Cancer has quietly become the pharmaceutical industry’s most lucrative disease area. In 2024 alone, global cancer drug sales exceeded $200 billion, making oncology the single largest revenue category in biopharma, well ahead of even the fast-growing obesity drug market. Yet behind the blockbuster numbers and steady stream of approvals, a more troubling reality is emerging. Many of today’s most profitable cancer drugs do not meaningfully extend patients’ lives. A recent Bloomberg investigation underscored th ...

An updated edition of the December 17, 2025, article.The global oncology market is entering a phase of accelerated transformation, driven by rising cancer incidence, demographic shifts and rapid scientific progress. The American Cancer Society estimates that the United States will see about 2.1 million new cancer diagnoses and more than 626,000 cancer-related deaths in 2026. Globally, lifestyle-related risk factors and demographic shifts continue to increase cancer prevalence, supporting sustained growth in ...

Core Insights - AIM ImmunoTech Inc. reported positive data from the ongoing Phase 2 clinical study of Ampligen combined with AstraZeneca's Imfinzi for treating metastatic pancreatic cancer, showing median survival of 19.7 months compared to 8.6 months with standard care [1][2] - The study aims to assess the clinical benefit rate, overall survival, progression-free survival, immune monitoring, and quality of life for patients [2][3] Group 1: Clinical Study Details - The DURIPANC study is an exploratory, open-label trial expected to enroll up to 25 subjects, with 18 patients already enrolled [3] - The study has shown promising results in progression-free survival and overall survival, with no significant toxicity reported, indicating a favorable safety profile [3][4] - The combination therapy appears to enhance the body's immune response, suggesting a coordinated activation of both innate and adaptive immune systems [5] Group 2: Market Potential and Intellectual Property - AIM holds a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, extending protection until August 9, 2039 [7] - The company has received orphan drug designations in pancreatic cancer from both the U.S. and EU, providing market exclusivity post-commercial approval [7][8] - AIM believes that advancing Ampligen to Phase 3 clinical trials could present significant financial opportunities for the company and its shareholders [5][8]

Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant MSS mCRC with interim data expected by the end of 2026 Pelareorep now has Fast Track Designation for two gastrointestinal cancers, solidifying its potential as an immunotherapeutic platform therapy in gastrointestinal cancers SAN DIEGO, Feb. 04, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) ( ...

Clinical progress, pipeline expansion, and operational momentum underpin leadership continuity as the Company advances into 2026 and beyond SEATTLE, WA / ACCESS Newswire / February 3, 2026 / Aptevo Therapeutics Inc. (Nasdaq:APVO), a clinical-stage biotechnology company developing novel immune-oncology therapeutics based on its proprietary ADAPTIRâ"¢ and ADAPTIR-FLEXâ"¢ platform technologies, today announced executive leadership transitions to support the Company's continued execution, drive achievement of l ...

FDA Approvals & Rejections - Intellia Therapeutics has received FDA approval to resume its MAGNITUDE-2 Phase 3 trial for nexiguran ziclumeran (nex-z) targeting hereditary transthyretin amyloidosis with polyneuropathy, increasing target enrollment from 50 to 60 patients [2][4] - Outset Medical's next-generation Tablo Hemodialysis System has been granted FDA 510(k) clearance, making it the first dialysis device to meet enhanced cybersecurity standards, with shipping expected to begin in Q2 2026 [6][7] - OKYO Pharma has received positive feedback from the FDA for its Phase 2b/3 trial design for Urcosimod, a candidate for neuropathic corneal pain, with plans to start the trial in the first half of 2026 [8][9] - REGENXBIO has faced clinical holds on its RGX-111 and RGX-121 gene therapy programs due to a case of CNS tumor in a child treated with RGX-111, although no similar findings were reported in other patients [10][11] - Almirall has received NMPA approval for Seysara in China for treating moderate-to-severe acne vulgaris, expanding its dermatology portfolio in the region [12][13] Clinical Trials - Breakthroughs - Aprea Therapeutics reported early clinical activity for APR-1051 in endometrial cancer, achieving a 50% reduction in target lesion size in a patient with PPP2R1A-mutated uterine serous carcinoma [19][21] - Fractyl Health's Revita demonstrated positive results in weight maintenance after GLP-1 drug discontinuation, showing a 4.5% weight regain compared to 7.5% in the sham group [22][24] - Ascletis Pharma announced positive Phase 3 results for Denifanstat in moderate-to-severe acne vulgaris, focusing on long-term safety in a trial with 240 patients [25][26] - GRI Bio reported new gene expression data from its Phase 2a study of GRI-0621 in idiopathic pulmonary fibrosis, showing significant improvements in lung injury and fibrosis progression [27][28] - Cardiff Oncology announced encouraging results from its Phase 2 trial of Onvansertib in RAS-mutated metastatic colorectal cancer, with a well-tolerated regimen and plans to advance to a registrational program [31][32] - Genentech's CT-388 Phase 2 trial for obesity showed a significant placebo-adjusted weight loss of 22.5% at 48 weeks, with a high percentage of participants achieving significant weight loss [34][36] - Sarepta Therapeutics reported positive three-year results from its EMBARK study for ELEVIDYS in Duchenne muscular dystrophy, showing significant slowing of disease progression in treated patients [38][41] Deals - YD Bio Limited has signed a letter of intent to acquire Safe Save Medical for approximately $26.87 million, aiming to enhance its capabilities in advanced cellular therapeutics [14][15][17]

