CERo Therapeutics Gains FDA Orphan Drug Designation

CERo Therapeutics Holdings ( (CERO) ) has shared an update.

On June 17, 2025, CERo Therapeutics Holdings announced that the FDA granted Orphan Drug Designation to its lead drug candidate, CER-1236, for treating acute myeloid leukemia (AML). CER-1236 is currently in Phase 1 clinical trials, aiming to assess its safety and efficacy in AML patients. The Orphan Drug Designation provides CERo with incentives such as FDA assistance in clinical trial design, exemption from drug approval application fees, and seven years of marketing exclusivity. This designation underscores the potential of CER-1236 to offer a new treatment approach for AML, enhancing CERo’s position in the immuno-oncology field.

The most recent analyst rating on (CERO) stock is a Buy with a $3.00 price target. To see the full list of analyst forecasts on CERo Therapeutics Holdings stock, see the CERO Stock Forecast page.

More about CERo Therapeutics Holdings

CERo Therapeutics Holdings, Inc. is an innovative immunotherapy company focused on developing next-generation engineered T cell therapeutics for cancer treatment. The company employs a proprietary approach to T cell engineering, integrating both innate and adaptive immunity characteristics to optimize cancer therapy. CERo’s platform aims to redirect patient-derived T cells to eliminate tumors using phagocytic mechanisms, creating Chimeric Engulfment Receptor T cells (CER-T). This approach is expected to have broader therapeutic applications than existing CAR-T cell therapies, potentially addressing both hematological malignancies and solid tumors.

Average Trading Volume: 105,807

Technical Sentiment Signal: Sell

Current Market Cap: $3.54M

For an in-depth examination of CERO stock, go to TipRanks’ Overview page.