Biofrontera Announces Positive Results in Phase 3 Study of Ameluz® PDT for Actinic Keratoses on the Extremities, Neck, and Trunk, Meeting Primary Endpoint

Rhea-AI Summary

Biofrontera (Nasdaq: BFRI) reported positive Phase 3 results showing Ameluz® PDT met the primary endpoint for treating mild-to-moderate actinic keratoses (AK) on extremities, neck, and trunk.

In the Full Analysis Set, subject complete clearance was 45.6% vs. 16.7% for vehicle (p<0.0003); Per Protocol rates were 53.2% vs. 22.2% (p<0.001). Lesion clearance was 73.1% (FAS) and 80.3% (PPS). Investigators reported favorable cosmetic outcomes and high patient satisfaction. Biofrontera plans an sNDA submission in Q3 2026.

Positive

• Complete clearance 45.6% (FAS) versus 16.7% vehicle
• Per Protocol clearance 53.2% for Ameluz versus 22.2% vehicle
• Lesion clearance 73.1% (FAS) and 80.3% (PPS)

Negative

• Majority not fully cleared—54.4% of FAS patients lacked complete clearance
• Small control arm—vehicle group only 36 patients (4:1 randomization)

News Market Reaction – BFRI

-1.30% 87.0x vol

16 alerts

-1.30% Session close to close

+7.5% Peak Tracked

-39.2% Trough Tracked

$9.56M Market Cap

87.0x Rel. Volume

In the Feb 9 session, BFRI declined 1.30%, reflecting a mild negative market reaction. Argus tracked a peak move of +7.5% during that session. Argus tracked a trough of -39.2% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. Trading volume was exceptionally heavy at 87.0x the daily average, suggesting significant selling pressure.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement delivers statistically strong Phase 3 results for Ameluz® PDT in actinic keratoses...

Analysis

This announcement delivers statistically strong Phase 3 results for Ameluz® PDT in actinic keratoses on extremities, neck, and trunk, with complete clearance rates up to 53.2% and lesion clearance above 80% in the PPS. It advances the program toward a planned sNDA in Q3 2026, building on prior database-lock and Phase 1 updates. Investors may watch for final one‑year follow-up, FDA interactions, and how future approvals intersect with Biofrontera’s capital position and Nasdaq compliance path.

Key Figures

Phase 3 enrollment: 172 patients Primary endpoint FAS: 45.6% vs 16.7% Primary endpoint PPS: 53.2% vs 22.2% +5 more

8 metrics

Phase 3 enrollment 172 patients Ameluz® PDT AK study on extremities, neck, trunk

Primary endpoint FAS 45.6% vs 16.7% Complete clearance Ameluz® vs vehicle at 12 weeks (FAS)

Primary endpoint PPS 53.2% vs 22.2% Complete clearance Ameluz® vs vehicle at 12 weeks (PPS)

Lesion clearance FAS 73.1% AK lesion clearance 12 weeks after last PDT (FAS)

Lesion clearance PPS 80.3% AK lesion clearance 12 weeks after last PDT (PPS)

p-value primary endpoint p<0.0003 Superiority of Ameluz® vs vehicle for primary endpoint

Cosmetic outcome rating 75.2% investigators; 70.9% patients Aesthetic appearance rated good/very good

Retreatment willingness 86.3% Patients who would choose PDT again

Previous Clinical trial Reports

5 past events · Latest: Jan 08 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jan 08	Clinical data lock	Positive	+3.1%	Phase 3 AK and Phase 2 acne databases locked enabling topline analyses.
Dec 04	Phase 1 completion	Positive	+3.2%	Last patient visit completed in Phase 1 PK study on neck, trunk, extremities.
Dec 02	sNDA filing sBCC	Positive	-0.1%	sNDA filed for superficial basal cell carcinoma based on positive Phase 3 data.
Sep 16	Phase 3 LPO AK	Positive	+4.0%	Last patient out in Phase 3 AK trial on extremities, neck and trunk.
May 15	Patent and Phase 2b	Positive	+0.1%	Patent extension to 2043 and completion of enrollment in acne Phase 2b.

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

Pattern Detected

Clinical and trial-related updates have usually been followed by modestly positive price reactions, with only one slight divergence.

