ImmunityBio Stock Jumps 26% as FDA Details ANKTIVA Resubmission Plan
ImmunityBio, Inc. experienced a significant stock increase of nearly 26%, reaching $6.95 per share. This surge follows crucial regulatory updates regarding its cancer treatment ANKTIVA.
FDA Guidance on ANKTIVA Resubmission
The U.S. Food and Drug Administration (FDA) has provided ImmunityBio with vital guidance for the potential resubmission of ANKTIVA. This treatment targets BCG-unresponsive papillary non-muscle invasive bladder cancer.
Positive Regulatory Developments
Investors welcomed the news that the FDA did not request additional clinical trials for the resubmission. Instead, they outlined the necessary information for a supplemental Biologics License Application (sBLA).
- Stock price jumped 25.82%, up $1.43.
- Opened the day lower before climbing to an intraday high.
- Shares traded on the Nasdaq market.
- Trading volume significantly surpassed average daily levels.
Market Reaction and Stock Volatility
The sharp increase in ImmunityBio’s stock reflects robust investor confidence in the updated regulatory pathway for ANKTIVA. The announcement led to a buying momentum that drove prices higher, significantly outperforming the previous close.
ImmunityBio’s stock has exhibited considerable volatility over the past year. Its 52-week range indicates sensitivity to clinical news and regulatory developments regarding ANKTIVA’s commercialization.
This recent approval from the FDA is seen as a de-risking factor in the regulatory process. It also holds the potential for significant label expansion in the future.
