Will ImmunityBio submit an sNDA/BLA for ANKTIVA in BCG-naive NMIBC to the FDA by December 31, 2026?
Current Prediction
Prediction History
Baseline 0.35 reflected enrollment and timeline risk. With enrollment complete and IDMC confirmation of statistical power, the single largest risk factor (trial execution) has been removed. Submission timing now depends on routine data cleanup and CMC documentation. Recalibrated up to 0.74.
Why This Question Matters
QUILT 2.005 BCG-naive label expansion is the single highest-value catalyst. The Regulatory Reader identified this as the key to expanding the addressable market from ~5K to ~25K+ patients. An FDA submission in 2026 would validate the clinical data and timeline. Delay or failure would constrain ANKTIVA to a limited market.
Prediction Distribution
Individual Predictions(9 runs)
Full enrollment with IDMC confirmation of adequate statistical power removes the single largest risk factor. Management explicitly stated sBLA submission on track for 2026. Biotech companies that guide to a specific submission year after full enrollment hit that guidance ~75-80% of the time, with slippage to the following year as the main miss mode.
Clinical data readout → BLA preparation → submission typically takes 4-6 months post full enrollment for a well-resourced submission. Enrollment completed before April 9, 2026; allows ~8 months for readout and submission. The risk is topline disappointment requiring a pivot, not operational timing.
The interim data (84% vs 52% CR, p=0.0455) was already statistically significant. Final topline is likely to confirm or strengthen. The FDA has an active relationship with the company (recent sBLA filing for papillary-only). Submission by year-end is the base case, with ~25% slippage risk into H1 2027.
Enrollment complete is the de-risking milestone. Management reiterated 2026 submission target. Execution risk remains (data cleaning, CMC documentation, FDA pre-submission meetings) but no red flags. The FDA warning letter does not directly impair submission capability but could create a slower-tone regulatory interaction.
Historical base rate for biotech 'BLA on track for X year' guidance after enrollment completion is 70-80% clear. The company has demonstrated capability to file (recent sBLA for papillary-only). Down-weight slightly for warning letter overhang and multi-workstream execution demands.
Full enrollment confirmed + management guidance → high probability but not certainty. Key residual uncertainty is whether the topline data cleans cleanly or reveals subgroup issues requiring additional analysis. Data packages for sBLAs under accelerated approval can take 6+ months from database lock.
Enrollment complete, management guides 2026 submission, FDA relationship active. High probability.
Base case is on-time submission. Slippage risk modest. Warning letter not a direct blocker.
Major pipeline milestone de-risked by IDMC statistical power confirmation. Submission execution is routine from here.
Resolution Criteria
Resolves YES if ImmunityBio publicly discloses (via 8-K, press release, or earnings call) that it has submitted a supplemental NDA or BLA to the FDA for ANKTIVA in BCG-naive NMIBC by December 31, 2026.
Resolution Source
ImmunityBio press releases, 8-K filings, or FDA acceptance letter disclosure
Source Trigger
QUILT 2.005 final data readout and regulatory submission
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