ImmunityBio (IBRX) Resubmits sBLA to FDA for ANKTIVA in Papillary Bladder Cancer [Yahoo! Finance]
ImmunityBio, Inc. (IBRX)
Company Research
Source: Yahoo! Finance
highest upside potential . On March 9, ImmunityBio announced the resubmission of its sBLA to the FDA for ANKTIVA in combination with Bacillus Calmette-Guérin/BCG. This filing specifically targets patients with BCG-unresponsive non-muscle invasive bladder cancer/NMIBC who present with papillary disease. The resubmission follows an initial review in early 2026, during which the FDA requested additional long-term efficacy and follow-up data to support the treatment's potential in this specific patient population. The sBLA is supported by results from the QUILT 3.032 Phase 2/3 trial, which showed durable outcomes for patients with high-grade papillary-only disease. Data published in The Journal of Urology showed a 12-month disease-free survival rate of 58.2% and a bladder preservation rate of 81.8% at 36 months. These findings highlight ANKTIVA's role as an IL-15 superagonist that activates natural killer and killer T cells to prevent progression to muscle-invasive disease without the n
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News
- ImmunityBio Highlights ANKTIVA Surge, FDA Papillary Filing and Key 2026 Milestones at Conference [Yahoo! Finance]Yahoo! Finance
- ImmunityBio's Anktiva Could See More Upside: My Updated Thoughts On Expansion [Seeking Alpha]Seeking Alpha
- NCCN Guideline Expansion Puts ANKTIVA And ImmunityBio Growth In Focus [Yahoo! Finance]Yahoo! Finance
- ImmunityBio (IBRX) had its "buy" rating reaffirmed by D. Boral Capital. They now have a $23.00 price target on the stock.MarketBeat
- ImmunityBio Announces NCCN® Clinical Practice Guidelines in Oncology Have Been Updated to Include ANKTIVA® Plus BCG for Patients With BCG-Unresponsive NMIBC With Papillary-Only Disease [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/12/25 - Miss
IBRX
Sec Filings
- 2/26/26 - Form 4
- 2/25/26 - Form SCHEDULE
- 2/24/26 - Form 4
- IBRX's page on the SEC website