Fortress Biotech, Inc. - FBIO STOCK NEWS

Urica Therapeutics, a subsidiary of Fortress Biotech (FBIO), has appointed Jay D. Kranzler, M.D., Ph.D., as Chairman and CEO, and Vibeke Strand, M.D., to its Board. Dr. Kranzler brings over 30 years of drug development experience, particularly with the lead candidate dotinurad, currently in Phase 1 trials for gout in the U.S. Dotinurad, approved in Japan, is a urate transporter inhibitor showing promise in clinical trials. The company anticipates topline data from its Phase 1 trial later in 2022, aiming to expand treatment options for millions of U.S. gout patients.

Fortress Biotech announced that CEO Lindsay A. Rosenwald will provide a corporate update at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022. The company focuses on acquiring and developing therapeutic products and has nine marketed drugs and over 30 programs in development in areas such as oncology and rare diseases. Fortress collaborates with leading research institutions and biopharmaceutical companies to enhance its portfolio and drive shareholder value.

Journey Medical Corporation (NASDAQ: DERM) has enrolled over 50% of participants in its Phase 3 trials evaluating DFD-29 (Minocycline Modified Release Capsules 40 mg) for treating papulopustular rosacea. This milestone indicates progress in collaboration with Dr. Reddy’s Laboratories. The company anticipates topline data in early 2023, followed by a New Drug Application filing later that year, expecting DFD-29 to achieve peak annual sales exceeding $100 million. Previous Phase 2 trials showed DFD-29's efficacy nearly double that of doxycycline in reducing inflammatory lesions.

Fortress Biotech reported a 45.5% growth in net revenue for H1 2022, totaling $42.8 million. The company anticipates significant regulatory milestones, including a BLA submission for cosibelimab for metastatic cutaneous squamous cell carcinoma expected by year-end 2022. Journey Medical, a partner, achieved $18.3 million in Q2 2022, up 20% from Q2 2021. Fortress reported a net loss of $21.4 million for Q2 2022, contrasting with a $3.5 million loss in Q2 2021. Strong ongoing clinical trials and expanded product offerings position the company for future growth.

Fortress Biotech (NASDAQ: FBIO) announced that its subsidiary Helocyte received a grant from NIAID/NIH exceeding $20 million to fund a Phase 2 clinical trial for the Triplex CMV vaccine. This multi-center, randomized study will take place at up to 15 transplant centers across the U.S., focusing on liver transplant patients. The COLT trial aims to demonstrate Triplex's potential to enhance outcomes for these patients. Previous studies have shown Triplex to be safe and immunogenic, with over 100 subjects dosed.

Journey Medical reported a 20% increase in net revenue for Q2 2022, totaling $18.3 million, compared to $15.3 million in Q2 2021. This growth was supported by settlement agreements with Padagis ensuring exclusivity for key products. Enrollment in the DFD-29 Phase 3 trials is progressing, with top-line data expected in early 2023 and an NDA filing anticipated in the second half of 2023. Despite a $7.5 million net loss, there was an improved Non-GAAP Adjusted EBITDA loss of $(2.6) million. The company’s cash reserves are at $38.1 million.

Journey Medical Corporation (NASDAQ: DERM) will release its Q2 2022 financial results on August 9, 2022, after market close. A conference call will follow at 4:30 p.m. ET, allowing investors to discuss the results and receive a corporate update. Interested participants can dial in 10 minutes early and join the call. A live audio webcast will also be available on their website, with a replay option for 30 days. Journey Medical focuses on developing and commercializing dermatology products, with nine marketed treatments currently.

Fortress Biotech, Inc. (NASDAQ: FBIO) has appointed David Jin as Chief Financial Officer effective August 16, 2022, while Robyn Hunter will step down after 11 years to pursue other opportunities. Chairman Lindsay A. Rosenwald expressed confidence in Jin's capabilities, highlighting his contributions to the company and its strategy. Jin noted Fortress's ongoing projects, including FDA submissions and collaborations, while emphasizing the company's commitment to innovation in biopharmaceuticals. The transition aims to maintain stability and growth during this critical period.

Fortress Biotech (FBIO) announced that its subsidiary UR-1 Therapeutics has dosed the first patient in a Phase 1 clinical trial of Dotinurad, a URAT1 inhibitor for gout in the U.S. This trial aims to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of Dotinurad, building on its previous success in Japan where it showed efficacy in over 500 patients. Fortress expects topline data release in the second half of 2022 and aims to establish Dotinurad as a leading oral therapy for serum uric acid reduction, potentially reaching millions in the U.S.