Biofrontera Inc Stock Price, News & Analysis

Biofrontera Inc. (Nasdaq: BFRI) has reported a significant milestone in its phase III clinical study for treating superficial basal cell carcinoma with Ameluz photodynamic therapy. Currently, 70% of the targeted 186 patients have been enrolled, with expectations to complete recruitment by the end of 2022. The study aims to position Ameluz as the only FDA-approved drug for this treatment in the U.S, increasing its market potential. Challenges included a stringent study protocol and delays due to the COVID-19 pandemic.

Biofrontera Inc. (Nasdaq: BFRI) released a letter from CEO Erica Monaco and Executive Chairman Hermann Lübbert, reflecting on their successful 2021 and outlining plans for 2022. The company achieved significant revenue growth, anticipating $24.1 million to $24.2 million in 2021, a 27% increase from 2020. Focused on increasing market share for FDA-approved products Ameluz and Xepi, Biofrontera aims to expand its commercial opportunities and leverage new clinical developments, including new product approvals and ongoing studies.

Biofrontera Inc. (Nasdaq: BFRI) announced preliminary, unaudited revenues for Q4 and full year 2021. Q4 revenue is estimated between $9.1 million and $9.2 million, marking a 7% increase year-over-year. Full-year revenue is projected at $24.1 million to $24.2 million, up 27% compared to 2020. CEO Erica Monaco expressed pride in the team’s performance despite ongoing challenges from the COVID-19 pandemic. The company plans to release audited financial results in March 2022, but cautioned that these preliminary figures may change.

Biofrontera (Nasdaq: BFRI) announced its participation in two dermatology conferences in January 2022: the Winter Clinical Dermatology Conference from January 14-19 and Maui Derm for Dermatologists 2022 from January 24-28. At these events, clinical data on its FDA-approved products, Ameluz® and Xepi® will be presented, focusing on photodynamic therapy (PDT) and recent studies of Ameluz-PDT. An expert advisory board meeting with dermatologists will also be held to discuss clinical messaging and the new RhodoLED XL PDT-lamp.

Biofrontera Inc. (Nasdaq: BFRI) announced a significant milestone as Biofrontera AG's ownership in the company diluted below 50%, resulting in Biofrontera Inc. no longer being considered a subsidiary. Despite this, Biofrontera AG retains its role as the licensor for key dermatological products, including Ameluz® and BF-RhodoLED® lamps in the U.S. CEO Erica Monaco stated this transition marks Biofrontera Inc.'s progress towards independence from its former parent company.

Biofrontera Inc. (Nasdaq: BFRI) announced the enrollment of the first subject in its Phase 2b study to evaluate the safety and efficacy of Ameluz® combined with the BF-RhodoLED® lamp for treating moderate-to-severe acne through photodynamic therapy.

This multicenter trial will involve 126 patients, assessing the treatment's efficacy against placebo. The study aims to expand Ameluz®'s FDA approval, potentially benefiting millions of Americans with acne.

Biofrontera Inc. (Nasdaq: BFRI) announced that the USPTO has granted a Notice of Allowance for patent number 17/215,785, covering innovations in the RhodoLED XL lamp for photodynamic therapy (PDT). This patent strengthens the intellectual property around Ameluz and enhances its competitive position in the U.S. market. The patent includes advancements such as optimized illumination and improved device positioning through distance sensors. Biofrontera plans to initiate a Phase 3 trial for treating actinic keratoses in 2022, utilizing this patented technology.

Biofrontera Inc. (Nasdaq: BFRI) has initiated a Phase 1 study to assess the safety and tolerability of photodynamic therapy (PDT) for actinic keratosis (AK) using three tubes of Ameluz® in combination with the BF-RhodoLED® XL lamp. Conducted across eight sites, the study will enroll 100 subjects with varying severity of AK. CEO Erica Monaco emphasized this study's potential to enhance Ameluz®'s market competitiveness in the U.S. The study follows a pharmacokinetics study completed in 2021, which prompted the FDA to request further safety evaluations.

Biofrontera Inc. (Nasdaq: BFRI) announced that the USPTO has issued a Notice of Allowance for its patent on an innovative pain-reducing illumination protocol for photodynamic therapy (PDT). This advancement strengthens the competitiveness of Ameluz® and BF-RhodoLED® in the U.S. market, enabling potential label expansion. Biofrontera plans to start a Phase 3 trial in 2022 to test this protocol for treating actinic keratoses. The company focuses on dermatological products, including Ameluz® and Xepi®.