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Abeona Therapeutics Inc.

Company NameAbeona Therapeutics Inc.
Stock SymbolABEO

On April 22, 2024, Abeona disclosed that it had received a Complete Response Letter (“CRL”) from the FDA regarding its recessive dystrophic epidermolysis bullosa treatment, pz-cel, stating that “the FDA noted that certain additional information needed to satisfy Chemistry Manufacturing and Controls (CMC) requirements must be satisfactorily resolved before the application can be approved.” Specifically, the “information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods.”

On this news, Abeona’s stock price fell $3.95, or 53.7%, to close at $3.41 per share on April 23, 2024, thereby injuring investors.

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