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)

 Company to Provide Regulatory, Sales, and Platform Updates at Investor Day including: In Q1, the company submitted a supplemental Biologics License Application (sBLA) for use of ANKTIVA® plus Bacillus Calmette-Guérin (BCG) in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) for the indication of papillary disease. In Q2, the company submitted to the U.S. Food and Drug Administration (FDA) an Expanded Access Protocol (EAP) for ANKTIVA for the treatment of lymphopenia as a BioShield against the adverse effects of chemotherapy, radiation and checkpoint inhibitors, following authorization of a Regenerative Medicine Advanced Therapy (RMAT) designation for this indication in Q1.

ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced that it has executed financing to provide further working capital and support its ongoing business operations. The Company entered into a securities purchase agreement for a registered direct offering with a single institutional investor, providing for the issuance of common stock of ImmunityBio as well as warrants for the purchase of additional shares of common stock of ImmunityBio that is expected to result in gross proceeds at closing of approximately $75 million before deducting any offering-related expenses, subject to customary closing conditions. If fully exercised, the warrants could result in additional gro

ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced details about its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company's business operations, U.S. and global regulatory advances of its clinical-stage products, with fireside chats hosted by Dr. Patrick Soon-Shiong and key opinion leaders involved in the company's research programs. The discussions will include clinical and regulatory updates on the company's bladder cancer program, regenerative medicine advanced therapy (RMAT) designations, including results on non-small cell lung cancer (NSCLC) and metastatic pancreatic cancer tri

ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, invites current and prospective investors to its Investor Day program to be held on Tuesday, April 15, 2025, at 10:00 am PDT. The program will include an in-depth update on the company's business operations and recent R&D advancements. Key timelines for catalysts of product candidates will be presented, along with a discussion of ongoing clinical trials. "ImmunityBio commenced 2025 with notable scientific and business milestones," said Richard Adcock, President and CEO of ImmunityBio. "With a promising future ahead, we are eager to engage with our investors and share the reasons we're optimistic and excited about the company's gro

U.S. Urology Partners is one of the first providers to offer patients ImmunityBio's recombinant Bacillus Calmette-Guérin (rBCG) The FDA recently authorized ImmunityBio's EAP for rBCG to address U.S. shortages and provide an alternative source of BCG, a critical standard-of-care in bladder cancer Multiple urology centers across the U.S. are in the process of activating their sites to administer rBCG ImmunityBio, Inc. ((IBRX), a leading immunotherapy company, today announced U.S. Urology Partners, one of the nation's largest independent providers of urology and related specialty services, is one of the first providers to participate in ImmunityBio's Expanded Access Program (EAP) for re

With a permanent J-code (J9028) awarded in January 2025, ImmunityBio's February 2025 ANKTIVA® unit sales volume grew 97% over unit sales volume in December 2024 ANKTIVA sales momentum continues to trend upward quarter to date 2025, with sales volume in February representing a 67% increase month-over-month from January Sales volume in the 2 months in 2025 to date shows a 69% increase over the sales volume in the 2 months prior (November and December 2024) and already exceeds the total units for all of Q4 2024 For the three-month period ending December 31, 2024 prior to permanent J-code approval, ImmunityBio achieved net product revenue of approximately $7.2 million, surpassing net

Regenerative Medicine Advanced Therapy (RMAT) designation follows clinical data of Absolute Lymphocyte Count (ALC) and significant Overall Survival (OS) correlations in QUILT trials across multiple tumor types, including third line or greater metastatic pancreatic cancer, checkpoint relapsed NSCLC, and supportive data from healthy volunteers The reversal of lymphopenia by ImmunityBio's IL-15 superagonist is consistent with the mechanism of action of ANKTIVA demonstrating proliferation and activation of NK cells, CD4+ T cells, CD8+ T cells and memory T cells without upregulation of suppressive T regulatory cells and approved in the ANKTIVA label Company intends to submit Biologic Lice

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

Jefferies initiated coverage of ImmunityBio with a rating of Buy and set a new price target of $8.00

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

Dr. Soon-Shiong's priority will be to continue to align scientific and medical goals that are focused on the delivery of cutting-edge therapeutics for patients. The role connects Dr. Soon-Shiong's long-time expertise, track record and innovative thinking as a clinician scientist directly with the company's talented research/discovery, clinical development, and medical teams. The new position is in addition to Dr. Soon-Shiong's existing role as the company's Executive Chairman of the Board. ImmunityBio, Inc. (NASDAQ:IBRX), a clinical-stage immunotherapy company, appointed Patrick Soon-Shiong, M.D., to the newly created role of Global Chief Scientific and Medical Officer, effective as

​Ambrx (NYSE:AMAM), a clinical stage biopharmaceutical company using an expanded genetic code technology platform to create Engineered Precision Biologics, today announced the appointment of Sonja Nelson to Chief Financial Officer. "I am delighted to welcome Sonja to Ambrx as we expand our executive team, in light of our ongoing expansion," said Feng Tian, Ph.D., Chairman of the Board, President and CEO of Ambrx. "Sonja brings a breadth of experience in financial operations, planning and strategy from within the biotechnology industry. Her arrival at Ambrx solidifies the company's management team, and I look forward to leaning on her experience as we transition into the next stages of our

FORT LAUDERDALE, Fla., June 23, 2021 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ:MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions that improve clinical outcomes and enhance the cost-efficiency associated with the diagnosis and management of gastrointestinal conditions, announced the appointment of Sonja Nelson, CPA to the Company's Board of Directors and as Chair of the Audit Committee. Ms. Nelson brings more than 25 years of financial and operational leadership and expertise in biotechnology, diagnostics, and biopharmaceuticals markets, including playing an integral role in the successful merger between NantKwest, Inc. (NASDAQ:NK) an

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, today announced the appointment of health innovation expert and executive Linda Maxwell, M.D., MBA, as an independent member of the company’s board of directors. The company also appointed CEO Richard Adcock to the board; he was named CEO of NantKwest in October and remains the CEO of the company after the merger of NantKwest with ImmunityBio in March. Both appointments are effective March 29, 2021. The nine-member ImmunityBio board is led by Founder and Executive Chairman Patrick Soon-Shiong, M.D. The board includes two other recently appointed outside members, former

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

Designated an FDA Breakthrough Therapy, the novel immunotherapy ANKTIVA activates the body's natural killer (NK) and killer T-cell immune system to attack tumor cells Therapy stimulates memory T cells, leading to long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet to be determined The percentage of patients with durable responses at 12 and 24 months exceeded the benchmark for magnitude of clinically meaningful results established by experts at the International Bladder Cancer Group (IBCG) ANKTIVA in combination with BCG is approved for maintenance therapy for up to 37 months with tolerable side effects ranging from 0%

EMERYVILLE, Calif., Nov. 8, 2021 /PRNewswire/ -- Amyris, Inc. (NASDAQ:AMRS), a leading synthetic biotechnology company accelerating the world to sustainable consumption through its Lab-to-MarketTM operating platform, today announced financial results for its third quarter ended September 30, 2021. "Amyris delivered another strong quarter along with solid strategic execution amid challenging external global supply chain conditions," said John Melo, President and Chief Executive Officer. "Once again, we realized record underlying revenue and record consumer revenue demonstrating