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 advancing cyclodextrin-based therapies for rare neurodegenerative diseases, including Niemann-Pick Type C. This page provides investors and researchers with timely updates on the company’s clinical progress, regulatory milestones, and strategic initiatives.
Access the latest press releases, financial reports, and scientific developments related to Trappsol Cyclo and other pipeline programs. Our curated news collection ensures transparent tracking of corporate announcements, partnership agreements, and research advancements in cyclodextrin therapeutics.
Key updates include clinical trial data, FDA communications, intellectual property filings, and industry conference presentations. Bookmark this page for centralized access to verified information supporting informed analysis of Cyclo Therapeutics’ progress in addressing unmet medical needs.
Cyclo Therapeutics (NASDAQ: CYTH) presented positive preliminary data from its ongoing Phase 3 TransportNPC™ open-label sub-study in patients under 3 years old with Niemann-Pick Disease Type C1 (NPC1). The data shows promising results, with 87% of patients (7 of 8) at 24 weeks and 86% (6 of 7) at 48 weeks demonstrating stabilization or improvement in Clinical Global Impression – Change Scale.
The sub-study is part of the company's comprehensive TransportNPC™ pivotal Phase 3 global study evaluating Trappsol® Cyclo™. The main study completed enrollment in May 2024 with 104 patients, and topline data is expected in H1 2025. The safety profile remains consistent with previous findings, with mostly mild (77%) or moderate (22%) adverse effects, and no serious adverse events related to the study drug.
Cyclo Therapeutics (NASDAQ: CYTH) has announced its participation in the 21st Annual WORLDSymposium™ 2025, scheduled for February 3-7, 2025 in San Diego. The company will present research on their drug Trappsol® Cyclo™ through multiple sessions.
The presentations include an oral session by Dr. Ronen Spiegel focusing on the TransportNPC™ Sub-Study in patients under age 3 with Niemann-Pick Disease Type C1, scheduled for February 6, 2025. Additionally, Dr. Caroline Hastings will present two posters on the long-term treatment efficacy and safety data from clinical studies and the ongoing Expanded Access Program.
Trappsol® Cyclo™, which has received orphan drug designation in the United States and Europe, is currently being evaluated in four formal clinical trials for Niemann-Pick Disease Type C1 and a Phase 2b trial for early Alzheimer's disease. The research presentations will highlight clinical applications and outcomes of the treatment.
Cyclo Therapeutics (NASDAQ: CYTH) reported Q3 2024 financial results and business updates. Key highlights include a strategic merger with Rafael Holdings expected to close in Q4 2024, completion of enrollment in Phase 3 TransportNPC™ trial, and qualification for Priority Review Voucher. The company targets topline data from 48-week interim analysis in H1 2025, followed by NDA and MAA submissions in H2 2025. Financial results show a net loss of $8.8 million, with R&D expenses increasing 57% to $5.5 million compared to Q3 2023. Cash position at quarter-end was $0.9 million.
Cyclo Therapeutics (Nasdaq: CYTH) presented encouraging preliminary safety data from its ongoing pivotal Phase 3 study (TransportNPC™) and substudy evaluating Trappsol® Cyclo™ for Niemann-Pick Disease Type C1 (NPC1) at the SSIEM Annual Symposium 2024. The TransportNPC™ study, with 104 enrolled patients, is the most comprehensive controlled pivotal study for NPC1. Key highlights include:
1. Topline data from the 48-week interim analysis expected in H1 2025
2. Trappsol® Cyclo™ demonstrated to be well-tolerated with a consistent safety profile
3. 625 Adverse Events reported, 80% Grade 1 (mild)
4. No patients withdrew due to safety concerns
5. Substudy completed enrollment with ten patients under 3 years old
Cyclo Therapeutics (Nasdaq: CYTH) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Completed enrollment in the pivotal Phase 3 TransportNPC™ trial for Niemann-Pick Disease Type C1 (NPC1).
2. Topline data from the 48-week interim analysis expected in H1 2025.
3. Targeting NDA and MAA submissions in 2H 2025 if data shows significance.
4. Net loss for Q2 2024 was approximately $6.0 million.
5. R&D expenses increased 10% to $3.5 million.
6. Cash position at quarter-end was approximately $1.1 million.
The company is focused on developing Trappsol® Cyclo™ for NPC1 and early Alzheimer's disease, with potential for a Priority Review Voucher upon NDA submission.
Cyclo Therapeutics (Nasdaq: CYTH) has received a notice from the European Patent Office of a decision to grant European patent application No. 19805439.7 titled, 'Methods for Treating Alzheimer's Disease' under European patent number 3873604B. The patent will take effect on August 21, 2024.
CEO N. Scott Fine emphasized the importance of this milestone for the company's Alzheimer's disease asset and overall patent portfolio. Cyclo Therapeutics is developing Trappsol® Cyclo™, an orphan drug designated product, which is currently the subject of four formal clinical trials for Niemann-Pick Disease Type C and a Phase 2b clinical trial for early Alzheimer's disease.
Cyclo Therapeutics (Nasdaq: CYTH), a clinical-stage biotechnology company, announced two abstracts accepted for poster presentation at the SSIEM Annual Symposium 2024 in Porto, Portugal, scheduled for September 3-6, 2024. The company will showcase data from its comprehensive TransportNPC™ Phase 3 global trial, focusing on Niemann-Pick Disease Type C1 (NPC1). One poster will discuss the safety data, patient cohort data, neurological outcomes, and novel assessment technologies for patients aged three years and older. Another poster will cover an open-label sub-study for patients below three years of age, emphasizing safety, clinical endpoints, early intervention, and disease prevention. CEO N. Scott Fine highlighted the study's global impact and the opportunity to engage with the NPC community at this key event.
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.
Cyclo Therapeutics (Nasdaq: CYTH) reported its Q1 2024 financial results, highlighting ongoing progress in its TransportNPC™ Phase 3 study for Niemann-Pick Disease Type C1 (NPC1). The study expects to enroll the last patient by Q2 2024, with topline data anticipated in H1 2025. The company also received a U.S. patent for using Trappsol® Cyclo™ to treat Alzheimer's Disease.
Financially, Cyclo Therapeutics reported a net loss of $4.3 million for Q1 2024. However, research and development expenses decreased by 16% to $2.8 million due to reduced spending on the Alzheimer’s program and adjustments in personnel costs. The company ended the quarter with $2.9 million in cash.
Cyclo Therapeutics focuses on developing life-changing medicines, with Trappsol® Cyclo™ in multiple clinical trials for NPC1 and early Alzheimer’s disease.
FAQ
What is the current stock price of Cyclo Therapeutics (CYTH)?
What is the market cap of Cyclo Therapeutics (CYTH)?
