July 8, 2026

The need-to-know this morning

Prime Medicine and Beam Therapeutics have settled a dispute through arbitration that allows Prime to develop a genetic medicine for alpha-1 antitrypsin deficiency, a chronic lung and liver disease.

biotech

FDA clears Vera drug for autoimmune kidney disease

The FDA yesterday granted accelerated approval to Vera Therapeutics' treatment for IgA nephropathy (IgAN), a disease caused by the buildup of immune antibodies in the kidneys that leads to progressive loss of kidney function.

While there already have been therapies on the market for IgAN, kidney function in some patients on those treatments continues to decline, leaving room for more effective therapies that attack the disease in different ways.

This is a competitive field. The FDA approved a competing treatment from Japan’s Otsuka last year, and a third drug from Vertex is expected to secure approval later this year.

oncology

Europe will accelerate its review of RevMed's drug

From STAT's Drew Joseph: European regulators will speed up their review of a closely watched pancreatic cancer drug, a sign of both the interest surrounding the field-changing medicine and the broader efforts by health officials to get paradigm-shifting drugs to patients faster.

The drug, daraxonrasib from Revolution Medicines, roughly doubled overall survival for patients with advanced disease versus chemotherapy, results that have never been seen before in the notoriously difficult-to-treat cancer type. It's led to major demand for the medicine.

In a statement, the European Medicines Agency said it had started a phased review of daraxonrasib, meaning regulators will evaluate data as they become available, instead of waiting for a complete submission. The aim is to shorten the timeline of the review overall.

The agency said that the move is an example of how the E.U.'s ongoing pharmaceutical reforms will encourage more phased reviews, which the EMA said will "allow for a more agile, streamlined evaluation of medicines" and "ultimately lead to earlier patient access to promising treatments." It said that phased reviews will take place going forward on a case-by-case basis when the drug in question is for an unmet medical need or when there's a major public health interest.

In the U.S., meanwhile, the FDA has worked with Revolution to offer the drug to patients through an expanded access program as the regulatory review proceeds.

obesity

Data on Kailera's GLP-1 pill raise tolerability concerns

Kailera reported yesterday that the small molecule GLP-1 pill it's developing was efficacious in a Phase 3 trial conducted in China, but high rates of side effects raise questions about the attractiveness of the treatment.

In the trial, the highest dose of the drug, which Kailera is developing with Chinese company Hengrui Pharma, led to 9.8% weight loss after 44 weeks, compared with 2.4% in the placebo group, when looking at all patients. However, nausea and vomiting each affected about 70% the high-dose group.

Kailera is running a global Phase 2 trial of the drug, and it expects data next year.

The biotech launched in 2024 with significant financing — $400 million. It's not clear, though, if that investment will pay off, particularly as more candidates from other companies get on the market.

More around STAT

Thanks for reading! Until next time,

elaine.chen@statnews.com