Welcome to our dedicated page for Fortress Biotech news (Ticker: FBIO), a resource for investors and traders seeking the latest updates and insights on Fortress Biotech stock.
Fortress Biotech, Inc. (Nasdaq: FBIO) is a biopharmaceutical company that regularly issues news about its portfolio of prescription pharmaceutical products and development programs. Its press releases cover updates from Fortress itself and from majority-owned and partner companies that it has founded or supports, providing investors with a consolidated view of activity across oncology, dermatology and rare disease assets.
Recent announcements highlight regulatory milestones, clinical progress and transaction-driven events. Fortress and its majority-owned subsidiary Cyprium Therapeutics have reported U.S. Food and Drug Administration (FDA) approval of ZYCUBO (copper histidinate, formerly CUTX-101) for the treatment of Menkes disease in pediatric patients, noting that it is the first and only FDA-approved treatment for Menkes disease in the United States. Earlier updates described FDA acceptance of the resubmission of the New Drug Application for CUTX-101 and the transfer of development and commercialization responsibilities to Sentynl Therapeutics, with Cyprium eligible for royalties and milestone payments.
News related to Journey Medical Corporation, which was founded by Fortress, includes financial results driven by net revenues from dermatology products and the commercial launch of Emrosi (DFD-29) for inflammatory lesions of rosacea in adults. Releases also present clinical data, such as pooled Phase 3 analyses demonstrating Emrosi’s efficacy versus comparators, and discuss payer access and prescription trends.
Additional Fortress news items describe monetization events and pipeline updates, such as the acquisition of Checkpoint Therapeutics by Sun Pharma, the sale of dotinurad rights to Crystalys Therapeutics with associated equity and royalty interests, and the initiation of Phase 3 trials of dotinurad for gout by Crystalys. Investors following FBIO news can use this page to review these types of announcements, track regulatory interactions, and monitor how Fortress’ subsidiaries and partners contribute to the overall portfolio.
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.
Fortress Biotech, Inc. (Nasdaq: FBIO) has declared a monthly dividend of $0.1953125 per share for its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock for October, November, and December 2022. The dividends will be paid on October 31, November 30, and December 31, 2022, to shareholders on record as of October 15, November 15, and December 15, respectively. Future dividend notifications will be available on Fortress's website. Fortress focuses on developing and commercializing biopharmaceutical products across various therapeutic areas.
Journey Medical Corporation (Nasdaq: DERM) announced CEO Claude Maraoui's participation in two upcoming investor conferences. The first is the Roth Inaugural Healthcare Opportunities Conference on October 6, 2022, at 12:15 p.m. ET in New York City, which includes one-on-one meetings. The second is the LD Micro Main Event XV Conference on October 25, 2022, at 3:00 p.m. PT in Los Angeles, also with one-on-one meetings. Journey Medical focuses on dermatological products and markets nine branded and three authorized generic products.