Galderma: Relfydess receives US CRL, fairly well anticipated, still disappointing, but not a thesis breaker

研报英文原文证据摘录

Galderma: Relfydess receives US CRL, fairly well anticipated, still disappointing, but not a thesis breaker

Equity Research

European Pharmaceuticals, Biotechnology & Life Sciences

1 July 2026

Galderma

Relfydess receives US CRL, fairly

well anticipated, still First Look

GALD.S/GALD SE OVERWEIGHTdisappointing, but not a thesis

European Pharmaceuticals,

Biotechnology & Life NEUTRAL

Sciencesbreaker

Price Target CHF 200.00

Price (30-Jun-26) CHF 183.90Neuromod Relfydess received FDA CRL on manufacturing site

and analytical method (not efficacy or safety), BARCe at least PotentialSource: Bloomberg,Upside/DownsideBarclays Research +8.8%

1y approval delay. Update fairly well anticipated (e.g., see our

preview), doesn't change '26 or mid-term guidance, or v. European Pharmaceuticals,

strong group long-term outlook, we would buy on weakness. BiotechnologyJames Gordon & Life Sciences

+44 (0)20 7116 2784

This morning, GALD announced receiving a CRL from the FDA for Relfydess james.gordon@barclays.com

Barclays, UK(RelabotulinumtoxinA) with comments related to observations: (1.) during manufacturing

site inspection and (2.) analytical method optimisation. We note this is Relfydess' 2nd FDA Yihan Li, PhD

CRL, with manufacturing and analytical method also previously mentioned. We believe the +44 (0)20 3555 3563

scope of FDA's issue have been significantly narrowed this time, though work still to be yihan.li@barclays.com

Barclays, UKdone. There were no efficacy or safety issues raised.

Sidhartha Modi

We include no specific contribution from Relfydess in our GALD model, but a US approval +91 (0)22 6175 1326

delay does push back a potential further accelerant for the already strong US sidhartha.modi@barclays.com

Neuromodulator growth outlook.