Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

FDA approval of Ameluz for superficial basal cell carcinoma expands Biofrontera’s PDT platform and addressable dermatology market in the United States.

Rhea-AI Summary

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.

Positive

• First and only FDA‑approved PDT for any skin cancer in the U.S.
• New sBCC indication adds to existing actinic keratosis use, broadening Ameluz’s label
• Large potential market: estimated 540,000–720,000 superficial BCC cases annually in the U.S.
• Phase 3 primary endpoint met: 66% complete response with Ameluz PDT vs 5% with placebo‑PDT
• High histological clearance: 76% with Ameluz PDT vs 19% with placebo‑PDT
• Installed base leverage: launch planned using existing sales force and RhodoLED lamps

Negative

• None.

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Details

Market reaction after FDA approval for sBCC: BFRI -8.38%

$1.39 $1.61 Day Range

$21.09M Market Cap

Following this news, BFRI has declined 8.38%, reflecting a notable negative market reaction. Our momentum scanner has triggered 14 alerts so far, indicating notable trading interest and price volatility. The stock is currently trading at $1.42. Trading volume is exceptionally heavy at 8.4x the average, suggesting significant selling pressure.

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Market Context

A 16.26% gain followed the Jun 03 Ameluz patent-listing announcement, while this approval adds a new...

Analysis

A 16.26% gain followed the Jun 03 Ameluz patent-listing announcement, while this approval adds a new sBCC indication to the same product platform rather than a formulation-protection update.

Key Figures

sBCC approval: FDA approved Planned launch: Late Q4 2026 through Q1 2027 Phase 3 trial size: 187 adults +5 more

sBCC approval

FDA approved

Ameluz with BF-RhodoLED for superficial basal cell carcinoma

Planned launch

Late Q4 2026 through Q1 2027

Official launch of the sBCC indication

Phase 3 trial size

187 adults

Multicenter randomized vehicle-controlled trial

Complete response

66% (95/145) vs. 5% (2/42)

Ameluz PDT versus placebo-PDT at 12 weeks

Histological clearance

76% vs. 19%

Ameluz PDT versus placebo-PDT

Clinical clearance

83% vs. 21%

Complete clearance of all target lesions

Annual U.S. BCC cases

Approximately 3.6 million cases

Basal cell carcinoma cases diagnosed annually

Annual U.S. sBCC cases

540,000 to 720,000 cases

Estimated superficial basal cell carcinoma cases annually

Previous Fda approval Reports

3 past events · Latest: Dec 18

Same Type 3 events

1. Dec 18

   FDA portfolio transfer

   24h Move

   +5.6%

   Company gained U.S. regulatory control of Ameluz and RhodoLED approvals.

2. Jun 03

   Ameluz patent listing

   24h Move

   +16.3%

   FDA Orange Book listed Ameluz formulation patent with protection extending through December 2043.

3. Oct 07

   Ameluz dosage approval

   24h Move

   -9.5%

   FDA authorized up to three Ameluz tubes per actinic keratosis treatment.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

snda, photodynamic therapy, vehicle-controlled, histological clearance

4 terms

snda regulatory

"approved the Company's supplemental New Drug Application (sNDA)"

A SNDA (Subordination, Non‑Disturbance and Attornment Agreement) is a legal pact among a property owner’s lender, the owner’s tenants, and sometimes the landlord that sets who keeps lease rights if the property is sold or a mortgage is enforced. Think of it as a rulebook that decides whether a tenant can stay and keep paying rent or must answer to a new owner after a foreclosure. For investors, an SNDA matters because it protects predictable rental income, clarifies who has priority on claims against a property, and therefore affects a property’s value and the security of related loans.

photodynamic therapy medical

"specializing in the development and commercialization of photodynamic therapy"

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.

vehicle-controlled medical

"a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

histological clearance medical

"Histological clearance of the main target lesion was seen in 76%"

Histological clearance means that tissue examined under a microscope shows no remaining disease cells at the edges of a surgical or biopsy sample, indicating the abnormal tissue was fully removed at the cellular level. Investors care because it is a concrete measure of a treatment’s or procedure’s effectiveness and is often used as an endpoint in clinical studies and regulatory evaluations, which can influence a therapy’s market prospects and future revenue.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Ameluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform

WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Ameluz^® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED^® lamp series, for the treatment of superficial Basal Cell Carcinoma (sBCC) in adults¹.

