Month: December 2025

Medicus Pharma Ltd. Completes Enrolment of Ninety (90) Patients for Phase 2 Clinical Study (SKNJCT-003) to Non-Invasively Treat Basal Cell Carcinoma (BCC) of the Skin

12/29/2025

THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 Excerpt from the Press Release: PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) — Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”),…

Palvella Therapeutics Announces Positive Topline Results from Phase 2 TOIVA Clinical Trial of QTORIN™ 3.9% Rapamycin Anhydrous Gel (QTORIN™ rapamycin) for the Treatment of Cutaneous Venous Malformations, a Serious, Rare Genetic Disease with No FDA-approved Therapies

12/26/2025

73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints,…

Pilatus Biosciences Announces FDA Clearance of IND Application for PLT012, a First-in-Class Anti-CD36 Metabolic Checkpoint Antibody in Solid Tumors

12/25/2025

Excerpt from the Press Release: DOVER, Del. & EPALINGES, Switzerland–(BUSINESS WIRE)–Pilatus Biosciences Inc., a biopharmaceutical company developing novel metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for PLT012, a first-in-class anti-CD36 monoclonal antibody, to enter clinical…

Kenai Therapeutics Announces First Patient Dosed in Phase 1 REPLACE™ Clinical Trial of Neuron Replacement Cell Therapy RNDP-001 for Idiopathic Parkinson’s Disease

12/24/2025

Fast Track designation granted by U.S. FDA Initial safety, tolerability and brain imaging data from the trial are expected in 2026 Excerpt from the Press Release: SAN DIEGO, Dec. 15, 2025 /PRNewswire/ — Kenai Therapeutics, a clinical-stage biotechnology company pioneering next generation approaches to cure neurological conditions, today announced that the first patient has been…

Cullgen Reports Positive Results from Phase 1 Study of its Novel Non-Opioid Product Candidate CG001419 for Pain

12/23/2025

IND filing and initiation of Phase 2 clinical trials on track for 1H 2026 Excerpt from the Press Release: SAN DIEGO, Dec. 12, 2025 (GLOBE NEWSWIRE) — Cullgen Inc. (“Cullgen”), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader therapies, today announced the completion of its Phase 1 clinical…

Happy Holidays From the TrialStat Team

12/22/2025

Marengo to Present Initial Results from Invikafusp Alfa and TRODELVY® Combination Study, STARt-002, at the 2025 San Antonio Breast Cancer Symposium

12/19/2025

Excerpt from the Press Release: CAMBRIDGE, Mass., Dec. 12, 2025 /PRNewswire/ — Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapy for oncology and inflammation & immunology (I&I), today unveiled initial clinical results from its ongoing STARt-002 phase 1b/2 trial during a late breaking presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS)…

BBOT Announces Late-Breaking Preclinical Data on BBO-10203, a First-in-Class RAS:PI3Kα Breaker, at the San Antonio Breast Cancer Symposium (SABCS)

12/18/2025

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) — BridgeBio Oncology Therapeutics, Inc. (“BBOT”) (Nasdaq: BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway malignancies, today announced late-breaking preclinical data on BBO-10203, a first-in-class covalent small molecule RAS:PI3Kα breaker that selectively and specifically blocks the physical interaction between RAS and…

IDEAYA Biosciences Completes Targeted Full Enrollment in Randomized Pivotal Phase 2/3 Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in First-line HLA*A2-Negative Metastatic Uveal Melanoma

12/17/2025

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Dec. 11, 2025 /PRNewswire/ — IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a leading precision medicine oncology company, today announced it has completed its targeted full enrollment of 435 patients in the registration-enabling Phase 2/3 trial (OptimUM-02) evaluating darovasertib, the company’s investigational oral protein kinase C (PKC) inhibitor,…

Arima Genomics Reports New Data at ASH 2025 Supporting More Complete Rearrangement Profiling in DLBCL With Hi-C Technology Used in Aventa Lymphoma

12/16/2025

Largest DLBCL cohort studied to date with a genome-wide structural assay highlights the limitations of target-limited FISH and the added diagnostic context of Hi-C from FFPE tissue Excerpt from the Press Release:. CARLSBAD, Calif.–(BUSINESS WIRE)–Arima Genomics, Inc., a company leveraging whole-genome sequence and structure information to provide comprehensive cancer therapy selection insights, today announced new…