已收盤 01-30 16:00:00 美东时间
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BUZZ-U.S. STOCKS ON THE MOVE-Lockheed Martin, ManpowerGroup, Parker-Hannifin, Eikon search string for individual stock moves: STXBZ The Day Ahead newsletter: https://refini.tv/3LI4BU7 The Morning News Call newsletter: https://refini.tv/3dKUyB8 Wall Street looked set for a choppy open on Thursday as
01-29 23:48
BUZZ-U.S. STOCKS ON THE MOVE-Blackstone, Summit, Lockheed Martin Eikon search string for individual stock moves: STXBZ The Day Ahead newsletter: https://refini.tv/3LI4BU7 The Morning News Call newsletter: https://refini.tv/3dKUyB8 Wall Street looked set for a choppy open on Thursday as investors wad
01-29 22:18
BUZZ-Unicycive rises as FDA accepts resubmitted filing for kidney drug ** Shares of drug developer Unicycive Therapeutics UNCY.O rise 9.5% to $7.69 premarket ** Co says FDA accepted for review its resubmitted application for oxylanthanum carbonate, a pill for high phosphate levels in dialysis patien
01-29 20:15
Unicycive Therapeutics announced on January 29, 2026, that the FDA has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. The FDA assigned a PDUFA target date of June 27, 2026, to review the resubmission. The company ended 2025 with $41.3 million in cash, supporting its commercial...
01-29 12:05
Unicycive Therapeutics (UNCY) has resubmitted an NDA to the US FDA for its candidate for hyperphosphatemia in individuals with chronic kidney disease, oxylanthanum carbonate. In late June, the company...
2025-12-30 05:25
The NDA for OLC was resubmitted based on continued progress by the original third-party manufacturing vendor in resolving FDA-cited deficiencies and demonstrating inspection readiness. Unicycive previously discussed
2025-12-29 20:08
Unicycive Therapeutics has resubmitted its NDA for oxylanthanum carbonate (OLC) to the FDA for treating hyperphosphatemia in CKD dialysis patients. The resubmission follows progress by the third-party manufacturer to regain FDA compliance. With adequate funding, the company aims to complete the regulatory process and bring the treatment to market soon. The NDA resubmission aligns with a Type A meeting with the FDA in September 2025, addressing pr...
2025-12-29 12:05
Unicycive Therapeutics, Inc., a biotechnology company focused on developing treatments for kidney diseases, announced that its CEO, Shalabh Gupta, M.D., will participate in two investor events in December. The events include a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025, and a virtual presentation by Noble Capital Markets on December 10, 2025. Links to the webcasts will be available on the company's we...
2025-11-25 12:05
Unicycive Therapeutics ( ($UNCY) ) just unveiled an announcement. On November 1...
2025-11-15 06:34
Unicycive Therapeutics announced its Q3 2025 financial results and business updates, highlighting its plan to resubmit the New Drug Application (NDA) for oxylanthanum carbonate (OLC) by year-end. OLC showed significant reduction in pill burden for hyperphosphatemia patients, with 7x lower volume and 2x fewer pills compared to existing treatments. The company ended Q3 with $42.7 million in cash, expecting runway into 2027. R&D expenses decreased s...
2025-11-12 12:05