Recent Company History

Over the past year, Biofrontera has consistently advanced Ameluz® through clinical and regulatory milestones. Prior clinical updates, including database locks and last-patient-out in AK and acne studies, as well as an sNDA filing for sBCC, typically saw modest positive moves of around 2–4%. Today’s Phase 3 AK results on extremities, neck, and trunk build directly on the 172-patient trial referenced in prior updates and support the planned sNDA timing in 2026.

Key Terms

photodynamic therapy, actinic keratosis, squamous cell carcinoma, randomized, double-blind, +4 more

8 terms

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.

actinic keratosis medical

"Actinic keratosis (AK) is the most common skin condition diagnosed by US dermatologists"

Actinic keratosis is a rough, scaly patch on the skin caused by long-term sun exposure that is considered a precancerous lesion because it can sometimes progress to skin cancer. For investors, its importance lies in the size of the patient pool, clinical trial outcomes, and regulatory approvals for drugs or devices—think of it as a frayed area in fabric that may need repair to prevent a much larger tear, driving demand for treatments and diagnostics.

squamous cell carcinoma medical

"If left untreated, AK may progress to squamous cell carcinoma"

Squamous cell carcinoma is a type of skin cancer that develops when the cells in the outer layer of the skin grow abnormally and uncontrollably. It can also occur in other parts of the body, such as the mouth or throat. For investors, understanding diseases like this is important because they can impact healthcare companies, influence medical research funding, and affect overall public health trends.

randomized, double-blind medical

"The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy"

A randomized, double-blind study is a clinical trial design where participants are assigned by chance to different groups (for example, a new treatment or a control) and neither the participants nor the researchers know who is in which group. This setup reduces conscious or unconscious bias—think of it like a blind taste test—so results are more reliable and investors can have greater confidence that reported effects reflect the treatment itself rather than expectations or selective reporting.

vehicle-controlled medical

"randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy"

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.

full analysis set medical

"In the Full Analysis Set (FAS), complete clearance was achieved in 45.6% of patients"

The full analysis set is the group of clinical trial participants whose data are included in the main effectiveness analyses — typically everyone who was enrolled, received treatment, and provided at least some follow-up data. For investors, this matters because the size and composition of that group affect how credible and representative the reported results are; it’s like judging a product by reading all customer reviews rather than a few selected ones.

per protocol set medical

"In the Per Protocol Set (PPS), complete clearance rates were 53.2%"

A per protocol set is the group of clinical trial participants who followed the study rules closely—received the assigned treatment, attended required visits, and had no major protocol violations—so their data show the treatment’s effect under ideal conditions. Investors watch per protocol results because they can reveal a cleaner measure of a therapy’s true effectiveness (like judging a recipe when everyone followed the instructions), which affects regulatory outlook, market expectations, and valuation.

supplemental new drug application regulatory

"Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration"

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.

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

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• Study findings met its primary endpoint and showed highly statistically significant superiority for Ameluz^® vs. vehicle gel (p<0.0003)
• Actinic keratosis (AK) is the most common skin condition diagnosed by US dermatologists¹
• If left untreated, AK may progress to squamous cell carcinoma^2,3
  
  

WOBURN, Mass., Feb. 09, 2026 (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 positive and statistically significant top-line results from its Phase 3 clinical trial evaluating Ameluz^® PDT with the red-light LED (RhodoLED^®) platform for the treatment of mild to moderate actinic keratoses (AKs) on the extremities, neck, and trunk.

The multicenter, randomized, double-blind, vehicle-controlled Phase 3 study evaluated the efficacy and tolerability of field-directed Ameluz^® PDT compared with vehicle PDT in patients with AKs located on the extremities, neck, and trunk. The study enrolled 172 patients, randomized 4:1 to receive Ameluz^® gel or vehicle gel, respectively.

The study was designed to assess treatment of increasing field sizes through the application of one, two, or three tubes of Ameluz^® over areas of approximately 80, 160, or 240 cm², applied either continuously or in patches, followed by PDT using a RhodoLED^® XL or BF-RhodoLED^® lamp. Patients received one PDT treatment, with a second PDT treatment administered at Week 12 if any AK lesions remained. Patients are being followed for approximately one year after their final PDT treatment.

The primary endpoint was “subject complete clearance rate,” defined as the percentage of patients with complete clearance of all treated AK lesions 12 weeks after the last PDT treatment.

