Biogen is pushing its experimental Alzheimer’s drug diranersen into Phase 3 trials despite missing the primary dose-response goal in its 416-patient CELIA study, after the lowest tested dose paradoxically delivered the strongest results—slowing cognitive decline on the CDR-SB scale by 26% over 18 months. Unlike traditional antibodies that attempt to clear extracellular tau proteins and have repeatedly failed in Phase 2, the Ionis-licensed antisense oligonucleotide blocks intracellular tau production at the genetic level, achieving a clinical efficacy signal nearly identical to approved anti-amyloid treatments like Leqembi while avoiding their signature brain-swelling side effects. A Trial Designed to Prove Dose Response, and Didn’t Biogen’s CELIA study set out to answer a specific question: would higher doses of diranersen, an experimental therapy that targets the Alzheimer’s-linked protein tau, produce a bigger clinical benefit than lower doses? The 416-patient, 18-month Phase 2 trial tested three regimens of the drug, an antisense oligonucleotide licensed …

Biogen’s Alzheimer’s Tau Drug Splits Experts: Can Diranersen Challenge Leqembi? Read More »

Definium Therapeutics reported positive Phase 3 results for DT120, its LSD-based treatment for generalized anxiety disorder, marking the drug’s second late-stage clinical success in less than two months. A single 100-microgram dose significantly reduced anxiety symptoms compared with placebo in the 214-patient Voyage trial, with benefits emerging within two days and continuing through Week 12. The results strengthen Definium’s late-stage program across anxiety and major depressive disorder as the company prepares additional Phase 3 data and evaluates a potential regulatory path. DT120 remains investigational, and the company must complete further trials and secure FDA approval before the treatment can reach patients. The Voyage Trial, By the Numbers Definium Therapeutics said Wednesday that DT120, its lysergide-based orally disintegrating tablet, met the primary endpoint of Voyage, a Phase 3 trial in generalized anxiety disorder, the company announced. Participants who received a single 100-microgram dose saw their Hamilton Anxiety Rating Scale score fall …

Definium’s Psychedelic Anxiety Drug DT120 Moves Closer to the Mainstream With a Phase 3 Win Read More »

With the continuous evolution of cancer treatments worldwide, precision oncology is experiencing a growing demand. In response, HanchorBio Inc. (TWSE: 7827), a global, clinical-stage biotechnology company dedicated to creating next-generation immunotherapies for cancer and immune-mediated conditions, has revealed a new collaboration. The company is teaming up with a National Taiwan University (NTU) research group led by Professor Sung-Liang Yu from the Department of Clinical Laboratory Sciences and Medical Biotechnology, which plays a vital role in the Taiwan Cancer Moonshot Project (TCMP). This cross-disciplinary alliance was officially established via a memorandum of understanding (MOU) signed on August 7, setting the stage for long-term cooperation aimed at accelerating precision immunotherapy and the development of novel cancer therapeutics. Taiwan Cancer Moonshot Project Drives Asian Tumor Multi-Omics Research Launched in 2016 through a memorandum of understanding with the U.S. National Cancer Institute (NCI), TCMP is a precision-oncology research initiative that joined the US-led Cancer …

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