Galderma Group AG saw its Zurich‑listed stock plunge 6.6% on Wednesday, the steepest intraday slide since April 2025. The drop followed a U.S. Food and Drug Administration complete response letter that rejected the firm’s Botox rival Relfydess. Unlike AbbVie’s Botox, which requires reconstitution, Relfydess is ready‑to‑use and promises longer‑lasting effects. The decision also delays a U.S. rollout expected to generate significant revenue.

Regulators cited observations from a pre‑license inspection, prompting Galderma to launch corrective and preventive actions. The company previously faced an FDA refusal in 2023 over chemistry, manufacturing and controls deficiencies. Barclays analyst James Gordon noted the agency’s concerns are narrower this time, while Jefferies’ Benjamin Jackson estimates the setback will add a 9‑ to 12‑month approval lag for its next‑generation neuromodulator.

Investors now weigh the impact of a delayed entry into the fast‑growing neuromodulator market, where AbbVie’s Botox dominates US sales. Galderma’s share price reaction underscores market sensitivity to regulatory hurdles, and the prolonged timeline could pressure the Swiss firm’s broader pipeline. Analysts warn the lag may erode share.