STAFFORD, Texas, Feb. 24, 2026 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today announced that two abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2026, including two corresponding posters. The ...

Core Insights - ImmunityBio, Inc. is focused on developing innovative immunotherapy treatments, with its flagship product Anktiva playing a crucial role in treating cancers unresponsive to traditional therapies [1] - The company has a market capitalization of approximately $9.57 billion, reflecting its growth potential and market confidence in its cancer treatment solutions [5] Financial Performance - H.C. Wainwright set a price target of $15 for IBRX, indicating a potential upside of 54.56% from its current price of $9.71 [2][6] - Anktiva reported a remarkable 700% sales increase in 2025 and a 20% quarter-over-quarter growth in the fourth quarter [3][6] - Despite a negative earnings per share of $0.06, the company has shown profitability improvement for three consecutive quarters, contributing to a stock price increase of five times in 2026 [3] Product and Market Strategy - The Cancer BioShield platform and Anktiva biologic product are key to ImmunityBio's strategy, stimulating natural killer cells, cytotoxic T cells, and memory T cells to help patients combat various cancers [4] - The majority of revenue comes from U.S. sales of Anktiva, particularly for bladder cancer cases unresponsive to Bacille Calmette-Guérin treatment [4]

ImmunityBio Inc. (NASDAQ:IBRX) shares are up on Monday following the company’s announcement of significant revenue growth. • ImmunityBio stock is challenging resistance. Why are IBRX shares at highs?The stock has jumped around 55% over the last month, thanks to investor interest after preliminary earnings and several strategic partnerships.The company’s lead drug, Anktiva, is approved in the U.S. and several international markets for BCG-unresponsive NMIBC with carcinoma in situ.700% Sales JumpImmunityBio r ...

Investor Day February 23rd, 2026 MoonLake Immunotherapeutics © 2026 | Proprietary | MoonLake TX Welcome to our Investor Day Date: February 23rd, 2026 Time: 8.00 am EST Agenda | Topic | Sub-topics | Speaker | Timing | | --- | --- | --- | --- | | Introduction | Welcome | Matthias | 10 mins | | | MLTX & SLK summary | | | | | Key points for the session | | | | axSpA update | axSpA market update | Kristian | 20 mins | | | S-OLARIS program overview | | | | | Efficacy & safety overview | | | | HS and FDA | FDA upd ...

Core Viewpoint - CStone Pharmaceuticals has received a new indication approval from the UK MHRA for sugemalimab as a monotherapy for adult patients with unresectable stage III NSCLC, expanding its therapeutic applications and commercial potential globally [1][4]. Group 1: Product Approval and Indications - Sugemalimab is now approved as a monotherapy for adult patients with unresectable stage III NSCLC with PD-L1 expression on 1% of tumor cells and no sensitizing EGFR mutations or ALK, ROS1 genomic aberrations [1][5]. - The approval is based on the GEMSTONE-301 study, which showed statistically significant improvement in progression-free survival (PFS) and clinically meaningful prolongation of overall survival (OS) for patients with stage III NSCLC [4]. Group 2: Market Expansion and Commercialization - Sugemalimab has become one of only two PD-(L)1 antibodies approved for stage III NSCLC in Europe since its initial EU approval in July 2024, with a commercial footprint now extending to over 60 countries and regions [2][4]. - The product has been included in multiple national reimbursement systems, indicating its recognized clinical value and pharmacoeconomic benefit [2]. Group 3: Future Development and Regulatory Strategy - CStone plans to advance regulatory filings for sugemalimab in additional indications, including gastric cancer and esophageal squamous cell carcinoma [2]. - The company has established four commercialization partnerships for sugemalimab across Europe, the Middle East, Africa, and Latin America, actively rolling out its global commercial strategy [4]. Group 4: Company Overview - CStone Pharmaceuticals, established in late 2015, focuses on the research and development of therapies for oncology and other key disease areas, having launched 4 innovative drugs and secured approvals for 20 new drug applications covering 9 indications [6]. - The company's pipeline includes 16 promising candidates, featuring potentially first-in-class or best-in-class antibody-drug conjugates, multispecific antibodies, immunotherapies, and precision medicines [6].

