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 announced the initiation of its pivotal Phase 3 study for Trappsol® Cyclo™, targeting Niemann-Pick Disease type C1 (NPC1). Both FDA and EMA have approved the study's protocol. This randomized, double-blind trial will enroll at least 93 patients across 9 countries, assessing the treatment's safety and efficacy over 96 weeks. NPC affects cholesterol processing in cells, leading to severe health issues. Currently, no approved therapies exist in the U.S. for NPC.
Cyclo Therapeutics (Nasdaq: CYTH) has received positive feedback from the FDA regarding its development strategy for Trappsol® Cyclo™ aimed at treating early Alzheimer’s disease. Following a Type B interaction, the company plans to file an IND for a Phase 2 study, expected later this year. Additionally, Cyclo Therapeutics is advancing Trappsol® Cyclo™ in a pivotal Phase 3 study for Niemann-Pick Type C, scheduled to begin this quarter. The CEO expressed confidence in the program's potential and is seeking partners for future development.
Cyclo Therapeutics (Nasdaq: CYTH) announced its 2020 financial results, reporting a net loss of $8.9 million. The company completed a Phase 1 study and reported positive interim results for its Trappsol® Cyclo™ treatment for Niemann-Pick Disease (NPC). In 2021, Cyclo plans to initiate a pivotal Phase 3 study for NPC and expand its trials to Alzheimer’s Disease. Research and development expenses rose 25% to $6 million due to increased clinical activities. Following a public offering, the company raised $14.4 million, increasing cash reserves to approximately $12.9 million.
Cyclo Therapeutics (Nasdaq: CYTH) announced that CEO N. Scott Fine will present at the Inaugural Emerging Growth Virtual Conference on March 17-18. The event will feature discussions and presentations led by C-suite executives and is hosted by M-Vest LLC and Maxim Group LLC. Additionally, Cyclo Therapeutics' management will participate in a live fireside chat on March 17 at 2:30 PM ET. The conference aims to connect issuers and investors, providing an opportunity to explore emerging growth companies. A replay of the chat will be available post-event.
Cyclo Therapeutics (Nasdaq: CYTH) announced the appointment of Russ Belden as Acting Chief Commercial Officer. With over 33 years in the biotech industry, Belden brings extensive experience in commercialization and product development. His leadership is expected to enhance efforts in advancing Trappsol® Cyclo™ toward regulatory approval, particularly for Niemann-Pick disease. The company is committed to driving its pipeline forward, with ongoing clinical trials for its orphan drug candidate aimed at treating serious conditions.
Cyclo Therapeutics (Nasdaq: CYTH) announced a positive opinion from the European Medicines Agency's Paediatric Committee regarding its Paediatric Investigation Plan for Trappsol® Cyclo™, aimed at treating Niemann-Pick Type C (NPC). This approval supports the company's ongoing clinical trials and paves the way for a potential Marketing Authorization Application in Europe. The adoption of the PIP additionally positions Cyclo Therapeutics to secure extra marketing exclusivity. NPC is a rare genetic disease with no approved therapies in the U.S. and only one in Europe.
Cyclo Therapeutics (Nasdaq: CYTH) reports that the last patient has completed their visits in the Phase 1/2 study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1). The trial enrolled 12 patients and administered varying doses of the drug over 48 weeks. Initial data indicates a favorable safety profile, with significant reductions in cholesterol markers and neurodegeneration biomarkers. The Company expects to announce topline results by March 2021 and has received regulatory acknowledgment for a Phase 3 study, anticipated to begin in Q2 2021.
Cyclo Therapeutics (Nasdaq: CYTH) has appointed Dr. Gerald F. Cox as Acting Chief Medical Officer. With over 20 years in drug development for rare diseases, Dr. Cox has contributed to 15+ IND applications and 6 orphan drug authorizations, generating over $5 billion in revenue. His leadership is expected to advance the company's Trappsol® Cyclo™ programs targeting Niemann-Pick Type C (NPC) and Alzheimer's Disease. Cyclo Therapeutics is preparing for the pivotal Phase 3 NPC study, with topline results from a Phase 1/2 study anticipated soon, positioning the company for impactful advancements in treatment.
Cyclo Therapeutics (Nasdaq: CYTH) has launched a new corporate identity ahead of Rare Disease Day, emphasizing its commitment to patients with unmet medical needs. The company focuses on developing Trappsol® Cyclo™, an intravenous treatment for Niemann-Pick Disease Type C and late-onset Alzheimer’s Disease. FDA has acknowledged their pivotal Phase 3 study for NPC1 may commence, with enrollment expected in Q2 2021. The company aims to innovate and improve patient quality of life through its drug development initiatives.
Cyclo Therapeutics (Nasdaq: CYTH) presented positive data from its clinical program for Trappsol® Cyclo™, targeting Niemann-Pick Disease Type C (NPC). Findings indicate strong safety and efficacy signals, with a Phase 1/2 study showing 86% of participants meeting initial efficacy criteria. The company aims to commence enrollment in a pivotal Phase 3 study soon, addressing an unmet medical need. Data presented at the 17th Annual WORLD Symposium highlight the drug's potential in treating both systemic and neurological manifestations of NPC.