BIOFRONTERA INC PLANS TO SUBMIT PHASE 2B DATA FOR AMELUZ PDT TO FDA IN Q3 2026

Written by Emily J. Thompson, Senior Investment Analyst

Source: moomoo

Updated: 1 day ago

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BFRI+0.36%

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Should l Buy BFRI?

Source: moomoo

Project Overview: The BioFrontier AI initiative is set to present Phase 2 data for the Ameluz PDT treatment in Q3 2026.
Focus on Ameluz: The data presentation will specifically highlight the efficacy and outcomes of Ameluz in photodynamic therapy (PDT).

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Analyst Views on BFRI

Wall Street analysts forecast BFRI stock price to rise

2 Analyst Rating

2 Buy

0 Hold

0 Sell

Moderate Buy

Current: 0.824

Low

3.00

Averages

6.00

High

9.00

Current: 0.824

Low

3.00

Averages

6.00

High

9.00

Roth Capital

Buy

upgrade

$8 -> $10

2025-06-30

Reason

Roth Capital

Price Target

$8 -> $10

AI Analysis

2025-06-30

upgrade

Buy

Reason

Roth Capital raised the firm's price target on Biofrontera Inc. to $10 from $8 and keeps a Buy rating on the shares. The firm notes Biofrontera Inc. acquired full U.S. Ameluz and RhodoLED rights from former parent company Biofrontera AG, which, when combined with the $11M investment from existing institutional investors, funds Biofrontera Inc. to profitability.

Benchmark

Bruce Jackson

Buy

downgrade

2025-05-19

Reason

Benchmark

Bruce Jackson

Price Target

2025-05-19

downgrade

Buy

Reason

Benchmark analyst Bruce Jackson lowered the firm's price target on Biofrontera Inc. to $2.75 from $7 and keeps a Buy rating on the shares. After Q1 revenue of $8.6M lagged the firm's $10.6M estimate, its new revenue estimate is $41.1M for 2025, down from $43.1M, notes the analyst, who adds that historic sales patterns would suggest that the "already seasonally heavy" Q4 will be "the key to this year's revenue growth."

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About BFRI

Biofrontera Inc. is a biopharmaceutical company. The Company specializes in the development and commercialization of pharmaceutical products for the treatment of dermatological conditions with a focus on photodynamic therapy (PDT). The PDT treatment is used for the lesion-directed and field-directed treatment of actinic keratoses of mild-to-moderate severity on the face and scalp. The Company’s primary licensed products, which include Ameluz as well as the BF-RhodoLED and RhodoLED XL lamps (the RhodoLED Lamps), are used for the treatment of actinic keratoses, which are pre-cancerous skin lesions. 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. Its belixos ACTIVE CARE is a skin-soothing care foam for irritated and itchy skin, which can be used as basic care for atopic dermatitis and psoriasis as well as for soothing intensive care for everyday skin problems.

About the author

Emily J. Thompson

Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.

Biofrontera to Report 2025 Financial Results on March 19

21 hours agoNewsfilter

Financial Reporting Schedule: Biofrontera will announce its financial results for the year ended December 31, 2025, after the U.S. market closes on March 19, 2026, reflecting the company's commitment to financial transparency.
Conference Call Timing: The company will host a conference call at 10:00 AM ET on the same day to discuss the financial results and provide a business update, aiming to bolster investor confidence in the company's future prospects.
Product Focus Area: Biofrontera specializes in photodynamic therapy (PDT), commercializing the drug-device combination Ameluz® with the RhodoLED® lamp series for treating precancerous skin lesions, showcasing its expertise in dermatological treatments.
Clinical Trial Expansion: The company is conducting clinical trials to extend the use of its products to treat non-melanoma skin cancers and moderate-to-severe acne, indicating its proactive approach to product development and market expansion potential.

Biofrontera Announces Ameluz® Clinical Trial Results

1 day agoNewsfilter

Clinical Trial Results: Biofrontera's Phase 2b study demonstrated that Ameluz® achieved a 57.97% reduction in inflammatory acne lesions with a 3-hour incubation, significantly outperforming the control group's 36.51%, indicating the treatment's potential in acne management.
Efficacy Assessment: In the mIGA analysis, 25% of patients treated with Ameluz® met the co-primary endpoint compared to 21.4% in the vehicle group, further validating Ameluz®'s effectiveness in improving skin conditions.
Safety and Tolerability: Ameluz® exhibited a favorable safety profile, with treatment-related adverse events primarily consisting of mild to moderate burning sensations and pruritus, and average pain scores during the 3-hour treatments ranged from 3.4 to 3.8, indicating good tolerability.
Market Potential: Acne vulgaris is one of the most common dermatological conditions in the U.S., and Biofrontera plans to present these findings to the FDA in Q3 2026 to seek approval for Ameluz® in treating moderate to severe acne, thereby expanding its dermatology product line.