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Phase 3 momentum and label expansion in multiple myeloma
Johnson & Johnson scored positive Phase 3 results for Talvey (talquetamab-tgvs) when paired with Darzalex Faspro (daratumumab and hyaluronidase-fihj), with data presented in the New England...
FDA-linked product and reimbursement policy changes for Medicare
A new Medicare demonstration pathway would make weight-loss drugs available to adults 65 and older for the first time next month, bypassing a legal prohibition on direct Medicare payment for...
Takeda’s AI-designed psoriasis pill outperforms Sotyktu in Phase 3
Takeda reported that its AI-designed oral psoriasis candidate zasocitinib achieved complete skin clearance in more than 35% of patients at 16 weeks in a Phase 3 study, outperforming Bristol Myers...
Setback in Phase 3 depression program and layoffs
Neumora Therapeutics reported that navacaprant failed to achieve statistical significance in two additional Phase 3 trials for major depressive disorder, Koastal-2 and Koastal-3. With the clean...
RARE disease gene editing in hereditary angioedema—new Phase 3 readouts
Intellia Therapeutics released additional positive data for its in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) in a Phase 3 trial for hereditary angioedema (HAE). The company said...
Diagnostic partnership for CRISPR-based tuberculosis testing in Mexico
IntelliGenome partnered with CTR Scientific to commercialize a CRISPR-based tuberculosis (TB) blood test in Mexico. The firms said CTR Scientific will serve as IntelliGenome’s exclusive...
Biotech capital markets milestone—record IPO for Parabilis
Parabilis Medicines priced what it described as the largest-ever U.S. IPO by a drug developer, raising $770.5 million in gross proceeds. The company sold 33.5 million shares at $20 each (with an...
Digital pathology expansion—AI quality control for throughput scanning
Leica Biosystems expanded availability of its Aperio GT Elite AI-enabled digital pathology scanner across Europe, the Middle East, and Africa after a March U.S. launch. Leica said the system is...
Patent litigation—Amgen ordered to pay after Harbour antibody case
A federal jury in Delaware found that Amgen and its acquired Teneobio willfully infringed an antibody patent owned by Harbour Antibodies, a Dutch subsidiary of China’s Harbour BioMed. The jury...
Regulatory and development turns
Traws Pharma said U.K. regulators issued a “negative review” of its planned human influenza challenge study, forcing the company to defer a phase 2a trial linked to $20 million in funding. The...
Late-stage failures and workforce impact
Neumora Therapeutics reported that its navacaprant program missed in two late-stage studies of major depressive disorder (Koastal-2 and Koastal-3), failing to achieve statistical significance on...
Psoriasis pipeline: head-to-head efficacy signal
Takeda reported Phase 3 psoriasis data for its AI-designed oral drug zasocitinib (TYK2-targeting), claiming it outperformed Bristol Myers Squibb’s Sotyktu in a head-to-head comparison. The company...
Cell therapy: move toward outpatient CAR T
Legend Biotech presented first-in-human data for LB-2501, a CD19/CD20 dual-targeting off-the-shelf CAR T, at EHA2026. Across 12 treated participants with relapsed or refractory B-cell non-Hodgkin...
Rare disease genomics: operational lift from long-read sequencing
Researchers at Radboud University Medical Center and Maastricht University reported early implementation results that long-read genome sequencing (Pacific Biosciences) improves interpretation and...
Oncology: tumor genomics plus ancestry for survival models
A European Society of Human Genetics (ESHG) presentation highlighted how combining genetic ancestry information with tumor mutation profiling can improve survival prediction in cancer. The study...
Public capital markets: biotech IPO record
Parabilis Medicines priced and began trading its IPO at the largest drug-developer offering on record in the U.S., raising $770.5 million in gross proceeds after an upsized share sale. The company...
FDA-related funding: priority review voucher cash
Rocket Pharmaceuticals said it received $180 million from the sale of a rare pediatric disease priority review voucher tied to the accelerated FDA approval of Kresladi in March. Rocket described...
Clinical neuroscience: adaptive DBS for Parkinson’s walking
UCSF researchers introduced adaptive deep brain stimulation (DBS) that changes in real time based on a person’s walking behavior, aiming to improve Parkinson’s symptom control beyond what...
Regulatory policy and access: Virginia PDAB veto
Patient advocates and industry groups praised Virginia Gov. Abigail Spanberger’s veto of Prescription Drug Affordability Board (PDAB) legislation (HB 483 and SB 271). Advocates argued that similar...
Regulatory fast-track and high-value dealmaking
Rocket Pharmaceuticals monetized a rare regulatory asset, selling an FDA pediatric disease priority review voucher tied to the accelerated approval for Kresladi in March. The company disclosed it...