Financial Data and Key Metrics Changes - Total revenue for Q4 2025 was $3.9 billion, reflecting a 3% year-over-year increase, driven by higher collaboration revenue and strong sales growth of Dupixent, EYLEA HD, and Libtayo [40][41] - Diluted net income per share was $11.44, with net income of $1.2 billion [40] - Regeneron's share of collaboration profits from Sanofi grew 42% year-over-year, primarily due to Dupixent [41] Business Line Data and Key Metrics Changes - Global net product sales for Dupixent reached $4.9 billion in Q4 2025, a 32% increase year-over-year [7] - Libtayo's global net sales were $425 million in Q4 2025, up 13% year-over-year [37] - EYLEA HD net product sales in the U.S. were $506 million in Q4 2025, representing a 66% increase [9] Market Data and Key Metrics Changes - Dupixent is now approved in eight indications, with over 1.4 million patients on therapy globally, indicating significant market penetration potential [7] - EYLEA HD has become a growing proportion of Regeneron's total anti-VEGF franchise, contributing nearly half of total net sales [33] - Libtayo is recognized as the leading immunotherapy for advanced non-melanoma skin cancers, with strong demand growth across all approved indications [37] Company Strategy and Development Direction - Regeneron anticipates at least four FDA approvals in 2026, including three for new molecular entities and one for the EYLEA HD prefilled syringe [11] - The company plans to initiate 18 additional phase 3 studies, targeting approximately 35,000 patients over multiple years [13] - Regeneron aims to continue capital deployment for share repurchases, dividends, and complementary business development to drive long-term shareholder value [14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about reaching an agreement with the U.S. government to reduce drug costs while ensuring access to innovative treatments [11] - The company highlighted the importance of its innovative pipeline, with multiple pivotal readouts and regulatory milestones expected in 2026 [30] - Management emphasized the competitive advantages of Dupixent, including its efficacy and safety profile compared to other immunomodulators [59] Other Important Information - Regeneron generated $4.1 billion in free cash flow in 2025 and returned $3.8 billion to shareholders, primarily through share repurchases [44][45] - The company initiated a quarterly dividend, providing additional flexibility to return capital to shareholders [45] Q&A Session Summary Question: Update on Libtayo plus fianlimab readouts - Management indicated that the best estimate for advanced melanoma readout is in the first half of the year, with adjuvant timing also expected in the same timeframe [52] Question: Dupixent IP and future potential - Management refrained from providing additional comments but acknowledged Sanofi's commentary on extending the IP runway [55] Question: Frontline metastatic melanoma data and hazard ratio - Management stated that the study is powered to achieve a primary endpoint similar to the current standard of care, with hopes for better outcomes [63] Question: Broader R&D strategy and focus areas - Management confirmed a commitment to a balanced approach across therapeutic areas, driven by genetics to identify new drug opportunities [70] Question: Development of a new version of Dupixent - Management discussed the potential of a "souped-up" version of Dupixent that may offer longer-lasting effects and other advantages, with plans to move it forward in clinical development [76]

