ImmunityBio Charts Path Forward for Anktiva Resubmission Following FDA Alignment

ImmunityBio’s stock price climbed 17.4% after the company announced productive in-person discussions with senior FDA officials regarding the regulatory approval pathway for Anktiva in an expanded indication. The biotech company plans to move forward with a resubmission of its supplemental biologics license application (sBLA) for Anktiva (nogapendekin alfa inbakicept) combined with Bacillus Calmette-Guérin (BCG) to treat patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) presenting with papillary tumors. The original resubmission package had received a refusal-to-file (RTF) letter from the FDA in 2025. It’s worth noting that Anktiva already carries U.S., EU, and UK approvals in combination with BCG for adults with BCG-unresponsive NMIBC featuring carcinoma in situ (CIS), with or without papillary disease.

During the recent regulatory meeting, ImmunityBio presented an extensive update on its papillary disease program, showcasing more than five years of follow-up clinical outcomes that support efficacy in the papillary indication. The safety profile of the combination regimen aligned with data from the currently approved CIS population. Additionally, prominent urologists shared their real-world clinical experiences managing BCG-unresponsive patients—a population for which radical cystectomy (complete bladder removal) remains the primary treatment option.

The FDA subsequently requested supplementary information to advance the resubmission for the papillary indication. ImmunityBio has completed these requested analyses and expects to file the updated package within the next month. Notably, the company clarified that the FDA’s requests do not require new clinical study initiation or alternative study designs. The discussion also covered current standard-of-care approaches, chemotherapy limitations, patient management complexities, and clinical data interpretation. Over the past six months, ImmunityBio shares have surged 139.2%, substantially outpacing the broader industry gain of 19.8%.

Clinical Evidence Supports the Bladder Cancer Resubmission Initiative

ImmunityBio’s planned sBLA resubmission for Anktiva in BCG-unresponsive papillary NMIBC is anchored in robust long-term data from the Phase II/III QUILT-3.032 study (Cohort B), which enrolled 80 patients with high-grade papillary-only disease. The study successfully achieved its primary endpoint, demonstrating a 12-month disease-free survival rate of 58.2%—a meaningful result in a high-risk patient population with severely limited therapeutic alternatives.

Extended follow-up data strengthened the durability signal. Disease-specific survival reached 96% at 36 months with median survival not yet attained, while progression-free survival held strong at 94.9% at 12 months and 83.1% at 36 months. These findings indicate sustained disease suppression and a sustained reduction in progression risk toward muscle-invasive bladder cancer.

A particularly compelling aspect of the data involves bladder preservation. The cystectomy-free survival rate was 92.2% at 12 months and 81.8% at 36 months, meaning over four-fifths of patients successfully avoided major surgical intervention through three years of observation. High-grade papillary NMIBC that no longer responds to BCG constitutes a critical unmet medical need, as no targeted immunotherapies currently exist for this population. Standard treatment—radical cystectomy—carries substantial morbidity and negatively impacts patient quality of life.

By pursuing this indication, ImmunityBio aims to introduce a bladder-sparing therapeutic option. The long-term QUILT-3.032 findings suggest that Anktiva combined with BCG can deliver sustained remissions while delaying or eliminating the need for surgery in most responding patients. If approved, Anktiva would become the first immunotherapy specifically indicated for BCG-unresponsive papillary NMIBC, building on its existing CIS approval and potentially transforming treatment paradigms for these patients. ImmunityBio is also engaged in discussions with international regulatory bodies, including the European Medicines Agency, to pursue label expansion into papillary-only disease following potential U.S. approval.

Market Perspective: Biotech Sector Comparisons

ImmunityBio currently maintains a Zacks Rank of #3 (Hold). In the biotech sector, several better-positioned companies merit investor consideration. Amicus Therapeutics [FOLD] carries a Zacks Rank #1 (Strong Buy), with 2026 EPS estimates ranging from 65 cents (down from 67 cents over the past 60 days). FOLD shares appreciated 130.1% over the past six months. The company delivered earnings beats in one of the last four quarters while missing in three others, averaging a -20.21% surprise.

Alkermes [ALKS] also holds a Zacks Rank #1 (Strong Buy), with 2026 EPS estimates climbing from $1.54 to $1.90 during the past 60 days. ALKS gained 17.5% over the past six months and achieved earnings beats in three of the trailing four quarters, missing once, with an average positive surprise of 4.58%.

Krystal Biotech [KRYS] rounds out the Strong Buy-rated cohort, with 2026 EPS estimates rising to $8.49 from $8.34. KRYS stock rallied 80.9% over the past six months and beat earnings expectations in three of the last four quarters, posting an impressive average positive surprise of 40.43%.

The broader biotech landscape offers diverse investment opportunities alongside ImmunityBio’s regulatory advancement story, each with distinct risk-reward profiles and momentum trajectories in the current market environment.