ImmunityBio Inc. Stock Declines Following FDA RTF Letter

ImmunityBio, Inc., a biotechnology company specializing in cell and immunotherapy products for treating diseases such as cancers and infectious and inflammatory diseases, has experienced a significant drop in its stock price. This decline is attributed to the issuance of a Refuse to File (RTF) letter by the U.S. Food and Drug Administration (FDA).

Stock Performance Overview

As of May 1, 2025, ImmunityBio’s stock closed at $2.54. The company’s stock has been on a downward trajectory, with the 52-week low recorded at $2.28 on January 13, 2025. This recent decline follows the 52-week high of $9.16, achieved on May 13, 2024. The market capitalization of ImmunityBio stands at $2.2 billion USD, with a Price-to-Earnings (P/E) ratio of -4.16, indicating the company is currently not profitable.

Impact of FDA’s RTF Letter

The RTF letter from the FDA has had a notable impact on ImmunityBio’s stock, causing it to sink. This regulatory action typically indicates that the FDA has found significant deficiencies in a company’s submission, preventing it from being reviewed. Such a letter can have serious implications for a biotech company’s development timeline and investor confidence.

Company Background

ImmunityBio operates within the Health Care sector, specifically in the Biotechnology industry. The company is headquartered in Culver City, United States, and is listed on the Nasdaq exchange. ImmunityBio’s mission is to revolutionize the treatment of various diseases through innovative cell and immunotherapy techniques.

Conclusion

The issuance of the RTF letter by the FDA has led to a decline in ImmunityBio’s stock price, reflecting investor concerns over the company’s regulatory challenges. As ImmunityBio navigates this setback, the company’s ability to address the FDA’s concerns will be crucial in restoring investor confidence and advancing its product development efforts.