CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that the Saudi Food and Drug Authority (SFDA) has granted approval of ANKTIVA® (nogapendekin alfa inbakicept) plus Bacillus Calmette-Guérin (BCG) for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ, with or without papillary disease. This regulatory action by the SFDA adds to the existing approvals in the Uni. ...

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgency to invest now [1][13] - The energy demands of AI technologies are significant, with data centers consuming as much energy as small cities, leading to concerns about power grid strain and rising electricity prices [2][3] Investment Opportunity - A specific company is highlighted as a critical player in the AI energy sector, owning essential energy infrastructure assets that are poised to benefit from the increasing energy demands of AI [3][7] - This company is not a chipmaker or cloud platform but is positioned to profit from the surge in electricity demand driven by AI data centers [3][6] Market Position - The company is described as a "toll booth" operator in the AI energy boom, collecting fees from energy exports and benefiting from the onshoring trend due to tariffs [5][6] - It has a unique footprint in nuclear energy, which is crucial for America's future power strategy, and is capable of executing large-scale engineering projects across various energy sectors [7][8] Financial Health - The company is noted for being debt-free and holding a significant cash reserve, amounting to nearly one-third of its market capitalization, which positions it favorably compared to other energy firms burdened by debt [8][10] - It also has a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth opportunities without the associated premium [9][10] Market Sentiment - There is a growing interest from Wall Street in this company, as it is seen as undervalued and capable of delivering real cash flows while being tied to the booming AI and energy sectors [8][10] - The company is trading at less than 7 times earnings, making it an attractive investment option in the current market landscape [10]

Industry Overview - The biotech and drug industry experienced a significant rebound in 2025 after a cautious start, driven by drug pricing agreements and increased M&A activity [1] - The FDA approved 44 novel therapies in 2025, with 26 approvals occurring in the second half of the year, indicating an acceleration in regulatory activity [1][2] Company Analysis: Altimmune (ALT) - Altimmune is focused on developing therapies for liver diseases, with its lead candidate pemvidutide currently in mid-stage studies for metabolic dysfunction-associated steatohepatitis (MASH) [4] - Shares of Altimmune have decreased over 46% year-to-date due to mixed results from the phase IIb IMPACT study, although it met one primary endpoint related to MASH resolution [5] - Recent 48-week results from the IMPACT study showed further improvements in non-invasive tests and significant reductions in liver health biomarkers [6] - Altimmune plans to initiate a late-stage study for pemvidutide in MASH in 2026 after aligning with the FDA on key parameters [7] - The company is also exploring pemvidutide for alcohol use disorder and alcohol-associated liver disease, with data expected next year [8] Company Analysis: ImmunityBio (IBRX) - ImmunityBio focuses on therapies for cancer and infectious diseases, with its marketed drug Anktiva approved for bladder cancer [11] - Shares of ImmunityBio have declined over 16% this year due to a regulatory setback from the FDA regarding a label expansion for Anktiva [12] - Despite the setback, Anktiva generated nearly $75 million in sales this year, a significant increase from $7 million in the previous year, and the company is seeking EU market expansion [13] - ImmunityBio is also developing Anktiva for other cancer indications, with promising data in non-small cell lung cancer and glioblastoma expected to be updated in 2026 [14] - Loss per share estimates for 2026 have improved from $0.37 to $0.33 in the past 60 days [15] Company Analysis: Seres Therapeutics (MCRB) - Seres Therapeutics is developing SER-155, an oral live biotherapeutic aimed at preventing bloodstream infections in patients undergoing stem cell transplantation [16] - Investor interest in SER-155 increased after a phase Ib study showed a 77% relative reduction in bacterial infections compared to placebo [17] - The FDA has provided positive feedback for SER-155's advancement to mid-stage development, with an interim update expected within 12 months of study initiation [18] - Shares of Seres Therapeutics have decreased nearly 12% year-to-date, but loss per share estimates for 2026 have improved from $10.66 to $7.67 in the past 60 days [18]

CULVER CITY, Calif.--(BUSINESS WIRE)--ImmunityBio, Inc. (NASDAQ: IBRX), a commercial-stage immunotherapy company, today announced that OncoDaily has recognized Dr. Patrick Soon-Shiong as being one of "The 100 Most Influential People in Oncology in 2025.†Soon-Shiong is the company's Founder, Executive Chairman and Global Chief Scientific and Medical Officer, and is a global thought leader in advancing the goal of a cancer-free society. On its website announcing the honor, OncoDaily highlighted. ...

