Flamingo Therapeutics is standing on one leg no more, as Dynacure folds into the biotech in a merger agreement that will see the combined company work on RNA-targeted oncology therapies.
Dynacure has ended its Unite-CNM Phase I/II trial on DYN101, an investigational therapy for the treatment of myotubular and centronuclear myopathies (CNM).
Dynacure, a clinical stage biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation for its lead product candidate, DYN101. The Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and address significant unmet medical need.
Nippon Shinyaku Co., Ltd. announced that Nippon Shinyaku and Dynacure, a clinical-stage company, has entered into an option agreement for the development and commercialization of DYN101 in the territory of Japan.
STRASBOURG, France and PHILADELPHIA and KYOTO, Nov. 10, 2021 /PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that Dynacure and Nippon Shinyaku Co., Ltd. (HQs: Kyoto, President: Toru Nakai) have entered a long-term strategic development and commercialization agreement.
STRASBOURG, France and PHILADELPHIA, June 9, 2021 /PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for DYN101, an investigational antisense product candidate designed to reduce the expression of dynamin 2 protein (DNM2), for the treatment of Myotubular and Centronuclear Myopathies (CNM). DYN101 is currently being evaluated in a Phase 1/2 clinical trial, UNITE-CNM (DYN101-C101), at multiple clinical sites in Europe. DYN101 has been granted orphan drug designation by the FDA and European Medicines Agency (EMA) and rare pediatric disease designation by the FDA. There is currently no FDA- or EMA-approved therapeutic treatment for CNM.
STRASBOURG, France and PHILADELPHIA, Jan. 26, 2021 /PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. US 10, 865, 414 related to DYN101, an investigational antisense product candidate designed to reduce the expression of dynamin 2 protein (DNM2), for the treatment of Myotubular and Centronuclear Myopathies (CNM). The U.S. patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. This patent family includes one additional U.S. pending application and one European application and 18 other foreign pending applications (Australia, Brazil, Canada, Chili, China, Colombia, Israel, India, Japan, Korea, Mexico, Malaysia, New-Zealand, Peru, Russia, Singapore, South Africa and Taiwan). Patents issuing from the pending applications in this family, if any, are expected to expire in 2039, exclusive of possible patent term adjustments or extensions or other forms of exclusivity.
STRASBOURG, France and PHILADELPHIA, Jan. 26, 2021 /PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced today that the U.S. Patent and Trademark Office (USPTO) has granted U.S. Patent No. US 10, 865, 414 related to DYN101, an investigational antisense product candidate designed to reduce the expression of dynamin 2 protein (DNM2), for the treatment of Myotubular and Centronuclear Myopathies (CNM). The U.S. patent is part of a patent family, exclusively licensed from Ionis Pharmaceuticals, which covers modulators of DNM2 expression. This patent family includes one additional U.S. pending application and one European application and 18 other foreign pending applications (Australia, Brazil, Canada, Chili, China, Colombia, Israel, India, Japan, Korea, Mexico, Malaysia, New-Zealand, Peru, Russia, Singapore, South Africa and Taiwan). Patents issuing from the pending applications in this family, if any, are expected to expire in 2039, exclusive of possible patent term adjustments or extensions or other forms of exclusivity.
STRASBOURG, France and PHILADELPHIA, Jan. 15, 2021 /PRNewswire/ -- Dynacure, a clinical-stage company focused on developing and commercializing novel therapies to transform the lives of patients with rare diseases who have limited or no treatment options, announced the publication of a paper entitled, Hierarchical Bayesian modelling of disease progression to inform clinical trial design in centronuclear myopathy (CNM). The paper was published this month in Orphanet Journal of Rare Diseases, a scientific, peer-reviewed publication and can be accessed here.