Abeona shares rise 5% on ‘regenerative medicine advanced therapy’ designation from FDA

Abeona Therapeutics Inc. shares rose 5% in premarket trade on Monday after the company’s cell therapy received a Regenerative Medicine Advanced Therapy designation from the Food and Drug Administration. The designation allows for accelerated approval, among other benefits. Abeona’s cell therapy, EB-101, is being developed for recessive dystrophic epidermolysis bullosa, a rare genetic condition with no cure that is marked by widespread blistering. The condition makes it difficult for patients to eat and can lead to vision loss, disfigurement and aggressive skin cancer, according to the National Institutes of Health. EB-101 aims to re-engineer a patient’s cells to produce collagen, helping reduce blistering and improve healing, Abeona said. The company plans to begin a phase 3 trial for the cell therapy later this year. Company shares have dropped 6% over the last three months, compared with a 11.3% rise in the S&P 500 and a 13.6% rise in the Dow Jones Industrial Average .

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