Welcome to our dedicated page for Cyclo Therapeutics news (Ticker: CYTH), a resource for investors and traders seeking the latest updates and insights on Cyclo Therapeutics stock.
Cyclo Therapeutics, Inc. (NASDAQ: CYTH) is a clinical-stage biotechnology company whose news flow centers on the development of its lead investigational product, Trappsol® Cyclo™, for Niemann-Pick Disease Type C1 (NPC1) and early Alzheimer’s disease. News updates commonly highlight progress in the pivotal Phase 3 TransportNPC™ trial, data from clinical sub-studies, and regulatory and intellectual property milestones.
Investors and followers of CYTH can expect clinical trial updates, including completion of enrollment milestones, interim analyses plans, and preliminary safety and efficacy findings from the TransportNPC™ study and its open-label sub-study in very young NPC1 patients. The company frequently reports on presentations at major scientific meetings such as WORLDSymposium™ and the SSIEM Annual Symposium, where it shares poster and oral presentation data on long-term treatment, safety profiles and clinical outcomes.
Cyclo Therapeutics’ news also covers regulatory strategy developments, such as alignment with the U.S. Food and Drug Administration and European Medicines Agency on potential NDA and MAA submissions based on interim Phase 3 data, as well as the impact of Orphan Drug, Fast Track and Rare Pediatric Disease designations. In addition, the company issues updates on its Alzheimer’s disease program, including patent grants in the U.S. and Europe for methods of treating Alzheimer’s disease with Trappsol® Cyclo™ and progress in its Phase 2b trial.
Corporate and financial announcements, including quarterly and annual results, merger activity with entities such as Applied Molecular Transport and agreements with Rafael Holdings, Inc., are also part of the CYTH news stream. Readers who track CYTH news gain insight into the company’s clinical progress, regulatory path, scientific visibility and financing strategy as it advances Trappsol® Cyclo™ in rare disease and neurodegenerative indications.
Cyclo Therapeutics (NASDAQ: CYTH) has enrolled and dosed the first patient in its Phase 2b study of Trappsol® Cyclo™ for early Alzheimer’s disease. The study will analyze the safety and efficacy of the drug over six months, targeting about 120 patients experiencing cognitive decline. This milestone follows promising results from previous studies highlighting Trappsol's ability to manage cholesterol transport, a critical factor in neurodegenerative diseases. The company is also testing Trappsol in a Phase 3 trial for Niemann-Pick disease Type C.
Cyclo Therapeutics (CYTH) has completed a registered direct offering of 2,608,696 shares at $1.61 per share, totaling approximately $4.2 million in gross proceeds. Additionally, the company issued series A-1 and A-2 warrants for the same number of shares with exercise prices of $1.36. The net proceeds will be used for working capital and to advance its Phase III trial for Niemann-Pick Disease Type C with Trappsol® Cyclo™. H.C. Wainwright & Co. acted as the exclusive placement agent for this offering.
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) announced that its abstract has been accepted for a poster presentation at the Society for Inherited Metabolic Disorders (SIMD) Annual Meeting on March 18-21, 2023, in Salt Lake City, Utah. The presentation will focus on their Phase 3 clinical trial, TransportNPC, which evaluates Trappsol® Cyclo™ as a potential therapy for Niemann-Pick Disease Type C. The study aims to address unmet medical needs for this rare disease. The poster will be presented by Dr. Joseph Mejia on March 19th.
Cyclo Therapeutics, Inc. (NASDAQ: CYTH) has announced a definitive securities purchase agreement to sell 2,608,696 shares of common stock at $1.61 each in a registered direct offering, expected to close around January 3, 2023, generating approximately $4.2 million in gross proceeds. Concurrently, the company will issue series A-1 and A-2 warrants, each exercisable at $1.36 per share. The funds will primarily support the pivotal Phase III trial for Trappsol® Cyclo™ in treating Niemann-Pick Disease Type C.
Cyclo Therapeutics (NASDAQ: CYTH) reported its Q3 2022 earnings, highlighting significant advancements in its clinical programs for Trappsol® Cyclo™. The company launched a Phase 2b study for early Alzheimer’s Disease, commencing patient enrollment and site activation. Research and development expenses rose by 55% to approximately
Cyclo Therapeutics has published positive results from its Phase 1 trial of Trappsol® Cyclo™ for treating Niemann-Pick Disease type C1 (NPC1), addressing cholesterol accumulation in cells. The data, published in Molecular Genetics and Metabolism, highlighted the treatment's safety and efficacy, showing reduced cholesterol in the liver and improved biomarkers in both peripheral and central nervous systems.
The ongoing pivotal Phase 3 study, TransportNPC™, will involve at least 93 patients across 23 centers in 9 countries, further evaluating the drug's potential benefits.
Cyclo Therapeutics, Inc. (NASDAQ: CYTH) has initiated its Phase 2b clinical trial of Trappsol® Cyclo™ to treat early Alzheimer’s disease, with patient enrollment underway. The study is randomized, placebo-controlled, and will involve approximately 120 patients over 6 months to evaluate the drug's safety and potential efficacy. Experts highlight the investigational drug's ability to stabilize disease progression and its access to the central nervous system as critical factors. The company is committed to developing innovative treatments for Alzheimer's and similar diseases.
Cyclo Therapeutics (NASDAQ: CYTH) announces progress in its clinical programs, specifically for Trappsol® Cyclo™, targeting Alzheimer’s and Niemann-Pick Disease Type C1. The company plans to begin patient enrollment and dosing for a Phase 2 Alzheimer’s study by year-end 2022. Concurrently, the ongoing pivotal Phase 3 study (TransportNPC™) aims to enroll 93 patients across nine countries. Additionally, Cyclo plans to participate in the NPUK Annual Family Conference on October 6-7, 2022, to raise awareness about Niemann-Pick Disease.
Cyclo Therapeutics, Inc. (NASDAQ: CYTH) announced that CEO N. Scott Fine will present at the H.C. Wainwright 24th Annual Global Investment Conference in New York City, taking place from September 12-14, 2022. In addition to the presentation, the management team will hold virtual one-on-one meetings with qualified investors. A video webcast of the presentation will be available on-demand starting September 12 at 7:00 AM ET and accessible for 90 days on Cyclo Therapeutics' website.
Cyclo Therapeutics is focused on developing therapies for rare diseases, including Niemann-Pick Disease Type C.
Cyclo Therapeutics (CYTH) reported a net loss of $3.5 million for Q2 2022, with R&D expenses decreasing 29% to $1.9 million. The company is advancing its clinical programs for Trappsol® Cyclo™, targeting Niemann-Pick Disease and Alzheimer’s Disease. The Phase 2 study for Alzheimer’s is set to begin by year-end, while the pivotal Phase 3 study for Niemann-Pick aims to enroll at least 93 patients across 9 countries. Cyclo Therapeutics holds Orphan Drug Designation in both the U.S. and EU for NPC1 and has a cash reserve of $7.5 million.