Paragon Biosciences-backed Castle Creek Biosciences Inc. pulled off an oversubscribed and upsized preferred stock financing of $112.8 million. The money should let the firm tie the bow on a phase III study and roll out top-line results of its lead ex vivo product candidate for recessive dystrophic epidermolysis bullosa (RDEB) called D-Fi (dabocemagene autoficel, also known as FCX-007).
Like many companies, New York-based Abeona Therapeutics Inc. faltered clinically as a result of the COVID-19 virus, which delayed enrollment in the phase III study with EB-101 gene therapy in recessive dystrophic epidermolysis bullosa (RDEB), but the company earlier this month disclosed the restart of patient enrollment in the experiment called Viital.
Castle Creek Biosciences Inc. CEO John Maslowski told BioWorld the firm’s $75 million financing will propel phase III research with FCX-007 in recessive dystrophic epidermolysis bullosa (RDEB), with top-line data due in the first quarter of 2021 – “a big inflection point” for the Exton, Pa.-based company, which plans a BLA filing for that year as well.
Investigators at Stanford University Medical Center have treated the first patient in a pivotal phase III study of Abeona Therapeutics Inc.'s EB-101, an autologous cell therapy for recessive dystrophic epidermolysis bullosa (RDEB). The trial, delayed by an FDA clinical hold placed in September 2019, has now resumed, with the majority of its 15 expected participants pre-screened.