Priority review

Inluryo plus Verzenio enters after disease progression, adding another treatment choice as competition moves earlier.

And Elio Pharma says its pill for painful light sensitivity has priority review.

We'll look at what the trial measured and what more time in sunlight actually means.

Welcome to the Pharma Closeout for Friday, September eighteenth.

If the Pharma Closeout is how you close out your day, follow the show on Spotify or Apple Podcasts.

That second story is LEO Pharma's Dercimilagen.

LEO says the FDA accepted its application with priority review, targeting a decision by the end of February twenty twenty-seven.

It's a once-daily oral candidate for EPP and XLP, rare disorders in which light exposure can trigger intense pain.

To regulatory watch.

Roche said yesterday that FDA accepted its application to expand Enspryng into MOGAD and granted priority review.

The decision is expected January 10th, twenty-twenty seven.

MOGAD is an antibody-associated inflammatory disease affecting the optic nerves, spinal cord, or brain.

We discussed broad population benefit in March.

Today's advance is the full replicate data and priority review, with AstraZeneca anticipating an FDA decision in the first quarter of 2027.

For competitors, broad trial enrollment and a broad final label are still separate assumptions.

That distinction matters when sizing the opportunity.

And it remains ahead.

The companies still expect the merger to close in November, so the proposed integration itself is also unfinished.

On the regulatory side, Intelia says the FDA accepted its application for LonvoZ, the gene-editing therapy for hereditary angioedema, and granted priority review.

The company reports a March 10, 2027 action date.