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Polaryx Therapeutics Receives FDA Fast Track Designation
Polaryx Therapeutics announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track Designation, FTD, to PLX-200 for the treatment of Juvenile Neuronal Ceroid Lipofuscinosis, Krabbe disease, and Sandhoff disease. "We are delighted by the FDA's decision to further extend Fast Track Designation to CLN3, Krabbe disease, and Sandhoff disease," said Alex Yang, Chair and Chief Executive Officer of Polaryx Therapeutics. "As we prepare to advance the SOTERIA Phase 2 basket trial, receiving this designation across all four indications underscores the enormous need that exists in the current LSD landscape while also recognizing PLX-200's potential to meaningfully address treatment gaps across multiple LSDs."
Polaryx Receives FDA Fast Track Designation for PLX-200
Polaryx announced that the FDA has granted Fast Track Designation to PLX-200 for the treatment of Late-Infantile Neuronal Ceroid Lipofuscinosis, or LINCL/CLN2 disease. The Fast Track program is designed to facilitate and expedite the review of therapies intended to treat serious or life-threatening conditions with unmet medical need. Companies receiving Fast Track designation may benefit from more frequent interactions with the FDA and the potential for rolling review of a future marketing application.
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Polaryx Therapeutics, Inc trading halted, volatility trading pause
Polaryx Therapeutics Selects CRO for Soteria Clinical Trial
Polaryx Therapeutics announces it has selected a contract research organization, CRO, for Soteria, a phase 2, open-label, single-arm trial designed to evaluate the safety, tolerability, and clinical activity of Polaryx's lead candidate, PLX-200, across four different LSDs. "Our selection of a CRO partner marks an important milestone for us as we continue to advance the clinical development of SOTERIA and move closer to the clinic," said Lisa Bollinger, M.D., Chief Medical Officer of Polaryx Therapeutics, Inc. "Our new partner brings meaningful experience working with and managing LSD and rare pediatric trials, as well as deep-rooted relationships with the dedicated key opinion leaders and patient advocacy groups who work closely with patients and their families."
Polaryx Therapeutics Presents New Data for PLX-200 at WORLDSymposium
Polaryx Therapeutics announced that the late-breaking presentation of new data for PLX-200, an investigational therapy for the treatment of Krabbe disease at the 22nd Annual WORLDSymposium, was given on February 6, 2026 in San Diego, Calif. Key Findings and Scientific Perspective. At the Contemporary Forum, Late-breaking Science and the Rapid Fire Competition, Shrijay Vijayan, Ph.D., MBA, Polaryx Therapeutics' Chief Scientific and Business Development Officer, presented preclinical findings highlighting that orally administered gemfibrozil in a mouse model of Krabbe disease: Reduces astrogliosis and neuro-inflammation; Protects myelin; Reduces psychosine accumulation, a hallmark toxic metabolite found in Krabbe disease patients.
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