MINNEAPOLIS, Feb. 12, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Charles (Chip) R. Romp to its Board of Directors. Mr. Romp brings over 25 years of experience in the pharmaceutical industry to Celcuity, including leadership of sales teams and commercial organizations in the oncology setting. “Chip brings a wealth of oncology-related commercial expertise to our Board, ...

Industry Overview - The global oncology market is undergoing rapid transformation due to increasing cancer incidence, demographic changes, and scientific advancements, with an estimated 2.1 million new cancer diagnoses and over 626,000 cancer-related deaths expected in the U.S. in 2026 [2] - Lifestyle-related risk factors and demographic shifts are contributing to a rise in cancer prevalence, leading to sustained growth in oncology healthcare spending [2] Innovation in Cancer Treatment - Advances in immunotherapies, targeted medicines, and personalized vaccines are reshaping cancer treatment, moving beyond traditional chemotherapy and radiation [3] - Immune-based approaches, such as checkpoint inhibitors and CAR-T therapies, utilize the immune system to target tumors, while targeted therapies focus on specific molecular and genetic disease drivers [3] - Technologies like genomic sequencing and AI are enhancing biomarker discovery and patient stratification, leading to earlier diagnoses and improved survival rates across various cancer types [4] Pharmaceutical Investment - Major pharmaceutical companies, including Novartis, AstraZeneca, and Pfizer, are investing heavily in oncology pipelines, developing new therapies such as antibody-drug conjugates and next-generation immuno-oncology treatments [5] - Smaller biotech firms are also crucial in driving innovation through partnerships, licensing deals, and acquisitions [5] Market Resilience - The oncology sector is viewed as one of the most resilient and attractive segments of the global healthcare market for long-term investors, supported by ongoing innovation and favorable reimbursement trends [6] Company Highlights - **ImmunityBio**: Its lead drug, Anktiva, approved in April 2024, generated $113 million in preliminary sales in 2025, with a 750% increase in volumes. The drug is under review in the EU and is being evaluated for expanded use in various cancers [8][9] - **Arcus Biosciences**: Developing casdatifan, a potential best-in-class HIF-2a inhibitor for treating clear cell renal cell carcinoma, with a market opportunity of over $5 billion. Multiple data readouts are expected in 2026 [10] - **Allogene Therapeutics**: Focused on genetically engineered T-cell therapies, with lead candidate cema-cel in a pivotal phase II study for large B-cell lymphoma. Another candidate, ALLO-316, shows early anti-tumor activity in advanced renal cell carcinoma [12][13]

Core Insights - Revolution Medicines, Inc. is a late-stage clinical oncology company focused on developing targeted therapies for RAS-addicted cancers [3] Company Overview - The company is developing a pipeline of RAS(ON) inhibitors aimed at suppressing various oncogenic variants of RAS proteins [3] - Current clinical development includes daraxonrasib (RMC-6236), a multi-selective inhibitor; elironrasib (RMC-6291), a G12C-selective inhibitor; zoldonrasib (RMC-9805), a G12D-selective inhibitor; and RMC-5127, a G12V-selective inhibitor [3] - Additional pipeline opportunities focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C) [3] Upcoming Events - Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines, will participate in a fireside chat at the Guggenheim Securities Emerging Outlook: Biotech Summit 2026 on February 11 at 9:30 a.m. ET [1]

Core Viewpoint - The FDA has accepted Celcuity Inc.'s New Drug Application for gedatolisib, granting it Priority Review with a PDUFA goal date of July 17, 2026, for the treatment of HR+/HER2- advanced breast cancer [1][2][3]. Group 1: FDA Review and Application - The New Drug Application (NDA) for gedatolisib was submitted under the FDA's Real-Time Oncology Review (RTOR) program, aimed at expediting regulatory review periods [2]. - Gedatolisib has previously received Breakthrough Therapy and Fast Track designations due to promising preliminary clinical data [2]. - The NDA submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial [2]. Group 2: Product Details - Gedatolisib is a multi-target PI3K/AKT/mTOR inhibitor that targets all four Class I PI3K isoforms, mTORC1, and mTORC2, providing comprehensive blockade of the PAM pathway [4]. - The mechanism of action of gedatolisib is differentiated from currently approved single-target inhibitors, allowing for full suppression of the PAM pathway [4]. - Nonclinical studies and early clinical data indicate that gedatolisib demonstrates comparable potency and cytotoxicity in both PIK3CA-mutant and wild-type breast tumor cells [4]. Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumor indications, with gedatolisib as its lead candidate [5]. - The company has completed enrollment for the PIK3CA wild-type cohort in the VIKTORIA-1 trial and is currently enrolling patients for the PIK3CA mutant cohort [5]. - A Phase 3 clinical trial, VIKTORIA-2, is ongoing, evaluating gedatolisib in combination with a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [5].

