SEC Form 10-K filed by ImmunityBio Inc.
$IBRX
Biotechnology: Biological Products (No Diagnostic Substances)
Health Care
Unavailable
Unavailable
Save time and jump to the most important pieces.
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 3/6/2025 | $8.00 | Buy | H.C. Wainwright |
| 1/10/2025 | $6.00 | Buy | BTIG Research |
| 5/12/2023 | $10.00 → $4.00 | Overweight → Neutral | Piper Sandler |
| 8/3/2022 | $8.00 | Buy | Jefferies |
ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced that the Company received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for the supplemental biologics license application (sBLA) for use of ANKTIVA plus Bacillus Calmette-Guerin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. This RTF letter was received despite reaching unanimous guidance and encouragement at the in-person January 2025 meeting from the leadership of the Agency, including from CBER, CDER and OCE to submit this sBLA. At this meeting all key decision makers were specifically asked and unanimously confirmed
CIS with or without Papillary: Oral presentation from QUILT-3.032 study showed 71% complete response rate (N=100), with duration of response ranging up to more than 53 months, in BCG-unresponsive NMIBC CIS with or without papillary disease Probability of duration of complete response of at least 45 months in the FDA label population (N=77) is 51%, with median duration of complete response of 45.4 months Cystectomy avoidance rate in responders of 84% at 36 months Disease-specific overall survival rate of 99% at 36 months Longest follow-up of BCG-unresponsive CIS patients with unmatched more than 5 years data available (as of July 2024 data cutoff) Papillary without CIS: Disease
Oral presentation provides update from QUILT-3.032 on durable complete responses to ANKTIVA® plus BCG in BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ (NMIBC CIS) with or without Ta/T1 papillary disease and papillary disease alone ImmunityBio to present keynote events on NMIBC and experience in prostate cancer, unveiling lymphopenia, the Absolute Lymphocyte Count (ALC) biomarker for all tumor types, and the ‘Cancer BioShield' Supplemental Biologics License Application for BCG unresponsive NMIBC for papillary disease alone submitted to the FDA Updates to be provided on status of Expanded Access Authorization of ANKTIVA as a BioShield ImmunityBio, Inc. ((IBRX)
H.C. Wainwright initiated coverage of ImmunityBio with a rating of Buy and set a new price target of $8.00
BTIG Research initiated coverage of ImmunityBio with a rating of Buy and set a new price target of $6.00
Piper Sandler downgraded ImmunityBio from Overweight to Neutral and set a new price target of $4.00 from $10.00 previously
4 - ImmunityBio, Inc. (0001326110) (Issuer)
4 - ImmunityBio, Inc. (0001326110) (Issuer)
4 - ImmunityBio, Inc. (0001326110) (Issuer)
8-K - ImmunityBio, Inc. (0001326110) (Filer)
DEFA14A - ImmunityBio, Inc. (0001326110) (Filer)
DEF 14A - ImmunityBio, Inc. (0001326110) (Filer)
SC 13D/A - ImmunityBio, Inc. (0001326110) (Subject)
SC 13D/A - ImmunityBio, Inc. (0001326110) (Subject)
SC 13D/A - ImmunityBio, Inc. (0001326110) (Subject)
ImmunityBio, Inc. ((IBRX) today announced its financial results for the third-quarter ended September 30, 2024. ANKTIVA® received a J-code (HCPCS Level II Code) in October 2024, effective January 1, 2025. ANKTIVA (FDA-approved and commercially available in the U.S. since May 2024) is now widely accessible to patients through commercial and government insurance programs (VA, DoD, Medicare). ImmunityBio has secured coverage for over 200 million medical lives through medical reimbursement policies. ImmunityBio achieved a net product revenue of approximately $6.0 million during the three months ended September 30, 2024, surpassing net product revenue of $1.0 million in the prior quarte
Dr. Sam S. Chang, Professor of Urology at Vanderbilt Cancer Program, to host the program "A Deep Dive with Patrick Soon-Shiong: Next-Generation Immunotherapy for NMBIC" Discussion about the basis for ANKTIVA's Breakthrough Therapy designation and the novel mechanism of how the IL-15 superagonist achieves durable complete responses in BCG unresponsive NMIBC The Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio, Inc. ((IBRX), a next-generation immunotherapy company, will discuss the implications of the recent FDA approval of ANKTIVA® (nogapendekin alfa inbakicept-pmln) for use in combination with bacillus Calmette-Guerin (BCG) for non-muscle invasive bl
QUILT 3.055 trial completed and shows median overall survival almost double that of standard of care chemotherapy in 2nd- and 3rd-line non-small cell lung cancer (NSCLC) patients whose cancer did not respond to checkpoint inhibitors with or without chemotherapy Positive results seen in both PD-L1 negative and PD-L1 positive participants with NSCLC Data reaffirms the mechanism of action of ANKTIVA as an immune cell enhancer that activates natural killer (NK) cells and memory T cells to rescue checkpoint inhibitor (pembrolizumab, nivolumab, atezolizumab) failures across multiple tumor types Meeting scheduled with FDA in June to discuss path to registration filing of ANKTIVA plus che
ImmunityBio, Inc. ((IBRX) announced today that its 2024 Annual Meeting of Stockholders will be held on Tuesday, June 11, 2024 at 9:30 a.m. Pacific Time. The Annual Meeting will be held in a virtual-only format and there will not be a physical location for the Annual Meeting. Stockholders of record at the close of business on April 17, 2024 are entitled to vote at and participate in the Annual Meeting. Richard Adcock, the Company's Chief Executive Officer and President, will provide a business update after the formal business of the Annual Meeting has ended. All interested parties are welcome to attend the Annual Meeting and listen to the Company update. Non-stockholders can attend the vir
- Yun Han named Chief Accounting Officer and Interim Chief Financial Officer - - Initial Funding Expected This Week Under $60 Million Financing Agreement - Faraday Future Intelligent Electric Inc. ("Faraday Future" or the "Company") (NASDAQ:FFIE), a California-based global shared intelligent electric mobility ecosystem company, today announced the appointment of Yun Han as Chief Accounting Officer and Interim Chief Financial Officer, effective October 25, 2022. Ms. Han replaces Becky Roof, who served as interim Chief Financial Officer until October 12, 2022, and is assisting the Company to ensure an orderly transition. This press release features multimedia. View the full release here: htt
Biopharma leaders bring proven market development talents in urology and oncology to bolster company's commercialization plan and long-term growth plans Helen Luu, former CEO of Cell BT, is named ImmunityBio's first Chief Commercial Officer and brings a strong background in product commercialization in the urology market, business development, sales growth, and oncology market expansion. Sigrid Schreiner joins as Senior Vice President of Global Market Access, adding decades of market access experience to the leadership team, including the market launch of chemotherapy Abraxane®. ImmunityBio, Inc. (NASDAQ:IBRX), a clinical-stage immunotherapy company, today announced two key executive