July 7 - Kalvista’s delayed OK, Apogee’s Dupixent competitor and Cogent’s catalyst

Apogee touts positive data for atopic dermatitis drug; Study results boost Cogent’s case for rare disease drug; 5 FDA decisions to watch in the third quarter of 2025; Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

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Daily Dive

July 7, 2025 | Today’s news and insights for biopharma leaders

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After delay, Kalvista wins FDA OK for drug to treat rare swelling disorder

The company had blamed FDA "resource constraints" for the delay, while a rival drug for hereditary angioedema received an on-time approval.

Apogee touts positive data for atopic dermatitis drug

The antibody treatment could compete with Sanofi’s Dupixent and Eli Lilly’s Ebgylss, while offering the potential for less frequent dosing.

Study results boost Cogent’s case for rare disease drug

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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UPDATED

5 FDA decisions to watch in the third quarter of 2025

The agency is set to decide by September on new therapies from Capricor Therapeutics, Scholar Rock and Ionis, among others.

Q&A

Acadia CEO sets sights on ‘much more assertive’ deals to invigorate pipeline

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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