$BFRI

Biofrontera Inc. (NASDAQ: BFRI) submitted a supplemental New Drug Application to the FDA to expand Ameluz®'s use for treating actinic keratoses (AKs) to the full body, beyond the face and scalp. The submission follows a 12% revenue growth in 2025 and a 25% increase in the first half of 2026. The application is supported by clinical trial data showing 45.6% complete clearance of AK lesions. If approved, Ameluz® would be the only PDT approved in the U.S. for full-body AK treatment.

Bristol Myers Squibb (BMY) and Egetis Therapeutics (EGTX) await FDA decisions on drug expansions. Biofrontera (BFRI), Scholar Rock (SRRK), and Mirum Pharmaceuticals (MIRM) received early approvals. BMY's Camzyos, if approved, would be the first cardiac myosin inhibitor for adolescents with oHCM. EGTX's Emcitate could be the first FDA-approved treatment for MCT8 deficiency. SRRK and BFRI shares declined post-approval, while MIRM shares rose.

IM Cannabis (IMCC) surged 245% with no clear catalyst, trading between $2.97 and $8.65. XORTX (XRTX) rose 12% on plans for a 2026 FDA application. Silo Pharma (SILO) gained 6.73% after a U.S. patent allowance. Biofrontera (BFRI) increased 5.65% despite no new news, following an FDA approval for Ameluz.

Biofrontera Inc. (BFRI) announced FDA approval for Ameluz to treat superficial Basal Cell Carcinoma. The approval follows a Phase 3 trial showing 76% histological clearance. The stock dropped 6.48% to $1.4449. Launch is planned for late 2026 to early 2027.

Biofrontera Inc. (BFRI) filed an SEC Form 8-K — Other Events. Exhibit 99.1 Biofrontera Announces FDA Approval of Ameluz ® Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma 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,

Pro-Dex (PDEX) rose 18% to $77 on FY'26 results, with net sales up 16% to $77.5M. Odyssey (ODTX) gained 8% to $29.05, reporting a Q2 loss of $52.8M. Evolus (EOLS) climbed 2% to $9.31, with Q2 revenue up 21% to $84.1M. Biofrontera (BFRI) increased 6% to $1.63, with Q2 product revenue up 32.9%. Alpha Tau (DRTS) hit $15.17, reporting a Q2 loss of $68.8M.

Several biotech stocks hit 52-week highs on August 28, 2026. RenovoRx (RNXT) rose 12% to $1.68 after positive Phase 3 trial data. BlossomHill (BLSM) reached $20.61, with FDA Fast Track designation for BH-30643. AtriCure (ATRC) hit $49.98, reporting Q2 revenue of $153.6M. Biofrontera (BFRI) climbed to $1.61 with 32.9% product revenue growth. Revvity (RVTY) reached $130.07, raising full-year revenue guidance to $2.83B-$2.86B.

Biofrontera (BFRI) reported Q2 2026 net product revenue of $12.0 million, up 32.9% YoY. Gross margin expanded to 80% from 71%, and adjusted EBITDA loss narrowed to -$200,000. The company faces risks from an ITC exclusion order on its RhodoLED XL lamp but plans a remediation. Ameluz volume grew 30%, and the company aims for FDA approvals in 2026-2027 for new indications. Cash and cash equivalents were $4.7 million as of June 30, 2026.

Biofrontera (BFRI) reported Q2 2026 net product revenue of $12.0M, up 32.9% from $9.0M, with gross margin rising to 80% from 71%. Net loss narrowed to $0.6M from $5.3M. For six months, revenue was $22.1M (+25.4%) and gross margin 80%. A PDUFA decision for Ameluz is expected Sept. 28, 2026.

Biofrontera Inc. (BFRI) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Biofrontera Inc. Reports Strong Second Quarter 2026 Financial Results Driven by 33% Revenue Growth WOBURN, Mass., August 13, 2026 — Biofrontera Inc. (NASDAQ: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and comme