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Unicycive turned away by FDA again over manufacturer’s plant shortfalls

After Unicycive Therapeutics had its drug application for oxylanthanum carbonate (OLC)

Raccontata dafiercepharma.comendpoints.newsbenzinga.com

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fiercepharma.comStai leggendo1 g fa

Unicycive turned away by FDA again over manufacturer’s plant shortfalls

After Unicycive Therapeutics had its drug application for oxylanthanum carbonate (OLC)

originale

endpoints.news1 g fa

Unicycive gets second CRL for kidney drug as manufacturing woes continue

Unicycive's CKD drug oxylanthanum carbonate gets a second FDA rejection over third-party manufacturing issues; shares drop ~50% premarket.

Leggi questa versione → originale

benzinga.com22 h fa

Why Is Unicycive Therapeutics Stock Falling Tuesday? - Unicycive Therapeutics (NASDAQ:UNCY)

Unicycive Therapeutics ($UNCY) stock crashes over 46% as FDA rejects kidney disease drug NDA again over third-party manufacturing issues.

Leggi questa versione → originale

Timeline cronologica

1. lunedì 29 giugno 2026·fiercepharma.com
   

   Look out, Amgen. Here comes Viridian with FDA nod for TED med Lumvoa

   Viridian Therapeutics has scored an FDA

2. martedì 30 giugno 2026·endpoints.news
   

   Unicycive gets second CRL for kidney drug as manufacturing woes continue

   Unicycive's CKD drug oxylanthanum carbonate gets a second FDA rejection over third-party manufacturing issues; shares drop ~50% premarket.

3. martedì 30 giugno 2026·fiercepharma.com
   

   Unicycive turned away by FDA again over manufacturer’s plant shortfalls

   After Unicycive Therapeutics had its drug application for oxylanthanum carbonate (OLC)

4. martedì 30 giugno 2026·benzinga.com
   

   Why Is Unicycive Therapeutics Stock Falling Tuesday? - Unicycive Therapeutics (NASDAQ:UNCY)

   Unicycive Therapeutics ($UNCY) stock crashes over 46% as FDA rejects kidney disease drug NDA again over third-party manufacturing issues.