Galderma Slumps After FDA Turns Down Botox Rival Relfydess

(Bloomberg) — Galderma Group AG shares slumped the most in more than a year after the US Food and Drug Administration turned down the Swiss dermatology firm’s rival Botox treatment Relfydess.

The US regulator made observations in a complete response letter following a pre-license inspection and Galderma is putting in place corrective and preventive actions, the company said in a statement Wednesday. The stock fell as much as 6.6% in Zurich, the most intraday since April 2025.

Galderma’s Relfydess is a rival to AbbVie Inc.’s Botox. While Botox needs to be reconstituted before it is injected, Relfydess comes ready to use. The effects also last longer than Botox.

It’s not the first time that Galderma’s Relfydess substance has faced issues with approval in the US. In 2023, the product was rejected by the FDA due to deficiencies related to chemistry, manufacturing and controls processes, the company said at the time.

Earlier this year, AbbVie also received an FDA letter asking for more information about the manufacturing process for its next-generation wrinkle product.

Complete response letters have become the “standard course of business when trying to get new neuromodulators” approved by the FDA, according to Barclays Plc analyst James Gordon. The scope of the agency’s issues with Galderma’s Relfydess have been “significantly narrowed this time,” though there’s still work to be done, he said in a note.

The receipt of another complete response letter from the FDA for Relfydess is “not desirable but not too surprising,” Jefferies analyst Benjamin Jackson wrote in a note. He sees a 9 to 12 month delay to approval.

(Updates with analyst comment in sixth paragraph.)

©2026 Bloomberg L.P.