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Good morning. Today, we have some AI drug development news and an examination of the growing longevity industry.
The need-to-know this morning
- The FDA has pushed back the decision date for AstraZeneca’s experimental breast cancer drug camizestrant, following a negative vote from a group of agency advisers, the company said. The extra time will allow the FDA to review additional analyses that AstraZeneca is providing. FDA advisers took issue with the study design of the pivotal SERENA-6 trial, though European regulators have recommended the drug be approved. AstraZeneca did not specify the new target date for an FDA decision.
- Blackstone Life Sciences, a private equity fund, is providing Apogee Therapeutics with up to $1.3 billion to pay for the Phase 3 development and potential commercialization of zumilokibart, the biotech’s long-acting treatment for atopic dermatitis.
Kailera’s own ‘triple-G’ drug also looks very powerful
Kailera said yesterday that its investigational obesity drug that targets three hormones led to significant weight loss in a Phase 1 study.
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