12:36 PM EDT, 03/18/2024 (MT Newswires) -- Abeona Therapeutics ( ABEO ) shares fell more than 10% in recent Monday trading after the company posted a wider-than-expected 2023 net loss, and some US Food and Drug Administration observations on its facility in Cleveland.

The company reported earlier Monday full-year 2023 net loss of $2.53 per diluted share, narrower than a loss of $5.53 in the prior year. Analysts polled by Capital IQ expected a loss of $2.23.

Revenue was $3.5 million, compared with $1.4 million in 2022. The revenue was in line with the average estimate polled by Capital IQ.

The FDA inspection was related to Abeona's Biologics License Application for pz-cel, a skin disease treatment. Following a two-week inspection, the FDA issued a Form 483 with some observations on process controls .

The company said it has submitted a response to the FDA outlining steps toward resolution as per FDA guidance.

Price: 7.74, Change: -0.89, Percent Change: -10.31