Core Insights - Fortress Biotech, Inc. announced significant developments including FDA approvals for Emrosi™ and UNLOXCYT™, and the acceptance of a New Drug Application for CUTX-101, indicating a transformative fourth quarter for the company [2][7] - The acquisition of Checkpoint Therapeutics by Sun Pharma is expected to enhance patient access to UNLOXCYT and provide Fortress with approximately $28 million at closing, along with a 2.5% royalty on net sales [2][3] - Fortress aims to leverage its pipeline of late clinical-stage candidates and recently approved products to drive revenue growth and shareholder value [2][10] Recent Corporate Highlights - Fortress' subsidiary Checkpoint Therapeutics is set to be acquired by Sun Pharma, with Fortress holding approximately 6.9 million shares of Checkpoint and eligible for a 2.5% royalty on future sales of UNLOXCYT [3] - The acquisition agreement includes an upfront cash payment of $4.10 per share for Checkpoint stockholders, plus a contingent value right potentially worth an additional $0.70 [3] - Fortress raised approximately $21.1 million through equity offerings in 2024, while Checkpoint raised about $32.8 million during the same period [11] Regulatory Updates - The FDA approved Emrosi (Minocycline Hydrochloride Extended-Release Capsules, 40mg) for treating inflammatory lesions of rosacea in November 2024, with commercial launch initiated in March 2025 [7][2] - UNLOXCYT was approved by the FDA in December 2024 for treating metastatic or locally advanced cutaneous squamous cell carcinoma [7] - The FDA accepted the New Drug Application for CUTX-101 for priority review, with a PDUFA goal date set for September 30, 2025 [7][2] Clinical Updates - Phase 3 clinical trials for Emrosi demonstrated its efficacy, safety, and tolerability in treating moderate-to-severe papulopustular rosacea, with results published in the Journal of the American Medical Association - Dermatology [7] - Clinical data for UNLOXCYT presented at the European Society for Medical Oncology Congress 2024 showed improved response rates over time [7] - A Phase 2 clinical trial for Triplex, a cytomegalovirus vaccine, commenced in January 2025, targeting patients undergoing hematopoietic stem cell transplantation [7] Financial Results - Fortress reported consolidated net revenue of $57.7 million for the year ended December 31, 2024, down from $84.5 million in 2023, with product revenue from dermatology products totaling $55.1 million [10][17] - Consolidated research and development expenses decreased to $56.9 million in 2024 from $106.1 million in 2023 [10][17] - The net loss attributable to common stockholders was $(55.9) million, or $(2.69) per share, for the year ended December 31, 2024, compared to a net loss of $(68.7) million, or $(8.47) per share, in 2023 [10][17]

Market Overview - U.S. stocks experienced a decline, with the Nasdaq Composite falling over 700 points, Dow down 1.43% to 42,190.51, NASDAQ down 3.90% to 17,486.28, and S&P 500 down 2.46% to 5,628.52 [1] - European shares also fell, with the eurozone's STOXX 600 down 1.28%, Germany's DAX 40 down 1.86%, and France's CAC 40 down 0.64% [6] - Asian markets closed mostly lower, with Japan's Nikkei gaining 0.38% while China's Shanghai Composite Index fell 0.19% and Hong Kong's Hang Seng Index fell 1.85% [7] Sector Performance - Energy shares rose by 2.1% on Monday, while information technology shares dipped by 4.1% [1] Company News - Mineralys Therapeutics, Inc. saw a 53% increase in shares to $16.13 after reporting positive data from its hypertension trials [9] - Redfin Corporation's shares surged 72% to $10.03 following an acquisition announcement by Rocket Companies valued at $12.50 per share [9] - Checkpoint Therapeutics, Inc. shares rose 64% to $4.0450 after Sun Pharma announced a $365 million acquisition [9] - NET Power Inc. shares dropped 58% to $2.8899 after reporting a fourth-quarter GAAP loss of 46 cents per share [9] - Rocket Companies, Inc. shares fell 13% to $13.73 after the announcement of the acquisition of Redfin [9] - Robinhood Markets, Inc. shares decreased by 14% to $38.35 [9]

As filed with the Securities and Exchange Commission on September 27, 2024 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FORTRESS BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 20-5157386 (State or other jurisdiction of incorporation or organization) 1111 Kane Concourse, Suite 301 Bay Harbor Islands, FL 33154 (Address, including zip code, and telephone number, inclu ...