Galderma Provides FDA Progress Update On RelabotulinumtoxinA Submission
(RTTNews) - Galderma (GDERF) announced it has received a Complete Response Letter (CRL) from the U.S. FDA regarding its Biologics License Application (BLA) for RelabotulinumtoxinA, a next-generation botulinum toxin candidate.
The feedback relates to observations made during a manufacturing site inspection and analytical method optimization, while no deficiencies were noted in the safety or efficacy portions of the filing.
The FDA conducted a Pre-License Inspection (PLI) of Galderma's facility, leading the company to implement corrective and preventive actions. Galderma stated it will maintain open dialogue with the agency to resolve the observations and emphasized that advancing RelabotulinumtoxinA in the U.S. remains a top priority.
Importantly, the FDA's comments do not affect approvals or launches in other international markets. Relfydess, the brand name for RelabotulinumtoxinA, is already approved in 33 markets and launched in more than 20, including Europe, the Middle East, Asia, and Australia. Early launch feedback from healthcare professionals has been encouraging, and regulatory filings in additional territories remain on track.
Since 2022, Galderma's manufacturing site has completed 10 inspections by global regulatory authorities, supporting international launches. The company reiterated its broader ambition to become a leading dermatology powerhouse across injectable aesthetics, skincare, and therapeutic dermatology.
Relfydess is a ready-to-use liquid neuromodulator. It is designed to simplify dosing by removing the need for reconstitution and aims to provide consistent treatment outcomes. Clinical data indicate that some patients experience early onset of effect, with improvements sustained for several months.
This update underscores Galderma's commitment to addressing FDA requirements while continuing its global rollout strategy for RelabotulinumtoxinA.
GDERF has traded between $142.40 and $248.46 over the past year. The stock closed Tuesday's trading at $238.05, up 12.95%.
