Fortress Biotech Inc Stock Price, News & Analysis

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.

Fortress Biotech (FBIO) reported a 29% year-over-year increase in product revenue, totaling $30.8 million for the first nine months of 2020. The company strengthened its balance sheet with a $12 million preferred stock offering and a $60 million refinancing agreement. Significant growth was seen despite the COVID-19 pandemic's impact on third-quarter sales. The company anticipates submitting a New Drug Application for CUTX-101 in Q1 2021. Clinical advancements for its products, including cosibelimab and CAEL-101, show promise, boosting its growth outlook.

Fortress Biotech (NASDAQ: FBIO) announced the acceptance of clinical data on CAEL-101 for AL amyloidosis and MB-106 CAR T cell therapy for non-Hodgkin lymphoma, to be presented at the 62nd ASH Annual Meeting from December 5-8, 2020. The Cleveland Clinic will present Phase 2 data for CAEL-101, which has recently progressed to Phase 3, while interim data for MB-106 will be presented by Fred Hutch. Both therapies aim to offer new treatment options for patients with severe conditions. CEO Lindsay A. Rosenwald highlighted the significance of these developments.

Samsung Biologics and Checkpoint Therapeutics have expanded their manufacturing partnership for the anti-PD-L1 antibody, cosibelimab, originally established in 2017. Under the new agreement, commercial-scale drug substance manufacturing will commence at Samsung's Plant 1 in 2021. This partnership aims to support Checkpoint's pivotal clinical trials and potential regulatory approvals for cosibelimab, which targets metastatic cutaneous squamous cell carcinoma. Checkpoint plans to release pivotal trial topline results by mid-2021.

Fortress Biotech (NASDAQ: FBIO) announced a webinar on October 21, 2020, hosted by Scott Henry of ROTH Capital, featuring Journey Medical Corporation executives. The session aims to discuss Journey Medical's innovative dermatology products and strategic commercialization efforts. Fortress Biotech is recognized for its rapid growth, ranking 10th in Deloitte’s 2019 Technology Fast 500, and has a diverse portfolio with five marketed products and over 25 in development. For more details, visit Fortress's website for the live stream and an archived replay.

Fortress Biotech's Caelum Biosciences, in partnership with Alexion Pharmaceuticals, has initiated the CARES Phase 3 clinical program for CAEL-101, targeting AL amyloidosis. This program comprises two parallel studies enrolling ~370 patients, aiming to assess overall survival and safety. Previous Phase 2 results confirmed CAEL-101's safety and tolerability, supporting its 1000 mg/m2 dose for Phase 3. Long-term Phase 1a/1b data revealed a 78% survival rate at 37 months, bolstering the drug's potential to improve organ function and overall survival.

Fortress Biotech, Inc. (NASDAQ: FBIO) announced that its CEO, Lindsay A. Rosenwald, M.D., will participate in three virtual investor conferences this September. The events include:

• H.C. Wainwright 22nd Annual Global Investment Conference on September 14 at 3:00 p.m. EDT
• Cantor Virtual Global Healthcare Conference on September 16 at 3:20 p.m. EDT
• Oppenheimer Fall Healthcare Life Sciences & MedTech Summit on September 22 at 1:40 p.m. EDT

Live webcasts will be available on Fortress's website, with archived versions accessible for 30 days post-event.

Fortress Biotech (Nasdaq: FBIO) announced positive results for CUTX-101, showing a statistically significant improvement in overall survival for patients with Menkes disease who received early treatment. The treatment demonstrated a nearly 80% reduction in the risk of death (Hazard Ratio = 0.21). Median survival for the treated cohort was 14.8 years versus 1.3 years for those untreated. The company plans to begin a rolling New Drug Application (NDA) submission to the FDA in Q4 2020, following its pre-NDA meeting. CUTX-101 has received multiple FDA designations, indicating its importance in treating this rare disease.