With this approval, Ameluz becomes the first and only PDT drug approved by the FDA for the treatment of a skin cancer, and the only topical PDT in the United States indicated to treat both a pre-cancerous skin condition, actinic keratosis (AK), and a skin cancer. The sBCC indication expands the addressable market for Ameluz and strengthens its position in medical dermatology. This label expansion also furthers Biofrontera's strategy of broadening the clinical utility of its Red-Light PDT platform. Hermann Luebbert, Chief Executive Officer and Chairman of Biofrontera, stated: "FDA approval of Ameluz for superficial basal cell carcinoma is a defining milestone for Biofrontera. Ameluz is now the first and only photodynamic therapy approved in the United States to treat a skin cancer, which sets our platform apart in medical dermatology and gives dermatologists an effective, non-surgical option for a very common tumor. This approval reflects years of disciplined investment in the clinical development of Ameluz, and the latest stage in the ongoing expansion of our PDT platform.” He added “We are planning an official launch of the sBCC indication late in the fourth quarter of 2026 through the first quarter of 2027 with our existing commercial organization and installed lamp base. We believe the approval represents a further driver of long-term growth for our existing customers. It also gives new Dermatology practices a reason to purchase a RhodoLED lamp and begin to use Ameluz PDT, expanding our overall installed base." This new indication utilizes the same topical product (Ameluz) and the same red-light device as the Company’s AK indication, so our existing customers will be able to rapidly adopt this new treatment option.

Basal cell carcinoma (BCC) is the most common skin cancer in the United States, with approximately 3.6 million cases diagnosed annually, according to the Skin Cancer Foundation. Published estimates suggest that the superficial subtype accounts for approximately 15%-20% of BCC cases, or an estimated 540,000 to 720,000 sBCC cases annually in the U.S.². Superficial BCC lesions can be up to several cm in diameter and are frequently located on the trunk and extremities and often present as multiple lesions, for which non-surgical, tissue-sparing treatment options are limited.

The approval is supported by a multicenter, randomized, double-blind, vehicle-controlled Phase 3 trial in 187 adults with histologically confirmed sBCC. The primary endpoint was a composite of both clinical and histological complete response of a main target lesion 12 weeks after the start of the last PDT cycle. This rigorous target was achieved in 66% of subjects treated with Ameluz PDT (95/145) compared with 5% of subjects treated with placebo-PDT (2/42). Histological clearance of the main target lesion was seen in 76% of Ameluz PDT treated patients versus 19% with Placebo-PDT, and 83% of Ameluz-treated subjects achieved complete clinical clearance of all target lesions compared with 21% for Placebo-PDT. The most common adverse reactions were application-site reactions consistent with the known safety profile of Ameluz PDT.

Dr. M. Shane Chapman, MBA, board certified dermatologist, Professor and Founding Chair, Department of Dermatology, Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicine, and a key contributor to the Phase 3 study added "For many patients with superficial basal cell carcinoma — those with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery would not be preferred — treatment options have been limited. This FDA approval for Ameluz® and the RhodoLED gives us a rigorously studied, non-surgical option that we can deliver in our office. As someone who has worked with PDT for many years, I see this as a meaningful expansion in the use of this treatment."

¹ Ameluz Prescribing information (https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/208081s040lbl.pdf)
² Scrivener Y, Grosshans E, Cribier B. Variations of basal cell carcinomas according to gender, age, location and histopathological subtype. Br J Dermatol. 2002;147(1):41–47

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions with photodynamic therapy (PDT). The Company's products are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions, and superficial basal cell carcinoma, and are in development for additional indications. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and X.

