Biofrontera Stock Price, News & Analysis

Biofrontera Inc. (BFRI) announced the inclusion of its patent for a propylene glycol-free formulation of Ameluz® nanoemulsion gel in the FDA's Orange Book. The patent, approved in April 2025, extends protection until December 2043 and prevents generic competition during this period. The revised formulation eliminates propylene glycol, a known allergen, demonstrating Biofrontera's focus on patient-centric development. The formulation has been in use since 2024 after FDA acceptance. The Orange Book listing confirms FDA recognition of the drug's safety, efficacy, and quality standards. This development represents a significant improvement for patients sensitive to propylene glycol while maintaining the treatment's effectiveness in photodynamic therapy (PDT).

Biofrontera Inc. (NASDAQ:BFRI) reported its Q1 2025 financial results with total revenues of $8.6 million, marking a 9% increase from Q1 2024. The company's cash position was $1.8 million as of March 31, 2025, down from $5.9 million at year-end 2024. Notable achievements include completing enrollment in Phase 3 trials for Ameluz® for actinic keratoses treatment, receiving patent protection through 2043, and finalizing a Phase 2b study for acne vulgaris treatment. The company reported a net loss of $4.2 million ($0.47 per share), improved from a $10.4 million loss in Q1 2024. Operating expenses decreased to $13.1 million from $13.4 million year-over-year, while Adjusted EBITDA improved to ($4.4) million from ($4.6) million.

Biofrontera Inc. (BFRI) has achieved two significant milestones: patent approval for Ameluz® extending protection until December 2043, and completion of patient enrollment in a Phase 2b study for acne treatment. The study evaluates Ameluz® photodynamic therapy (PDT) for moderate to severe acne vulgaris, enrolling 120 patients with treatments involving 1-hour and 3-hour incubation periods.

The U.S. acne treatment market, valued at $5.7 billion in 2024, is growing at a 5.3% CAGR. Over 55% of market spending goes to oral antibiotics and isotretinoin, which often have systemic side effects. With approximately 50 million Americans suffering from acne vulgaris, Ameluz® PDT could provide an alternative treatment option without the side effects associated with current systemic therapies.

The Phase 2b trial's last-patient-out is expected in Q3 2025, marking a crucial step in expanding Ameluz®'s indications beyond its current approval for mild to moderate actinic keratosis.

Biofrontera Inc. (NASDAQ:BFRI) and Almirall have launched the Hats On Challenge, a social media initiative to raise awareness about Actinic Keratosis (AK) ahead of Global AK Awareness Day on May 24, 2025. The campaign aims to support The Skin Cancer Foundation and Euromelanoma through a social media challenge where participants wear hats and post videos using specific hashtags.

AK is a common precancerous skin condition affecting an estimated 58 million Americans, with a global prevalence of 14%. The condition, characterized by rough, scaly patches on sun-exposed areas, can develop into squamous cell carcinoma if left untreated. The campaign will run throughout May 2025, with both companies making monetary donations to The Skin Cancer Foundation on behalf of participants.

Biofrontera Inc. (NASDAQ:BFRI) reported record financial results for fiscal year 2024, achieving total revenues of $37.3 million, a 9.5% increase from 2023. Q4 2024 revenue grew 18.5% to $12.6 million.

Key highlights include: reduced operating expenses to $54.5 million (down 3.9%), improved cash position to $5.9 million, and restructured agreements resulting in Ameluz® transfer price reduction from 50% to 25%. The company successfully placed 100 RhodoLED® XL lamps since June 2024 launch.

Notable achievements include FDA approval for using up to three Ameluz® tubes per treatment, significant Phase 3 study results for Superficial Basal Cell Carcinoma treatment, and accelerated patient recruitment in clinical trials. However, the company reported a net loss of $(17.8) million for 2024, though improved from $(20.1) million in 2023.

Biofrontera (Nasdaq: BFRI) has completed patient enrollment in its Phase 3 clinical trial evaluating Ameluz® for treating mild to moderate actinic keratoses (AKs) on extremities, neck and trunk. The study enrolled 172 patients in a 4:1 ratio receiving either Ameluz® or vehicle gel.

This multicenter, randomized, double-blind study will assess the safety and efficacy of Ameluz® PDT using 1-3 tubes over surface areas of 80-240cm². Patients receive one PDT treatment, with a second treatment at 12 weeks if AK lesions remain, followed by a one-year monitoring period.

The treatment phase is expected to complete by September 2025, with follow-up concluding in Q2 2026. Upon positive outcomes, Biofrontera plans to submit a supplemental New Drug Application to the FDA in second half of 2026.

Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products, has scheduled its fourth quarter and full year 2024 financial results announcement for March 21, 2025. The results will be released before market opening, followed by a conference call at 10:00am Eastern Time.

The company specializes in the commercialization of Ameluz® with the RhodoLED® lamp series for photodynamic therapy (PDT) of actinic keratosis (AK), which are pre-cancerous skin lesions. Biofrontera is also conducting clinical trials to expand these products' applications for treating non-melanoma skin cancers and moderate to severe acne.

Biofrontera Inc. (BFRI) has achieved a significant milestone in its Phase 3 study of Ameluz-PDT for treating superficial Basal Cell Carcinoma (sBCC), with the last patient completing the 1-year follow-up in December 2024. The study, involving 187 patients, demonstrated highly statistically significant results (p <0.0001) for all primary and secondary endpoints in October 2024.

The double-blind, randomized, placebo-controlled trial evaluated patients with confirmed sBCC who received either Ameluz-PDT or placebo-PDT treatments. The company plans to submit an sNDA to the FDA in Q3 2025, including the one-year follow-up data. While this data supports the FDA submission, patients will be monitored for a total of five years due to risks of local recurrence.

BCC represents the most common skin cancer in the US, with over 3 million cases annually, making this potential treatment expansion significant for Biofrontera's market presence.

Biofrontera Inc. (BFRI) announced the successful placement of its 100th RhodoLED® XL Lamp in the US market since its commercial launch in June 2024. The device, FDA-approved in 2022 for use with Ameluz® gel for photodynamic therapy (PDT) of actinic keratoses, has seen rapid adoption with more than 10% of Ameluz-using offices installing the system.

The RhodoLED XL features more LED panels than its predecessor BF-RhodoLED, enabling treatment of larger surface areas in a single session. Dr. Aaron Hoover of Front Range Dermatology highlighted the lamp's design, maneuverability, and enhanced patient throughput. Following FDA approval in October 2024, physicians can now use up to 3 tubes of Ameluz® in one treatment, maximizing the benefits of the larger illumination area.