Company Overview - Arcellx is a clinical-stage biotechnology company focused on proprietary cell therapy platforms to address unmet medical needs in oncology [5] - The company has a specialized pipeline targeting multiple myeloma and hematologic malignancies, positioning itself at the forefront of next-generation immunotherapies [5] - As of February 17, 2026, Arcellx's market capitalization is $4.06 billion, with a revenue of $35.90 million and a net income of -$217.90 million [4] Recent Developments - Perceptive Advisors disclosed a sale of 1,002,282 shares of Arcellx, valued at approximately $79.96 million, during the fourth quarter of 2026 [2][1] - The quarter-end value of Arcellx's position declined by $107.06 million, reflecting both the share reduction and share price movements [2] - Arcellx shares were priced at $70.20, representing a 9.2% increase over the past year, but underperforming the S&P 500 by 4.3 percentage points [7] Pipeline and Product Focus - Arcellx develops immunotherapies, primarily focusing on CART-ddBCMA for relapsed or refractory multiple myeloma, with additional candidates targeting acute myeloid leukemia, myelodysplastic syndrome, and solid tumors [8] - The company's anito-cel is in Phase 3 trials for relapsed or refractory multiple myeloma in partnership with Gilead's Kite unit, indicating a more advanced position compared to early proof-of-concept data [10] Market Position and Competition - The recent share sale by Perceptive Advisors indicates a strategic move as Arcellx faces competition not only from other approved CAR-T therapies but also from new delivery models [6] - The volatility in Arcellx's stock price highlights the rapid shifts in sentiment within the biotechnology sector, particularly following data releases and market reactions [9][10] - Analysts from Guggenheim and Citi suggested that the sell-off following a three-patient data set was overdone, indicating potential for recovery [9]

Core Viewpoint - PDS Biotechnology Corporation has amended its Phase 3 VERSATILE-003 clinical trial protocol to include progression-free survival (PFS) as an interim primary endpoint, which may facilitate an accelerated approval pathway for PDS0101 in treating HPV16-positive recurrent and/or metastatic head and neck cancer [1][2]. Group 1: Clinical Trial Details - The amendment allows for a potentially shorter duration of the VERSATILE-003 trial and aims to accelerate the timeline for regulatory submission while enhancing cost efficiency [2]. - The primary endpoint for full approval remains median overall survival (mOS), consistent with prior communications with the U.S. Food and Drug Administration (FDA) [1]. - The FDA did not object to the amended protocol during the standard 30-day wait period following the filing of the Investigational New Drug (IND) Application [1]. Group 2: Company Overview - PDS Biotechnology is a late-stage immunotherapy company focused on innovative cancer treatments, particularly targeting how the immune system can effectively kill cancer cells [3]. - The company's lead investigational product, PDS0101 (Versamune® HPV), is being developed in combination with a standard immune checkpoint inhibitor and a triple combination that includes PDS01ADC, an IL-12 fused antibody drug conjugate [3].

