Industry Analysis.
4 articles on industry analysis — analysis from the Asthra team and our advisor network.
2026
First PROTAC Approval Rewrites the Regulatory Playbook for Degraders
FDA's approval of vepdegestrant establishes the first regulatory precedent for PROTAC protein degraders, creating a framework that will shape development strategies across the emerging degrader landscape.
2026
FDA's First Non-Antipsychotic Dementia Agitation Approval Changes Treatment Paradigm
FDA approves Auvelity for Alzheimer's agitation, marking a breakthrough in dementia care. We analyze the regulatory pathway, novel endpoints, and what this means for CNS drug development.
2026
Kymera's KT-621 Fast Track: What Degrader Designations Signal for Respiratory Programs
FDA grants Fast Track to Kymera's IRAK4 degrader KT-621 for eosinophilic asthma. We analyze what this designation reveals about regulatory pathways for targeted protein degradation in respiratory disease.
2026
When Partnerships End, Documentation Inheritance Becomes a Regulatory Burden
Big pharma partnership terminations leave smaller biotechs holding jointly-authored documents that need sponsor re-issue. The regulatory writing burden of these terminations is rarely discussed but significant.
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