Core Insights - The New Drug Application (NDA) for savolitinib has been accepted and granted priority review by the China National Medical Products Administration (NMPA) for treating gastric cancer patients with MET amplification who have failed at least two prior systemic treatments [1][2] - Savolitinib is positioned to be the first selective MET inhibitor in China for MET-amplified gastric cancer, which has a poor prognosis [1][3] - The NDA is supported by positive Phase II registration study data demonstrating a significant objective response rate [2][4] Company Overview - HUTCHMED is an innovative biopharmaceutical company focused on the discovery and commercialization of targeted therapies and immunotherapies for cancer and immunological diseases [7] - Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and it is already approved in China under the brand name ORPATHYS [6][5] - The drug has been included in the National Reimbursement Drug List of China since March 2023, indicating its significance in the market [6] Industry Context - Gastric cancer is one of the most common cancers and a leading cause of cancer death in China, with MET amplification occurring in approximately 4-6% of gastric cancer patients [3] - The annual incidence of MET amplification gastric cancer in China is estimated to be around 18,000 cases [3] - The NMPA granted Breakthrough Therapy Designation to savolitinib in 2023, highlighting its potential advantages over existing therapies [4]

Core Insights - The global antibody discovery market is projected to grow from USD 8.42 billion in 2024 to USD 17.68 billion by 2032, with a CAGR of 9.74% from 2025 to 2032, driven by the increasing demand for targeted therapeutics for chronic diseases [1][4][17] - The U.S. antibody discovery market is expected to grow from USD 2.75 billion in 2024 to USD 5.12 billion by 2032, with a CAGR of 8.13% during the same period, supported by substantial R&D investments [2][17] Market Drivers - The primary growth driver for the antibody discovery market is the rising need for precision medicine and targeted therapies, particularly in the treatment of complex diseases such as cancer and autoimmune disorders [4] - The biopharmaceutical industry is making significant investments in monoclonal antibodies and biologics due to the increasing prevalence of complicated diseases [4] Market Challenges - High costs and technical complexities in the development of antibodies pose significant challenges, with the average time to bring a novel biologic to market estimated at 10 to 15 years and costs exceeding USD 2.6 billion [5] - The technical intricacies involved in antibody selection and optimization require substantial investment and expertise [5] Market Segmentation - By Antibody Type: Monoclonal antibodies held a market share of approximately 68% in 2024, while polyclonal antibodies are the fastest-growing segment due to their versatility in binding to multiple epitopes [7] - By Service: Phage display accounted for 47% of the market in 2024, with hybridoma technology being the fastest-growing segment [8] - By End-User: The pharmaceutical and biotech sectors dominated the market with a 64% share, while research laboratories are the fastest-growing end-user segment [9] Regional Insights - North America was the largest market for antibody discovery in 2024, attributed to significant investments in biopharmaceutical R&D and a robust clinical trial infrastructure [10] - The Asia Pacific region is identified as the fastest-growing market, driven by a developing biotech industry and increasing healthcare spending [11] Recent Developments - In April 2025, Sanofi licensed global rights to bispecific antibody candidates from Earendil Labs for USD 125 million upfront, with potential milestones of USD 1.72 billion [14] - Evotec announced progress in its collaboration with Bristol Myers Squibb, resulting in USD 75 million in milestone payments [14]

Core Insights - Celcuity Inc. is participating in the 8th Annual Evercore Healthcare Conference from December 2-4, 2025, in Miami, Florida [1] - CEO Brian Sullivan will have a fireside chat on December 3, 2025, at 7:30 a.m. ET, with a live webcast available [2] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for multiple solid tumor indications [3] - The lead therapeutic candidate, gedatolisib, is a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PI3K/AKT/mTor pathway [3] - Ongoing clinical trials include VIKTORIA-1, which has completed enrollment for both PIK3CA wild-type and mutant cohorts, and VIKTORIA-2, which is currently enrolling patients [3] - A Phase 1/2 trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

Core Insights - Celcuity Inc. reported significant clinical and regulatory advancements in Q3 2025, particularly regarding the gedatolisib regimens for advanced breast cancer, with plans to submit a New Drug Application (NDA) to the FDA later this year [2][4][6] Business Highlights - The company presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial at the ESMO Congress, indicating potential practice-changing outcomes for patients with HR+, HER2- advanced breast cancer [4][5] - The gedatolisib triplet (gedatolisib, fulvestrant, and palbociclib) demonstrated a 76% reduction in the risk of disease progression or death compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months [5] - The gedatolisib doublet (gedatolisib and fulvestrant) showed a 67% reduction in the risk of disease progression or death, with a median PFS of 7.4 months [5] - The PIK3CA mutant cohort of the VIKTORIA-1 trial is fully enrolled, with topline data expected in late Q1 or Q2 2026 [4][8] Financial Results - Total operating expenses for Q3 2025 were $42.8 million, up from $30.1 million in Q3 2024 [6] - Research and development (R&D) expenses increased to $34.9 million from $27.6 million year-over-year, primarily due to higher employee and consulting costs [7] - General and administrative (G&A) expenses rose to $7.9 million from $2.5 million, largely due to increased employee and consulting expenses [9] - The net loss for Q3 2025 was $43.8 million, or $0.92 loss per share, compared to a net loss of $29.8 million, or $0.70 loss per share, in Q3 2024 [10] - Cash, cash equivalents, and short-term investments totaled $455.0 million as of September 30, 2025, expected to fund operations through 2027 [11]

