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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. has been granted a new patent by the USPTO for a photodynamic therapy (PDT) protocol that is expected to be less painful but similarly effective to conventional PDT. The patent covers the use of a composition comprising a photosensitizer and two different photo-activating wavelengths of light. This adds to Biofrontera's growing licensed patent portfolio and establishes them as a leader in PDT and dermatologic innovation.
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Biofrontera Inc. reported Q1 2023 financial results, with total revenues of $8.7 million and cash and cash equivalents of $13.5 million. The company also announced a secured line of credit up to $6.5 million and significant expansion of its commercial team. Clinical studies for Ameluz-PDT are progressing, with the first patient dosed in a Phase 3 study for the treatment of actinic keratosis.
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Biofrontera Inc. (NASDAQ:BFRI) announced the completion of the last patient visit in a Phase I study for Ameluz® - PDT aimed at treating mild to severe actinic keratosis (AK). The study, conducted by Biofrontera Bioscience GmbH, explored the safety and tolerability of using three tubes of BF-200 ALA 10% gel in expanded treatment fields. Top line results are anticipated in Q4 2023. CEO Erica Monaco emphasized this milestone as a significant advancement, potentially allowing broader treatment areas and fewer office visits for patients. Actinic keratosis is a common pre-cancerous condition affecting approximately 58 million U.S. residents, highlighting the importance of effective treatment options.

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Biofrontera Inc. (NASDAQ:BFRI) announced a significant investment in expanding its salesforce by almost 30%, thereby increasing coverage to 40 territories in 2023. This strategic move aims to enhance outreach for their FDA-approved therapy for actinic keratosis, Ameluz®-PDT, further penetrating dermatology markets. CEO Erica Monaco highlighted the company’s success in 2022, achieving record revenues and market share with a reduced sales team. The addition of 140 years of healthcare experience is expected to bolster growth and market presence. The company remains optimistic about future performance despite potential challenges outlined in their forward-looking statements.

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Biofrontera Inc. (NASDAQ:BFRI) is set to showcase its FDA-approved dermatological products at the 2023 American Academy of Dermatology (AAD) Annual Meeting from March 17-21 in New Orleans, LA. The company will demonstrate the photodynamic therapy (PDT) procedure using the RhodoLED lamp at booth #2224. CEO Erica Monaco stated the event is an opportunity to educate dermatologists about the Ameluz PDT therapy for treating actinic keratoses. The AAD Annual Meeting is the largest dermatologic event, attracting about 18,000 attendees, including around 10,000 medical personnel. Biofrontera aims to enhance its outreach among dermatology professionals during this major conference.

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FAQ

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

The current stock price of Biofrontera (BFRI) is $1.07 as of December 26, 2024.

What is the market cap of Biofrontera (BFRI)?

The market cap of Biofrontera (BFRI) is approximately 8.1M.

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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8.06M
5.84M
32.06%
20.68%
8.25%
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