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. (CYTH) is a clinical-stage biotechnology company dedicated to developing cyclodextrin-based treatments for neurodegenerative diseases, particularly Niemann-Pick Type C disease (NPC). The company was originally organized in 1990 and began operations in 1992. Over the years, Cyclo Therapeutics has evolved into a holding company operating under various subsidiaries, including CTD, Inc.; Nanosonic Products, Inc.; Sphingo Biotech, Inc.; and Ferrazo Environmental Technologies, Inc.
The company's flagship product, Trappsol Cyclo, is at the forefront of its clinical trials for NPC treatment. Cyclo Therapeutics is committed to advancing this promising treatment through various phases of clinical testing, aiming to bring it to market to provide relief for NPC patients.
In addition to its focus on rare diseases, Cyclo Therapeutics generates revenue from the sale of cyclodextrins and related products to pharmaceutical and nutritional industries. Key products include Trappsol HPB and Trappsol Fine Chemical, which are widely used in various industries.
Recent Achievements:
- Successfully completed Phase I clinical trials for Trappsol Cyclo.
- Expanded partnerships with pharmaceutical companies for cyclodextrin-based product development.
- Enhanced research and development capabilities through strategic collaborations.
Cyclo Therapeutics' commitment to innovation and its strategic approach to product development and commercialization have positioned it as a significant player in the biotechnology sector. The company remains focused on its mission to develop effective treatments for rare and neurodegenerative diseases.
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.
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.
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