FDA Approves ImmunityBio's Bladder Cancer Drug, Stock Rallies [Yahoo! Finance]
ImmunityBio, Inc. (IBRX)
Company Research
Source: Yahoo! Finance
BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors The drug is combined with the BCG vaccine, mainly used against tuberculosis and as a common treatment for some forms of bladder cancer. Last year in May, the FDA issued a complete response letter to Anktiva plus BCG treatment, citing deficiencies related to the FDA's pre-license inspection of the company's third-party contract manufacturing organizations “The FDA's approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. The company says Anktiva is a first-in-class IL-15 agonist immunotherapy for NMIBC and received FDA Breakthrough Therapy Designation and approval based on the safety and efficacy outcome of complete responses (CR) and duration of complete response (DOR). The CR rate for the 77 evaluabl
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IBRX
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