#biotech

The latest annual survey of Alzheimer’s drug development finds a larger and more diverse clinical pipeline, with more trials, more therapeutic approaches, and a declining share of amyloid-targeted programs.

Johnson & Johnson is discontinuing two CAR-T therapy programs for B-cell lymphoma, pointing to an increasingly crowded treatment landscape shaped by recent approvals in cell therapy and antibody-based drugs.

Three biotech IPOs priced with more than $850 million combined as Avalyn surged in its Nasdaq debut, offering an early signal of renewed investor appetite for the sector.

Summit Therapeutics shares fell sharply after what was described as an apparent statistical miss in part of a Phase 3 trial for ivonescimab, highlighting how little tolerance investors currently have for clinical gray

Axsome Therapeutics says the FDA has approved Auvelity for agitation associated with Alzheimer’s disease, a condition the company says affects up to 76% of patients.

After years of limited treatment options, kidney disease research is moving into a more active phase, with targeted therapies ranging from immunomodulators to genetically defined drugs.

Incyte says its JAK1 inhibitor povorcitinib met goals in twin Phase 3 trials in nonsegmental vitiligo, setting up a regulatory filing and putting fresh attention on the autoimmune skin disorder market.

Intellia has reported what the source material describes as the first Phase 3 success for an in vivo CRISPR therapy, a milestone that could move gene editing inside the body closer to regulatory approval.

Intellia Therapeutics says a gene-editing treatment for hereditary angioedema succeeded in Phase 3, marking what the company describes as the first Phase 3 CRISPR readout and a consequential step for the field.

A pilot trial reported that selectively removing circulating sFlt-1 in women with very preterm preeclampsia was feasible, appeared safe in the study setting, and was associated with modest blood-pressure reductions.

The U.S. FDA has approved Regeneron’s Otarmeni, the first gene therapy cleared for hearing loss caused by OTOF mutations, marking a major milestone for genetic medicine and auditory research.

Isomorphic Labs says it is preparing to enter the clinic with drugs designed using AlphaFold-based AI tools, bringing one of the boldest promises in AI drug discovery closer to a real-world test.

Regeneron says it has secured the first FDA approval for a gene therapy targeting a rare inherited form of hearing loss and plans to offer the treatment free in the United States.

Amgen says longtime executive David Reese, who currently serves as chief technology officer, will retire at the end of June, marking a leadership change inside one of biotech’s largest companies.

A pancreatic cancer drug candidate from Revolution Medicines, daraxonrasib, is being described as one of the most promising developments in decades, with early signs of unusually strong results against a target long seen

A new Breakthrough Prize for the team behind the first gene therapy approved in the United States highlights how a once-experimental field became a clinical reality.

A sparse but telling weekly roundup from Endpoints News points to three pressures shaping biotech right now: regulation, clinical momentum, and investor scrutiny.

OpenAI has introduced GPT-Rosalind, a purpose-built reasoning model for life sciences research, aiming to support tasks from genomics and protein work to hypothesis generation and early drug discovery

Researchers in Sweden report a more reliable way to make insulin-producing cells from human stem cells, with transplanted cells restoring blood sugar control in diabetic mice for months.

Bain Capital has officially launched Beeline Medicines with five assets from Bristol Myers Squibb, creating a new biotech centered on shelved immunology drugs.