Immunitybio Inc Stock Price, News & Analysis

ImmunityBio's QUILT 3.032 trial results for N-803 plus BCG show promising efficacy for bladder cancer patients. In the carcinoma in situ cohort, 71% achieved complete response (CR) with a median duration of 26.6 months. The treatment demonstrated a 90% probability of avoiding cystectomy in responders. In the NMIBC cohort, 55% remained disease-free at 12 months. The FDA is reviewing the Biologics License Application for this combination therapy, with a decision expected by May 23, 2023. N-803's safety profile was comparable to BCG alone, indicating its potential role in treating BCG-unresponsive bladder cancer.

ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, will present at the Jefferies London Healthcare Conference in London from November 15-17, 2022. The presentation is scheduled for November 15 from 4:25–4:55 PM BST and will include a corporate presentation followed by a Q&A session. A webcast link for the presentation is available online, and a replay will be archived for 90 days. ImmunityBio is focused on developing therapies and vaccines to enhance the immune system against cancers and infectious diseases, with a clinical pipeline of 27 trials.

Faraday Future has appointed Yun Han as Chief Accounting Officer and Interim Chief Financial Officer, effective October 25, 2022. Han replaces Becky Roof, who served in the interim role until October 12, 2022. The company expects to receive $10 million this week as part of a $60 million financing agreement, following the successful acquisition of $55 million in financing. The funds will support Faraday Future’s operations and its efforts to bring the FF 91 to market. CEO Dr. Carsten Breitfeld expressed confidence in Han’s experience and the company’s growth potential.

The FDA has accepted ImmunityBio's Biologics License Application (BLA) for N-803, an IL-15 superagonist, targeting BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC). This marks a significant milestone for ImmunityBio as it is their first BLA submission. The application is supported by positive results from the QUILT 3.032 trial, where 71% of patients exhibited a complete response, with a median response duration of 26.6 months. The target action date for FDA review is May 23, 2023.

ImmunityBio has released positive data from pivotal clinical trials for treatments in bladder cancer and advanced pancreatic cancer, presented at the ASCO Annual Meeting. In bladder cancer, 71% of patients achieved a complete response, with a median duration of 26.6 months, and a 91% rate of avoiding cystectomy. In pancreatic cancer, the Nant Vaccine doubled median overall survival to 6.2 months. The company is advancing combination immunotherapy strategies and aims to launch additional trials in earlier treatment settings.

ImmunityBio, Inc. has submitted a Biologics License Application (BLA) to the FDA for N-803, a first-in-class IL-15 superagonist, combined with Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). The pivotal QUILT 3032 study showed a 71% response rate in previously untreated patients, outperforming existing therapies. If approved, this would introduce the first new immunotherapy for this condition in 23 years, potentially reducing the need for radical cystectomy.

ImmunityBio, Inc. (NASDAQ: IBRX) announced that data from its QUILT 3.032 trial for BCG-unresponsive non-muscle invasive bladder cancer will be presented at the ASCO Annual Meeting, taking place from June 3-7 in Chicago. Principal Investigator Karim Chamie, M.D., will share final clinical results of the pivotal trial involving the IL-15RαFc superagonist N-803 combined with BCG. Additionally, the QUILT 88 trial results showcasing improved survival rates in advanced pancreatic cancer patients will also be presented. ImmunityBio will exhibit at booth 26135.

ImmunityBio (NASDAQ: IBRX) has enrolled the first participants in a significant clinical trial studying its IL-15 superagonist, Anktiva, combined with Keytruda for patients with non-small cell lung cancer (NSCLC) who have not responded to prior checkpoint inhibitors. This trial, part of the Lung Cancer Master Protocol, aims to enroll 478 patients across nearly 200 U.S. sites. With lung cancer being the second most common cancer in the U.S., the results could significantly impact treatment options and patient outcomes, offering a chemotherapy-free alternative.

ImmunityBio (NASDAQ: IBRX) announced significant progress in its QUILT-3.032 clinical trial for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Over 80 subjects completed at least 12 months of follow-up, with results indicating a 71% complete response rate and a median duration of response of 26.6 months. The company plans to submit its Biologics License Application (BLA) to the FDA this month, following the achievement of Fast Track and Breakthrough Therapy Designations. This positions ImmunityBio as a promising alternative for NMIBC patients.