Core Insights - AlphaTON Capital Corp. reported $24.5 million in assets, with $11 million in cash and no debt or convertible securities, indicating a strong financial position [1][5] - The company has 23.4 million shares outstanding and has made a $4 million deposit towards acquiring 576 Nvidia B300 GPUs for AI revenue production [5] - AlphaTON is focused on scaling the Telegram super-app, targeting an addressable market of one billion monthly active users, while managing a strategic reserve of digital assets [2] Financial Position - Total assets amount to $24.5 million [5] - Cash reserves stand at $11 million [5] - The company has no outstanding debt or convertible securities, reflecting a solid balance sheet [5] Share Structure - AlphaTON has 23.4 million shares outstanding, which provides insight into its market capitalization and shareholder structure [5] Strategic Investments - The company has made a $4 million deposit for Nvidia B300 GPUs, which are intended for AI revenue production, indicating a commitment to technological advancement [5] - AlphaTON's strategy includes direct digital asset acquisition, validator operations, and investments in decentralized finance protocols and gaming platforms [2] Leadership and Governance - The company is led by CEO Brittany Kaiser, Executive Chairman Enzo Villani, and Chief Business Development Officer Yury Mitin, emphasizing a strong management team [2]

Core Insights - Immutep Limited has made significant progress in its immunotherapy development, particularly with eftilagimod alfa (efti), through a strategic collaboration with Dr. Reddy's Laboratories for commercialization outside key markets [3][5][6] Efti Development Program in Oncology - The strategic collaboration with Dr. Reddy's includes an upfront payment of USD 20 million (~AUD 30.2 million) and potential milestone payments of up to USD 349.5 million (~AUD 528.4 million) [5][6] - Efti is currently under evaluation in a Phase III trial (TACTI-004) for first-line non-small cell lung cancer (1L NSCLC), with strong operational progress reported [4][8] - The combination of efti with KEYTRUDA and chemotherapy has shown a 61.7% overall response rate (ORR) in patients with low and no PD-L1 expression, significantly higher than the historical control of 40.8% [14] - The EFTISARC-NEO Phase II trial met its primary endpoint with a median tumor hyalinization/fibrosis of 51.5%, indicating potential for improved survival outcomes in soft tissue sarcoma [17][20] Financial Summary - As of December 31, 2025, the company reported a strong cash position of approximately AUD 99.1 million, which will extend its cash reach into Q2 CY2027 [35][40] - The company received EUR 2.59 million (~AUD 4.6 million) in R&D tax incentives from the French government to support ongoing clinical development [36] - Total cash outflows for R&D activities during the quarter were AUD 9.9 million, a decrease from AUD 15.8 million in the previous quarter [37] Intellectual Property - Immutep was granted four patents during the quarter, including a new patent in New Zealand for a binding assay related to LAG-3 protein and three new patents for IMP761 in Brazil and Japan [32] Corporate Activities - The company successfully held its Annual General Meeting (AGM), with all resolutions approved by shareholders, reflecting strong support for its strategic objectives [33]

Core Insights - BioVaxys Technology Corp. announced positive findings from a Phase 2 clinical study of maveropepimut-S (MVP-S) in combination with pembrolizumab and low-dose cyclophosphamide for advanced or metastatic bladder cancer, reinforcing the potential of MVP-S to enhance checkpoint inhibitor activity across multiple solid tumor indications [1][4] Group 1: Clinical Study Findings - The Phase 2 study assessed the safety, tolerability, and clinical activity of the combination regimen in patients with metastatic bladder cancer, including those who had progressed on prior anti-PD1/PD-L1 therapies [2] - Key findings indicate that combining MVP-S with checkpoint inhibitors can expand antigen-specific T cell responses, reduce regulatory T-cell activity, and amplify anti-tumor activity [2] - Of 17 evaluable subjects, five showed objective responses, including 2 confirmed complete responses (CRs) and 3 partial responses (PRs), with notable responses in patients previously resistant to checkpoint inhibitors [5] Group 2: MVP-S Mechanism and Composition - MVP-S is a DPX-based immunotherapy that includes multiple survivin-derived peptides, a T-helper peptide, and an innate immune stimulant, promoting efficient antigen uptake and robust T-cell activation [3] - The DPX platform employs a novel, non-aqueous, lipid-in-oil formulation that mimics natural immune processes, resulting in durable immune responses without systemic release at the injection site [3] Group 3: Market Context and Future Opportunities - The encouraging results from the Phase 2 study support advancing MVP-S toward Phase 3 development in ovarian cancer and exploring broader partnering opportunities across additional indications [4] - Major anti-PD1 therapies, such as Merck's Keytruda and Bristol Myers Squibb's Opdivo, are approaching significant patent expirations by 2028, creating opportunities for MVP-S in a competitive market [4] - BioVaxys continues to advance its oncology pipeline, with MVP-S demonstrating consistent tolerability and immune activation across various cancer indications [6]