Fortress Biotech, Inc. (Nasdaq: FBIO) has announced key corporate highlights, including the FDA approval of Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for the treatment of inflammatory lesions of rosacea in adults. This marks a significant milestone as the first FDA approval across the Fortress portfolio. The company anticipates a potential launch of Emrosi in late Q1 or early Q2 2025, through their partner company, Journey Medical (Nasdaq: DERM).
Regulatory and Clinical Updates
In addition to the Emrosi approval, the FDA has accepted the Biologics License Application (BLA) resubmission for cosibelimab, an investigational anti-PD-L1 antibody, with a PDUFA goal date of December 28, 2024. Cosibelimab is being developed for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) who are not candidates for curative surgery or radiation. Checkpoint Therapeutics (Nasdaq: CKPT), a partner company, is currently developing cosibelimab.
Clinical data presented at the 44th Fall Clinical Dermatology Conference assessed the pharmacokinetics of Emrosi versus oral doxycycline 40 mg capsules in healthy subjects. The data 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.
Longer-term data from the pivotal trial of cosibelimab in locally advanced and metastatic cSCC were presented during the European Society for Medical Oncology (ESMO) Congress 2024. The results showed 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 exploring the combined therapeutic potential of cosibelimab with GC Cell’s Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy. Additionally, Urica Therapeutics, a majority-owned subsidiary, entered into an asset purchase agreement with Crystalys Therapeutics, transferring rights to dotinurad, a URAT1 inhibitor for the treatment of gout.
Financial Overview
As of September 30, 2024, Fortress Biotech’s consolidated cash and cash equivalents totaled $58.9 million. Consolidated net revenue for the third quarter ended September 30, 2024, was $14.6 million, generated from marketed dermatology products. Consolidated research and development expenses, including license acquisitions, totaled $9.4 million for the same period. The consolidated net loss attributable to common stockholders was $(15.0) million, or $(0.76) per share, for the third quarter ended September 30, 2024.
