ImmunityBio stock jumps as FDA clears bladder cancer therapy [Seeking Alpha]
ImmunityBio, Inc. (IBRX)
Company Research
Source: Seeking Alpha
The U.S. Food and Drug Administration (FDA) approved ImmunityBio's ANKTIVA, an IL-15 agonist immunotherapy, in combination with the Bacillus Calmette-Guérin (BCG) vaccine for the treatment of patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ, with or without papillary tumors. Designated an FDA Breakthrough Therapy, the ANKTIVA works by activating the body's natural killer cells and killer T-cell immune system to attack tumor cells. The approval was based on the safety and efficacy outcome of complete responses and duration of complete response from a single-arm, multicenter trial, under which 77 evaluable patients received ANKTIVA with BCG maintenance therapy for up to 37 months. The complete response rate for the 77 evaluable patients was 62% with the upper end of the confidence interval being 73%. The duration of complete response as of the November 2023 cut-off was more than 47 months and is ongoing to date. The percentage of
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News
- Connecting the Dots of ANKTIVA's Triangle Offense: A Deep Dive with Dr. Patrick Soon-Shiong and Dr. Ashish Kamat in a Three-Part UroToday Podcast [Yahoo! Finance]Yahoo! Finance
- Connecting the Dots of ANKTIVA’s Triangle Offense: A Deep Dive with Dr. Patrick Soon-Shiong and Dr. Ashish Kamat in a Three-Part UroToday PodcastBusiness Wire
- ImmunityBio Completes GMP Drug Substance Manufacturing Sufficient for 170,000 Doses of ANKTIVA® [Yahoo! Finance]Yahoo! Finance
- ImmunityBio Completes GMP Drug Substance Manufacturing Sufficient for 170,000 Doses of ANKTIVA®Business Wire
- ImmunityBio partners with Serum Institute for BCG vaccines [Yahoo! Finance]Yahoo! Finance
IBRX
Earnings
- 5/9/24 - Miss
IBRX
Sec Filings
- 5/9/24 - Form 10-Q
- 5/3/24 - Form EFFECT
- 4/29/24 - Form DEFA14A
- IBRX's page on the SEC website