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.
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®.
Biofrontera Inc. (Nasdaq: BFRI; BFRIW) announced a successful private placement, raising $15 million through the sale of 2,857,143 shares and warrants to an institutional investor. Each share and accompanying warrant were priced at $5.25 under Nasdaq regulations. The warrants are immediately exercisable and will expire five years from issuance. Biofrontera must file a registration statement with the SEC within 15 days and ensure it's effective within 90 days.
Biofrontera Inc. (Nasdaq: BFRI) reported a 33% increase in Q3 2021 revenues to $4.3 million and a 45% increase year-to-date to $14.9 million, driven by strong sales of Ameluz®. The company raised $18 million through an IPO and a $15 million private placement. However, operating expenses surged to $20.4 million, leading to a net loss of $16.0 million. Despite the financial strain, management emphasized the positive sales trend, indicating recovery from the COVID-19 pandemic and continued clinical studies for Ameluz®. Cash reserves stood at $1.7 million as of September 30, 2021.
Biofrontera announced a securities purchase agreement with an institutional investor for 2,857,143 shares and warrants to purchase an equal number of shares at a price of $5.25 per share. This private placement is expected to generate approximately $15 million in gross proceeds, closing on or about December 1, 2021. The warrants are immediately exercisable and will expire in five years. The company must file a registration statement with the SEC within 15 days to cover the resale of these securities.
Biofrontera Inc. (Nasdaq: BFRI) will announce its financial results for the three and nine months ending September 30, 2021, before the U.S. markets open on November 30, 2021. The company will host a conference call that day at 4:30 p.m. Eastern time to discuss the results and provide a business update. Biofrontera specializes in dermatological products and focuses on treating conditions such as actinic keratoses and impetigo. Investors can access the live webcast and replay on their website.
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