Darolutamide

USA News Group News Commentary Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Oct. 7, 2025 /PRNewswire/ -- USA News Group News Commentary – Major pharmaceutical companies are unveiling breakthrough cancer data at the European Society for Medical Oncology Congress taking place October 17-21 in Berlin[1], while the global cancer immunotherapy market reached $137.70 billion in 2024 and analysts project explosive growth toward $261.74 billion by 2033[2]. The timing reflects a critical inflection point as HHS doubled federal funding for its Childhood Cancer Data Initiative from $50 million to $100 million, while researchers discovered how cancer uses a hidden hormone to shield itself from immune attack[3]. Against this backdrop of scientific momentum and institutional capital deployment, clinical-stage immunotherapy developers including GT Biopharma, Inc. (NASDAQ: GTBP), Leap Therapeutics, Inc. (NASDAQ: LPTX), IO Biotech (NASDAQ: IOBT), Celcuity Inc. (NASDAQ: CELC), and MAIA Biotechnology, Inc. (NYSE-American: MAIA). With eight new oncology approvals issued from July through September[4] and regulatory agencies accelerating approval pathways through breakthrough therapy designations, institutional forecasters at Precedence Research project the market will expand at a 10.65% CAGR through 2034[5] as long-term survival data validates immunotherapy durability. The convergence of rising disease burden, proven efficacy across cancer types, and expanded federal research support creates favorable conditions for early-positioned companies with differentiated mechanisms advancing through clinical milestones before broader institutional recognition materializes. GT Biopharma, Inc. (NASDAQ: GTBP) is a clinical-stage immunotherapy company making significant progress in its fight against difficult-to-treat cancers. The San Francisco-based biotech has been advancing its lead drug candidate, GTB-3650, through a Phase 1 clinical trial targeting blood cancers that have stopped responding to other treatments. In August, the company successfully moved into Cohort 3 after formal safety reviews of the first two patient groups showed no safety or tolerability problems. The trial had treated five patients by mid-August, with encouraging early signals of immune system activation. "We are pleased with the enrollment momentum in our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which continues to advance on schedule," said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma. "Moving into the third dose cohort after a successful safety review and encouraging early evidence of immunological activity, mark important steps forward in the development of GTB-3650. We look forward to sharing more data later this year to reinforce the ability of our TriKE constructs to activate endogenous NK cells, and the potential for broader utility with other targets to treat solid tumors (GTB-5550) and autoimmune indications (GTB-7550)." The Phase 1 trial is testing GTB-3650 in patients with relapsed or refractory CD33-expressing blood cancers, including acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These are patients whose cancers have come back or never responded to standard therapies. The drug works by activating the body's own natural killer cells to attack cancer cells. Patients receive the treatment through continuous infusions in two-week cycles, alternating two weeks on and two weeks off, for up to four months based on how well they're responding. What makes the early data particularly interesting is the biomarker evidence. Multiple blood tests from the first four patients showed measurable increases in natural killer cell activity and expansion. This suggests the drug is doing exactly what it was designed to do—wake up the immune system and direct it against cancer. GT Biopharma expects to release more detailed Phase 1 results later this year after completing additional dose cohorts. Beyond blood cancers, GT Biopharma has a second drug candidate moving toward the clinic. GTB-5550 targets a protein called B7H3 that appears in many different types of solid tumors, including breast, lung, ovarian, head and neck, pancreatic, bladder, and prostate cancers. The company expects to submit its application to start human testing of GTB-5550 during the fourth quarter of this year. Unlike many cancer immunotherapies that require lengthy hospital infusions, GTB-5550 is being developed as a simple injection that patients could potentially give themselves at home, similar to insulin shots. Both drug candidates are built on GT Biopharma's proprietary TriKE platform, which uses specialized antibody fragments originally discovered in camels and llamas. These molecules are smaller and more stable than traditional antibodies, allowing them to work more effectively. GT Biopharma holds an exclusive worldwide license from the University of Minnesota to develop and commercialize therapies using this technology. As of June 30, 2025, GT Biopharmareported cash and cash equivalents of approximately $5.3 million, which management expected would fund operations into the first quarter of 2026. CONTINUED… Read this and more news for GT Biopharma, Inc. at: Leap Therapeutics, Inc. (NASDAQ: LPTX) are set to present final clinical results from Part B of the DeFianCe study at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21 in Berlin, Germany. The Phase 2 study evaluated sirexatamab (DKN-01), an anti-DKK1 monoclonal antibody, in combination with bevacizumab and chemotherapy compared to bevacizumab and chemotherapy alone in patients with advanced microsatellite stable colorectal cancer who received one prior systemic therapy for advanced disease. The final results will be presented in a Mini Oral Session on October 19, 2025 at 4:05 p.m. CEST, with the presentation providing detailed efficacy and safety data from the second-line treatment cohort. Leap Therapeutics' pipeline also includes FL-501, a humanized monoclonal antibody targeting the growth and differentiation factor 15 protein, as the company continues developing targeted and immuno-oncology therapeutics for solid tumor indications. IO Biotech (NASDAQ: IOBT) announced that the U.S. Food and Drug Administration has recommended against submitting a Biologics License Application based on data from the IOB-013 clinical trial, in which Cylembio plus pembrolizumab improved progression free survival but narrowly missed statistical significance. The company is implementing a restructuring that includes an approximate 50 percent reduction in full-time employees and expects to incur a non-recurring charge of between $1.0 