Abeona’s new Form 483 is another manufacturing setback for its rare skin condition asset

Abeona Therapeutics was handed a Form 483 “related to process controls” for its epidermolysis bullosa candidate in a second manufacturing-related roadblock for the program, with the biotech’s stock dropping by as much as 16% on Monday.

The biotech submitted a response to the document on Friday, which noted concerns at the company’s manufacturing site in Cleveland, OH, according to a full-year earnings release. The document was issued after a two-week pre-license inspection, which concluded on March 1.

The FDA’s data dashboard does not provide any further detail on the Form 483. The company did not immediately respond to questions from Endpoints News.

This is the second manufacturing-linked setback for Abeona, with the FDA asking in June last year for more information on how the treatment candidate, dubbed pz-cel, was made. This delayed plans for the BLA submission, which was…
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