Cyclo Therapeutics, Inc. - CYTH STOCK NEWS

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.

Cyclo Therapeutics (Nasdaq: CYTH) announced its participation in the 17th Annual WORLD Symposium 2021, a virtual conference focused on lysosomal storage diseases, scheduled from February 8–12, 2021. Key presentations will feature updates on the Trappsol® Cyclo™ clinical trials for Niemann-Pick Disease Type C, with a platform presentation on February 9 by Dr. Julian Raiman and ePosters presented by both Dr. Raiman and Dr. Caroline Hastings. Full details and updates will be available on Cyclo Therapeutics' website post-presentation.

Cyclo Therapeutics (NasdaqCM:CYTH, CYTHW) announced initial data from its open-label study of Trappsol® Cyclo™ for Niemann-Pick Disease Type C (NPC). All eight patients in the study demonstrated disease stability or improvement in NPC Severity Scores over 10 months. Notably, patients receiving 1500 mg/kg showed stable scores, while those at 2500 mg/kg improved significantly. The safety profile was favorable, with only mild adverse events reported. Cyclo Therapeutics has FDA authorization to begin a Phase 3 trial, expected to enroll patients in early 2021, enhancing the company's position in the neurodegenerative disease market.