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Galderma Group Forecasts Revised as BofA Notes US FDA Response to Relfydess Application

BofA Global Research adjusted its forecasts for Galderma Group (GALD.SW) as it took note of the second complete response letter from the US Food and Drug Administration for the group's Relfydess neuromodulator. "Management had been cautious since2H25 on the likelihood of an acceptance, considering recent neuromodulator entries in the US received at least 2 CRLs before getting approved. There is no risk in our view on consensus for 2026, nor the potential for a guidance upgrade as early as 1H results," analysts said Thursday. "Galderma will receive guidance from FDA on how to address the two 'leftover' issues in its application (observations on site inspection, analytical method optimization). We expect this to happen in the coming days/weeks, which will enable management to provide guidance on timeline for a resubmission thereafter." Taking this into consideration, the research firm "modestly" lowered its 2027 and 2028 earnings estimates for Galderma, including a 1% reduction in EPS forecasts over the two-year period. Meanwhile, BofA expects the Swiss dermatology group to report a 20.4% increase in total sales in constant currency in the second quarter when it releases its.

GALD.SW

BofA Global Research adjusted its forecasts for Galderma Group (GALD.SW) as it took note of the second complete response letter from the US Food and Drug Administration for the group's Relfydess neuromodulator. "Management had been cautious since2H25 on the likelihood of an acceptance, considering recent neuromodulator entries in the US received at least 2 CRLs before getting approved.

There is no risk in our view on consensus for 2026, nor the potential for a guidance upgrade as early as 1H results," analysts said Thursday. "Galderma will receive guidance from FDA on how to address the two 'leftover' issues in its application (observations on site inspection, analytical method optimization).

We expect this to happen in the coming days/weeks, which will enable management to provide guidance on timeline for a resubmission thereafter." Taking this into consideration, the research firm "modestly" lowered its 2027 and 2028 earnings estimates for Galderma, including a 1% reduction in EPS forecasts over the two-year period.

Meanwhile, BofA expects the Swiss dermatology group to report a 20.4% increase in total sales in constant currency in the second quarter when it releases its.