June 30, 2026 08:55 AM EDT
PharmaFDA+Manufacturing
Unicycive gets second CRL for kidney drug as manufacturing woes continue
Anna Brown
News Reporter
Unicycive's CKD drug oxylanthanum carbonate gets a second FDA rejection over third-party manufacturing issues; shares drop ~50% premarket.
June 30, 2026 08:55 AM EDT
PharmaFDA+Manufacturing
Unicycive gets second CRL for kidney drug as manufacturing woes continue
Anna Brown
News Reporter

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

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

FDA rejects Sobi’s gout drug over manufacturing issues, sparing Amgen blockbuster

Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms

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

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

After submitting its timed-release version of a decades-old ADHD drug to the FDA nearly a year ago, Kansas City's Cingulate has…

The oral drug, pociredir, was being tested to treat sickle-cell disease, an inherited blood disorder that can trigger pain,…

Sobi’s plan to introduce a challenger to Amgen’s blockbuster gout drug Krystexxa has been put on hold by the FDA. | Sobi’s plan…

More than three years after Gilead Sciences’ hepatitis D drug bulevirtide was rebuffed by the FDA on manufacturing and delivery…