FDA Rejects Approval Of Abeona Therapeutics' Skin Disorder Treatment, Shares Sink
Portfolio Pulse from Vandana Singh
The FDA issued a Complete Response Letter (CRL) to Abeona Therapeutics Inc (NASDAQ:ABEO) for its Biologics License Application (BLA) for prademagene zamikeracel (pz-cel), a treatment for recessive dystrophic epidermolysis bullosa (RDEB). The CRL cited the need for additional Chemistry Manufacturing and Controls (CMC) information but did not identify deficiencies in clinical efficacy or safety. ABEO shares dropped 45.10% to $4.04 following the announcement.
April 23, 2024 | 1:43 pm
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Abeona Therapeutics' stock plummeted 45.10% to $4.04 after the FDA rejected its BLA for pz-cel, citing additional CMC information needs.
The FDA's rejection of Abeona Therapeutics' BLA for its RDEB treatment due to unmet CMC requirements directly impacts the company's stock value, as evidenced by a significant drop. The absence of clinical efficacy or safety concerns suggests the potential for future approval, but the immediate financial impact is negative.
CONFIDENCE 90
IMPORTANCE 95
RELEVANCE 100