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Top Biotech News (19 August 2026)

First-of-its-kind narcolepsy drug opens door to new therapies for the brain

Summary:

A first-in-class orexin agonist targets narcolepsy’s biological root, offering transformative symptom relief while opening new possibilities for treating broader neurological and neuropsychiatric disorders.

FDA Approves Tauklarify to Identify Tau Pathology in Patients Being Evaluated for Alzheimer Disease

Summary:

FDA-approved Tauklarify enables PET imaging of Alzheimer’s-associated tau pathology, strengthening early disease evaluation while highlighting the complexities of interpreting tau biomarkers.

Skye and Redx form new entity with $125M to advance fibrosis assets

Summary:

Skye and Redx are combining to launch Fibrx Therapeutics with $125 million, advancing a fibrosis-focused pipeline led by a potential therapy for fibrostenotic Crohn’s disease.

Evaxion scraps solid tumor vaccine to focus on Duke-partnered brain cancer candidate

Summary:

Evaxion is dropping its solid tumor vaccine to prioritize an AI-designed glioblastoma vaccine targeting endogenous retrovirus antigens in partnership with Duke University.

After 2 undisclosed gene therapy deaths, can China’s alternative regulatory path still be trusted?

Summary:

Two undisclosed gene therapy deaths are testing confidence in China’s fast-track investigator-initiated trials, even as new regulations seek to strengthen oversight and transparency.

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