since the start of the year.
The company said it received a complete response letter from the FDA declining its application for the product--marketed in some countries as Relfydess and also known as relabotulinumtoxinA--with comments related to observations during an inspection of the company's manufacturing site and its analytical method optimization.
"We view this as a further delay to U.S. Relfydess approval rather than a fundamental issue," RBC Capital Markets analysts wrote in a note to clients.
Galderma said it is putting in place corrective and preventive actions and that it continues to see a U.S. launch of Relfydess as a top priority.
The FDA had already declined Galderma's initial application for Relfydess in October 2023, citing deficiencies related to chemistry, manufacturing, and controls processes, the company said at the time.
The decision isn't entirely surprising as two or three rejection letters in this space isn't unusual, analysts at Jefferies said. The U.S. approval for Relfydess is likely to be pushed back by nine to 12 months, they added.
Write to Adria Calatayud at adria.calatayud@wsj.com