ImmunityBio Inc. (NASDAQ: IBRX) reported on Tuesday plans to submit additional documentation to the U.S. Food and Drug Administration (FDA) within the next 30 days. This submission follows a Type B end-of-phase meeting focused on the company’s supplemental biologics license application (sBLA) for Anktiva, targeting patients with papillary non-muscle-invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guérin (BCG) therapy.
The market reacted swiftly to the announcement as ImmunityBio’s shares experienced a significant uptick, trading with an unusually high volume of approximately 179 million shares compared to its average daily volume of 15.9 million, according to data from Benzinga Pro. This surge elevated the stock to a new 52-week high, reflecting investor optimism around the treatment candidate’s regulatory progress.
During the meeting, the FDA offered detailed feedback pertaining to Anktiva (nogapendekin alfa inbakicept) when used concurrently with BCG for patients exhibiting BCG-unresponsive papillary NMIBC. ImmunityBio indicated the regulatory guidance received aims to facilitate the possible resubmission of the sBLA, originally filed in 2025, and importantly, the FDA did not require initiation of any new clinical trials as part of the process.
ImmunityBio leveraged this interaction to present updated clinical outcomes from its papillary disease program, highlighting data spanning over five years of follow-up. Key findings were shared, including disease-specific survival rates near 96% at 36 months, with the median survival duration yet to be reached, underscoring the therapy’s potential longevity benefits. Additionally, cystectomy avoidance rates were noted at 92% after one year and 82% after three years of treatment, indicating that a majority of patients were able to avoid radical bladder removal surgery.
The favorable safety profile maintained consistency with Anktiva’s currently approved indication for carcinoma in situ within NMIBC patients, reinforcing the treatment’s tolerability.
The supporting evidence for the papillary indication arises from the QUILT-3.032 Phase 2/3 trial, which enrolled 80 patients suffering from high-grade papillary-only BCG-unresponsive NMIBC. This pivotal study, published in The Journal of Urology in 2025, met its primary endpoint by achieving a 12-month disease-free survival rate of 58.2%. Additionally, reported progression-free survival rates were 94.9% at 12 months and 83.1% at 36 months. More than 80% of patients maintained bladder-sparing status through a three-year follow-up period, positioning Anktiva as an effective alternative to cystectomy in this high-risk population.
Anktiva currently possesses FDA approval in the United States and is authorized in multiple international markets for the treatment of BCG-unresponsive NMIBC with carcinoma in situ. ImmunityBio also recently disclosed encouraging enrollment progress in its randomized registrational trial, QUILT-2.005, investigating treatment in BCG-naïve NMIBC patients. Enrollment has surpassed 85% of the total target, with expectations to complete patient recruitment by the second quarter of 2026.
From a commercial perspective, ImmunityBio revealed preliminary net product revenue for Anktiva reached approximately $113 million for fiscal year 2025, reflecting a staggering 700% year-over-year increase. The fourth quarter alone recorded revenue of roughly $38.3 million, which marks a 20% rise sequentially from $31.8 million and a 431% increase compared to the same quarter in the previous year.
Analyst commentary underscores positive sentiment toward ImmunityBio’s prospects. Piper Sandler retained an Overweight rating and raised the price target from $5 to $7. D. Boral Capital also reaffirmed its Buy rating, maintaining a price target of $24.
Following the announcement, ImmunityBio’s share price surged 20.44% to $6.64 at the time of reporting, reflecting broad investor enthusiasm driven by recent clinical and commercial developments.