ImmunityBio Stock Surges 26% After FDA Outlines Resubmission Path For ANKTIVA
Nasdaq • • business
Key Points:
- ImmunityBio, Inc. (IBRX) shares surged 25.82% to $6.95 following progress in regulatory discussions with the FDA regarding a potential resubmission path for ANKTIVA in BCG-unresponsive papillary non-muscle invasive bladder cancer.
- The FDA provided guidance on additional information needed for a supplemental Biologics License Application resubmission without requesting new clinical trials, seen as de-risking the regulatory process and supporting potential label expansion.
- The stock experienced strong buying momentum and significantly higher trading volume, reflecting positive investor reaction to the regulatory update.
- ImmunityBio's shares have shown substantial volatility over the past year, largely influenced by clinical and regulatory developments related to ANKTIVA's commercialization
