Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA on November 28, 2025 seeking approval of Ameluz®-PDT for treatment of superficial basal cell carcinoma (sBCC).

The submission includes full Phase 3 treatment and one-year follow-up data from a randomized, double-blind, placebo-controlled U.S. study of 187 patients. Primary endpoint: 65.5% clearance with Ameluz®-PDT vs 4.8% with placebo (p<0.0001). Key secondary endpoints showed histological clearance 75.9%, clinical clearance 83.4%, and total lesion clearance 64.1% with low one-year recurrence and high patient satisfaction.

Positive

• sNDA submitted to FDA on Nov 28, 2025
• Primary endpoint: 65.5% clearance vs 4.8% (p<0.0001)
• Histological clearance 75.9% and clinical clearance 83.4%
• One-year follow-up showed low recurrence and strong aesthetics
• 85.5% patient satisfaction rated good or very good

Negative

• Regulatory outcome uncertain—sNDA approval is pending
• U.S. Phase 3 represents a single trial of 187 patients

News Market Reaction – BFRI

-0.11% 2.1x vol

6 alerts

-0.11% News Effect

+14.9% Peak Tracked

-14.2% Trough Tracked

-$10K Valuation Impact

$9M Market Cap

2.1x Rel. Volume

On the day this news was published, BFRI declined 0.11%, reflecting a mild negative market reaction. Argus tracked a peak move of +14.9% during that session. Argus tracked a trough of -14.2% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $10K from the company's valuation, bringing the market cap to $9M at that time. Trading volume was elevated at 2.1x the daily average, suggesting increased selling activity.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Study size: 187 patients Primary endpoint clearance: 65.5% vs 4.8% Histological clearance: 75.9% vs 19.0% +5 more

8 metrics

Study size 187 patients U.S. Phase 3 sBCC Ameluz®-PDT trial

Primary endpoint clearance 65.5% vs 4.8% Complete clearance of main target lesion at 12 weeks (Ameluz vs placebo)

Histological clearance 75.9% vs 19.0% Complete histological clearance of main target lesion (Ameluz vs placebo)

Clinical clearance 83.4% vs 21.4% Complete clinical clearance of main target lesion (Ameluz vs placebo)

Total lesion clearance 64.1% vs 4.8% Total clearance of all sBCC lesions (Ameluz vs placebo)

P-value p<0.0001 Primary and key secondary endpoints statistical significance

Patient satisfaction 85.5% Rated overall treatment and aesthetic outcome as very good or good

Annual BCC cases more than 3 million Estimated superficial basal cell carcinoma cases in the U.S. per year

Market Reality Check

Price: $0.8628 Vol: Volume 16,377 is 0.12x th...

low vol

$0.8628 Last Close

Volume Volume 16,377 is 0.12x the 20-day average of 136,114, showing limited pre-news activity. low

Technical Shares traded below the 200-day MA, at $0.8129 versus the MA of $0.85 before this news.

Peers on Argus

BFRI was up 1.21% pre‑news while close peers were mixed: EVOK +0.27%, IMCC +1.21...

1 Up

BFRI was up 1.21% pre‑news while close peers were mixed: EVOK +0.27%, IMCC +1.21%, SBFM -0.68%, SNOA +0.82%, YCBD +1.11%. Momentum scans only flagged FLGC at +5.07%, suggesting this headline is stock-specific rather than part of a broad sector move.

Historical Context

5 past events · Latest: Dec 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 04	Phase 1 PK update	Positive	+3.2%	Completed Phase 1 PK study for Ameluz in AK on trunk and extremities.
Dec 02	sNDA filing sBCC	Positive	-0.1%	Filed sNDA for sBCC with strong Phase 3 clearance and follow‑up data.
Nov 13	Q3 2025 earnings	Negative	-8.6%	Reported lower revenues year over year and detailed financing and asset sale.
Nov 07	Asset sale Xepi	Positive	-6.9%	Sold U.S. Xepi rights for up to $10M to bolster cash and PDT focus.
Nov 06	Earnings call date	Neutral	+6.4%	Announced timing for Q3 2025 results release and investor conference call.

Pattern Detected

Recent news shows a mix of aligned and divergent reactions: positive clinical and business updates sometimes sold off, while other milestones saw supportive price moves.

