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.
Checkpoint Therapeutics (Nasdaq: CKPT) announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for cosibelimab, an anti-PD-L1 antibody, for treating advanced cutaneous squamous cell carcinoma (cSCC). The FDA set a PDUFA goal date of December 28, 2024. This resubmission addresses the complete response letter (CRL) issued in December 2023, which only cited issues with the third-party contract manufacturing organization. Notably, the CRL did not raise concerns about the clinical data package, safety, or labeling for cosibelimab's approvability. Checkpoint's CEO expressed satisfaction with the FDA's acceptance and looks forward to potentially delivering cosibelimab's unique dual mechanism of action to cSCC patients.
GC Cell (KRX: 144510.KS) and Checkpoint Therapeutics (Nasdaq: CKPT) have announced a collaboration to explore the combined therapeutic potential of cosibelimab, Checkpoint's anti-PD-L1 antibody, with GC Cell's Immuncell-LC, an autologous Cytokine Induced Killer (CIK) T cell therapy. The partnership will initially focus on in vitro combination studies to evaluate synergistic effects on cancer cell destruction.
The anticipated synergy leverages cosibelimab's antibody-dependent cellular cytotoxicity (ADCC) mechanism and Immuncell-LC's CIK T cell response. Positive preliminary data could lead to future in vivo research and clinical studies. Both companies' CEOs expressed optimism about the collaboration's potential to set new standards in immuno-oncology and possibly result in commercial licensing or joint development opportunities.
Journey Medical (Nasdaq: DERM) has appointed Michael C. Pearce to its Board of Directors, effective July 9, 2024. Pearce, an experienced principal investor and advisor in the healthcare sector, has an extensive background, including roles at EP Group, Evening Post Industries (EPI), and as Chairman of Range Therapeutics. His appointment comes as Journey Medical approaches the potential FDA approval of DFD-29, a promising treatment for rosacea, in November 2024. Pearce's strategic, business, and financial expertise is expected to bring significant value to Journey Medical's leadership as it continues to pursue its corporate goals.
Fortress Biotech (Nasdaq: FBIO; FBIOP) announced a pause in dividend payments on its 9.375% Series A Cumulative Redeemable Perpetual Preferred Stock, effective July 1, 2024. This decision affects the dividend payment scheduled for July 31, 2024, and will defer around $0.7 million in monthly cash payments. The dividends will continue to accrue until further notice. The Board will regularly review this decision, considering the company’s profitability and cash flow. This move aims to maintain financial flexibility ahead of significant regulatory milestones, including potential approvals for DFD-29, cosibelimab, and CUTX-101 within the next 12 months.
Checkpoint Therapeutics (Nasdaq: CKPT) announced a $12 million registered direct offering with a healthcare-focused institutional investor. The deal includes 5,853,659 shares of common stock at $2.05 per share. Concurrently, Checkpoint will issue unregistered warrants for the same number of shares, exercisable at $2.05 per share post-shareholder approval and expiring in five years. H.C. Wainwright & Co. is the exclusive placement agent. The offering is expected to close around July 3, 2024. Gross proceeds will support working capital and general corporate purposes. Shares are offered under a previously filed and effective shelf registration statement with the SEC.
Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) to the FDA for cosibelimab, an anti-PD-L1 antibody aimed at treating metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). The resubmission follows alignment with the FDA to address issues cited in a December CRL, which highlighted deficiencies found during a CMO inspection but did not raise concerns about clinical data, safety, or labeling. The BLA is supported by positive results from pivotal studies in cSCC, showing high objective and complete response rates, with longer-term data revealing deepening responses over time. Cosibelimab is a high-affinity, fully-human IgG1 subtype antibody designed to block PD-L1 interactions and potentially enhance anti-tumor immune responses.
Checkpoint Therapeutics has announced alignment with the FDA on its resubmission strategy for cosibelimab's biologics license application (BLA).
The BLA resubmission aims to gain U.S. marketing approval for cosibelimab as a treatment for metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC) in patients unsuitable for curative surgery or radiation.
The alignment follows a complete response letter (CRL) from the FDA in December 2023, which identified issues with the contract manufacturing organization but did not raise concerns about clinical data, safety, or labeling.
Fortress Biotech (NASDAQ: FBIO) will participate in the Alliance Global Partners' Virtual Healthcare Company Showcase on May 21, 2024. Dr. Lindsay A. Rosenwald, Chairman, President, and CEO, will represent the company in a fireside chat at 4:20 p.m. ET. This participation aims to enhance long-term shareholder value through product revenue, equity holdings, and dividend and royalty revenue. The event will be accessible via registration, with a replay available on the company's website for 30 days.
Fortress Biotech (Nasdaq: FBIO) reported first quarter 2024 financial results and corporate highlights. The company achieved a 7% year-over-year product revenue growth, driven by over 20% growth in flagship products Qbrexza and Accutane. The FDA accepted the NDA for DFD-29, with a PDUFA goal date of November 4, 2024. Phase 2 trials for Triplex for CMV control in liver transplantation and other clinical trials are progressing. Revenue for Q1 2024 was $13 million, up from $12.2 million in Q1 2023. Consolidated net loss was $17.7 million, or $1.03 per share, improved from a $23.5 million loss, or $3.47 per share, in Q1 2023.
Journey Medical (Nasdaq: DERM), a commercial-stage pharmaceutical company specializing in FDA-approved dermatological treatments, announces its participation in the Alliance Global Partners’ Virtual Healthcare Company Showcase.
CEO Claude Maraoui will participate in a fireside chat on May 21, 2024, at 1:00 p.m. ET. The event will provide insights into the company's operations and future plans.
Registration for the conference is available online, and a replay of the chat will be accessible on Journey Medical’s website for 30 days after the event.