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Cardiovascular—failed late-stage Lp(a) strategy
Novartis’ pelacarsen failed to reduce cardiovascular risk in the Phase 3 HORIZON trial, dealing a blow to one of the most closely watched attempts to lower Lp(a), a cardiovascular risk factor...
Oncology—AbbVie myeloma bispecific hits Phase 3 goals
AbbVie reported Phase 3 success for etentamig, a dual-acting bispecific antibody for multiple myeloma, meeting the trial’s main goal of improving progression outcomes versus standard regimens. The...
Gene therapy manufacturing—stable rAAV producer cell lines
NewBiologix and Synastra Biotechnology agreed to develop a stable producer cell line for Synastra’s investigational Duchenne muscular dystrophy (DMD) AAV gene therapy program. NewBiologix will use...
Biotech finance—$60M series B for first clinical study
Superluminal Medicines secured an oversubscribed $60 million Series B to advance its obesity program toward a first-in-human clinical study. The company said the funding supports continued...
US biotech—NeuShen brain-health drug funding
NeuShen Therapeutics, described as a Shanghai and Boston biotech led by a veteran transpacific drug developer, raised more than $80 million in a Series B to advance three clinical-stage...
Drug delivery / RNA therapeutics—milk-derived vesicles for Alzheimer’s biology
Researchers in Türkiye reported that milk-derived vesicles loaded with miR-126-3p can blunt amyloid-β–driven cellular stress in neurons. The approach targets Alzheimer’s disease biology by...
Oncology platform—bispecific TCR-like antibody targeting PRAME complex
South Korean researchers engineered a new TCR-like bispecific antibody designed to target the PRAME complex as a cancer immunotherapy strategy. The work, published in Cancer Immunology,...
Cardiology—new regimen approvals in China
China’s National Medical Products Administration approved two therapies aimed at reducing acute seasonal and at-home disease burden. Everest Medicines’ Cardamyst, a self-administered nasal spray...
Biomarker / imaging—radiology AI predicts lung adenocarcinoma invasiveness
A Tianjin Chest Hospital team reported a high-resolution radiomics model that predicts invasiveness of pure ground-glass lung adenocarcinoma using CT imaging combined with machine learning. The...
FDA approval – rare neurology
Ionis Pharmaceuticals won U.S. FDA approval for Zanvastro (zilganersen), the first disease-modifying therapy for Alexander disease in both pediatric and adult patients. The antisense RNA therapy...
Late-stage trial failure – cardiovascular risk
Novartis’ pelacarsen failed to reduce cardiovascular death and emergencies in the Phase 3 HORIZON trial, the company disclosed. The experimental therapy, built in partnership with Ionis, targets...
Biotech financing – Series B
Superluminal Medicines closed an oversubscribed $60 million Series B to advance its obesity program into a first clinical study. The company is building next-generation small-molecule...
Gene therapy manufacturing – rAAV cell banks
NewBiologix and Synastra Biotechnology agreed to develop a stable producer cell line for Synastra’s investigational Duchenne muscular dystrophy rAAV gene therapy program. Under the agreement,...
Immunotherapy – PRAME TCR-like bispecific
Scientists in South Korea engineered a new cancer-targeting, TCR-like antibody that binds the PRAME complex, aiming to extend immunotherapy to patients who have lacked effective options. The...
Rare disease – FDA approval and pipeline positioning
Ionis’ Zanvastro approval for Alexander disease also signals how rare neurology programs are being structured to reach the market without commercialization partners. The FDA’s green light...
Oncology – Phase 3 readout
AbbVie reported that its dual-acting bispecific antibody etentamig met the main goal of a Phase 3 trial in multiple myeloma. In the study of 421 patients, etentamig improved survival without...
Dealmaking – European GLP-1 rights
Menarini secured European rights to Gan & Lee’s biweekly GLP-1 receptor agonist bofanglutide in a licensing deal covering 39 countries. Menarini will pay Gan & Lee €62 million upfront with...
Biotech expansion – manufacturing capacity
Watchmaker Genomics expanded manufacturing capacity with a long-term lease for roughly 100,000 square feet at Flatiron Park in Boulder, Colorado. The new site is expected to more than double...
Preclinical therapeutics – oncology supportive care
MD Anderson Cancer Center is set to begin a clinical trial of psilocybin to prevent chemotherapy-induced peripheral neuropathy (CIPN). The trial follows preclinical work reported in Science...
Regulatory approvals
The FDA approved Ionis Pharmaceuticals’ antisense therapy Zanvastro (zilganersen) for Alexander disease in both pediatric and adult patients, establishing the first disease-modifying treatment for...