July 7, 2025
| Today’s news and insights for biopharma leaders
The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an on-time approval.
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The antibody treatment could compete with Sanofi’s Dupixent and Eli Lilly’s Ebgylss, while offering the potential for less frequent dosing.
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One analyst described Cogent’s data as a “home run scenario” for bezuclastinib, which the company is positioning as a competitor to Blueprint Medicines’ Ayvakit.
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Smarter data. Stronger evidence. Better outcomes. See how top life sciences firms use RWD/RWE to lead.
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UPDATED
The agency is set to decide by September on new therapies from Capricor Therapeutics, Scholar Rock and Ionis, among others.
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Q&A
Industry veteran Catherine Owen Adams expects external innovation will be key to getting the brain-focused drug developer to “the next level.”
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