Galderma's shares experienced a slump following the U.S. FDA's decision to issue a Complete Response Letter (CRL) for its Biologics License Application (BLA) resubmission of RelabotulinumtoxinA, also known as Relfydess. This new liquid neuromodulator was being developed as a rival to existing Botox products. The CRL indicated concerns primarily related to Chemistry, Manufacturing, and Controls (CMC) issues in the manufacturing process, rather than efficacy or safety.
The FDA had previously issued a CRL for Relfydess in 2023, also due to CMC issues. Galderma had since worked closely with the FDA to implement adjustments to its manufacturing process, leading to the resubmission of the BLA. The resubmission was accepted by the FDA on February 2, 2026, indicating it was sufficiently complete for a substantive review. Investors and analysts had been anticipating potential U.S. approval by mid-to-late 2026, with some considering a Class 1 review (two months) plausible given the focus on manufacturing issues, but the latest CRL pushes back this timeline.
Relfydess, which has already been approved in over 20 markets globally, including the European Union and the United Kingdom, is touted as the first ready-to-use liquid neuromodulator manufactured with PEARL Technology. This technology is designed to preserve molecule integrity, offering a fast onset of action as early as Day 1 and sustained results for six months in treating moderate-to-severe glabellar lines (frown lines) and lateral canthal lines (crow's feet). The product's liquid formulation eliminates the need for reconstitution, aiming to simplify the injection process and ensure consistent dosing. The delay in U.S. approval is a setback for Galderma's plans to expand its neuromodulator portfolio in a key market.
