CARDINAL Phase 1/2 trial of TERN-701 enrolling well, with multiple important milestones in 2026 Planned milestones include pivotal dose selection, EOP2 regulatory interaction in mid-2026, updated and expanded CARDINAL data by 2H26, and initiation of 2L+ pivotal trial in late 2026/early 2027 TERN-701 was granted U.S. FDA Fast Track designation for the treatment of CML in Q4 2025 Year-end 2025 unaudited cash, cash equivalents and marketable securities of approximately $1.0 billion, expected to provide runway ...

BOSTON, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases, today announced the appointments of Arjun Prasad, MBA, MPH as Chief Commercial Officer and Cynthia Sirard, MD as Chief Medical Officer, both effective as of January 1, 2026. “We are thrilled to welcome Arjun and Cyndi to the Compass team. They are highly accomplished leaders with ...

Pyxis Oncology Inc. (NASDAQ:PYXS) on Thursday released preliminary data from its ongoing Phase 1 studies of micvotabart pelidotin (MICVO) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).The update includes preliminary data from both the Phase 1 monotherapy study in second line (2L+) R/M HNSCC and the Phase 1/2 study evaluating MICVO in combination with Merck & Co. Inc.’s (NYSE:MRK) Keytruda (pembrolizumab), in (first and second line) 1L/2L+ R/M HNSCC.The data reported below reflec ...

Core Insights - Arcus Biosciences has a promising oncology pipeline, supported by positive clinical data and a strong balance sheet, positioning it as a potential high-upside growth stock [1][2] - The company faced a significant setback with the cancellation of its Phase 3 STAR-221 trial due to inefficiency, which has raised questions about its investment case [2][6] - Despite the challenges, Arcus is focusing its resources on its key programs, particularly casdatifan, which shows potential as a leading treatment for kidney cancer [7] Company Overview - Arcus Biosciences is valued at $2.7 billion and operates as a clinical-stage biopharmaceutical company, developing treatments for cancer and autoimmune diseases [4] - The company does not currently sell any approved medicines, with its main oncology programs including casdatifan for clear cell kidney cancer and quemliclustat for pancreatic cancer [4] STAR-221 Trial Details - The STAR-221 trial was a large Phase 3 study involving over 1,000 participants across approximately 30 countries, aimed at improving survival rates in advanced upper gastrointestinal cancers [5] - The trial was discontinued after an interim review indicated no overall survival improvement compared to standard therapy [6] Future Focus - Following the discontinuation of STAR-221, Arcus will concentrate its capital and R&D efforts on casdatifan and its immuno-oncology portfolio [7] - Positive results from the Phase 1/1b ARC-20 study have strengthened the company's belief in casdatifan's potential as a best-in-class medication for kidney cancer [7]

Financial Data and Key Metrics Changes - The company expects to finish the year with close to $700 million in cash, indicating strong financial health and access to capital [11] - A significant capital raise of $500 million was completed in just 48 hours, demonstrating investor confidence in the company's prospects [11] Business Line Data and Key Metrics Changes - The company has four Phase 3 clinical trials ongoing, with positive results reported from HARMONY-A and HARMONY-2, showing strong progression-free survival (PFS) and overall survival (OS) benefits [20][22] - The drug ivonescimab has shown a statistically significant OS benefit in the HARMONY-A study, reinforcing its competitive position against PD-1 therapies [20] Market Data and Key Metrics Changes - The competitive landscape includes other PD-1 and VEGF therapies, but the company has achieved four positive Phase 3 trial results, which is unique in the market [22] - The company is expanding its Phase 3 program beyond non-small cell lung cancer (NSCLC) to include colorectal cancer, indicating a strategic move to capture additional market share [53] Company Strategy and Development Direction - The company is focused on establishing a strong presence in the oncology market, particularly in NSCLC, with HARMONY-3 and HARMONY-7 seen as pivotal studies for market dominance [33] - There is a strategic emphasis on maintaining control and ownership of assets while exploring partnerships when appropriate, ensuring that the company can leverage its strong position without compromising its strategy [61][64] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's trajectory, citing a pristine safety profile and strong efficacy data as key drivers for future success [11][30] - The management team believes that the current market conditions present a ripe opportunity for growth, with significant potential for ivonescimab to impact various oncology indications [67] Other Important Information - The company has a robust pipeline with 10 Phase 3 studies running in collaboration with partners, indicating a strong commitment to expanding its therapeutic offerings [54] - The management highlighted the importance of strategic timing in clinical trials to ensure regulatory success and market access [47] Q&A Session Summary Question: What are the key data points that show confidence in the drug's efficacy? - Management highlighted the strong PFS benefit of ivonescimab over PD-1 therapies and the consistency of results across different studies, reinforcing confidence in the drug's performance [20][22] Question: How does the company plan to expand beyond lung cancer? - The company is prioritizing colorectal cancer as a significant opportunity and is exploring additional Phase 3 programs based on promising Phase 2 data [53][54] Question: Is there a need for a large pharma partnership to accelerate growth? - Management indicated that while partnerships are considered, the company currently has sufficient resources and is moving at a fast pace without the immediate need for a partnership [61][62]

