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 Inc. (BFRI) announced the successful placement of its 100th RhodoLED® XL Lamp in the US market since its commercial launch in June 2024. The device, FDA-approved in 2022 for use with Ameluz® gel for photodynamic therapy (PDT) of actinic keratoses, has seen rapid adoption with more than 10% of Ameluz-using offices installing the system.
The RhodoLED XL features more LED panels than its predecessor BF-RhodoLED, enabling treatment of larger surface areas in a single session. Dr. Aaron Hoover of Front Range Dermatology highlighted the lamp's design, maneuverability, and enhanced patient throughput. Following FDA approval in October 2024, physicians can now use up to 3 tubes of Ameluz® in one treatment, maximizing the benefits of the larger illumination area.
Biofrontera Inc. (Nasdaq:BFRI), a biopharmaceutical company focused on photodynamic therapy (PDT), has announced its participation in The Benchmark Company's 13th Annual Discovery One-on-One Investor Conference. The event will take place on December 11th, 2024 at the New York Athletic Club in New York City.
The conference provides a platform for emerging growth companies to connect with institutional and individual investors through one-on-one meetings. Biofrontera will engage in individual meetings with investors and analysts throughout the day. Interested parties can schedule meetings through the provided registration link.
Biofrontera (Nasdaq: BFRI) has completed a private placement of a $4.2 million senior secured convertible note with its principal shareholders. The note matures on November 22, 2027, with a 10% annual PIK interest rate and is secured by company assets. The note is convertible to common shares at $0.78 per share at holder's discretion, or automatically if the 10-day VWAP exceeds $2.50. The financing includes restrictive covenants limiting the company's ability to create liens, pay dividends, incur debt, or enter affiliate transactions. Proceeds will support general operations and strategic investments, including commercial and clinical development initiatives.
Biofrontera reported Q3 2024 revenues of $9.0 million, up 1.5% from Q3 2023, with potential 19% growth impacted by Hurricane Milton delays. Nine-month revenues reached $24.8 million, showing 5.6% growth. Ameluz achieved record volume in September 2024, while SG&A expenses decreased 14% year-over-year. The company successfully launched RhodoLED XL with 39 installations since June 2024. Notable developments include FDA approval to increase Ameluz dosage to three tubes per treatment and highly significant Phase 3 sBCC study results showing 75.9% histological clearance versus 19% with placebo.
Biofrontera (Nasdaq: BFRI), a biopharmaceutical company focused on PDT development and commercialization, will release its financial results for Q3 2024 and the nine months ended September 30, 2024, after market close on November 13, 2024. The company will host a conference call to discuss the results on November 14, 2024, at 10:00 AM ET. The call will be accessible via phone and webcast for both U.S. and international participants.
Biofrontera announced significant results from its Phase 3 study of Ameluz®-PDT for treating superficial basal cell carcinoma (sBCC). The study involved 187 patients and showed 65.5% success rate with Ameluz®-PDT compared to 4.8% with placebo in achieving complete clinical and histological clearance. Secondary endpoints were also highly significant (p<0.0001), with 64.1% of Ameluz®-PDT patients achieving total clearance of all sBCC lesions versus 4.8% for placebo. Patient satisfaction was notable, with 64.3% rating the treatment as very good and 22.2% as good. The company plans to submit FDA documentation in Q2/Q3 2025 after completing the one-year follow-up phase in December.
Biofrontera Inc. (Nasdaq: BFRI) has announced the database lock for its Phase 3 study ALA-BCC-CT013, evaluating Ameluz®-Photodynamic Therapy (PDT) for treating superficial Basal Cell Carcinoma (sBCC). This marks the end of data collection for the treatment phase, with analysis now underway. The study, involving 186 patients, is the first Phase 3 PDT trial for sBCC in the United States.
Key points:
- Double-blind, randomized, placebo-controlled multi-center study
- Primary endpoint: complete clinical and histological clearance of target BCC lesion
- Interim results expected November 2024
- FDA submission targeted for Q1 2025, including 1-year follow-up data
If approved, this would expand Biofrontera's label from premalignant applications to treating cutaneous malignancy, advancing their goal of becoming market leaders in PDT.
The FDA has approved Biofrontera’s sNDA to increase the maximum dosage of Ameluz® (aminolevulinic acid HCI) Topical Gel, 10%, from one to three tubes per treatment. This approval enhances the treatment of actinic keratosis (AK) on the face and scalp using Ameluz®-PDT with the BF-RhodoLED or RhodoLED XL lamp. The decision is based on two Phase 1 safety studies involving 116 patients, which confirmed that the increased dosage maintains safety and efficacy levels. This approval allows healthcare providers to treat larger or multiple areas more effectively, improving convenience for both providers and patients. Biofrontera is working with Medicare and commercial payers to secure reimbursement for this update.
Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company focused on commercializing dermatologic products, has announced its participation in the 3rd Annual ROTH Healthcare Opportunities Conference. The event will take place at the Metropolitan Club in New York, NY.
Key details of Biofrontera's presentation include:
- Date: October 9, 2024
- Time: 12:30 - 1:10 PM ET
- Format: Live Presentation
The company has also made provisions for one-on-one meetings during the conference. Interested parties are advised to contact their Roth representative to schedule these meetings.
This presentation offers an opportunity for Biofrontera to showcase its developments in the dermatologic products sector to potential investors and industry professionals.
Biofrontera Inc. (NASDAQ:BFRI) reported financial results for Q2 2024, showing significant growth. Total revenues increased 34% to $7.8 million compared to Q2 2023. The company's cash position improved to $4.4 million as of June 30, 2024. Biofrontera launched the FDA-approved RhodoLED® XL lamp in June and took control of all U.S. clinical trials for Ameluz®.
Despite revenue growth, the company reported a net loss of $257,000 for Q2 2024, a substantial improvement from the $9.8 million loss in Q2 2023. Adjusted EBITDA was negative $4.7 million, compared to negative $7.9 million in the prior-year quarter. The company raised an additional $8.0 million in May 2024 from warrant exercises and has paid down all outstanding debt.
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