TuHURA Biosciences, Inc. has announced a comprehensive corporate update that includes progress across three of its major immuno-oncology programs. The update covers the company’s lead asset IFx-2.0, currently in a Phase 3 trial in combination with pembrolizumab for advanced Merkel cell carcinoma; the next-stage development of TBS-2025, a VISTA-blocking monoclonal antibody being advanced for relapsed
Atossa Therapeutics has received Rare Pediatric Disease (RPD) designation from the U.S. Food and Drug Administration for (Z)-Endoxifen in Duchenne muscular dystrophy (DMD), a strategic shift that positions the estrogen receptor modulator for possible use in pediatric neuromuscular disorders. If approved, the program could qualify for a transferable Priority Review Voucher, but the timeline and
Allegria Therapeutics has secured USD 5.1 million in a seed extension financing round led by ALK-Abelló, with additional participation from HighLight Capital, the Lichtsteiner Foundation, and existing backer Forty51 Ventures. The Swiss biotechnology company will use the funds to nominate its first clinical candidate and advance its portfolio of mast cell-modulating therapies for allergy and
TransCode Therapeutics, Inc. and Quantum Leap Healthcare Collaborative have launched a Phase 2a dose-expansion trial of TTX-MC138, an RNA-targeting therapeutic aimed at preventing metastatic recurrence in colorectal cancer patients who are ctDNA-positive after standard curative treatment. The trial is part of the PRE-I-SPY platform and will enroll up to 45 patients in early 2026, led
Sen-Jam Pharmaceutical has disclosed a significant equity-based agreement with TASK Clinical, under which the global contract research organization will fund two-thirds of the Phase 3 trial for SJP-001. The candidate, a first-in-class therapy targeting alcohol-induced inflammation, now becomes one of the few mid-stage biotech programs to receive such substantial CRO-driven capital support. The partnership is
Sōlaria Biō has disclosed new mechanistic data showing that its synbiotic medical food, Bondia, reinforces gut barrier integrity, reduces systemic inflammation, and suppresses osteoclast activity—offering biological insight into the 85 percent improvement in bone density reported in a prior large-scale clinical trial. These results support Bondia’s positioning as a novel intervention for osteopenia and age-related
Neurizon Therapeutics Limited has received clearance from the United States Food and Drug Administration for its investigational therapy NUZ-001 to be included in the HEALEY ALS Platform Trial, a globally recognized adaptive trial framework for amyotrophic lateral sclerosis. The decision formally designates NUZ-001 as Regimen I in the platform, allowing clinical site activation and study
Anixa Biosciences Inc. has reported final Phase 1 results for its investigational breast cancer vaccine targeting the α-lactalbumin protein, showing that the primary endpoints were met and 74 percent of participants demonstrated protocol-defined immune responses. The data were presented at the 2025 San Antonio Breast Cancer Symposium and build the case for a Phase 2
A new phase III clinical trial published in The Lancet has shown that proton therapy significantly improves overall survival and reduces treatment-related toxicities in patients with oropharyngeal cancers compared to traditional photon-based radiation. Conducted across 21 U.S. institutions and led by researchers at the University of Texas MD Anderson Cancer Center, the study is the
Amgen has received approval from the United States Food and Drug Administration for Uplizna (inebilizumab-cdon) to treat adults with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. The greenlight makes Uplizna the first and only CD19-targeted B cell therapy approved for this patient population, introducing a twice-yearly dosing regimen