Summary of Immunome FY Conference Call (November 11, 2025) Company Overview - **Company**: Immunome (NasdaqCM:IMNM) - **Focus**: Standalone pure-play cancer company specializing in targeted therapies, including antibody-based therapies, radioligands, and small molecules [1][1] Key Points on Varegacestat - **Asset**: Varegacestat, a gamma-secretase inhibitor, is nearing completion of phase three clinical trials for desmoid tumors [2][2] - **Market Opportunity**: The commercial opportunity in desmoid tumors is substantial, with approximately 1,650 new cases per year in the US and a prevalence of about 30,000 [9][15] - **Differentiation**: Varegacestat is expected to differentiate itself from Ogsivo (nirogacestat) due to better efficacy and dosing convenience (once daily vs. twice daily) [10][10][22][22] - **Phase 2 Data**: Phase 2 data indicated a significant improvement over nirogacestat, with a median tumor volume reduction that was 20-25% better [10][10] - **Regulatory Readiness**: The company is well-prepared for regulatory submission and product launch, with a strong team in place [14][14] Clinical Trial Insights - **Enrollment**: Enrollment for the phase 3 trial was completed in February 2024, with data expected to be released soon [11][11] - **Data Monitoring**: A Data Safety Monitoring Board (DSMB) has been overseeing the trial, ensuring safety and compliance [24][24] - **Comparison with Competitors**: The trial design and patient enrollment criteria are nearly identical to those used in SpringWorks' trial for nirogacestat, which is considered the gold standard [17][18] ADC Development - **ROR1 ADC**: Immunome is developing an antibody-drug conjugate (ADC) targeting ROR1, utilizing a proprietary payload (HC74) [27][27] - **Technology Differentiation**: The ADC aims to improve upon existing technologies by addressing common resistance pathways and enhancing permeability for better therapeutic activity [32][32][33][33] - **Future Pipeline**: The company plans to introduce additional ADCs in 2026 and 2027, with a focus on high internalization antibodies [34][34] Market Potential - **Revenue Potential**: A drug targeting 3,000 patients could generate over a billion dollars in revenue, with a significant number of treatable patients available in the US and Europe [15][15] - **Patient Compliance**: The once-daily dosing of Varegacestat is expected to improve patient compliance compared to competitors [10][10] Conclusion - Immunome is positioned to capitalize on the growing market for targeted cancer therapies, with a strong focus on developing innovative treatments that offer significant advantages over existing options. The upcoming data release for Varegacestat is highly anticipated and could be a pivotal moment for the company.

Core Insights - The report "Biomarker Deals: Terms Value and Trends 2019-2025" indicates a shift in investment priorities and an increase in biomarker innovation through partnerships to enhance development and market reach [1][2] Market Dynamics - The global biomarkers industry is experiencing a surge in strategic transactions, including licensing, acquisitions, and collaborations, with various deal structures such as upfront payments and milestone-based compensation [2] - The demand for precision medicine, early disease detection, and targeted therapies is driving new biomarker-related partnerships and acquisitions [3] Growth Drivers - The rising incidence of chronic and infectious diseases, such as cancer and diabetes, is increasing the need for early diagnosis and effective treatment, thereby driving demand for biomarkers [4] - Advances in omics and imaging technologies are revolutionizing biomarker discovery and validation, making development more efficient and precise [5] - The shift towards personalized medicine is increasing the need for reliable biomarkers, leading to more partnerships and licensing deals focused on targeted diagnostics and therapies [6] Market Segmentation - The report segments the market based on deal type, including licensing, acquisitions, and collaborations, with partnerships expected to dominate through 2025 [13][14] Challenges and Opportunities - Key challenges in the biomarkers market include high development costs and the need for skilled labor, while opportunities lie in emerging markets and the growth of personalized medicine [15] Emerging Startups - Notable emerging startups in the biomarker space include Grail, Nucleix, Biodesix, and SomaLogic [10][19] Market Leaders - Major players in the biomarkers industry include Abbott, Agilent Technologies, Bayer AG, and Thermo Fisher Scientific, among others [20]