Abeona Therapeutics is preparing for the potential launch of pz-cel (prademagene zamikeracel) to treat recessive dystrophic epidermolysis bullosa (RDEB), after the U.S. Food and Drug Administration (FDA) initiated discussions on the medication label and post-marketing requirements, according to a company press release. Last fall, the…

Abeona Therapeutics is preparing to request U.S. approval of EB-101, a cell therapy candidate for treating recessive dystrophic epidermolysis bullosa (RDEB). The announcement follows a successful pre-biologics license application (BLA) meeting with the U.S. Food and Drug Administration (FDA). “With the constructive feedback from the FDA now in-hand,…

Abeona Therapeutics has submitted a data briefing package on its cell therapy candidate EB-101 to the U.S. Food and Drug Administration (FDA) ahead of a meeting with the agency planned for this month. The meeting’s purpose is to discuss Abeona’s planned application seeking approval of EB-101 to treat recessive …

The pivotal Phase 3 VIITAL clinical trial of EB-101, Abeona Therapeutics’ experimental cell therapy for wound healing in people with recessive dystrophic epidermolysis bullosa (RDEB), has met its enrollment target. The company also announced that top-line results from the VIITAL trial (NCT04227106) are expected…

The pivotal VIITAL study of EB-101, Abeona Therapeutics‘ experimental therapy for recessive dystrophic epidermolysis bullosa (RDEB), now has a second clinical site on the other U.S. coast — at the UMass Memorial Medical Center in Worcester, Massachusetts — the company announced. The first clinical site, where the Phase…

Abeona Therapeutics will proceed with enrollment for its pivotal Phase 3 study of EB-101 as a treatment for recessive dystrophic epidermolysis bullosa (RDEB), following a meeting with the U.S. Food and Drug Administration (FDA). “We appreciate the clarity provided by the FDA and we are pleased to be…

Abeona Therapeutics has restarted patient enrollment in the VIITAL Phase 3 clinical trial of EB-101, a potential gene-corrected cell therapy for people with recessive dystrophic epidermolysis bullosa (RDEB). Recruitment into the VIITAL trial (NCT04227106), conducted at Stanford Medicine in California, had been placed on…

The first patient has been treated in the VIITAL Phase 3 trial testing EB-101, a gene-corrected cell therapy candidate for people with recessive dystrophic epidermolysis bullosa (RDEB). Abeona Therapeutics, the company developing EB-101, announced the launch of this trial earlier this year following clearance…

Abeona Therapeutics has begun its Phase 3 VIITAL trial evaluating EB-101, a gene-corrected cell therapy for the treatment of recessive dystrophic epidermolysis bullosa (RDEB), the company recently announced. An institutional review board at Stanford University approved the start of the pivotal…

After its recent clinical hold by regulators, the Phase 3 VIITAL trial has been given the green light to investigate EB-101, a gene-corrected cell therapy for people with recessive dystrophic epidermolysis bullosa (RDEB). Abeona Therapeutics, the company developing EB-101, plans to start VIITAL in early 2020. RDEB…

The experimental cell therapy EB-101 was safe and led to successful wound healing in seven adults with recessive dystrophic epidermolysis bullosa (RDEB), followed-up for five years, the results of a Phase 1/2a clinical trial show. The study detailing the results, “Phase 1/2a clinical trial of gene-corrected…

The U.S. Food and Drug Administration (FDA) has refused to approve the initiation of Abeona Therapeutics‘s Phase 3 clinical trial evaluating its gene-corrected cell therapy EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The clinical hold, the company explained, is…