The FDA has granted orphan drug designation to Nuformix PLC's tranilast lysate candidate for treating idiopathic pulmonary fibrosis. The designation provides regulatory incentives including potential market exclusivity in the US. Nuformix is a London-based developer focused on fibrosis and oncology treatments.
Sagimet Biosciences reported fourth quarter and full year 2025 financial results, announcing plans to initiate a Phase 2 trial of denifanstat and resmetirom combination in F4 MASH patients in the second half of 2026, with a 26-week biomarker readout expected in the first half of 2028.
Altimmune's pemvidutide received FDA Breakthrough Therapy Designation for MASH treatment, with Phase 3 trial initiation planned for 2026. The company raised $75 million in January 2026 to fund development.
Can-Fite BioPharma's drug candidate namodenoson met its primary endpoint in a Phase 2a pancreatic cancer trial and demonstrated anti-obesity effects in a peer-reviewed preclinical study published in the International Journal of Obesity.
Insilico Medicine has formed a strategic partnership with Liquid AI to develop lightweight scientific foundation models for drug discovery and entered a drug development collaboration with China Medical System Holdings targeting CNS and autoimmune diseases.
Drug candidates designed via generative artificial intelligence are achieving a 90% success rate in Phase I safety trials in early 2026, nearly double the historical industry average of approximately 50%, while compressing development timelines from six years to under 18 months.
The FDA has granted Fast Track designation to PLT012, a first-in-class anti-CD36 monoclonal antibody for hepatocellular carcinoma treatment. The Phase 1 trial is currently enrolling patients in Texas.
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|---|---|---|---|
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Copper Supplementation in Cirrhosis |
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ACTIVE_NOT_RECRUITING | |
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COMPLETED | PHASE3 |
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