What is the name of Galderma's Botox rival?

The drug is marketed as Relfydess and known scientifically as relabotulinumtoxinA.

How does this rejection affect AbbVie?

The rejection gives AbbVie more time to maintain its dominance in the Botox market, as its Botox product is the top seller.

Galderma Shares Fall 5.6% After Second FDA Rejection of Botox Rival

Galderma received a Complete Response Letter from the FDA declining its application for relabotulinumtoxinA (Relfydess), a rival to AbbVie's Botox, for the second time. Shares fell 5.6% in European morning trading.

July 1, 2026

2 min read

Source: The Wall Street Journal

Key Numbers

stock drop

5.6%

ytd gain

Swiss skincare specialist Galderma announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) rejecting its application for relabotulinumtoxinA, marketed as Relfydess in some countries, which is intended to compete with AbbVie's (ABBV) Botox. This marks the second FDA rejection for the product.

Details of the Action

The FDA's letter cited observations from an inspection of Galderma's manufacturing site and the need for analytical method optimization. The product is an aesthetic treatment used to reduce wrinkles.

Company Response

Galderma stated it will review the FDA's comments and work to address them before resubmitting. No timeline for resubmission was provided.

Precedents and Context

This is the second rejection for the same product, raising concerns about manufacturing quality and data adequacy. The global Botox market is worth billions, with AbbVie holding a dominant position through its Botox brand.

Potential Financial Impact

Galderma shares fell 5.6% in European morning trading on Wednesday, leaving the stock up 7% year-to-date. The setback delays Galderma's entry into the U.S. market, potentially allowing AbbVie to maintain its market share longer.

Frequently Asked Questions

The FDA cited observations from a manufacturing site inspection and the need for analytical method optimization.

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This article was rewritten in Wrqti's editorial style based on information from the original source above. Content is informational only — not investment advice.