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Immunitybio nasdaq Ibrx Stock Surges 11 Whats the Buzz

ImmunityBio (NASDAQ: IBRX) Stock Surges 11% – What’s The Buzz!

ImmunityBio (NASDAQ: IBRX) stock soared over 11% in the intraday trading after the FDA approved its bladder cancer therapy.

ImmunityBio (NASDAQ: IBRX) has made a significant breakthrough in cancer treatment with the U.S. Food and Drug Administration (FDA) granting approval for ANKTIVA (N-803, or nogapendekin alfa inbakicept-pmln) in combination with Bacillus Calmette-Guérin (BCG) for patients suffering from BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors.

Patrick Soon-Shiong, the Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio, expressed his excitement about this development. He stated,

“The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors.”

ANKTIVA, a first-in-class IL-15 agonist immunotherapy for NMIBC, earned Breakthrough Therapy Designation and FDA approval based on its safety and efficacy outcomes, including complete response (CR) rates and duration of complete response (DOR).

A single-arm, multicenter trial evaluated 77 patients. The results were promising, with a complete response (CR) rate of 62% and the upper end of the confidence interval at 73%. The duration of complete response (DOR) as of the November 2023 cut-off was more than 47 months and is still ongoing.

The company reveals that ANKTIVA and BCG’s response results, extending over 24 months, surpass the IBCG expert panel’s suggested benchmark for significant clinical outcomes.

Moreover, the ongoing nature of the response underscores the potential long-term benefits of ANKTIVA in treating NMIBC. Notably, 58% of patients with complete response exhibited a duration of response (DOR) of at least 12 months, while 40% had a DOR of at least 24 months.

ImmunityBio anticipates making ANKTIVA available in the U.S. by mid-May 2024.

ImmunityBio (NASDAQ: IBRX) Stock Movement

At the time of this report, IBRX stock is priced at $5.49, indicating an 11.13% increase from the previous trading session. This week, it has seen an 11.59% surge in value. Trading activity shows that 30,606,873 (30.60 million) shares have exchanged hands, significantly higher than the average daily volume of 4.22 million.