Fortress Biotech, Inc. - FBIO STOCK NEWS

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.