Ameluz^® PDT demonstrated highly statistically significant superiority over vehicle PDT for the primary endpoint. In the Full Analysis Set (FAS), complete clearance was achieved in 45.6% of patients treated with Ameluz^® PDT (62/136), compared with 16.7% of patients treated with vehicle PDT (6/36) (p < 0.0003). In the Per Protocol Set (PPS), complete clearance rates were 53.2% (58/109) for Ameluz^® PDT versus 22.2% (6/27) for vehicle PDT (p < 0.001).

Key secondary outcomes further supported the efficacy of Ameluz^® PDT. The percentage of AK lesion clearance 12 weeks after the last PDT was 73.1% in the FAS and 80.3% in the PPS. Subject complete clearance rates by anatomical location were 38.5% (FAS) and 46.5% (PPS) on the extremities, and 74.1% (FAS) and 78.3% (PPS) on the neck and trunk.

In addition to efficacy, Ameluz^® PDT demonstrated favorable cosmetic outcomes and high patient satisfaction. Investigators rated the aesthetic appearance of treated skin as “good” or “very good” in 75.2% of patients, while 70.9% of patients reported similar assessments. Consistent with these results, 86.3% of patients indicated they would choose PDT again for future treatment.

“These results represent a critical milestone in our clinical program,” said Hermann Luebbert, CEO and Chairman of Biofrontera Inc. “These data support Ameluz^®’s potential to treat broader, high-burden AK fields beyond the face and scalp, significantly expanding its potential clinical use across multiple sun-exposed body areas, underscoring the potential to expand Ameluz®’s addressable market beyond the face and scalp. If approved, this label expansion would provide meaningful benefit to patients with actinic keratoses on the extremities, neck, and trunk and represent an important step forward in advancing our vision to establish leadership in photodynamic therapy.”

Nathalie Zeitouni, Professor of Dermatology at the University of Arizona College of Medicine – Phoenix and Adjunct Professor of Oncology at Roswell Park Comprehensive Cancer Center, and coordinating investigator of the study, commented: “Ameluz^® PDT is already a valuable treatment option for actinic keratoses on the face and scalp. Many patients present with lesions on other areas of the body, and these data support the potential for Ameluz^® PDT to expand treatment options for physicians and their patients.”

Based on these positive Phase 3 results, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration in the third quarter of 2026.

About Biofrontera Inc.

Biofrontera 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 Actinic Keratosis, pre-cancerous skin lesions which may progress to invasive skin cancers³. 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.

References

1. J Clin Aesthet Dermatol. 2022;15(5):E82–E86
2. Cancer. 2009;115(11):2523-2530
3. Dermatol Surg. 2007;33(9):1099-1101
   
   

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 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; the impact of any extraordinary external events; the Company’s ability to achieve and sustain profitability; whether 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 coverage, reimbursement and pricing for procedures using the Company’s products; 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
Ben Shamsian
646-829-9701
shamsian@lythampartners.com

FAQ

What were the Phase 3 subject complete clearance results for Ameluz (BFRI)?

Ameluz achieved 45.6% complete clearance in the Full Analysis Set. According to the company, vehicle PDT achieved 16.7% (p<0.0003); Per Protocol rates were 53.2% versus 22.2% (p<0.001), supporting statistical superiority.

How effective was Ameluz (BFRI) at clearing AK lesions 12 weeks after treatment?

Ameluz produced 73.1% lesion clearance in the FAS and 80.3% in the PPS. According to the company, these key secondary outcomes further support clinical efficacy across treated fields.

What anatomical areas did the Ameluz (BFRI) Phase 3 study cover and how did rates vary?

The trial evaluated extremities, neck, and trunk with differing clearance rates by site. According to the company, extremities showed 38.5% (FAS) while neck and trunk showed 74.1% (FAS).

Will Biofrontera (BFRI) seek FDA approval based on these Phase 3 results?

Biofrontera plans to submit a supplemental NDA in Q3 2026 based on positive Phase 3 findings. According to the company, the sNDA targets label expansion for extremities, neck, and trunk.

What safety, cosmetic, and patient satisfaction outcomes were reported for Ameluz (BFRI)?

Investigators rated treated skin appearance as 'good' or 'very good' in 75.2% of patients, with 70.9% patient agreement. According to the company, 86.3% said they would choose PDT again, indicating favorable tolerability and satisfaction.