Abeona Therapeutics

Abeona receives FDA breakthrough designation for epidermolysis bullosa

Wednesday, August 30, 2017

Abeona Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel gene therapies for life-threatening rare diseases, announced that the FDA has granted Breakthrough Therapy designation status to the company’s EB-101 gene therapy program for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB). The designation from the FDA enables collaborative discussions with senior FDA personnel, priority review and an expedited approval process to drug candidates where preliminary clinical trials indicate that a therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.

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Plasmatech Biopharmaceuticals to acquire Abeona Therapeutics

Friday, May 8, 2015

PlasmaTech Biopharmaceuticals, a Texas-based biopharmaceutical company advancing protein biologic therapies and oncology supportive care products, has entered into a definitive agreement to acquire Abeona Therapeutics, a company engaged in the development and commercialization of therapies for patients with lysosomal storage diseases. The company will issue to Abeona Therapeutic members a total of 3,979,761 common shares upon closing of the transaction, and up to an additional $9 million in performance milestones, in common stock or cash, at the company’s option.

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Abeona Therapeutics receives FDA Orphan Drug Designations for Sanfilippo

Wednesday, May 14, 2014

Abeona Therapeutics, a start-up company created around intellectual property licensed from Nationwide Children’s Hospital to develop treatments for Sanfilippo Syndrome Types A and B, has been granted Orphan Drug Designations for its lead investigational therapies by the FDA Office of Orphan Products Development. Following the successful close of seed financing in late 2013, Abeona is raising funds to advance its gene therapy-based clinical programs for both Sanfilippo Syndrome type A and B. Phase I/II clinical trials for both diseases are anticipated to begin in 2014.

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