Galderma (GALD.S) Relfydess receives another CRL in the US, further delaying regulatory approval

Research evidence excerpt

Galderma (GALD.S) Relfydess receives another CRL in the US, further delaying regulatory approval

Equity Research

1 July 2026 | 7:39AM BST

Galderma (GALD.S): Relfydess receives another CRL in the US, further

delaying regulatory approval

This morning (July 1, 2026), Galderma announced it has received another Shyam Kotadia

+44(20)7051-6153 |

Complete Response Letter (CRL) from the FDA for Relfydess, its ready-to-use shyam.kotadia@gs.com

Goldman Sachs International

liquid, longer-acting, neuromodulator, with comments related to observations

James Quigley

during manufacturing site inspection and analytical method optimisation. Per +44(20)7051-3800 |

james.quigley@gs.com

the release, we note the FDA conducted a pre-license inspection of Galderma’s Goldman Sachs International

Uppsala manufacturing site, with all other aspects of its Biologics License Kaaviya Ganesan

Application, including safety and e " cacy-related aspects, not agging de Eciencies. +1(332)245-7519kaaviya.ganesan@gs.com|

Galderma looks to put in place corrective and preventive actions to work towards a Goldman Sachs India SPL

resolution, with plans to rapidly respond to the CRL to obtain approval in the US. As a

reminder, Galderma has previously highlighted the strength of Relfydess’ launch

trajectory and market share gains in ex-US markets, noting it being approved in 33

markets and already launched in more than 20 (incl. Europe, the Middle East, Asia,

and Australia).

Our view: Overall, we see this as a sentiment negative, with the FDA regulatory

decision for Relfydess (RelabotulinumtoxinA) being one of the key remaining

catalysts for the stock ahead of 1H’26 results. We note the press release does not

mention whether this decision impacts its FY26 or 2023-27E mid-term guidance,