Unicycive Therapeutics outlines oxylanthanum carbonate program for hyperphosphatemia in dialysis patients
Reuters2026/09/09 19:03- Unicycive outlined near-term plans to resubmit the NDA for oxylanthanum carbonate, its lead program for hyperphosphatemia in dialysis patients.
- FDA discussions center on a pending inspection of a third-party manufacturing vendor cited for deficiencies in a complete response letter.
- Approval is expected in the near term if the NDA is resubmitted and manufacturing issues are cleared; cash runway is projected into 2027.
- The company reiterated a US hyperphosphatemia market opportunity of more than USD 1 billion, citing roughly 450,000 dialysis patients using binders.
- Pivotal study results highlighted 91% phosphate control in maintenance and 69% hitting target at ≤1,500 mg/day, with 6% discontinuations.
Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.
You may also like
Hassett: Trump's $5,000 plan "can be achieved in a fiscally responsible manner," and if rates are raised, "the President will have something to say"
White House National Economic Council (NEC) Director Hassett characterized the proposal as a "serious proposal," stating that "it can be achieved in a fiscally responsible manner," and that offset programs would need to be negotiated with Congress. He noted that the proposal could advance through the budget reconciliation process, thereby bypassing minority party obstruction. Hassett also remarked, "I guess if the Federal Reserve takes significant action, the President will have something to say about it."
Lifecare completes Ocean TuniCell acquisition, lifts stake to 86.7%
HII wins USD 336 million U.S. Navy contract for CVN 82 long-lead materials
Egrag Crypto Updates the Full XRP Elliott Wave Price Targets
Crypto prices
More
