Biofrontera Inc Stock Price, News & Analysis

Biofrontera Inc. (NASDAQ: BFRI), a biopharmaceutical company focused on photodynamic therapy (PDT), has engaged Lytham Partners to lead its strategic investor relations and shareholder communication program. The company has recently completed several transformative actions, including restructuring its relationship with its former parent company, acquiring U.S. intellectual property and new drug applications, taking control of manufacturing, and securing $11 million in new funding.

Biofrontera commercializes Ameluz® with RhodoLED® lamp series for PDT treatment of actinic keratosis (AK), pre-cancerous skin lesions. The company is conducting clinical trials to expand product use for non-melanoma skin cancers and moderate to severe acne. Management expects to achieve meaningful profitability in the coming quarters.

Biofrontera (NASDAQ:BFRI) has announced the completion of the active treatment phase in its Phase 3 clinical trial for Ameluz® PDT, evaluating its effectiveness in treating actinic keratoses (AKs) on extremities, neck and trunk. The study, involving 172 patients, follows the October 2024 approval for using up to 3 tubes of Ameluz® per treatment.

The multicenter, randomized, double-blind trial tested Ameluz® PDT versus vehicle gel, with treatment areas ranging from 80 to 240 cm². Patients received one or two PDT treatments and have now entered a 12-month follow-up phase, expected to conclude in Q2 2026. Upon completion, Biofrontera plans to submit a supplemental New Drug Application (sNDA) to the FDA.

[ "Trial builds upon recent FDA approval for expanded Ameluz® usage (up to 3 tubes per treatment)", "Large market potential with 58 million US adults having at least one AK lesion", "Study addresses critical unmet need in dermatology for AK treatment beyond face and scalp", "Successful completion of active treatment phase with all 172 patients enrolled" ]

Biofrontera Inc. (NASDAQ: BFRI) announced completion of patient participation in its Phase 2b clinical trial evaluating Ameluz® for treating moderate to severe acne vulgaris. The multicenter, randomized, double-blind study compared Ameluz® with vehicle gel using red-light Photodynamic Therapy (PDT), with top-line results expected in Q1 2026.

The trial involved up to 3 PDT sessions at monthly intervals, with participants receiving either 1 or 3-hour incubation before BF-RhodoLED® lamp illumination. Following anticipated positive results, Biofrontera plans FDA discussions in Q3 2026 to advance Phase 3 program for potential label expansion.

The study addresses a significant market opportunity, with acne affecting 50 million Americans annually and a market valued at $5.7 billion in 2024. Current treatments face limitations including side effects and antibiotic resistance concerns, highlighting the need for alternative solutions.

Biofrontera Inc. (NASDAQ:BFRI) reported strong Q2 2025 financial results with total revenues of $9.0 million, marking a 15% increase year-over-year. The company achieved significant milestones, including a major restructuring of its relationship with Biofrontera AG, acquiring U.S. IP rights and NDAs for Ameluz® and RhodoLED®.

Key financial highlights include H1 2025 revenue of $17.7 million (up 12% YoY) and cash position of $7.2 million. The company secured an additional $11 million in funding and negotiated a new royalty structure of 12-15% with Biofrontera AG, replacing the previous 25-35% transfer pricing model.

Clinical progress includes completion of patient follow-up in sBCC Phase 3 study and enrollment completion in Phase 3 study for AK treatment and Phase 2b acne vulgaris study. A new U.S. patent extends Ameluz® protection through 2043.

Biofrontera Inc. (Nasdaq: BFRI) has appointed George Jones as Chief Commercial Officer (CCO), effective August 25, 2025. This strategic hire follows the company's recent acquisition of all US rights and assets for Ameluz® and RhodoLED® from Biofrontera AG, which includes a restructured royalty payment of 12-15% versus the previous 25-35% transfer pricing model.

Jones brings over 25 years of commercial leadership experience in specialty pharmaceuticals and biotech. His track record includes successful roles at Currax Pharmaceuticals, Pernix Therapeutics, and most recently as COO at UpScriptHealth, where he achieved a threefold increase in partnership revenues.

Biofrontera (NASDAQ:BFRI), a biopharmaceutical company focused on dermatological products commercialization, has scheduled its Second Quarter 2025 Financial Results announcement for August 13, 2025 after market close.

The company will host a conference call and webcast to discuss the results on Thursday, August 14, 2025, at 10:00 AM ET. Investors can access the call via U.S. toll-free number (1-877-877-1275) or international number (1-412-858-5202).

Biofrontera Inc. (NASDAQ: BFRI) has announced a major restructuring agreement with Biofrontera AG, backed by an $11 million investment from Rosalind Advisors and AIGH Capital Management LLC. The company will acquire all US assets related to Ameluz® and RhodoLED®, including the New Drug Application (NDA) and associated patents.

Under the new agreement, Biofrontera Inc. will pay a significantly reduced royalty rate of 12% of net sales (increasing to 15% for revenue above $65 million), down from the previous 25-35% transfer pricing model. Biofrontera AG will receive a 10% post-money equity stake in Biofrontera Inc.

The $11 million investment will be funded in two tranches: $8.5 million with the signing of the royalty agreement and $2.5 million upon finalizing the asset transfer agreement by September 30, 2025. The capital will be provided as preferred shares convertible to common shares at $0.6249 per share.

Biofrontera Inc. (BFRI) has confirmed ongoing negotiations with Biofrontera AG regarding potential significant changes to their business relationship. The discussions center around two possible outcomes: a merger between the companies or modifications to their existing license and supply agreement. The potential agreement modifications could involve transferring certain rights and obligations from Biofrontera AG to Biofrontera Inc., along with a reduction in transfer pricing for Biofrontera Inc.'s US-licensed products. However, no definitive terms have been established yet, and any final agreement remains subject to various conditions and the execution of definitive agreements between both parties.

Biofrontera Inc. (BFRI) announced the inclusion of its patent for a propylene glycol-free formulation of Ameluz® nanoemulsion gel in the FDA's Orange Book. The patent, approved in April 2025, extends protection until December 2043 and prevents generic competition during this period. The revised formulation eliminates propylene glycol, a known allergen, demonstrating Biofrontera's focus on patient-centric development. The formulation has been in use since 2024 after FDA acceptance. The Orange Book listing confirms FDA recognition of the drug's safety, efficacy, and quality standards. This development represents a significant improvement for patients sensitive to propylene glycol while maintaining the treatment's effectiveness in photodynamic therapy (PDT).