ImmunityBio Inc. (NASDAQ:IBRX) shares climbed nearly 20% in premarket trading on Tuesday after the company said it held positive discussions with the U.S. Food and Drug Administration regarding its supplemental Biologics License Application for ANKTIVA in bladder cancer patients with papillary tumors.
The clinical-stage immunotherapy group said the FDA advised it to submit additional information that could support a resubmission of the sBLA for BCG-unresponsive papillary non-muscle invasive bladder cancer. Crucially, the regulator did not ask for any new clinical trials, and ImmunityBio said it expects to deliver the requested materials within 30 days.
ImmunityBio pointed to long-term data published in The Journal of Urology showing roughly 96% bladder cancer–specific survival and more than 80% bladder preservation at three years among patients with papillary disease treated with ANKTIVA. Median outcomes have yet to be reached in the 80-patient study.
ANKTIVA was approved by the FDA in April 2024 for patients with carcinoma in situ, with or without papillary tumors. The therapy has also gained approval in the United Kingdom and Saudi Arabia, and received conditional authorization in the European Union.
“We appreciate the FDA’s collaboration throughout this process and remain fully committed to delivering this much-needed therapy to patients who currently have no approved alternatives when standard of care fails,” said Richard Adcock, president and chief executive officer of ImmunityBio.
After the update, Piper Sandler analyst Edward Tenthoff lifted his price target on ImmunityBio to $7.00 from $5.00, while reiterating an Overweight rating on the stock.