Recent Company History

Over the last few months, Biofrontera has focused on expanding Ameluz®’s indications and strengthening its PDT franchise. Clinical updates, including Phase 3 milestones in sBCC and actinic keratoses and a Phase 1 PK study, generally produced modest moves between about -2% and +6%. Strategic steps such as the Xepi® divestiture and Q3 results drew sharper negative reactions. Today’s sNDA submission for sBCC builds directly on the earlier Phase 3 sBCC milestone from January 2025 and fits the ongoing label-expansion strategy.

Market Pulse Summary

This announcement details an sNDA submission to the FDA for Ameluz®-PDT in superficial basal cell ca...

Analysis

This announcement details an sNDA submission to the FDA for Ameluz®-PDT in superficial basal cell carcinoma, backed by a 187‑patient Phase 3 trial showing large efficacy deltas and highly significant p‑values (p<0.0001). The filing also includes one‑year follow-up data with low recurrence and strong cosmetic outcomes. In context of prior Ameluz® trials for actinic keratoses and acne, investors may track FDA review progress, durability data, and how this potential label expansion interacts with the company’s recent financing and asset-sale activities.

Key Terms

supplemental new drug application, photodynamic therapy, basal cell carcinoma, double-blind, +4 more

8 terms

supplemental new drug application regulatory

"announced the submission of an sNDA to the FDA, seeking approval"

A supplemental new drug application is a request submitted to regulatory authorities to make changes to an existing approved medication, such as adding new uses, strengths, or formulations. For investors, it signals that a pharmaceutical company is seeking approval for new product developments or expanded applications, which can impact the company's future sales, market potential, and stock value.

photodynamic therapy medical

"a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT)"

Photodynamic therapy is a medical treatment that uses a special light-sensitive substance and a specific type of light to target and destroy abnormal or diseased cells, often in cancer treatment. It is important to investors because advances in this technology can lead to new, minimally invasive treatment options, potentially expanding healthcare markets and driving growth for biotech companies involved in developing such therapies.

basal cell carcinoma medical

"for the treatment of superficial basal cell carcinoma (sBCC)"

A type of skin cancer that starts in the cells at the bottom layer of the skin and usually grows slowly and stays local rather than spreading to other organs. It matters to investors because its high frequency and generally surgical treatment drive steady demand for diagnostics, procedures, topical or surgical products, and follow‑on therapies, while new drugs, devices or regulatory approvals can shift market value and reimbursement dynamics. Think of it as a common maintenance issue whose repair options and costs influence healthcare spending and related businesses.

double-blind medical

"The double-blind, randomized, placebo-controlled, multi-center Phase 3 study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

randomized medical

"The double-blind, randomized, placebo-controlled, multi-center Phase 3 study"

Randomized means participants or units in a study are assigned to different groups by chance rather than by choice, like flipping a coin to decide who gets a new treatment and who gets a comparison. For investors, randomized designs matter because they reduce bias and make results more trustworthy, so outcomes from randomized studies carry more weight when assessing regulatory approval, commercial prospects, and the risk that trial results will change a company’s valuation.

placebo-controlled medical

"The double-blind, randomized, placebo-controlled, multi-center Phase 3 study"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

histological medical

"complete clinical and histological clearance of one preselected"

Relating to the microscopic study of tissues, histological describes how cells and tissue structures look when viewed under a microscope. For investors, histological results can confirm whether a drug or medical procedure actually changes disease tissue or causes harm — like inspecting the weave of fabric to spot repairs or tears — and those findings often influence trial outcomes, regulatory decisions, and commercial prospects.

p<0.0001 medical

"a highly significant statistical difference (p<0.0001)"

p<0.0001 indicates a statistical result whose probability of appearing by random chance is less than 0.01%, so the observed effect is extremely unlikely to be accidental. For investors this raises confidence that a study, test or claim cited in an announcement is reliable, but it does not say how large or economically important the effect is — like finding a tiny but very consistent difference versus a big change.

AI-generated analysis. Not financial advice.

• sNDA for treatment of sBCC with Ameluz^®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025
• First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA
• Primary and key secondary endpoints met with high statistical significance (p <0.0001)
• Favorable recurrence outcomes at one-year follow-up
• BCC is the most common skin cancer in the US with more than 3 million cases diagnosed annually¹
  

WOBURN, Mass., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced the submission of an sNDA to the FDA, seeking approval of Ameluz^®-PDT for the treatment of sBCC.

