Abivax, Fulcrum, Convergent, Vera: Readout Newsletter

Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

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Good morning. Today, we’re looking at mixed reactions to a closely watched immunology trial and growing scrutiny of a type of telehealth business model.

The need-to-know this morning

• Vera Therapeutics and the FDA reached an agreement to allow Vera to accelerate the analysis of a confirmatory Phase 3 study involving atacicept, its treatment for the chronic kidney disease IgA nephropathy. The drug is already under review for accelerated approval, with a decision expected by July 7. The new FDA agreement will allow Vera to analyze its Phase 3 study, needed for full approval, in the third quarter, rather than wait for an additional year of data to accrue.

Abivax’s positive data weighed down by cancer concerns

Abivax said yesterday that its experimental treatment for ulcerative colitis showed significant efficacy in a closely watched maintenance trial.

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