Autoimmune disease
The FDA is looking at a slew of label expansions this month, including one that could open up home-based treatments for Alzheimer’s disease.
Leading Beeline Medicines’ pipeline is afimetoran, which is in Phase 2 development for systemic lupus erythematosus with data expected later this year.
The deal gets Lilly access to Orna’s in vivo CAR T technology. The biotech’s lead asset, which has yet to start clinical testing, is focused on B cell–driven autoimmune diseases.
With Biogen’s multiple sclerosis portfolio facing more generic pressure than ever, the company is eyeing a busy late-stage pipeline and hunting for deals to build its return to growth.
A Phase III readout in September 2024 for rocatinlimab, on which Amgen and Kyowa Kirin were collaborating in atopic dermatitis, appeared underwhelming to analysts, with Jefferies noting that the data “came in at the lower end of efficacy and expectations.”
Despite falling short of its primary Phase II objective, Nektar plans to push its T cell stimulator rezpeg into Phase III development.
Sanofi bought Dren’s DR-0201 program earlier this year for $600 million upfront and is running two Phase I trials in undisclosed inflammatory indications.
Vyvgart, an FcRn inhibitor already approved for generalized myasthenia gravis, is also being tested in myositis, Sjögren’s disease and the “clinically related” Graves disease.
Generalized myasthenia gravis is Uplizna’s second new indication this year, after the FDA cleared the anti-CD19 antibody for IgG4-related disease in April.
Kezar Life Sciences suffered multiple clinical holds and four patient deaths in a trial testing zetomipzomib for lupus—a program that has since been canned. The company is still pursuing development in autoimmune hepatitis, but recent FDA communications could delay its timeline.
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