Fortress Biotech's Emrosi Receives FDA Approval for Rosacea Treatment
Key Insights
The FDA approved Emrosi (search) (minocycline hydrochloride extended-release capsules, 40mg) for treating inflammatory lesions of rosacea (search) in adults, marking Fortress Biotech's first FDA approval.
Clinical data presented at the Fall Clinical Dermatology Conference showed Emrosi (search) provides higher dermal concentration than doxycycline, potentially leading to clinically meaningful impact.
Fortress Biotech anticipates a PDUFA goal date of December 28, 2024, for cosibelimab, an anti-PD-L1 (search) antibody, for treating metastatic or locally advanced cutaneous squamous cell carcinoma (search).
Fortress Biotech, Inc. (Nasdaq: FBIO) has achieved a significant milestone with the FDA approval of Emrosi (search) (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for the treatment of inflammatory lesions of rosacea (search) in adults. This marks the first FDA approval across the Fortress portfolio, highlighting the company's ability to successfully develop clinical-stage programs through commercialization. The treatment is expected to launch late in the first quarter or early in the second quarter of 2025 by Journey Medical (Nasdaq: DERM).
Regulatory and Clinical Highlights
The FDA approved Emrosi (search) in November 2024, recognizing its potential as a new treatment paradigm for millions of rosacea (search) patients. Clinical data presented at the 44th Fall Clinical Dermatology Conference compared the dermal and systemic pharmacokinetics of Emrosi versus oral doxycycline 40 mg capsules in healthy subjects. The results indicated that Emrosi, with its extended-release formulation, provides higher dermal concentration than doxycycline from day 1 onward at a similar dose. This is expected to translate into a clinically meaningful impact for treating patients with rosacea, as demonstrated in Emrosi’s Phase 3 clinical trials.
Cosibelimab Update
In July 2024, the FDA accepted the Biologics License Application (BLA) resubmission for cosibelimab, an investigational anti-PD-L1 (search) antibody, for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (search) (cSCC) who are not candidates for curative surgery or radiation. The PDUFA goal date is set for December 28, 2024. Longer-term data from the pivotal trial of cosibelimab in locally advanced and metastatic cSCC, presented at the European Society for Medical Oncology (ESMO) Congress 2024, demonstrated a deepening of response over time, with higher objective response and complete response rates than initially observed at the primary analyses.
Other Developments
Fortress Biotech is also advancing other pipeline assets. In December 2023, the asset transfer of CUTX-101 (copper histidinate for Menkes disease (search)) to Sentynl Therapeutics was completed. Sentynl completed the rolling submission of the New Drug Application for CUTX-101 in the fourth quarter of 2024. Additionally, Urica Therapeutics entered into an agreement with Crystalys Therapeutics, transferring rights to dotinurad, its URAT1 inhibitor product candidate for gout (search).
Financial Overview
Fortress Biotech's consolidated net revenue totaled $14.6 million for the third quarter ended September 30, 2024, all of which was generated from marketed dermatology products. Consolidated research and development expenses, including license acquisitions, totaled $9.4 million for the same period. As of September 30, 2024, Fortress’ consolidated cash and cash equivalents totaled $58.9 million.