Ameluz photodynamic therapy with red light approved for superficial basal cell carcinoma, the first photodynamic therapy approved in the United States to treat a skin cancer (FDA action Sep 9 2026; announced Sep 14).
Run-up into the decision (T-120 → T+5)
Daily close, T-120 (3/18/26) through T+3. Run-up high $1.61 on 9/4/26, low $0.7789 on 3/30/26 (T-120 to T-1). FDA decision 9/9/26. Historical price action, not a forecast.
Key facts
FDA decision date2026-09-09
OutcomeApproved
Drug / candidateAmeluz (aminolevulinic acid hydrochloride) with RhodoLED red light
IndicationSuperficial basal cell carcinoma
CompanyBiofrontera Inc.
Market-cap tierNano
120-day run-up (T-120→T-1)+79.6%
Cohort decision-day move (history)8.0% median (n=117)
Two dates matter here and they are five days apart. The FDA's action date is September 9, 2026; openFDA records NDA 208081 supplement 40 as approved that day, and the PDUFA goal date was September 28, 2026, which Biofrontera stated in its 8-K of May 14, 2026. So the FDA acted 19 days early. But Biofrontera did not announce the approval until September 14, so no share-price movement before that date can be read as a reaction to it.
Run-up figures are the stock's own daily closing path over the 120 trading days before the decision, from our price history. Cohort move is the historical median absolute decision-day move for this market-cap tier. History, not a prediction.
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