I have been investing in the stock market since I was 17 years old, and over the 25+ years since I have learned the joy of compounding, the value of dividend reinvesting, and the principle that patient investing through good times and bad brings the greatest rewards. I believe the key to creating wealth is the slow accumulation of high quality assets, and the key to enjoying the process of investing is to mix this steady approach with some high risk/high reward opportunities, underappreciated turnaround pla ...

Industry Overview - The global oncology market is evolving significantly due to rising cancer incidence and rapid scientific advancements, with the American Cancer Society estimating approximately 2.04 million new cancer diagnoses and over 618,000 cancer-related deaths in the U.S. by 2025 [2] - Aging populations and lifestyle-related risk factors are contributing to higher cancer prevalence, leading to sustained growth in healthcare spending on oncology [2] Innovation in Cancer Care - Breakthroughs in immunotherapies, targeted treatments, and personalized vaccines are expanding therapeutic options beyond conventional chemotherapy and radiation [3] - Immune-based strategies, including checkpoint inhibitors and CAR-T therapies, are harnessing the body's immune system to target tumors, while targeted therapies focus on specific genetic alterations [3] - Emerging technologies like genomic sequencing, AI, and machine learning are enhancing biomarker discovery and supporting earlier diagnosis, improving survival rates and quality of life across several cancer types [4] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, Johnson & Johnson (J&J), Pfizer, AbbVie, Merck, Bristol Myers Squibb, and Eli Lilly, are investing aggressively in oncology portfolios with new therapies such as antibody-drug conjugates and bispecific antibodies [5] - Smaller biotech firms are also crucial in driving innovation through partnerships, licensing agreements, and acquisitions [5] Market Dynamics - Oncology is considered one of the most durable and attractive segments within the global healthcare sector for long-term investors, supported by ongoing innovation and favorable reimbursement dynamics [6] Company Focus: Johnson & Johnson - J&J's oncology segment currently accounts for approximately 27% of its total revenues, with oncology sales rising 20.6% to $18.52 billion in the first nine months, driven by key products like Darzalex and Erleada [9] - J&J's oncology pipeline has gained momentum with promising developments in colorectal and head and neck cancers, and the company expects its oncology sales to reach $50 billion by the end of the decade [10][12] - J&J is also enhancing its oncology pipeline through M&A, including a recent agreement to acquire Halda Therapeutics [11] Company Focus: ImmunityBio - ImmunityBio's lead drug, Anktiva, was approved for treating BCG-unresponsive non-muscle invasive bladder cancer, generating $74.7 million in sales with a 467% increase in volume [13] - The drug is under review in the EU, and ImmunityBio is evaluating Anktiva for expanded use in other cancer indications [15] Company Focus: Foghorn Therapeutics - Foghorn Therapeutics is developing precision therapies targeting genetically driven vulnerabilities, with a collaboration with Lilly to co-develop its selective SMARCA2 oncology program [17] - Foghorn's lead candidate, FHD-909, is advancing in a phase I study for SMARCA4-mutated cancers, with initial data expected in 2026 [17][18]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] Investment Opportunity - A specific company is highlighted as a potential investment opportunity, possessing critical energy infrastructure assets that are essential for meeting the increasing energy demands of AI data centers [3][7] - This company is not a chipmaker or cloud platform but is positioned to benefit significantly from the anticipated surge in electricity demand driven by AI technologies [3][6] Energy Demand and Infrastructure - AI technologies, particularly large language models like ChatGPT, are extremely energy-intensive, with data centers consuming as much energy as small cities [2] - The company in focus is involved in nuclear energy infrastructure, which is crucial for America's future power strategy, and is capable of executing large-scale engineering, procurement, and construction projects across various energy sectors [7][8] Financial Position - The company is noted for being completely debt-free and holding a substantial cash reserve, amounting to nearly one-third of its market capitalization, which positions it favorably compared to other energy firms burdened with debt [8] - It is trading at less than 7 times earnings, indicating a potentially undervalued investment opportunity in the context of its critical role in the AI and energy sectors [10] Market Trends - The company is expected to benefit from the onshoring trend driven by tariffs, as well as the surge in U.S. LNG exports under the current administration's energy policies [5][14] - There is a growing recognition on Wall Street of this company's potential, as it quietly capitalizes on multiple favorable market trends without the high valuations typical of many tech stocks [8][9] Future Outlook - The influx of talent into the AI sector is anticipated to drive continuous innovation and advancements, making investments in AI infrastructure increasingly attractive [12] - The overall narrative suggests that investing in this company represents a strategic move to capitalize on the intersection of AI and energy, with the potential for significant returns in the near future [15][19]

