Shares of pharmaceutical company Galderma plummeted: The U.S. has halted sales of a Botox generic

Shares of the Swiss dermatology company Galderma Group suffered their sharpest intraday plunge in more than a year on Wednesday, July 1. This came after the U.S. regulatory agency rejected the application for approval of Relfydess, a direct competitor to Botox. This puts the product’s planned launch into the U.S. aesthetic medicine market on hold, according to Bloomberg.

Galderma shares plummeted 6.6% during trading in Zurich—the sharpest intraday drop since April 2025. Investors reacted to a decision by the U.S. Food and Drug Administration (FDA), which issued findings regarding the manufacture of Relfydess that were identified during a pre-marketing inspection. Galderma is currently working to address these concerns, and bringing the drug to the U.S. market remains its top priority, according to a company statement.

Galderma added that the regulator’s decision applies exclusively to the U.S. application and will not affect registrations already granted, commercial launches, or ongoing reviews in other regions. The drug is already available in more than 20 countries, including Europe, the United Kingdom, Australia, and several Asian countries, according to Investing.com.

The delay in Relfydess’s launch in the U.S. market is temporarily weakening Galderma’s competitive position in the global aesthetic medicine market, notes Investing.com. The Swedish drug was developed as the main competitor to AbbVie’s famous Botox. Unlike Botox, which must be diluted before injection, Relfydess is sold ready-to-use, and its effects last longer, according to Bloomberg.

This is not the first time Galderma has faced challenges in the U.S. Back in 2023, the FDA rejected the initial application to bring the drug to the U.S. market due to concerns regarding its chemical composition, manufacturing process, and quality control.

Rejection letters have become “standard practice when attempting to register new neuromodulators” with the FDA, noted Barclays analyst James Gordon, as quoted by Bloomberg. Gordon pointed out that this time, the scope of the agency’s objections to Relfydess has “narrowed significantly,” although the company still has some work to do.

Receiving yet another rejection from the FDA is an “unwelcome but not entirely surprising” development, wrote Jefferies analyst Benjamin Jackson. He estimates that this will delay the drug’s approval by another 9–12 months.

"We view this more as another delay (...) rather than a fundamental problem," RBC Capital Markets experts noted in a research note to clients, as reported by The Wall Street Journal.

Since the beginning of the year, Galderma’s stock has risen 7%. According to the consensus forecast from S&P Global Market Intelligence, 14 of the 18 analysts surveyed recommend buying the stock, while only one advises selling it.

This article was AI-translated and verified by a human editor