Cancer Research

Candid Therapeutics Plans to Initiate Multiple Phase 2 Studies Following Promising Clinical Data of T-cell Engagers in Autoimmune Diseases

01/13/2026

Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Candid Therapeutics, Inc. (“Candid”), a clinical-stage biotechnology company redefining the treatment of autoimmune and inflammatory diseases through novel T-cell engagers (TCEs), today announced continued clinical progress with cizutamig (BCMA TCE) and CND261 (CD20 TCE). Clinical evaluation is ongoing under multiple active INDs, investigator-initiated trials and compassionate use across…

Zenas BioPharma Announces Positive Results from Phase 3 INDIGO Registrational Trial of Obexelimab in Immunoglobulin G4-Related Disease (IgG4-RD)

01/12/2026

– Obexelimab met the primary endpoint demonstrating a clinically meaningful and highly statistically significant 56% reduction in risk of IgG4-RD flare – – Obexelimab also met and demonstrated statistically significant activity on all four key secondary efficacy endpoints – – Obexelimab was well tolerated and no new safety signals were observed – – Zenas anticipates…

Neumora Therapeutics Announces Positive Results from NMRA-511 Phase 1b Signal-Seeking Study in Alzheimer’s Disease Agitation

01/07/2026

NMRA-511 demonstrated a 15.7 reduction on mean CMAI total score, representing a clinically meaningful effect  NMRA-511 demonstrated unsurpassed clinical effect size on CMAI total score in a pre-specified population with elevated anxiety NMRA-511 demonstrated a favorable tolerability and safety profile Neumora plans to evaluate higher doses of NMRA-511 via initiation of a multiple ascending dose…

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,…

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…

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)…

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,…

Estrella Advances STARLIGHT-1 Trial into Phase II Following Positive DSMB Recommendation

12/09/2025

Excerpt from the Press Release: EMERYVILLE, Calif.–(BUSINESS WIRE)–Estrella Immunopharma, Inc. (NASDAQ: ESLA) (“Estrella” or the “Company”), a clinical stage biopharmaceutical company developing CD19 and CD22-targeted ARTEMIS® T-cell therapies to treat cancer and autoimmune diseases, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its review of safety data from the Phase I…

Kelonia Therapeutics Announces Late-Breaking Oral Presentation of First-in-Human Data from in vivo BCMA CAR-T Therapy at the American Society of Hematology (ASH) 2025 Annual Meeting

12/08/2025

Early results from the Phase 1 inMMyCAR™ study demonstrate ongoing MRD-negative responses in all patients with a tolerable safety profile Robust CAR-T cell expansion occurred in the absence of preparative chemotherapy Persistent, memory CAR-T cells in all patients Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Kelonia Therapeutics, Inc., a clinical-stage biotechnology company pioneering in vivo gene…