Investor Contact

Ben Shamsian
Lytham Partners
646-829-9701
shamsian@lythampartners.com

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. All statements, other than statements of historical facts, in this press release, including statements regarding our strategy, future operations, regulatory process, future financial position, future revenue, projected costs, prospects, plans, objectives of management and expected market growth, are forward-looking statements. The words "believe", "anticipate", "intend", "expect", "target", "goal", "estimate", "plan", "assume", "may", "will", "predict", "project", "would", "could" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. You should read this press release and any documents referenced herein completely and with the understanding that our actual future results may be materially different from what we expect. While we have based these forward-looking statements on our current expectations and projections about future events, we may not actually achieve the plans, intentions or expectations disclosed in or implied by our forward-looking statements, and you should not place undue reliance on our forward-looking statements.

These forward-looking statements are subject to risks, uncertainties and assumptions about us and accordingly, 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: our ability to achieve and sustain profitability; our ability to compete effectively in selling our products; our ability to expand, manage and maintain our direct sales and marketing efforts, including our ability to obtain the financing to develop our marketing strategy, if needed; changes in our relationship with our manufacturing partners and the possible impact of tariffs; our ability to manufacture our products; our ability to adequately protect our intellectual property and operate the business without infringing upon the intellectual property rights of others; our actual financial results may vary significantly from forecasts and from period to period; our estimates regarding anticipated operating losses, future revenues, capital requirements and our needs for additional financing; market risks regarding consolidation and group purchasing organizations ("GPOs") in the healthcare industry; the willingness of healthcare providers to purchase our products if coverage, reimbursement and pricing from third-party payors for our products, or procedures using our products significantly declines; our ability to market, commercialize, achieve market acceptance for and sell our products; the fact that product quality issues or product defects may harm our business; any claims brought against the Company, including but not limited to product liability claims, claims of patent infringement, or claims challenging the validity of our intellectual property; our ability to maintain compliance with The Nasdaq Stock Market, LLC continued listing standards; our ability to comply with the requirements of being a public company; the progress, timing and completion of research, development and preclinical studies and clinical trials for our products; our ability to obtain and maintain the regulatory approvals necessary for the marketing of our products in the United States; and other factors that may be disclosed in the Company's filings with the Securities and Exchange Commission ("SEC"), which can be obtained on the SEC website at www.sec.gov. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Any forward-looking statements speak only as of the date on which they are made, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that may arise after the date of this press release, except as required by applicable law. Investors should evaluate any statements made by us in light of these important factors.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What makes this Ameluz approval unique among photodynamic therapies in the U.S.?

With this decision, Ameluz used with the BF‑RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, and the only topical PDT indicated for both actinic keratosis and superficial basal cell carcinoma.

When does Biofrontera plan to commercially launch the new sBCC indication for Ameluz?

The company plans an official launch of the superficial basal cell carcinoma indication from late Q4 2026 through Q1 2027, using its existing commercial organization and installed RhodoLED lamp base.

How large is the potential U.S. market for the new superficial basal cell carcinoma indication?

Basal cell carcinoma is cited at about 3.6 million cases annually in the U.S. Published estimates suggest the superficial subtype represents about 15%–20% of these, corresponding to roughly 540,000 to 720,000 superficial BCC cases each year.

What clinical trial evidence supported FDA approval of Ameluz for superficial basal cell carcinoma?

Approval is based on a multicenter, randomized, double‑blind, vehicle‑controlled Phase 3 trial in 187 adults with histologically confirmed superficial BCC. The primary endpoint was a composite clinical and histological complete response of the main target lesion 12 weeks after the start of the last PDT cycle. This endpoint was reached in 66% (95/145) of Ameluz PDT patients versus 5% (2/42) with placebo‑PDT. Histological clearance occurred in 76% vs 19%, and complete clinical clearance of all target lesions in 83% vs 21%, respectively.

What safety profile was observed for Ameluz PDT in superficial basal cell carcinoma treatment?

The most common adverse reactions were application‑site reactions such as local skin effects, which were described as consistent with the known safety profile of Ameluz photodynamic therapy.

How will existing Ameluz and RhodoLED users be able to adopt the new indication?

The new superficial basal cell carcinoma indication uses the same Ameluz topical product and the same red‑light BF‑RhodoLED lamp as the current actinic keratosis indication, so existing customers are expected to be able to adopt this treatment quickly with their current equipment.