Fortress Biotech Inc Stock Price, News & Analysis

Journey Medical Corporation (NASDAQ: DERM) has completed enrollment for its Phase 3 clinical trials assessing the safety and efficacy of DFD-29 for the treatment of papulopustular rosacea. The trials will compare DFD-29 with current treatments and aim to file a New Drug Application in late 2023. Preliminary Phase 2 trial results indicated DFD-29 is nearly twice as effective as doxycycline. The combined trials target 640 adult patients, and the company anticipates peak annual sales could exceed $100 million upon approval.

Journey Medical Corporation (NASDAQ: DERM) announced positive pharmacokinetic (PK) comparability data for its drug DFD-29 in a Phase 3 study focused on treatment for papulopustular rosacea. Conducted in collaboration with Dr. Reddy’s Laboratories, the study showed DFD-29's systemic exposure was significantly lower than SOLODYN, with no food effect on its pharmacokinetics. With enrollment at 96%, Journey Medical anticipates topline data in the first half of 2023 and plans to file a New Drug Application later in the year, aiming to provide an effective treatment for millions suffering from rosacea.

Fortress Biotech, Inc. (Nasdaq: FBIO) announced the appointment of Lucy Lu, M.D., to its Board of Directors. Dr. Lu brings over 20 years of experience in biotech and healthcare, previously serving as CEO of Avenue Therapeutics and CFO of Fortress. Her expertise in drug development and finance is expected to enhance the strategic direction of Fortress as it continues to advance its pipeline of eight marketed products and over 20 clinical-stage candidates. Fortress aims to leverage Dr. Lu's experience to create shareholder value and pursue new opportunities globally.

Urica Therapeutics, a subsidiary of Fortress Biotech (Nasdaq: FBIO), has expanded its exclusive license agreement with Fuji Yakuhin Co. Ltd. to develop dotinurad for gout treatment in the Middle East and North Africa (MENA) and Turkey. This follows a prior agreement covering the US, UK, EU, and Canada. Dotinurad, which is in Phase 1 trials in the US and launched in Japan in 2020, is designed to inhibit uric acid reabsorption and has been well-tolerated in clinical studies. Urica aims to expedite regulatory approvals for dotinurad in the new territories.

Fortress Biotech (Nasdaq: FBIO) will participate in one-on-one meetings at the Cantor Medical & Aesthetic Dermatology, Ophthalmology & MedTech/Diagnostic Conference on December 8, 2022, in Miami, FL. Fortress is focused on acquiring and developing high-potential biopharmaceuticals, boasting eight marketed products and over 30 in development. The company collaborates with leading institutions like AstraZeneca and St. Jude Children’s Research Hospital to maximize opportunities in oncology, rare diseases, and gene therapy, driving growth and shareholder value.

Journey Medical Corporation (Nasdaq: DERM) announced its management team will present at the Cantor Medical & Aesthetic Dermatology Conference on December 8, 2022, in Miami, FL. CEO Claude Maraoui will participate in a panel titled, “Is Derm Defensive?: Commercial Successes, Current & Upcoming Launches,” at 9:00 a.m. ET. Journey Medical focuses on dermatological products and currently markets eight treatments for skin conditions. The Company was founded by Fortress Biotech (Nasdaq: FBIO) and files periodic reports with the SEC.

Fortress Biotech reported a 17.5% increase in net revenue to $59.3 million for the nine months ending September 30, 2022, compared to the previous year. The company anticipates a BLA submission for cosibelimab by January 2023. Recent highlights include advances in 20 clinical-stage programs and significant data from MB-106 trials, showing high response rates in hematologic malignancies. However, the company faced a net loss of $(22.5) million for Q3 2022, with cash reserves decreasing to $210.6 million.

Journey Medical reported a 26% revenue increase to $57.7 million for the first nine months of 2022, despite third-quarter sales declining to $16.1 million, affected by Targadox generic competition. The company has achieved 75% enrollment in its DFD-29 Phase 3 trials for treating papulopustular rosacea, with top-line data expected in H1 2023. Journey Medical anticipates submitting a New Drug Application in H2 2023, predicting DFD-29 could generate over $100 million in peak annual sales. Cash reserves totaled $34.9 million as of September 30, 2022.

Journey Medical Corporation (Nasdaq: DERM) announced it will release its third quarter 2022 financial results on November 10, 2022, after market close. A conference call to discuss these results will take place at 4:30 p.m. ET the same day. Interested parties can participate by calling specific numbers provided in the announcement. Journey Medical, based in Scottsdale, Arizona, develops and commercializes innovative dermatological products, having successfully marketed eight treatment products to date.