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CASI Pharmaceuticals Faces Setback with FOLOTYN® License Expiration in China

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CASI Pharmaceuticals Faces Setback with FOLOTYN® License Expiration in China

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The latest announcement is out from CASI Pharmaceuticals ( (CASI) ).

CASI Pharmaceuticals announced that its Import Drug Registration License for FOLOTYN® in China expired on August 25, 2025, following the denial of its renewal application by the Chinese Center for Drug Evaluation. As a result, the company will cease sales of FOLOTYN® in China but will continue clinical trials as permitted. This development may impact CASI’s market operations in China and its stakeholders, as the company navigates the regulatory landscape and adjusts its commercialization strategy.

The most recent analyst rating on (CASI) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on CASI Pharmaceuticals stock, see the CASI Stock Forecast page.

Spark’s Take on CASI Stock

According to Spark, TipRanks’ AI Analyst, CASI is a Neutral.

CASI Pharmaceuticals’ overall stock score is primarily impacted by its weak financial performance, characterized by declining revenue and high leverage. Technical analysis provides some neutral signals, but the valuation remains unattractive due to negative earnings. The absence of earnings call data and corporate events limits additional insights.

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

More about CASI Pharmaceuticals

CASI Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing innovative therapies for organ transplant rejection and autoimmune diseases. The company is actively working on CID-103, an anti-CD38 monoclonal antibody, and is involved in clinical trials for immune thrombocytopenic purpura and renal allograft antibody-mediated rejection.

Average Trading Volume: 1,305,560

Technical Sentiment Signal: Sell

Current Market Cap: $35.48M

Learn more about CASI stock on TipRanks’ Stock Analysis page.

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