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Biofrontera files sNDA to expand Ameluz use to full-body skin lesions

Thu, 08 Oct 2026 09:22:16 -0400

Biofrontera Inc. (NASDAQ: BFRI) has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking to expand the approved use of Ameluz® (aminolevulinic acid hydrochloride) topical gel, 10%, to treat mild-to-moderate actinic keratoses (AKs) on the extremities, neck and trunk, in combination with photodynamic therapy (PDT) using the RhodoLED® lamp series.

Ameluz® PDT is currently FDA-approved for AKs on the face and scalp and, as of September 2026, for superficial basal cell carcinoma. If the new application is approved, the company claims Ameluz® with red light would be the only PDT approved in the U.S. for

Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body

Thu, 08 Oct 2026 09:22:00 -0400

Submission seeks to extend the Ameluz^® label beyond the face and scalp to treatment fields of up to approximately 240 cm² on the rest of the body, with an adjusted illumination protocol

WOBURN, Mass., Oct. 08, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) to expand the indication for Ameluz^® (aminolevulinic acid hydrochloride) topical gel, 10%,

Biofrontera Submits Supplemental New Drug Application to FDA to Expand Ameluz® Red Light PDT to Actinic Keratoses on the Full Body

Thu, 08 Oct 2026 09:22:00 -0400

Submission seeks to extend the Ameluz^® label beyond the face and scalp to treatment fields of up to approximately 240 cm² on the rest of the body, with an adjusted illumination protocol

Biofrontera (BFRI) Reiterated at Speculative Buy by StoneX as Ameluz Approved For sBCC

Tue, 15 Sep 2026 07:31:33 -0400

StoneX analyst Bruce Jackson reiterated a Speculative Buy rating and $3.00 price target on Biofrontera (NASDAQ: BFRI).

The analyst commented, " Biofrontera announced the receipt of FDA approval for the use of Ameluz for the treatment of Superficial Basal Cell Carcinoma (sBCC), which was earlier than the September 28 PDUFA date. The company is planning an official launch for the new indication during late 4Q 2026 or early 2027 through its existing commercial organization, which is slightly earlier than our current expectations. Ameluz is now the first and only photodynamic therapy (PDT) drug approved by the FDA for the treatment of

Form 8-K Biofrontera Inc. For: Sep 14

Mon, 14 Sep 2026 09:30:00 -0400

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FDA approves Biofrontera's Ameluz for superficial basal cell carcinoma

Mon, 14 Sep 2026 09:26:19 -0400

Biofrontera Inc. (NASDAQ: BFRI) announced that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, used with the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma (sBCC) in adults.

The company claims Ameluz is now the first PDT drug approved by the FDA to treat a skin cancer, and the only topical PDT in the U.S. indicated for both actinic keratosis, a pre-cancerous skin condition, and a skin cancer.

Basal cell carcinoma is the most common skin cancer in the U.S., with approximately 3.6 million cases diagnosed

Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

Mon, 14 Sep 2026 09:26:00 -0400

Ameluz used in conjunction with the RhodoLED lamp becomes the first and only photodynamic therapy approved in the United States to treat a skin cancer, creating an additional growth opportunity for Biofrontera’s photodynamic therapy platform

WOBURN, Mass., Sept. 14, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company's supplemental New Drug Application (sNDA) for Ameluz^® (aminolevulinic acid hydrochloride) topical gel, 10%, in combination

Biofrontera Announces FDA Approval of Ameluz® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma

Mon, 14 Sep 2026 09:26:00 -0400

Form 10-Q Biofrontera Inc. For: Jun 30

Thu, 13 Aug 2026 16:41:00 -0400

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Form 10-Q Biofrontera Inc. For: Jun 30

Thu, 13 Aug 2026 16:41:00 -0400

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Form 8-K Biofrontera Inc. For: Aug 13

Thu, 13 Aug 2026 09:01:00 -0400

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Form 8-K Biofrontera Inc. For: Aug 13

Thu, 13 Aug 2026 09:01:00 -0400

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Biofrontera Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue Growth

Thu, 13 Aug 2026 08:51:00 -0400

WOBURN, Mass., Aug. 13, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT) in dermatology, today reported financial results for the quarter ended June 30, 2026.

Second Quarter 2026 Highlights

Net product revenue of $12.0 million, an increase of 32.9% compared to $9.0 million in the prior-year period.
Gross margin of 80%, compared to 71% in the prior-year period, an improvement of approximately 920 basis points, reflecting the lower Ameluz^® cost structure established following the closing of

Biofrontera Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue Growth

Thu, 13 Aug 2026 08:51:00 -0400

Second Quarter 2026 Highlights

Net product revenue of $12.0 million, an increase of 32.9% compared to $9.0 million in the prior-year period.
Gross margin of 80%, compared to 71% in the prior-year period, an improvement of approximately 920 basis points, reflecting the lower Ameluz^® cost structure established following the closing of

Form SCHEDULE 13G/A Biofrontera Inc. Filed by: Rosalind Advisors, Inc.

Wed, 12 Aug 2026 14:31:00 -0400

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Form SCHEDULE 13G/A Biofrontera Inc. Filed by: Rosalind Advisors, Inc.

Wed, 12 Aug 2026 14:31:00 -0400

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Biofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026

Wed, 05 Aug 2026 16:15:00 -0400

WOBURN, Mass., Aug. 05, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (NASDAQ: BFRI) ("Biofrontera" or the "Company"), a U.S. specialty dermatology company commercializing Ameluz^® (aminolevulinic acid hydrochloride) Gel, 10% with the BF-RhodoLED^® lamp for photodynamic therapy (PDT) of actinic keratosis, today announced that it will report financial results for the second quarter ended June 30, 2026 before the market opens on Thursday, August 13, 2026.

Management will host a conference call and webcast the same day at 10:00 a.m. Eastern Time to discuss the results and provide a business update.

Conference Call and Webcast Details

Biofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026

Wed, 05 Aug 2026 16:15:00 -0400

Management will host a conference call and webcast the same day at 10:00 a.m. Eastern Time to discuss the results and provide a business update.

Conference Call and Webcast Details

Biofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026

Wed, 05 Aug 2026 16:15:00 -0400

Management will host a conference call and webcast the same day at 10:00 a.m. Eastern Time to discuss the results and provide a business update.

Conference Call and Webcast Details

Biofrontera Inc. to Report Second Quarter 2026 Financial Results on August 13, 2026

Wed, 05 Aug 2026 16:15:00 -0400

Management will host a conference call and webcast the same day at 10:00 a.m. Eastern Time to discuss the results and provide a business update.

Conference Call and Webcast Details

Form 4 Biofrontera Inc. For: Jul 28 Filed by: Luebbert Hermann

Wed, 29 Jul 2026 17:48:00 -0400

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Form 4 Biofrontera Inc. For: Jul 28 Filed by: Luebbert Hermann

Wed, 29 Jul 2026 17:48:00 -0400

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Form 4 Biofrontera Inc. For: Jul 28 Filed by: Leffler Eugene Frederick

Wed, 29 Jul 2026 17:44:00 -0400

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Form 4 Biofrontera Inc. For: Jul 28 Filed by: Leffler Eugene Frederick

Wed, 29 Jul 2026 17:44:00 -0400

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Form S-8 Biofrontera Inc.

Wed, 22 Jul 2026 17:25:00 -0400

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