The submission includes the full efficacy data sets from the Phase 3 treatment phase and the one-year follow-up, together with an integrated safety assessment combining data from Biofrontera’s U.S. and European Basal Cell Carcinoma clinical studies. The filing seeks to expand the Ameluz^® label to include treatment of sBCC treatment with PDT using its BF-RhodoLED^® or RhodoLED^® XL red light lamps.

The double-blind, randomized, placebo-controlled, multi-center Phase 3 study evaluated the safety and efficacy of Ameluz^®-PDT in 187 patients with one or more clinically and histologically confirmed superficial BCCs. Participants received one cycle of two PDT treatments (either Ameluz^®-PDT or placebo-PDT) 1-2 weeks apart. If required, a second treatment cycle was repeated at three months.

The study’s primary endpoint was a composite measure of complete clinical and histological clearance of one preselected “main target lesion” (MTL) at 12 weeks after the start of the last PDT cycle. This rigorous target was achieved with a 65.5% clearance rate in the Ameluz^®-PDT arm (95/145 subjects) compared to 4.8% in the placebo-PDT arm (2/42 subjects), a highly significant statistical difference (p<0.0001).

Key secondary endpoints demonstrated even higher efficacy with (i) complete histological clearance of the MTL seen in 75.9% (110/145) of patients with Ameluz^® compared to 19.0% (8/42) with placebo, (ii) complete clinical clearance of the MTL achieved in 83.4% (121/145) of patients treated with Ameluz^® compared to 21.4% (8/42) with placebo, and (iii) total clearance of all sBCC lesions in 64.1% of subjects treated with Ameluz compared to 4.8% with placebo (p<0.0001 for all endpoints).

Patient reported outcomes also supported these findings, with a large majority of them – 85.5% – rating the overall treatment satisfaction and aesthetic outcome with Ameluz^®-PDT as very good or good. One-year follow-up data further reinforced the durability of response and the long-term cosmetic advantages of Ameluz^®-PDT, demonstrating low recurrence rates and excellent aesthetic outcomes.

“We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC,” stated Dr Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “If approved, this would expand the Ameluz^® indication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT.”

Dr. Todd Schlesinger, board certified dermatologist and Mohs surgeon, Director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent publication of the Phase 3 results in the Journal of the American Academy of Dermatology (JAAD)² summarized “The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz^®-PDT for the treatment of sBCC. I look forward to potentially having this as an approved option for my patients with sBCC”.

About Actinic Keratosis

AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.³

1. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
2. https://www.jaad.org/article/S0190-9622(25)02656-8/fulltext
3. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/ 

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz^® with the RhodoLED^® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate-to-severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X .

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its products. We have based these forward-looking statements on our current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: the impact of any extraordinary external events; the ability of the Company’s manufacturing partners to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether any global disruptions in supply chains will impact the Company’s ability to obtain and distribute its products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of earlier clinical trials or trials of Ameluz^® in combination with BF-RhodoLED^® and/or RhodoLED^® XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz^® in combination with BF-RhodoLED^® and/or RhodoLED^® XL is consistent with the Company’s expectations; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing; and other factors that may be disclosed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. 

Investor Relations Contact:
Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

FAQ

What did Biofrontera (BFRI) file with the FDA on November 28, 2025?

Biofrontera filed an sNDA seeking approval of Ameluz®-PDT for superficial basal cell carcinoma.

What were the Phase 3 primary endpoint results for Ameluz®-PDT in sBCC (BFRI)?

Primary endpoint: 65.5% clearance in Ameluz®-PDT vs 4.8% with placebo (p<0.0001).

How many patients were in the U.S. Phase 3 sBCC study for Ameluz®-PDT (BFRI)?

The double-blind, randomized U.S. Phase 3 study enrolled 187 patients.

What did one-year follow-up show for Ameluz®-PDT in the BFRI Phase 3 study?

One-year data showed low recurrence rates and favorable long-term cosmetic outcomes.

Which light sources were included in Biofrontera’s sNDA for Ameluz®-PDT (BFRI)?

The filing seeks label expansion to include PDT with BF-RhodoLED or RhodoLED XL red light lamps.