Johnson & Johnson’s (J&J) blockbuster cancer immunotherapy, Darzalex (daratumumab), has secured European approval for self-administration, marking the first time an oncology injectable has achieved this milestone on the continent. Through this Type II label change, approved by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), Darzalex will now become available to European patients for either patient or caregiver administration after the fifth dose, provided the u ...

Meetings with all four regulatory agencies scheduled to occur in the second quarter of 2026, with expected Phase 3 commencement in the third quarter of 2026 initially in Australia Commencing the Phase 3 confirmatory study is a pre-requisite to being granted a Biologics License Application (BLA) under the Accelerated Approval Program in the U.S. and Conditional Marketing Authorisations (CMAs) in the U.K. & EuropeNew York, New York--(Newsfile Corp. - March 27, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ...

ATMP benefits include access to the Conditional Marketing Authorisation accelerated market access pathway in Europe, significantly reduced user fees for small and medium-sized enterprises (SMEs), tailored regulatory assessment via Committee for Advanced Therapies (CAT) and increased pricing power New York, New York--(Newsfile Corp. - March 25, 2026) - OS Therapies, Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), the world leader in listeria-based cancer immunotherapies, today announced that t ...

Shares of biopharma outfit ImmunityBio (IBRX +11.16%) are rising firmly again today, following through on last week's effort to rekindle the erratic rally that's been underway since early January. As of 3:15 p.m. ET Monday, in fact, shares are up 11.2%, mostly in response to late last week's announcement that Macau's regulatory body has approved the company's oncology drug Anktiva® for certain forms of bladder cancer. It is believed that this approval will open the door to approvals in other countries in an ...

Core Insights - TuHURA Biosciences has appointed Dr. Craig L. Tendler as the leader of its VISTA Program in AML and other blood-related cancers, while he continues his role on the Board of Directors [1][2] - Dr. Tendler brings over 29 years of experience in drug development, having coordinated over 30 oncology regulatory approvals and 15 new medical entity approvals, contributing to more than $16 billion in global sales from multiple myeloma treatments [1][2] - The company is focused on developing TBS-2025, a VISTA inhibiting antibody, which is expected to address immunosuppressive roles in AML, particularly in NPM1 mutated cases [2][6] Company Overview - TuHURA Biosciences, Inc. is a Phase 3 immuno-oncology company that develops novel therapeutics aimed at overcoming resistance to cancer immunotherapy [4] - The company’s lead product, IFx-2.0, is designed to counter primary resistance to checkpoint inhibitors and is currently undergoing a Phase 3 trial in combination with Keytruda® for advanced Merkel Cell Carcinoma [5] - TuHURA acquired TBS-2025 through a merger with Kineta Inc. and is advancing it into Phase 2 development for mutNPM1 r/r AML [6] Leadership and Experience - Dr. Tendler previously served as Vice President of Oncology Clinical Development at Johnson & Johnson, where he was instrumental in securing global approvals for several oncology treatments [2][3] - His experience includes leading clinical diligence teams for significant acquisitions and co-development agreements in the oncology sector [2][3] - Dr. Tendler has also held academic positions and has been involved in various cancer research initiatives, enhancing his expertise in the field [3]

Core Viewpoint - SELLAS Life Sciences (SLS) has experienced a significant stock increase of 346% over the past year, reaching $5.04, as its Phase 3 REGAL trial for the WT1-targeting cancer vaccine in acute myeloid leukemia (AML) patients approaches completion with 72 of the required 80 patient deaths recorded, indicating a potentially lower-than-expected mortality rate [2][6]. Company Overview - SELLAS Life Sciences is a late-stage clinical biopharmaceutical company focused on immunotherapy for various cancers, currently at a pivotal point due to its ongoing clinical trials [5]. - The company’s stock has seen a recent pullback of 13.4% in the past week, coinciding with the anticipation of Q4 earnings [6]. Trial Progress and Implications - The REGAL trial's slower-than-expected death rate is viewed positively, suggesting that the GPS vaccine may extend long-term survival for AML patients, with only 12 deaths among 66 at-risk patients recorded [3][8]. - The Independent Data Monitoring Committee (IDMC) has cleared the trial twice without modifications, indicating that the trial's two arms remain clearly separated [14]. Institutional Interest - Institutional ownership has surged from approximately 35-72 institutions prior to the interim results to over 171 institutions as of March 2026, with notable accumulation from firms like Vanguard and BlackRock [14]. Market Sentiment - Social sentiment around SELLAS has been very bullish, with scores ranging from 78 to 88 on platforms like Reddit, driven by the trial's progress and institutional accumulation [10][11]. - Analysts have set a consensus price target of $7.83, although the stock is trading near its 52-week high of $6.14, with the final REGAL readout expected by the end of 2026 [12][13].

