Posts  / #POST-250786
REDDIT

BFRI FDA Approved - Down 11%

Okay, so I will admit that I am bit of a regard when it comes to trading but I've been following biotech stocks for a while and I understand that Biotech stocks are binary. I've watched so many biotech stocks explode 800% and I've also seen biotech stocks down 80% so I knew the risks going in. Make a long story short, I buy BFRI because they were pending an FDA approval on a breakthrough skin cancer therapy. The FDA decision was supposed to be announced on or before 09/28/26. About 15 minutes after I buy the stock this bombshell drops:

**"Biofrontera (BFRI)** received U.S. FDA approval of a supplemental New Drug Application for **Ameluz** topical gel 10% with the BF‑RhodoLED lamp for treatment of **superficial basal cell carcinoma (sBCC) in adults**.

With this decision, Ameluz becomes the first and only FDA‑approved photodynamic therapy (PDT) for any skin cancer, and the only topical PDT in the U.S. indicated for both actinic keratosis and sBCC. The new label broadens Biofrontera’s red‑light PDT platform and expands Ameluz’s addressable market. The company plans an official sBCC launch between late Q4 2026 and Q1 2027 using its existing commercial organization and installed lamp base.

Approval is supported by a Phase 3 trial in 187 adults, where complete clinical and histological response of the main target lesion at 12 weeks was achieved in **66%** of Ameluz PDT patients versus **5%** with placebo‑PDT. Histological clearance occurred in 76% vs 19%, and complete clinical clearance of all target lesions in 83% vs 21%. The most common adverse reactions were application‑site effects consistent with the known safety profile."

15 minutes later the stock is down 11% and is continuing to drop. Please help me understand which Black Mirror episode I am on and what button do I need to push to switch to the next episode?