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 biopharmaceutical innovator specializing in dermatological treatments through photodynamic therapy and topical antibiotics. This news hub provides investors and healthcare professionals with direct access to the company's official communications and market developments.
Key resources include earnings reports, FDA regulatory updates, clinical trial progress, and partnership announcements. All content is sourced from verified corporate disclosures, ensuring reliable tracking of the company's progress in treating actinic keratoses, impetigo, and related skin conditions.
Users can expect timely updates on product commercialization efforts, financial performance metrics, and therapeutic advancements. The archive serves as both historical reference and current awareness tool for those monitoring Biofrontera's unique position in dermatology innovation.
Bookmark this page for streamlined access to BFRI's latest developments. Combine with SEC filings and medical publications for complete due diligence on the company's dermatology-focused biopharma strategy.
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.
Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company focused on dermatological products, has announced it will report its financial results for Q2 2024 on August 14, 2024, after market close. The company will host a conference call and webcast to discuss these results on August 15, 2024, at 10:00 AM ET.
Investors and interested parties can access the conference call by dialing 1-877-877-1275 (U.S.) or 1-412-858-5202 (international). A webcast of the call will also be available at the provided link. This announcement indicates Biofrontera's commitment to transparency and shareholder communication, allowing stakeholders to gain insights into the company's financial performance and business updates for the second quarter of 2024.
Biofrontera has launched its FDA-approved RhodoLED XL lamp, a red light emitting LED device for photodynamic therapy (PDT) of actinic keratoses. Used with the Ameluz topical gel, also FDA-approved, the RhodoLED XL is designed to treat mild-to-moderate actinic keratoses on the face and scalp. The device features an expanded treatment area and advanced positioning sensors to optimize energy delivery. It was first shipped on June 10, 2024, and has received positive feedback from dermatology practices, including Cleaver Dermatology. This launch aligns with Biofrontera's commitment to innovation in dermatologic care.
Biofrontera has reported its Q1 2024 results, indicating a 9% revenue decline to $7.9M compared to Q1 2023. Contributing factors include reimbursement issues stemming from the Change Healthcare data breach. The company secured $8M through a private placement and an additional $8M via warrant exercises. Operational costs were reduced through a renegotiated Ameluz agreement reducing transfer prices. Despite a net loss of $10.4M, cash reserves increased to $3.8M. Sales of the new RhodoLED XL lamp are expected to begin in Q2 2024. An FDA decision on Ameluz dosage is anticipated by October 2024.
Biofrontera Inc. (NASDAQ:BFRI) will announce its first quarter 2024 financial results on May 15, 2024. The company specializes in dermatological products and will host a conference call on May 16, 2024, to discuss the results.
Biofrontera Inc. announced the achievement of two milestones associated with Series B-3 Convertible Preferred Stock Warrants. The Board of Directors certified the fulfillment of criteria related to warrants issued in February 2024, triggering payments totaling $8 million. The milestones included a 5% revenue growth from January to April 2024 compared to the same period in 2023 and successful implementation of a new customer relationship management system with over 95% adoption. The company also received shareholder approval to increase its authorized capital and filed a registration statement with the SEC to register shares underlying the Series B-3 Convertible Preferred Stock.
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