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Celularity Receives FDA Warning Over Marketing Claims

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Celularity Receives FDA Warning Over Marketing Claims

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The latest update is out from Celularity ( (CELU) ).

On December 1, 2025, Celularity Inc. received a warning letter from the FDA concerning the marketing materials for Interfyl, a human connective tissue matrix. The letter emphasized the need to limit outcome-based claims and metabolic activity descriptions in marketing to comply with regulatory standards. Despite the warning, the company’s manufacturing and shipping operations remain unaffected, and no product recalls are required. Celularity is actively engaging with the FDA to address the issues, although there is no assurance of a swift resolution. The company does not anticipate any material impact on its operational or financial expectations due to the letter.

The most recent analyst rating on (CELU) stock is a Sell with a $2.00 price target. To see the full list of analyst forecasts on Celularity stock, see the CELU Stock Forecast page.

Spark’s Take on CELU Stock

According to Spark, TipRanks’ AI Analyst, CELU is a Underperform.

Celularity’s robust revenue growth is overshadowed by its lack of profitability and high financial leverage, which are significant risks. Technical indicators suggest a bearish trend with potential volatility. The negative P/E ratio and lack of dividend yield further weigh on the stock’s valuation.

To see Spark’s full report on CELU stock, click here.

More about Celularity

Celularity Inc. operates in the biotechnology industry, focusing on developing and manufacturing human cellular therapies and biomaterials. The company’s primary products include Interfyl, a human connective tissue matrix, with a market focus on regenerative medicine and tissue engineering.

Average Trading Volume: 131,046

Technical Sentiment Signal: Strong Sell

Current Market Cap: $55.89M

Find detailed analytics on CELU stock on TipRanks’ Stock Analysis page.

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