AIM ImmunoTech Conference Summary Company Overview - **Company**: AIM ImmunoTech (NYSEAM:AIM) - **Focus**: Development of Ampligen for the treatment of pancreatic cancer, a significant unmet medical need [1][3] Core Points and Arguments Strategic Focus on Pancreatic Cancer - AIM ImmunoTech has refined its development focus to prioritize pancreatic cancer due to its high lethality and lack of effective therapies [8][15] - The company believes Ampligen can alter the immunosuppressive status of tumors, leading to therapeutic effects in solid tumors, particularly pancreatic cancer [8][9] Market Need and Opportunity - Pancreatic cancer results in over 100,000 deaths annually in the U.S. and EU, with more than 450,000 deaths worldwide [11][13] - The company sees a moral obligation to address this unmet medical need, as current therapies are inadequate [9][15] - Ampligen has shown potential to extend overall survival beyond historical controls, with a median extension of over 8 months [39][84] Clinical Development and Data - The company has treated approximately 75 subjects in its phase II trials, demonstrating a strong safety profile and positive efficacy data [18][19][39] - Ampligen is positioned as both a monotherapy and a combination therapy, enhancing the effectiveness of checkpoint inhibitors [32][34] Business Model and Regulatory Strategy - AIM ImmunoTech aims to develop Ampligen to a stage suitable for acquisition by a larger pharmaceutical company [16][17] - The company has received orphan drug designations from the U.S. and EU, providing market exclusivity for an extended period post-approval [16][67] - The business model is supported by a strong intellectual property portfolio and positive clinical results [62][68] Future Plans and Milestones - The company is planning to transition from phase II to phase III trials, with a focus on designing a robust trial protocol [19][46] - AIM ImmunoTech anticipates announcing specific milestones related to the completion of phase II and the design of phase III trials [54][76] Additional Important Content - The company has collaborated with major pharmaceutical companies and research institutes, enhancing its credibility and resource access [25][24] - Ampligen's mechanism of action involves restoring the immune system, which is often compromised in cancer patients, thus improving their quality of life [28][30] - The company emphasizes the importance of designing trials that ensure success and drug approval, leveraging data from previous studies to inform current strategies [40][45] Conclusion - AIM ImmunoTech is strategically positioned to address a critical need in pancreatic cancer treatment with its lead product, Ampligen. The company is focused on advancing its clinical trials and securing partnerships to enhance its market presence and therapeutic impact [88][90]

Core Insights - Johnson & Johnson announced promising results from the Phase 1b/2 OrigAMI-4 study, showing a 56% overall response rate for RYBREVANT FASPRO™ in first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) [1][2] - The study demonstrated a 10% complete response rate and a clinical benefit rate of 74%, indicating significant antitumor activity compared to current standards of care [1][2] - The combination of subcutaneous amivantamab and pembrolizumab targets key drivers of tumor growth and resistance, suggesting a potential shift in treatment paradigms for HNSCC [1][2] Study Results - In Cohort 2 of the OrigAMI-4 study, the confirmed overall response rate was 56% (22 out of 39 patients), with 6 complete responses and 18 partial responses [1] - At a median follow-up of 10.4 months, 46% of patients remained on treatment, and tumor shrinkage was observed in 82% of patients [1] - The median progression-free survival was reported at 7.7 months, with a median time to first response of 9.7 weeks [1] Safety Profile - The safety profile of RYBREVANT FASPRO™ combined with pembrolizumab was consistent with individual agents, with no new safety signals identified [1] - Common treatment-emergent adverse events included rash (49%), paronychia (46%), and hypoalbuminemia (41%), with 15% of patients experiencing administration-related reactions [1][2] - Treatment discontinuation due to adverse events occurred in four patients, indicating manageable safety concerns [1] Industry Context - HNSCC is an aggressive cancer type, with current standard treatments yielding low response rates (approximately 18% for PD-1 monotherapy) [1][2] - The introduction of RYBREVANT FASPRO™ represents a significant advancement in addressing unmet needs in HNSCC treatment, particularly for HPV-unrelated cases [1][2] - Ongoing studies, including the Phase 3 OrigAMI-5 study, will further evaluate the efficacy of RYBREVANT FASPRO™ in combination with carboplatin and pembrolizumab [1][2]

Cullinan Therapeutics (NasdaqGS:CGEM) 2026 Conference February 19, 2026 10:00 AM ET Company ParticipantsJeffrey Jones - CMONadim Ahmed - President, CEO and DirectorSamantha Semenkow - VP of SMid Biotech Equity ResearchSamantha SemenkowGood morning, and thank you for joining our session of Citi's Virtual Oncology Leadership Summit. I'm Samantha Semenkow, one of the senior biotech analysts here at Citi, and it's my pleasure today to be hosting Cullinan Therapeutics CEO, Nadim Ahmed, and CMO, Jeff Jones. Nadim ...