On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.” Read More
At the Clinical Trials on Alzheimer’s Disease 2025 meeting, a panel of experts discussed the need for developing combination therapies for the complex diseases that result in Alzheimer's disease and other dementias. Read More
Arrakis Therapeutics Inc. has announced the presentation of preclinical data demonstrating the progress of its RNA-targeted small molecule (rSM) drug program for the treatment of myotonic dystrophy type 1 (DM1). Read More
Animate Biosciences Inc. has released new preclinical results demonstrating that AI-designed peptides generated by its Animateiq discovery platform significantly reduced hallmark inflammation and fibrosis signals across multiple human cell types, including skin, lung, heart and liver. Read More
Junevity Inc. has raised $10 million in new funding, bringing its seed financing to a total of $20 million. The new funding will enable Junevity to advance JUN-01, its lead siRNA program for type 2 diabetes and obesity, through IND-enabling and initial clinical studies. Read More
Université de Montréal has disclosed GTPase KRAS G12D mutant inhibitors reported to be useful for the treatment of cancer, inflammatory disorders and immunological disorders. Read More
Previous findings have shown that the bisteric mTORC1 inhibitor Rapalink-1 exerts superior efficacy than the parent inhibitors rapamycin and sapanisertib in orthotopic xenograft models of glioblastoma. The bitopic clinical derivative of this compound is RMC-5552 from Revolution Medicines Inc., which is currently in phase I/II clinical studies for glioblastoma. Read More
LRRK2 plays a key role in the biology of multiple neurodegenerative disorders, including Parkinson’s disease (PD) and progressive supranuclear palsy (PSP), where mutations or altered activity are associated with impaired cellular signaling and neuronal decline. Read More
Vycellix Inc. has successfully completed preclinical development for its universal cell engineering platform (VY-UC) and will now seek clinical trial clearance in Sweden to begin a phase I study of VNK-101, an allogeneic natural killer (NK) cell therapy engineered with VY-UC for relapsed or refractory multiple myeloma. Read More
Zhejiang Yangli Pharmaceutical Technology Co. Ltd. has synthesized thiazole-substituted pyrimidine amine compounds acting as CDK2/cyclin E1 inhibitors reported to be useful for the treatment of cancer. Read More
China Pharmaceutical University and Chongqing Innovation Institute, China Pharmaceutical University have identified compounds acting as stimulator of interferon genes protein (STING; TMEM173) antagonists reported to be useful for the treatment of cancer, fibrosis, infections, inflammation, autoimmune diseases, metabolic disorders, neurological disorders and cardiovascular disorders, among others. Read More
Abilita Therapeutics Inc. has developed a novel approach targeting CCR8 – ABT-863 – that works as a potent inverse agonist to block CCL1-dependent and basal receptor signaling. Read More
Qingdao Putaike Biomedical Technology Co. Ltd. has divulged hydrophobic tag-based degraders comprising heat shock protein 90 (HSP90) ligands covalently linked to an androgen receptor (AR)-targeting moiety through a linker acting as AR degradation inducers reported to be useful for the treatment of acne, androgenic alopecia, hirsutism, metabolic disorders, breast cancer and prostate cancer. Read More
Genescience Pharmaceuticals Co. Ltd. has described salts of known melanocortin MC4 receptor antagonists reported to be useful for the treatment of anorexia nervosa, cachexia, muscle atrophy, nausea and vomiting, sarcopenia, anxiety, bone disorders and inflammatory disorders. Read More
Hypoxic pulmonary hypertension (HPH) is a condition characterized by increased pulmonary artery pressure caused by prolonged exposure to a hypoxic environment. It frequently occurs among individuals residing at high altitudes and those with chronic obstructive pulmonary disease. Read More
