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Biofrontera

WOBURN, Massachusetts, United States · Biotechnology, Healthcare, Health Care

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the pr

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Key facts

Headquarters
WOBURN, Massachusetts, United States
Employees
70
Industries
Biotechnology, Healthcare, Health Care
Status
Public (BFRI)
Website
www.biofrontera.com
LinkedIn
Company page

Recent activity at Biofrontera

  • : SEC 8-K (8.01): On September 14, 2026, Biofrontera Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application concerning Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%. The approval facilitates the use of this drug in conjunction with photodynamic therapy. This significant development could enhance the company's product offerings in dermatological treatments, potentially increasing market share and revenue. The FDA's notification represents a critical milestone in the regulatory process for the company's product expansion strategy.
  • : SEC 8-K (7.01): On March 9, 2026, Biofrontera Inc. announced the results of its Phase 2b study of Ameluz® PDT for the treatment of moderate to severe Acne Vulgaris. The results were issued via a press release, which is included as Exhibit 99.1. This disclosure is part of the company's Regulation FD compliance to inform investors about significant clinical developments. The announcement highlights Biofrontera's ongoing efforts in dermatological treatments and may influence investor perception and stock valuation.
  • : SEC 8-K (8.01): On February 23, 2026, the U.S. Patent Trial and Appeal Board issued a Final Written Decision declaring all challenged claims of Sun Pharmaceutical Industries, Inc.'s U.S. Patent No. 11,697,028 to be unpatentable. This decision is part of ongoing legal proceedings that involve Biofrontera Inc. and relate to patent infringement allegations made by Sun. While Sun retains the right to seek a rehearing or appeal the Decision, the impact on current litigation in the U.S. District Court for the District of Massachusetts remains uncertain. The Company issued a press release detailing these developments on February 26, 2026, highlighting the strategic implications of these legal challenges on its operations.

Employee benefit plans

Biofrontera files 1 employee benefit plan with the U.S. Department of Labor, including a retirement plan. The next plan year renews in Feb 2027.

About Biofrontera: questions and answers

What does Biofrontera do?

Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the development and treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the pr

Where is Biofrontera headquartered?

Biofrontera is headquartered in WOBURN, Massachusetts, United States.

How many employees does Biofrontera have?

Biofrontera has about 70 employees.

What is the latest news on Biofrontera?

On Sep 14, 2026, SEC 8-K (8.01): On September 14, 2026, Biofrontera Inc. announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application concerning Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%. The approval facilitates the use of this

Is Biofrontera a public company?

Yes. Biofrontera is publicly traded under the ticker BFRI.

Source: Fundz records from SEC filings, press releases and company announcements. How Fundz measures data accuracy

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