Fortress Biotech Inc Stock Price, News & Analysis

Fortress Biotech (NASDAQ: FBIO), a biopharmaceutical company focused on acquiring and advancing assets for shareholder value through product revenue, equity holdings and dividend and royalty revenue, has announced its participation in the H.C. Wainwright 1st Annual Royalty Company Virtual Conference on May 13, 2025.

The company's CEO, Lindsay A. Rosenwald, M.D., will participate in two sessions: a Fireside Chat from 2:00 PM to 2:30 PM ET, and a Panel Presentation titled "Development Stage Companies – Where Do Royalty and Tech Platform Plays Fit?" from 5:00 PM to 6:00 PM ET.

Fortress Biotech (FBIO) reported significant developments for 2024, including two FDA approvals: Emrosi™ for rosacea treatment and UNLOXCYT™ for advanced skin cancer. The company's subsidiary Checkpoint Therapeutics is being acquired by Sun Pharma, expected to bring Fortress approximately $28 million at closing plus a 2.5% royalty on UNLOXCYT sales.

Key financial metrics for 2024 include consolidated net revenue of $57.7 million, down from $84.5 million in 2023. The company reported a net loss of $(55.9) million or $(2.69) per share, improved from $(68.7) million in 2023. Cash position stood at $57.3 million as of December 31, 2024.

Notable developments include FDA's acceptance of CUTX-101's New Drug Application for Menkes disease with a PDUFA date of September 30, 2025, and the commercial launch of Emrosi with first prescriptions filled.

Fortress Biotech (FBIO) and Partex NV have announced a strategic collaboration to leverage artificial intelligence for biopharmaceutical asset identification and evaluation. The partnership combines Fortress' expertise in identifying and developing promising assets with Partex's proprietary AI-based drug discovery platform.

Partex's technology will provide comprehensive analyses including target identification, indication expansion, and molecular profiling to accelerate bringing therapeutics to market. The collaboration aims to support Fortress' business model of acquiring and advancing assets to enhance shareholder value through product revenue, equity holdings, and dividend and royalty revenue.

Fortress currently has a late-stage pipeline, two recently approved medicines, and another candidate with a PDUFA date in Q3 2025. The company expects this AI collaboration to enable more efficient and cost-effective scaling of their asset evaluation process.

Fortress Biotech (FBIO) has initiated dosing in a Phase 2 clinical trial evaluating Triplex, a cytomegalovirus (CMV) vaccine, in stem cell donors. The trial aims to reduce CMV events in patients undergoing hematopoietic stem cell transplantation (HSCT).

The multicenter, placebo-controlled study is funded by the National Cancer Institute and builds upon encouraging pilot study results. Triplex works by inducing CMV-specific immune responses in donors, which is then transferred to transplant recipients through adoptive immunity.

CMV reactivation affects 60-70% of CMV-seropositive HSCT recipients, with primary infection occurring in 20-30% of CMV-seronegative recipients. The trial is being conducted across three major transplant centers in the United States. A second NCI-funded trial is planned for higher-risk transplant recipients with partial HLA matches.

Fortress Biotech and its subsidiary Cyprium Therapeutics announced that the U.S. FDA has accepted the New Drug Application (NDA) for CUTX-101 (Copper Histidinate) for the treatment of Menkes disease, a rare pediatric condition. The NDA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2025.

In December 2023, Sentynl Therapeutics assumed responsibility for the development and commercialization of CUTX-101. Cyprium will receive royalties and up to $129 million in aggregate development and sales milestones, and retains ownership of any Priority Review Voucher issued upon NDA approval.

The NDA submission is supported by positive clinical efficacy results, showing a nearly 80% reduction in the risk of death for early-treated Menkes disease patients compared to untreated controls. Median overall survival was 177.1 months for the treated cohort versus 16.1 months for the control group. CUTX-101 has previously received multiple FDA designations, including Breakthrough Therapy and Orphan Drug.

If approved, CUTX-101 could become the first FDA-approved treatment for Menkes disease.

Fortress Biotech reported Q3 2024 financial results and highlights, including FDA approval of Emrosi for adult rosacea treatment. The company has an upcoming PDUFA date of December 28, 2024, for cosibelimab in treating advanced skin cancer. Q3 net revenue was $14.6 million from dermatology products, compared to $34.8 million in Q3 2023. Cash position stood at $58.9 million as of September 30, 2024. The company reported a net loss of $(15.0) million or $(0.76) per share. The board paused preferred stock dividends to maintain financial flexibility.

Fortress Biotech, a biopharmaceutical company focused on acquiring and advancing assets, announced its participation in two upcoming investor conferences in October 2024. Lindsay A. Rosenwald, M.D., the company's Chairman, President, and CEO, will represent Fortress at these events:

1. Lytham Partners Fall 2024 Investor Conference on October 1, 2024, at 4:15 p.m. ET. This virtual event will feature a fireside chat and 1x1 meetings.

2. 3rd Annual ROTH Healthcare Opportunities Conference on October 9, 2024, in New York, consisting of 1x1 meetings.

A replay of the Lytham Partners fireside chat will be available on Fortress Biotech's website for approximately 30 days after the event.

Fortress Biotech (Nasdaq: FBIO) has announced a registered direct offering and concurrent private placements totaling approximately $8 million in gross proceeds. The company will issue 3,939,394 shares of common stock (or pre-funded warrants) at $1.65 per share to healthcare-focused institutional investors, along with warrants to purchase an additional 3,939,394 shares at $1.84 per share. In a separate private placement, the company's Chairman, CEO, and President purchased 763,359 shares at $1.84 per share and warrants for the same number of shares.

The offerings are expected to close around September 23, 2024. Fortress Biotech plans to use the net proceeds for operations, including research and development, clinical trials, and working capital. A.G.P./Alliance Global Partners is acting as the sole placement agent for the offerings.