Unicycive Therapeutics, Inc. engages in the development of treatment for kidney diseases. Its products include UNI-494, Renazorb, and UNI-220. The company was founded by Shalabh Gupta on August 18, 2016 and is headquartered in Los Altos, CA.
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- Unicycive Therapeutics has resubmitted its New Drug Application to the FDA for oxylanthanum carbonate, an investigational oral phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. - The resubmission follows resolution of manufacturing compliance issues by the company's third-party vendor, with the FDA expected to provide a new PDUFA date within 30 days. - The novel nanoparticle-based drug offers potential advantages over existing treatments by reducing pill burden for patients, addressing a significant adherence challenge in the over 450,000 U.S. patients requiring phosphate control medication annually. - Oxylanthanum carbonate is protected by patents extending until 2031, with potential extension to 2035, positioning the company for market exclusivity upon approval.
- Unicycive Therapeutics received U.S. Patent 12,377,082 for UNI-494 to treat chronic kidney disease, extending intellectual property protection until 2040. - UNI-494 is a novel nicotinamide ester derivative that functions as a selective ATP-sensitive mitochondrial potassium channel activator, targeting mitochondrial dysfunction in kidney disease. - The drug has received FDA orphan drug designation for preventing delayed graft function in kidney transplant patients and completed Phase I safety studies in healthy volunteers. - Acute kidney injury affects an estimated 2 million deaths worldwide annually, with survivors at increased risk of developing chronic kidney disease and end-stage renal disease.
- The FDA published more than 200 Complete Response Letters (CRLs) from 2020-2024 for drug applications that were initially rejected but later approved, marking a significant step toward increased regulatory transparency. - Commissioner Marty Makary stated that drug developers have been "playing a guessing game" with FDA navigation, emphasizing the need for greater predictability in the approval process. - The initiative addresses a longstanding issue where sponsors historically avoided mentioning 85% of FDA safety and efficacy concerns when publicly announcing rejections, according to a 2015 FDA analysis. - The letters are now accessible through openFDA, the first centralized database of past CRLs, with redactions for trade secrets and confidential commercial information.
- The FDA has identified manufacturing deficiencies at a third-party vendor for Unicycive Therapeutics' oxylanthanum carbonate, an investigational oral phosphate binder for kidney disease patients on dialysis. - The manufacturing issues have precluded FDA label discussions with the company, though a final decision is still expected by the June 28 PDUFA action date. - Oxylanthanum carbonate uses proprietary nanoparticle technology to deliver high phosphate binding potency while reducing pill burden for patients with hyperphosphatemia. - Unicycive's stock fell 27% in premarket trading following the announcement, as the company works with partners to resolve the FDA's cGMP compliance concerns.
- Unicycive Therapeutics' OLC shows promise in treating hyperphosphatemia by reducing pill burden and adverse events, potentially gaining FDA approval by June 2025. - ORIC Pharmaceuticals' ORIC-944, combined with apalutamide, demonstrates significant PSA level decreases in metastatic castration-resistant prostate cancer patients. - Durability of ORIC-944 responses, with some patients maintaining PSA90 responses for 38 weeks, supports confidence in Oric Pharmaceuticals' strategic advancements. - H.C. Wainwright analyst Ed Arce maintains a Buy rating on Unicycive with a $4.00 price target, while Robert Burns reiterates a Buy rating on Oric with a $21.00 target.
- The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) with a PDUFA target action date of June 28, 2025. - OLC aims to reduce the pill burden for chronic kidney disease (CKD) patients on dialysis who suffer from hyperphosphatemia, potentially improving patient adherence. - Unicycive has a long-term manufacturing agreement with Shilpa Medicare for commercial supply of OLC, anticipating a US market launch in the second half of 2025. - Hyperphosphatemia in CKD patients often requires multiple daily pills; OLC offers a simplified, easier-to-swallow treatment option.
- Unicycive's New Drug Application for oxylanthanum carbonate (OLC) has been accepted by the FDA, with a PDUFA target action date set for June 28, 2025. - Clinical trial data indicates OLC's potential as a preferred treatment option, with 79% of patients favoring it over previous phosphate binders. - UNI-494, Unicycive's second asset, successfully completed Phase 1 trial, showing promise for treating acute kidney injury (AKI).
- Unicycive Therapeutics' oxylanthanum carbonate (OLC) is under FDA review for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. - OLC aims to improve patient adherence with fewer, smaller, and easier-to-swallow pills compared to existing phosphate binders like Takeda's Fosrenol. - Clinical trial data showed that 69% of evaluable patients achieved target serum phosphate levels with OLC at a dose of 500mg three times daily. - The FDA is expected to make a decision on OLC by June 28, potentially marking Unicycive's first approved product in a market with significant unmet needs.
- The FDA has accepted Unicycive Therapeutics' New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. - The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025, for the OLC application. - Unicycive is seeking approval via the 505(b)(2) regulatory pathway, supported by data from three clinical studies and preclinical data. - If approved, OLC could significantly improve the treatment burden for hyperphosphatemia in CKD patients on dialysis, with a potential launch in the second half of 2025.
- The FDA has accepted Unicycive Therapeutics' New Drug Application for Oxylanthanum Carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. - The FDA has set a PDUFA target action date of June 28, 2025, for OLC, a next-generation lanthanum-based phosphate binding agent. - OLC aims to reduce pill burden and improve patient compliance, potentially offering a more convenient treatment option compared to existing therapies. - Clinical data supports OLC's safety and bioequivalence, with Unicycive preparing for a commercial launch in the second half of 2025, pending approval.
