Fortress Biotech Inc Stock Price, News & Analysis

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.

Fortress Biotech, in collaboration with its subsidiary Helocyte, announced the commencement of a Phase 2 clinical trial for Triplex, a vaccine targeting cytomegalovirus (CMV) in liver transplant patients. The trial is funded by a $9 million grant from the NIH/NIAID, with an additional $12 million expected over the next four years. Conducted at up to 20 U.S. transplant centers, this randomized, placebo-controlled study will involve 416 participants. The primary objective is to assess Triplex's efficacy in reducing CMV antiviral therapy duration within the first 100 days post-transplant. Secondary endpoints include the development and onset timing of CMV disease within six months post-transplant. This trial aims to address the significant unmet need for effective CMV therapies in transplant settings.

Journey Medical (Nasdaq: DERM) reported a 7% year-over-year increase in total revenues for Q1 2024, reaching $13 million. This growth was driven by significant increases in the sales of Qbrexza and Accutane, despite declines in other products like Amzeeq and Zilxi. The company reported a net loss of $10.4 million, slightly higher than the $10.1 million loss in Q1 2023. Research and development expenses surged due to a $4 million FDA filing fee and a $3 million milestone payment. Journey Medical's New Drug Application for DFD-29 to treat rosacea has been accepted by the FDA, with a PDUFA goal date of November 4, 2024, potentially making it a leading systemic therapy for rosacea.

Checkpoint Therapeutics, Inc. will participate in the H.C. Wainwright 2nd Annual BioConnect Investor Conference where James Oliviero, President and CEO, will have a fireside chat. The event will take place on May 20, 2024, at 12:30 p.m. ET at NASDAQ. Checkpoint will also have one-on-one meetings during the conference. A webcast of the fireside chat will be available on the News & Events page of Checkpoint's website for 30 days post-event.

Checkpoint Therapeutics, Inc. reported financial results for Q1 2024, revealing increased cash reserves, reduced R&D expenses, and an appointment to the Board of Directors. The company aims to address FDA feedback for potential BLA resubmission mid-year.