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Biofrontera Inc. - BFRI STOCK NEWS

Welcome to our dedicated page for Biofrontera news (Ticker: BFRI), a resource for investors and traders seeking the latest updates and insights on Biofrontera stock.

Biofrontera Inc. (Nasdaq: BFRI) is a U.S.-based biopharmaceutical company dedicated to the commercialization of innovative dermatological products. Specializing in the treatment of skin conditions such as actinic keratoses and impetigo, Biofrontera focuses on photodynamic therapy (PDT) and topical antibiotics.

One of the company's flagship products is Ameluz®, a prescription drug used in combination with the BF-RhodoLED® lamp series for PDT. Ameluz is approved for the treatment of actinic keratoses, pre-cancerous skin lesions that can develop into skin cancer if left untreated. Another key product in their portfolio is Xepi®, an antibiotic for treating impetigo, a bacterial skin infection.

In recent news, Biofrontera announced record high revenues for 2023, achieving approximately $34.3 million, up 19% compared to 2022. This growth was driven by increased sales of Ameluz and a stronger financial condition, supported by strategic partnerships and clinical trials. The company also reported a successful securities purchase agreement that raised up to $16 million, aimed at advancing product development and expanding indications for Ameluz.

Biofrontera's forward-looking strategy includes reducing the transfer price of Ameluz from 50% to 25% for 2024 and 2025, taking control of U.S. clinical trials, and making significant strides in regulatory approvals with the FDA. For instance, the FDA has commenced a substantive review of a supplementary New Drug Application to increase the approved dosage of Ameluz, indicating the potential for broader usage.

These developments underscore Biofrontera's commitment to enhancing patient care through advanced dermatological therapies and maintaining a robust growth trajectory in the competitive biopharmaceutical landscape.

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Biofrontera Inc. (Nasdaq: BFRI) reported a 28% revenue increase for 2021, reaching $24.1 million, with Q4 revenues at $9.2 million, up 7% year-over-year. Despite growth, the company faced a net loss of $37.7 million for the year. Cash reserves stood at $24.5 million, sufficient for operations through 2023. Biofrontera initiated two clinical studies for Ameluz® and aims for over 30% revenue growth in 2022, boosted by strong sales momentum and a focus on customer penetration. The company also received U.S. patents and regulatory approvals, enhancing its market position.

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Biofrontera (Nasdaq: BFRI) reported preliminary product revenues for Q1 2022, forecasting between $9.5 million and $10.0 million, an increase of approximately 102% to 113% year-over-year. CEO Erica Monaco highlighted this growth as evidence of the market's preference for their products. The revenue surge is partly attributed to advance purchases before a planned price hike. The final results will be disclosed in May 2022, with caution expressed about the potential for variance in estimates.

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Biofrontera Inc. (Nasdaq: BFRI) announced it will report its financial results for Q4 and the full year ended December 31, 2021, on April 8, 2022, prior to the opening of U.S. markets. The company will host a conference call at 11:00 a.m. ET the same day to discuss these results and provide a business update.

The call can be accessed through a toll-free number for U.S. participants and an international line. A webcast of the call will also be available for live viewing and a 90-day replay.

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Biofrontera Inc. (Nasdaq: BFRI) will prominently showcase its FDA-approved dermatological products at the AAD Annual Meeting from March 25-29, 2022, in Boston, with an expected attendance of 10,000 medical professionals. CEO Erica Monaco highlights the event's significance for enhancing visibility and promoting photodynamic therapy (PDT) for actinic keratoses. The company's booth will feature its flagship drug Ameluz® and Xepi®, aiming to strengthen connections with dermatologists and industry leaders. This participation aligns with Biofrontera's growth strategy in dermatology.

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Biofrontera (Nasdaq: BFRI) announced that its U.S. patent No. 11,235,169 for the BF-RhodoLED® XL illumination device is now included in the FDA's Orange Book. This patent protects Ameluz®-PDT through October 2040, serving as a barrier against generic competition. The FDA's listing confirms the patent's role in safeguarding the approved drug-device combination. The CEO, Erica Monaco, stated that this endorsement strengthens their market position. Additionally, two new patents for BF-RhodoLED® XL were granted, emphasizing the company's strategy to secure its competitive advantage.

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Biofrontera Inc. (Nasdaq: BFRI) has announced that CEO Erica Monaco will present at the 34th Annual Roth Conference from March 13-15, 2022, in Laguna Niguel, California. During the event, scheduled for March 15 at 11:00 AM PT, Monaco will engage with registered investors through meetings and presentations. The conference features various growth sector discussions, including healthcare and technology. A live audio webcast of Biofrontera's presentation will be accessible on the company's investor relations website.

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Biofrontera Inc. (Nasdaq: BFRI) has appointed Kevin D. Weber to its Board of Directors, expanding its membership to five. With over 30 years of experience in the pharmaceutical industry, Mr. Weber has expertise in clinical dermatology and product marketing, having previously served in various executive roles. His insight is expected to bolster Biofrontera's market position for its products, including Ameluz® and Xepi®. The company focuses on dermatological solutions, including treatments for actinic keratosis and impetigo.

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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.

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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.

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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.

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FAQ

What is the current stock price of Biofrontera (BFRI)?

The current stock price of Biofrontera (BFRI) is $1.01 as of December 24, 2024.

What is the market cap of Biofrontera (BFRI)?

The market cap of Biofrontera (BFRI) is approximately 7.8M.

What does Biofrontera Inc. specialize in?

Biofrontera Inc. specializes in the commercialization of dermatological products, focusing on photodynamic therapy (PDT) and topical antibiotics.

What are Biofrontera's main products?

Biofrontera's main products include Ameluz®, used in PDT for treating actinic keratoses, and Xepi®, a topical antibiotic for impetigo.

What recent financial milestones has Biofrontera achieved?

Biofrontera achieved record revenues in 2023, totaling approximately $34.3 million, a 19% increase compared to 2022.

What strategic partnerships has Biofrontera entered into?

Biofrontera recently entered into a securities purchase agreement with healthcare-focused institutional investors, raising up to $16 million for product development.

What is the significance of Ameluz in Biofrontera's portfolio?

Ameluz is a key product used in combination with the BF-RhodoLED® lamp series for PDT, primarily for treating actinic keratoses.

What recent regulatory progress has Biofrontera made?

The FDA has begun a substantive review of a supplementary New Drug Application to increase the approved dosage of Ameluz, showing potential for broader usage.

How is Biofrontera planning to manage its clinical trials?

Starting June 1, 2024, Biofrontera will take control of all U.S. clinical trials for Ameluz, allowing for more effective cost management and trial oversight.

What are Biofrontera's plans for future growth?

Biofrontera plans to lower the transfer price of Ameluz, expand clinical trials, and achieve regulatory milestones to enhance its market position and financial performance.

What is the market focus of Biofrontera?

Biofrontera focuses on treating dermatological conditions such as actinic keratoses and impetigo using advanced therapies like PDT and topical antibiotics.

How does Biofrontera contribute to patient care?

Biofrontera enhances patient care by developing and commercializing innovative treatments for pre-cancerous and bacterial skin conditions.

Biofrontera Inc.

Nasdaq:BFRI

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