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 released new data from its Phase 1 extension study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC). Presented at key medical conferences, the study shows a favorable safety profile with no drug-related adverse events. Clinically, 8 patients demonstrated disease stabilization over a mean exposure of 25 months, with some notable improvements in specific symptoms, despite some regressions in others. The company is advancing to pivotal Phase 3 trials, having received Orphan Drug and Fast Track designations from the FDA.
Cyclo Therapeutics (Nasdaq: CYTH) has announced the commercial-scale production of Trappsol® Cyclo™, its proprietary hydroxypropyl beta cyclodextrin formulation. This manufacturing milestone supports ongoing clinical trials for Niemann-Pick Disease Type C1 and Alzheimer’s disease. The company has received Orphan Drug Designation for Trappsol® Cyclo™ in the US and EU, alongside Fast Track and Rare Pediatric Disease Designations. Cyclo Therapeutics aims to file an IND for a Phase 2 study in Alzheimer’s treatment by late 2021.
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) will present at the 2021 NPC Conference on June 25-26, 2021. The session will cover their intravenous formulation of Trappsol® Cyclo™ for treating Niemann-Pick Disease Type C (NPC) and its clinical development progress. Presentations include results from Phase 1 and 1/2 studies and details on the pivotal Phase 3 study (TransportNPC) now underway. Cyclo Therapeutics has received Orphan Drug Designation for Trappsol® Cyclo™ in both the US and EU and aims for significant advancements in NPC treatment.
Cyclo Therapeutics (Nasdaq: CYTH) announced the initiation of its pivotal Phase 3 study, TransportNPC, evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1. With regulatory approval secured, patient enrollment is underway across 23 centers in 9 countries. The study will enroll at least 93 patients and assess safety and efficacy over 96 weeks with an interim analysis at 48 weeks. Positive prior Phase 1 data provides a basis for the trial, aiming to address NPC's systemic effects.
Cyclo Therapeutics (Nasdaq: CYTH) announced the launch of its new corporate website, cyclotherapeutics.com. The company focuses on developing innovative medicines for NPC and Alzheimer’s Disease. Its lead product, Trappsol® Cyclo™, is currently in clinical trials for NPC and received promising safety data in a recent Phase 1/2 trial. Cyclo Therapeutics is set to begin patient enrollment for a pivotal Phase 3 NPC study in June 2021 and plans to submit an IND for a Phase 2 Alzheimer’s study later this year.
Cyclo Therapeutics (Nasdaq: CYTH) has been added to the Russell 2000 Index, effective June 25, 2021. This inclusion is significant as the Russell 2000 is a key performance benchmark for small-cap stocks, representing about 10% of the total market capitalization of the Russell 3000 Index. The CEO, N. Scott Fine, emphasized that this milestone enhances market access and visibility while the company progresses through clinical studies for Niemann-Pick Disease Type C and Alzheimer's Disease. The Russell Indexes are widely utilized by investment managers and institutional investors.
Cyclo Therapeutics (Nasdaq: CYTH) announced its participation in the JMP Securities Life Sciences Conference on June 17, 2021, at 12:30 PM ET. Key executives, including CEO N. Scott Fine and CSO Sharon H. Hrynkow, will present during this virtual event. A live video webcast of the presentation will be available on their website, with an archive accessible for 90 days after the event. The company's Trappsol® Cyclo™ is currently involved in clinical trials for Niemann-Pick Disease Type C and is exploring applications in Alzheimer’s Disease.
Cyclo Therapeutics (Nasdaq: CYTH) will participate in the M-Vest Virtual Conference Series on Alzheimer’s Disease on May 26, 2021, at 11:00 AM ET. The company is advancing its lead candidate, Trappsol® Cyclo™, for early Alzheimer's Disease, with plans to file an IND application for a Phase 2 study later this year, following positive FDA feedback. The panel will include key industry leaders and will be moderated by Jason McCarthy, PhD, from Maxim Group. For more details on participation, visit the event website.
Cyclo Therapeutics (Nasdaq: CYTH) reported its financial results for Q1 2021, highlighting a net loss of approximately $4.0 million and a 58% increase in research and development expenses to $3.2 million, driven by intensifying clinical activities. The company is advancing towards a pivotal Phase 3 study for Trappsol® Cyclo™ in treating Niemann-Pick Disease Type C, with positive Phase 1/2 trial results indicating safety and efficacy. Additionally, it anticipates submitting an IND application for a Phase 2 Alzheimer’s study in H2 2021.
Cyclo Therapeutics, Inc. (Nasdaq: CYTH) announced the appointment of Lori McKenna Gorski as Global Head of Patient Advocacy. Gorski, with over 20 years of experience in biotechnology and rare disease advocacy, aims to enhance support for patients with Niemann-Pick Disease Type C1. The Company’s lead program, Trappsol® Cyclo™, is undergoing pivotal studies and aims to address significant unmet patient needs. Gorski's commitment aligns with Cyclo's mission to deliver patient-focused therapies, leveraging her expertise from Sanofi Genzyme and her consultancy work.