PHILADELPHIA and VANCOUVER, British Columbia, March 18, 2026 (GLOBE NEWSWIRE) -- BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXL) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology company developing novel immunotherapies to transform cancer care, announces that it will present four posters at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place April 17–22 at the San Diego Convention Center in San Diego, California. The presentations will include one ...

Core Insights - Anixa Biosciences is focused on cancer treatment and prevention, featuring its Chairman and CEO, Dr. Amit Kumar, on the Water Tower Research Healthcare Happenings podcast to discuss positive clinical trial data for its breast cancer vaccine and ovarian cancer CAR-T therapy [1] Company Overview - Anixa Biosciences, Inc. is a clinical-stage biotechnology company specializing in cancer treatment and prevention [1] - The company's therapeutic portfolio includes liraltagene autoleucel (lira-cel), an ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center, utilizing a novel CAR-T technology [1] - Anixa's vaccine portfolio includes vaccines for breast and ovarian cancer developed with Cleveland Clinic, as well as additional vaccines targeting high incidence malignancies in lung, colon, and prostate cancers [1] Technology and Collaboration - The CAR-T technology used by Anixa is differentiated by its mechanism, where the natural ligand of the FSHR receptor binds to tumor cells instead of using an antibody fragment [1] - Anixa partners with renowned research institutions to explore emerging technologies for further development and commercialization [1] Financial and Future Outlook - Dr. Kumar discussed the financial condition of the company and future plans during the podcast, indicating a focus on advancing their clinical programs [1]

Core Insights - Anixa Biosciences has received a Notice of Allowance for a patent from the Korean Ministry of Intellectual Property for its breast cancer vaccine technology, marking the first Korean patent for this platform [1] - The patent, titled "Vaccine Adjuvants and Formulations," provides composition of matter protection and is expected to enhance Anixa's global intellectual property portfolio [1] - The company aims to leverage this patent to pursue international commercialization opportunities and potential partnerships with larger pharmaceutical firms [1] Patent and Technology - The newly allowed patent reinforces Anixa's leadership in cancer immunotherapy and complements existing patents in the United States and other jurisdictions [1] - The breast cancer vaccine technology is based on immunizing against human -lactalbumin, a protein associated with lactation, which is aberrantly expressed in certain breast cancer types [1] - Anixa's vaccine has shown promising results in a Phase 1 clinical trial, meeting all major primary endpoints and generating immune responses in 74% of participants [1] Market Context - Breast cancer incidence rates are rising in South Korea, with a notable trend of earlier onset compared to Western nations [1] - Breast cancer remains the most commonly diagnosed cancer among women globally, and there are currently no approved vaccines for its prevention [1] - Anixa's approach aims to transform cancer prevention strategies, particularly for aggressive forms like triple-negative breast cancer [1] Company Overview - Anixa is a clinical-stage biotechnology company focused on cancer treatment and prevention, with a portfolio that includes an ovarian cancer immunotherapy developed in collaboration with Moffitt Cancer Center [1] - The company partners with renowned research institutions to develop vaccines targeting various cancers, including breast and ovarian cancer [1] - Anixa's business model emphasizes collaboration at all stages of development, allowing for the exploration of emerging technologies in complementary fields [1]

Core Insights - INOVIO and Akeso have announced a clinical collaboration to evaluate a novel combination therapy for glioblastoma (GBM), which includes INO-5412 and cadonilimab [1][2] - The combination therapy will be part of the INSIGhT Phase 2 adaptive platform trial, aiming to find new treatments for GBM [1][2] - Dosing for the trial is expected to begin in the second half of 2026 [1] Company Overview - INOVIO is focused on developing DNA medicines for cancer and infectious diseases, utilizing proprietary technology for the design and delivery of its therapies [2] - Akeso is a biopharmaceutical company committed to innovative biological medicines, with a robust pipeline of over 50 assets in various disease areas, including cancer [2] Treatment Details - INO-5412 combines INO-5401 and INO-9012, showing potential for enhanced immune responses and improved patient outcomes when used with checkpoint inhibitors [1][2] - Cadonilimab is a first-in-class PD-1/CTLA-4 bispecific antibody, already approved in China for multiple cancer indications, demonstrating effectiveness regardless of PD-L1 expression [1][2] Clinical Trial Insights - The INSIGhT trial is designed to test multiple investigational therapies simultaneously, with the collaboration between INOVIO and Akeso focusing on the safety and efficacy of the combination therapy in patients with confirmed GBM [1][2] - GBM has a poor prognosis, with a median overall survival of approximately 15 months for patients receiving standard care [2] Market Context - The estimated annual incidence of GBM in the U.S. is 11,362 cases, highlighting the significant unmet medical need in this area [2] - The collaboration aims to leverage the strengths of both companies to address the challenges of treating this aggressive form of brain cancer [1][2]