(RTTNews) – ImmunityBio, Inc. (IBRX) shares jumped 25.82%, trading at $6.95, up $1.43, after the company announced it has advanced regulatory discussions with the U.S. Food and Drug Administration on a potential resubmission path for ANKTIVA in BCG-unresponsive papillary non-muscle invasive bladder cancer.
The rally followed news that the FDA provided guidance on additional information required to support a supplemental Biologics License Application resubmission and did not request new clinical trials, which investors viewed as a meaningful de-risking of the regulatory process and a positive signal for a potential label expansion.
On the day of the announcement, IBRX opened lower before surging to an intraday high as buying momentum accelerated, with the stock trading well above its prior close. The shares trade on the Nasdaq.
Trading volume significantly exceeded the stock’s average daily volume, highlighting strong investor reaction to the regulatory update.
ImmunityBio’s 52-week range reflects substantial volatility, as the stock has been highly sensitive to clinical and regulatory developments tied to ANKTIVA’s commercialization and expansion prospects.
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