BFRI FDA decision: Sep 9, 2026

Ameluz (aminolevulinic acid hydrochloride) with RhodoLED red light - sBCC was approved by the FDA on September 9, 2026 for superficial basal cell carcinoma (sBCC), photodynamic therapy with the RhodoLED lamp series.

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)

Key facts

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.

Primary source: Biofrontera 8-K (EX-99.1), September 14, 2026

FDA record of the action: the FDA approved on September 9, 2026, per NDA 208081 S-040 (FDA letter). The sponsor announced it the same day. Action dates on pdufa.bio come from the FDA's own record, not the press release. Every FDA action we hold, by FDA date: FDA approval letters.