million and $1.5 million in the third quarter of 2025. "We had a productive meeting with FDA; while this is not the outcome we had hoped for, we respect FDA's feedback and remain confident in the therapeutic potential of Cylembio," said Mai-Britt Zocca, PhD, CEO of IO Biotech. "We look forward to continuing the dialogue with FDA to align on the design for a potential new registrational study. Additionally, we plan to discuss the data from our IOB-013 study with European regulators and determine a path to submission in the EU." The company plans to design a new registrational study for Cylembio for the treatment of first-line patients with advanced melanoma and currently has capital to run its operations into the first quarter of 2026. IO Biotech is pursuing a pathway to regulatory approval while working to complete ongoing studies of its immune-modulatory, off-the-shelf therapeutic cancer vaccine candidate. Celcuity Inc. (NASDAQ: CELC) will present detailed efficacy and safety data from the PIK3CA wild-type cohort of the pivotal Phase 3 VIKTORIA-1 trial at the European Society of Medical Oncology Congress 2025 in Berlin, Germany. The late breaking abstract has been selected for an oral presentation on October 18, 2025 at 10:15 a.m. CEST in a Proffered Paper Session, with the presentation covering results from gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in patients with HR+/HER2-/PIK3CA wildtype advanced breast cancer. The VIKTORIA-1 trial has completed enrollment and reported topline data for the PIK3CA wild-type cohort, while the company continues enrolling patients for the PIK3CA mutant cohort. Celcuity is also conducting its VIKTORIA-2 Phase 3 trial evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer, along with a Phase 1/2 trial combining gedatolisib with darolutamide in metastatic castration resistant prostate cancer patients. MAIA Biotechnology, Inc. (NYSE American: MAIA) has been awarded a $2.3 million grant by the National Institutes of Health for the expansion of its THIO-101 Phase 2 clinical trial evaluating ateganosine as a third-line treatment for patients with advanced non-small cell lung cancer. The grant, to be distributed over three years from 2025-2027, will support expenses related to enrollment of U.S. patients who are resistant to chemotherapy and immunotherapy, with Parts A and B of THIO-101 demonstrating median overall survival of 17.8 months for 22 patients in third-line treatment compared to 5 to 6 months for standard-of-care chemotherapy treatments. "We are thrilled to receive this prestigious NIH grant for the expansion of our Phase 2 trial," said Vlad Vitoc, M.D., CEO of MAIA Biotechnology. "It's a great honor to have the support of the National Institutes of Health as we seek to further validate the efficacy of our lead agent ateganosine and its potential to be a breakthrough treatment within the vastly underserved NSCLC market. With the clearance of FDA Investigational New Drug (IND) for THIO-101 in 2023, we can begin enrolling U.S. patients in the expansion phase of the trial immediately." The first patient in the expansion of the trial was dosed in July 2025 in Taiwan, with the NIH grant enabling MAIA to access a substantially larger patient pool across multiple continents. Ateganosine is a first-in-class investigational telomere-targeting agent that induces telomerase-dependent telomeric DNA modification and activates both innate and adaptive immune responses, currently being developed as a second or later line of treatment for NSCLC patients who have progressed beyond standard-of-care checkpoint inhibitor regimens. Article Sources: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. This article is being distributed by USA News Group on behalf of Market IQ Media Group Inc. ("MIQ"). MIQ has been paid a fee for GT Biopharma, Inc. advertising and digital media from Creative Digital Media Group ("CDMG"). 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The New York Supreme Court has, on appeal, upheld its original summary judgment ruling in favor of RedHill The New York Supreme Court unequivocally dismissed Kukbo Co. Ltd's ("Kukbo") defense again, further ruling that RedHill had fulfilled its agreement obligations even after Kukbo's breach RedHill has been granted approximately $10 million in total awards comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses (including 9% statutory interest accrual) RALEIGH, N.C., and TEL AVIV, Israel, Sept. 29, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that The New York Supreme Court has, on appeal, upheld its original summary judgment ruling and award in favor of RedHill, unequivocally dismissing, once again, the entirety of Kukbo Co. Ltd's ("Kukbo") defense, ruling that Kukbo was in breach of both the original subscription agreement and subsequent exclusive license agreements with the Company (the "Agreements"). In making its appeal judgment, the New York Supreme Court clearly stated that RedHill had properly fulfilled its obligations according to the Agreements, even after Kukbo's non-payment breach. RedHill has been granted approximately $10 million in total awards from related court actions, comprised of the $8.25 million original award and a subsequent $1.82 million award for legal costs and expenses (including 9% ongoing statutory interest accrual). Kukbo has the right to further appeal the Court's ruling. In addition, to the New York Supreme Court case, RedHill recently won an attachment grant against Kukbo, from Korea's Incheon District Court, providing a court-ordered seizure (attachment) of Kukbo's assets, preventing their disposal prior to judgment enforcement. About RedHill Biopharma RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults[1]. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anti-inflammatory, antiviral, and anticancer activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 study in prostate cancer in combination with darolutamide; (ii) RHB-204, a next-generation optimized formulation of RHB-104, with a planned Phase 2 study for Crohn's disease (based on RHB-104's positive Phase 3 Crohn's disease study results) and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (iv) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a U.S. Phase 3 study for acute gastroenteritis and gastritis and positive results from a U.S. Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. 1. Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information, see: . Logo: Company contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Corporate SOURCE RedHill Biopharma Ltd. 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