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgency to invest in AI technologies now [1][13] - The energy demands of AI technologies are highlighted, with data centers consuming as much energy as small cities, leading to concerns about power grid strain and rising electricity prices [2][3] Investment Opportunity - A specific company is presented as a critical player in the AI energy sector, owning essential energy infrastructure assets that are poised to benefit from the increasing energy demands of AI [3][7] - This company is described as a "toll booth" operator in the AI energy boom, collecting fees from energy exports and positioned to capitalize on the onshoring trend driven by tariffs [5][6] Financial Position - The company is noted for being debt-free and holding a significant cash reserve, amounting to nearly one-third of its market capitalization, which positions it favorably compared to other energy firms burdened by debt [8][10] - It also has a substantial equity stake in another AI-related company, providing investors with indirect exposure to multiple growth opportunities in the AI sector [9] Market Trends - The article discusses the broader trends of AI, energy, tariffs, and onshoring, emphasizing the interconnectedness of these factors and the company's strategic positioning within this landscape [6][14] - The influx of talent into the AI sector is mentioned, indicating a continuous stream of innovation and advancements that will drive future growth [12] Call to Action - The article encourages investors to act quickly to capitalize on the potential for significant returns, suggesting that the company is undervalued and presents a unique opportunity in the AI and energy markets [15][19]

Core Insights - ImmunityBio Inc. (NASDAQ:IBRX) has received authorization from the European Medicines Agency (EMA) to sell its bladder cancer treatment Anktiva in Europe, leading to a 7.76% increase in stock price to $2.36 [1][2] Group 1: Product Authorization and Market Expansion - The EMA has officially authorized Anktiva, in combination with Bacillus Calmette-Guerin (BCG), for the treatment of non-muscle invasive bladder cancer (NMIBC) carcinoma in situ, allowing ImmunityBio to expand its sales and operations across Europe [2] - Anktiva is expected to benefit bladder cancer patients whose disease does not respond to BCG, as there are currently no other treatment options available except for surgical removal of the bladder [3] Group 2: Competitive Advantage in Europe - Unlike the US, where only one BCG substrain is approved, Europe recognizes approximately six major BCG substrains, making standard-of-care therapy more broadly available across the region [4] - ImmunityBio's Executive Chairman Patrick Soon-Shiong emphasized that Anktiva represents an important evolution in the treatment of NMIBC CIS, enhancing the immune response and improving the durability of BCG [4] Group 3: Patient Access and Future Goals - Hundreds of patients in the US are already benefiting from Anktiva, and the company aims to make it available to patients in Europe and other regions as quickly and responsibly as possible to avoid radical cystectomy [5] - The EMA's positive recommendation was based on a single-arm trial, highlighting the importance of immediate availability of the medicine to patients [6]

Core Viewpoint - The European Medicines Agency (EMA) has recommended conditional marketing authorization for ImmunityBio's Anktiva in combination with BCG for treating BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) [1][4]. Group 1: Clinical Trial Results - A single-arm clinical trial involving 100 adults showed a complete response rate of 71%, with responses lasting up to 54+ months and an average duration of approximately 27 months [2]. - The complete response rates at 12 months and 24 months were 66% and 42%, respectively [3]. Group 2: Regulatory and Market Context - The conditional marketing authorization is part of an EU regulatory mechanism aimed at providing early access to medicines for unmet medical needs [4]. - Bladder cancer is the fifth-most common cancer and the seventh most frequently diagnosed cancer in men, with an estimated 200,000 new cases expected in 2025 [4]. - Approximately 75% of these patients (150,000) will have NMIBC, which is the most common form of bladder cancer [5]. Group 3: Next Steps and Market Reaction - ImmunityBio will continue to follow up with trial participants and submit long-term safety and efficacy results to the EMA post-marketing [3]. - Following the EMA's recommendation, the opinion will be forwarded to the European Commission for final approval of EU-wide marketing authorization [6]. - ImmunityBio's shares increased by 2.74% to $2.25 at the time of publication [6].