Fortress Biotech Inc Stock Price, News & Analysis

Fortress Biotech reported a 28% increase in revenue from its marketed dermatology products for 2020, totaling $44.5 million. The company is on track for a rolling NDA submission for CUTX-101 for Menkes disease in H2 2021, following a partnership agreement with Cyprium Therapeutics. Despite revenue growth, sales were affected by the COVID-19 pandemic. Fortress holds a strong pipeline with over 25 product candidates and expects further growth in 2021. However, ongoing monitoring of COVID-19's impact on revenues is essential.

Fortress Biotech announced the launch of Accutane®, an oral isotretinoin for severe recalcitrant nodular acne, by its partner Journey Medical Corporation. Available via prescription, Accutane joins Journey Medical's portfolio, which includes Targadox® and Ximino®. With over 1.8 million isotretinoin prescriptions written in 2020, the brand aims to utilize its established name and sales team for growth. Fortress CEO highlights the strategic acquisition of transformative assets, projecting significant revenue potential for this product.

Fortress Biotech, Inc. (NASDAQ: FBIO) has announced that its CEO, Lindsay A. Rosenwald, M.D., will participate in four virtual investor conferences throughout March 2021. Key presentations include:

• H.C. Wainwright Global Life Sciences Virtual Conference on March 9.
• Barclays Global Healthcare Virtual Conference on March 11.
• ROTH Conference on March 16.
• Oppenheimer Virtual Healthcare Conference on March 18.

Fortress focuses on developing and commercializing biopharmaceutical products across multiple market areas, enhancing shareholder value.

Fortress Biotech (NASDAQ: FBIO) supports Rare Disease Day on February 28, aiming to raise awareness for over 25 million Americans affected by rare diseases. The company, led by CEO Lindsay A. Rosenwald, has ongoing clinical programs for conditions like AL amyloidosis and X-linked severe combined immunodeficiency (XSCID). Notably, the Menkes disease NDA submission is planned for Q3 2021. Additionally, Fortress is engaged in related campaigns such as 'Light the Night for Amyloidosis.' Rare Disease Day emphasizes the challenges of patients, as many rare diseases lack FDA-approved treatments.

Cyprium Therapeutics and Sentynl Therapeutics have entered a $20 million asset purchase agreement for CUTX-101, a treatment for Menkes disease. The deal includes upfront payments and potential sales milestones and royalties based on sales. Cyprium retains responsibility for the development of CUTX-101 through NDA approval, while Sentynl will handle commercialization. This partnership aims to expedite the drug's availability, addressing a critical need in pediatric care. The FDA submission for CUTX-101 is projected to start in Q3 2021, with potential breakthrough treatment benefits for affected children.

Fortress Biotech, Inc. (Nasdaq: FBIO) has appointed Markus Peters, Ph.D., as President and CEO of its partner company, Aevitas Therapeutics, which focuses on gene therapy for complement-mediated diseases. Dr. Peters, with significant experience in AAV-based therapies, replaces a prior leader to advance Aevitas' innovative platform aimed at providing a shortened complement factor H gene. Additionally, Catherine Bowes Rickman, Ph.D., a leading researcher in age-related macular degeneration, joins the Scientific Advisory Board to enhance R&D efforts.

Fortress Biotech (NASDAQ: FBIO) announced participation in three virtual investor conferences in January 2021. CEO Lindsay A. Rosenwald will host one-on-one meetings during the 10th Annual LifeSci Partners Corporate Access Event from January 6-14. Additionally, Fortress will present at the 2021 CTIC 5th Healthcare Investment Digital Summit on January 9 at 8:00 p.m. EST and will offer an on-demand presentation at the H.C. Wainwright Virtual BioConnect Conference starting January 11 at 6:00 a.m. EST. Fortress focuses on developing innovative biopharmaceuticals and has a robust pipeline in oncology and rare diseases.

Fortress Biotech (Nasdaq: FBIO) announced that the FDA has granted Breakthrough Therapy Designation for CUTX-101, a potential treatment for Menkes disease. The rolling submission of the New Drug Application (NDA) is scheduled to start in Q1 2021 and complete by the end of Q2 2021. This designation aims to expedite the development of drugs for serious conditions. Previous designations for CUTX-101 include Orphan Drug, Fast Track, and Rare Pediatric Disease.

Menkes disease is a rare genetic disorder with no FDA-approved treatments.

Fortress Biotech, Inc. (NASDAQ: FBIO) has been recognized in Deloitte's 2020 Technology Fast 500™, ranking 135th due to an impressive 874% revenue growth from 2016 to 2019. This marks the second consecutive year Fortress has achieved this recognition. The company emphasizes its commitment to generating shareholder value by acquiring and developing a diverse portfolio of biopharmaceutical products, including five marketed products and over 25 development-stage programs. The Fast 500 rankings highlight the company's rapid growth amid a competitive landscape.