Yuviwel (navepegritide)

New molecular entityPriority review

Region: 🇺🇸 US
Active substance: navepegritide
Company: Ascendis
Status: Approved
FDA approval: Fri 27 Feb 2026
Designations: New molecular entity, Priority review
Application: NDA219164
Official record: www.accessdata.fda.gov

Regulatory milestones

Mon 21 Dec 2026🇪🇺 Expected EC decisionestimate

Yuviwel (Navepegritide): expected EC decision

Estimated as CHMP opinion (2026-10-15) + 67 days, the standard Commission decision period. Not an official date. · Ascendis Pharma Growth Disorders A/S · source

Thu 15 Oct 2026🇪🇺 CHMP positive opinion

Yuviwel (Navepegritide): CHMP positive opinion

Ascendis Pharma Growth Disorders A/S; Orphan · source

Fri 27 Feb 2026🇺🇸 FDA approval

FDA approves Yuviwel (navepegritide), a new medicine

Ascendis; NDA219164; New molecular entity, Priority review; powder · source

Same substance in other markets

🇪🇺 Yuviwel Opinion · Ascendis Pharma Growth Disorders A/S

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.