ImmunityBio Inc. (NASDAQ:IBRX) stock is up during Wednesday’s premarket session as the company is gaining attention following the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for ANKTIVA in combination with Bacillus Calmette-Guerin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
IBRX Jumps After FDA Accepts ANKTIVA sBLA For NMIBC
The FDA has accepted ImmunityBio’s sBLA for ANKTIVA, which is aimed at expanding treatment options for patients with BCG-unresponsive NMIBC.
The FDA assigned a PDUFA target action date of Jan. 6, 2027, indicating a significant step forward for the company’s product pipeline.
The supplemental application is supported by data from the QUILT 3.032 Phase 2/3 trial in 80 patients. The study met its primary endpoint with a 12-month disease-free survival (DFS) rate of 58.2%.
ANKTIVA plus BCG with BCG unresponsive non-muscle invasive bladder cancer and papillary disease alone demonstrated:
- 94.9% at 12 months and 82.0% at 36 months, indicating durable prevention of progression to muscle-invasive disease.
- Bladder preservation remained high, with cystectomy-free survival of 92.2% at 12 months and 83.1% at 36 months.
- Over 80% of patients avoided radical cystectomy through three years of follow-up.
- 96.0% Disease-Specific Survival (DSS) rate at 36 months, with median DSS not yet reached at the time of submission of the application
ANKTIVA plus BCG was previously approved by the FDA in April 2024 for adult patients with BCG-unresponsive NMIBC with carcinoma in situ (CIS), with or without papillary tumors.
How ImmunityBio (IBRX) Ranks On Momentum And Performance
Below is the Benzinga Edge scorecard for ImmunityBio, highlighting its strengths and weaknesses compared to the broader market:
- Momentum: Bullish (Score: 98.15) — Stock is outperforming the broader market.
The Verdict: ImmunityBio’s Benzinga Edge signal reveals a strong momentum-driven story, indicating that the stock is currently outperforming its peers.
IBRX ETF Exposure: Funds With The Biggest Stakes
- Virtus LifeSci Biotech Products ETF (NYSE:BBP): 4.03% Weight
- Clough Select Equity ETF (NYSE:CBSE): 2.84% Weight
- Roundhill Meme Stock ETF (NYSE:MEME): 9.91% Weight
IBRX Stock Price Activity: ImmunityBio shares were up 8.12% at $8.39 during premarket trading on Wednesday, according to Benzinga Pro data.
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