Summary of Syndax Pharmaceuticals Conference Call Company Overview - **Company**: Syndax Pharmaceuticals - **Focus**: Oncology, specifically acute leukemia and chronic graft-versus-host disease (GVHD) - **Key Products**: - **Revumenib**: First-in-class selective menin inhibitor for acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) - **Niktimba**: CSF1R antibody for chronic GVHD Key Points and Arguments Product Launch and Market Opportunity - **Revumenib** targets KMT2A acute leukemia (10% of AML and ALL) and NPM1 (30-35% of AML), representing a combined market opportunity of approximately **$5 billion** [4][3] - **Niktimba** launched in February 2025 for chronic GVHD, also showing strong initial performance [4][4] Clinical Performance and Feedback - Over **750 patients** treated with Revumenib, with **one-third** progressing to transplantation [9][11] - Positive physician feedback on Revumenib's efficacy and tolerability, with expectations of **70-80%** of patients potentially returning to maintenance therapy post-transplant [13][17] - Current average duration of therapy for Revumenib is projected at **4-6 months**, expected to extend to **6-12 months** as more patients return to maintenance [24][25] Regulatory and Safety Considerations - Recent FDA update includes a black box warning for Torsades de Pointes; however, physicians remain confident in managing this risk due to existing experience with similar drugs [26][28] - Efficacy remains the primary concern for physicians, overshadowing safety warnings [30][29] Future Clinical Development - Plans to initiate frontline trials for Revumenib, focusing on both unfit and fit patient populations [38][42] - Collaboration with HOVON to expedite phase three trials, aiming for rapid enrollment and high-quality data [50][52] - Anticipated data readouts from ongoing studies, including the **MAXIMYRE** trial for Niktimba in idiopathic pulmonary fibrosis (IPF), expected in late 2026 [65][66] Financial Outlook - Niktimba has generated approximately **$46 million** in its second full quarter, with a strong adoption rate and nearly **100%** payer coverage [58][59] - Syndax holds about **$456 million** in cash, positioning the company well for future growth and profitability [68][68] Upcoming Catalysts - Key upcoming events include data presentations at ASH, potential trial readouts for Niktimba in IPF, and ongoing developments in frontline trials for Revumenib [67][68] Additional Important Insights - The company is focused on maintaining a stable expense base while driving towards profitability, leveraging its first-mover advantage in the menin inhibitor space [68][68] - The potential for Revumenib to transform treatment paradigms in AML is emphasized, particularly in combination therapies [39][40]

Core Insights - Coherus Oncology has appointed Arvind Sood as Chief Strategy and Corporate Affairs Officer to enhance its strategic functions and investor relations [1][2] - The company is focused on advancing its innovative cancer therapeutics, particularly LOQTORZI® and its pipeline candidates, which target various cancers [2][3] - Coherus holds global rights to key products, CHS-114 and casdozokitug, which presents potential business development opportunities [2][4] Company Overview - Coherus Oncology is a commercial-stage innovative oncology company with an approved PD-1 inhibitor, LOQTORZI®, and a pipeline that includes mid-stage clinical candidates targeting multiple cancers [3] - The company's strategy includes growing LOQTORZI sales in nasopharyngeal carcinoma and developing new indications in combination with pipeline candidates [3] Pipeline Development - Coherus' pipeline features multiple antibody immunotherapy candidates aimed at enhancing immune responses against cancer [4] - CHS-114 is currently in Phase 1b/2a studies for advanced solid tumors, while casdozokitug is being evaluated in a Phase 2 study for hepatocellular carcinoma [4]

