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 specializing in dermatology and photodynamic therapy (PDT). Its news flow centers on the commercialization and clinical development of Ameluz® and the RhodoLED® lamp series for the treatment of actinic keratoses and other skin conditions.
On this page, readers can follow company announcements related to financial results, such as quarterly and annual revenue updates, as well as business updates describing trends in Ameluz® sales and operating expenses. Biofrontera frequently reports on revenue performance, gross margin developments, and the impact of its strategic agreements on its financial profile.
News items also highlight clinical and regulatory milestones. These include database locks and completion of clinical studies in actinic keratosis on peripheral body areas, Phase 1 pharmacokinetics data, Phase 3 results in superficial basal cell carcinoma, and Phase 2 progress in acne vulgaris. The company uses press releases to describe how these data support supplemental New Drug Applications and future Phase 3 programs.
In addition, Biofrontera issues updates on strategic transactions and capital markets activity, such as the acquisition of all U.S. rights to Ameluz® and RhodoLED® from Biofrontera AG, changes to royalty and earnout structures, private placements of convertible preferred stock, and the divestiture of its Xepi® antibiotic cream license. Regulatory notices regarding Nasdaq listing compliance and participation in investor conferences are also part of the company’s regular news flow.
Investors and observers who want to track developments in dermatologic photodynamic therapy, label expansion efforts for Ameluz®-PDT, and Biofrontera’s financial and strategic progress can use this news feed as a centralized source of company-issued updates.
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.
Biofrontera Inc. (BFRI) has initiated a clinical study program to optimize its FDA-approved drug, Ameluz®, for photodynamic therapy in the U.S. Two studies are set to begin recruiting patients before year-end, focusing on treating moderate-to-severe acne and assessing safety with multiple tubes of Ameluz®. Under a licensing agreement with Biofrontera AG, the company holds exclusive marketing rights. Ameluz® is crucial for Biofrontera's growth in the U.S. dermatological market, aiming to enhance its positioning against actinic keratosis.
Biofrontera Inc. announced the closing of its initial public offering on November 2, 2021, raising $18 million by issuing 3,600,000 units, each comprising one common share and one warrant, priced at $5.00 per unit. The offering was successful, with underwriters exercising an option for an additional 540,000 warrants. These warrants are exercisable over five years at the same price. Biofrontera's common stock and warrants trade under the symbols BFRI and BFRIW respectively.
Biofrontera Inc. (Nasdaq: BFRI) announced its initial public offering (IPO) of 3,600,000 units, each priced at $5.00, consisting of one share of common stock and one warrant. The offering could generate $18 million in gross proceeds, before deducting fees. A 30-day option allows underwriters to purchase an additional 540,000 shares. Trading for these securities is set to start on October 29, 2021, with the offering closing expected on November 2, 2021.
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