Welcome to our dedicated page for Rafael Holdings news (Ticker: RFL), a resource for investors and traders seeking the latest updates and insights on Rafael Holdings stock.
Rafael Holdings, Inc. reports developments as a biotechnology company focused on pharmaceutical development and interests in clinical-stage and early-stage pharmaceutical and medical device companies. Its lead program is Trappsol® Cyclo™, a hydroxypropyl-beta-cyclodextrin product candidate evaluated for Niemann-Pick Disease Type C1, with additional cyclodextrin-related work in neurodegenerative disease.
Recurring company news covers clinical development of Cyclo Therapeutics programs, scientific presentations, patent and licensing activity, quarterly and annual financial results, and governance changes. Updates also address the company’s consolidated expenses following the Cyclo Therapeutics acquisition and its portfolio interests in healthcare and medical-device development.
Rafael Holdings (NYSE: RFL) and Cyclo Therapeutics (Nasdaq: CYTH) have entered into a definitive merger agreement to combine their efforts in developing Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 treatment. The merger involves Rafael Holdings issuing Class B common stock to Cyclo Therapeutics shareholders, valuing Cyclo shares at $0.95 each. Rafael Holdings will fund Cyclo's operations through closing and support the TransportNPC™ clinical trial to its 48-week interim analysis.
The merger, expected to close in late 2024, is subject to shareholder approvals and other conditions. Cyclo Therapeutics recently completed enrollment in its pivotal TransportNPC™ Phase 3 clinical study, with results from the 48-week interim analysis expected in mid-2025. This merger represents a significant step in Rafael Holdings' strategy to invest in and develop clinical-stage assets for high unmet medical needs.
Rafael Holdings (NYSE: RFL) has announced its financial results for the third quarter and first nine months of fiscal 2024, ending April 30, 2024. The company reported a net loss from continuing operations of $32.4 million for the quarter, or $1.36 per diluted share, compared to a net loss of $1.4 million in the same period last year. This loss was primarily driven by an $89.9 million in-process R&D expense, partially offset by a $31.3 million recovery of receivables from Cornerstone. For the nine months ending April 30, 2024, the net loss was $29.9 million, or $1.26 per diluted share, compared to $9.6 million in the previous year. The company highlighted positive developments, including the completion of enrollment in Cyclo Therapeutics' Phase 3 study and revenue generation at Day Three Labs. Cash and cash equivalents stood at $72.4 million as of April 30, 2024. General and administrative expenses decreased to $1.9 million for the quarter, down from $2.3 million last year.
Cyclo Therapeutics has completed enrollment for its Phase 3 TransportNPC™ trial, the largest study of its kind for Niemann-Pick Disease Type C1 (NPC1). The study includes 104 patients and aims to evaluate the efficacy of Trappsol® Cyclo™ in treating systemic and neurological symptoms of NPC1.
Topline data from the 48-week interim analysis is expected in the first half of 2025. Positive results could lead to the submission of a New Drug Application (NDA) to the FDA and a Marketing Authorization Application (MAA) to the EMA in the second half of 2025.
The trial also features a substudy for newborns to 3-year-olds, targeting early-stage interventions. The company has received Orphan Drug Designation in both the U.S. and EU, Fast Track and Rare Pediatric Disease designations in the U.S., which could qualify them for a Priority Review Voucher.
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