Core Insights - Orion Corporation has secured an exclusive commercial license for a monoclonal antibody from Abzena, aimed at addressing a significant clinical need in oncology [1][2] - The antibody was developed using Abzena's proprietary Composite Human Antibody (CHAb™) technology, which emphasizes a comprehensive approach to selecting a lead candidate [2][3] - Abzena has over 20 years of experience in monoclonal antibody programs, with capabilities in both the UK and the US for development and manufacturing [3][4] Company Overview - Orion Corporation is a Nordic pharmaceutical company with over a century of experience, focusing on human and veterinary pharmaceuticals, as well as active pharmaceutical ingredients [5][7] - The company reported net sales of EUR 1,542 million in 2024 and employs approximately 3,700 professionals globally [5][7] - Orion's research and development primarily targets oncology and pain management, with proprietary products addressing various health conditions [5][7] Abzena Overview - Abzena is a leading end-to-end contract development and manufacturing organization (CDMO) specializing in bioconjugates and complex biologics [4] - The company offers integrated programs and services to streamline the development of new treatments, with facilities in San Diego, Bristol, and Cambridge [4] - Abzena is owned by Welsh, Carson, Anderson & Stowe, a prominent private equity investor [4]

Company Overview - Oncotelic Therapeutics, Inc. is a biopharmaceutical company focused on developing transformative medicines for cancer patients, utilizing its PDAOAI platform and expertise in nanomedicines and the tumor microenvironment [1][4] - The company has a special emphasis on rare pediatric cancers and holds rare pediatric designation for Diffuse Intrinsic Pontine Glioma (DIPG) through its joint venture [4] Recent Developments - Oncotelic will present at the 19th Annual Main Event on October 21, 2025, where CEO Vuong Trieu will discuss the company's progress and vision [1][3] - The lead program, Sapu, is a 45%-owned joint venture that is advancing in its nanomedicine platform, with key milestones in formulation optimization, regulatory engagement, and clinical trials [3] Event Details - The LD Micro Main Event XIX will take place from October 19 to 21, 2025, featuring around 120 companies presenting and engaging in one-on-one meetings with investors [3] - The event will include registration, keynote speakers, and company presentations over three days [3] Product Pipeline - Oncotelic has developed AL-101 for the intranasal delivery of apomorphine, targeting Parkinson's Disease, with over 60,000 new diagnoses annually in the U.S. and a projected increase to over 1.2 million patients by 2030 [5] - AL-101 is also being developed for Erectile Dysfunction (ED) and Female Sexual Dysfunction (FSD), addressing significant unmet medical needs in these areas [5][6]

Core Insights - Regeneron Pharmaceuticals, Inc. (REGN) has received FDA approval for the label expansion of its PD-1 inhibitor Libtayo (cemiplimab-rwlc) as an adjuvant treatment for adult patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery and radiation [1][9] Group 1: Approval and Efficacy - Libtayo is now approved for high-risk CSCC patients, marking it as the only immunotherapy to show efficacy in this setting [5][9] - The FDA's approval was based on the late-stage C-POST study, which demonstrated a 68% reduction in the risk of disease recurrence or death compared to placebo [4][9] - An additional regulatory application for Libtayo is under review in the European Union, with a decision expected by the first half of 2026 [3] Group 2: Financial Performance - Libtayo's sales reached $661.6 million in the first half of 2025, reflecting an 18% year-over-year increase [5] - REGN's stock has declined by 20.5% year to date, contrasting with the industry's growth of 10.5% [2] Group 3: Portfolio Diversification - REGN is actively working to diversify its portfolio, especially as its lead drug Eylea faces competition from Roche's Vabysmo [12] - Eylea sales in the U.S. increased by 29% in the second quarter due to higher demand for a higher dose version [13] - The oncology franchise has been bolstered by the recent FDA approvals of linvoseltamab-gcpt for relapsed or refractory multiple myeloma and Ordspono for follicular lymphoma, despite setbacks with odronextamab [10][11]