Nov. 12 at 5:35 PM
Unicycive Therapeutics (Nasdaq:
$UNCY ) announced Q3 2025 results and remains on track to resubmit its NDA for oxylanthanum carbonate (OLC) by year-end.
Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/unicycive.
The company reported solid progress on multiple fronts, including resolution of FDA manufacturing concerns, presentation of compelling pill burden reduction data at ASN Kidney Week 2025, and a strengthened balance sheet with
$42.7 million in cash providing runway into 2027. The company’s lead drug candidate OLC demonstrated a 7-fold reduction in pill volume and 2-fold reduction in pill count compared to current phosphate binders, addressing a major patient compliance challenge in dialysis treatment.
Among other highlights from the Q3 report were:
• Successful EU regulatory inspection of third-party manufacturing vendor with no deficiencies identified, supporting path to NDA resubmission
• FDA Type A meeting confirmed single CRL deficiency related to manufacturing vendor, with no issues regarding preclinical, clinical, or safety data
• Potential PDUFA date in first half of 2026 following anticipated NDA resubmission by year-end
Dr. Shalabh Gupta, MD Gupta, CEO of Unicycive, commented, “With a continued commitment to advancing OLC, we are poised to resubmit the NDA for OLC by the end of the year, following positive discussions with the FDA and our third-party manufacturing vendor. Our focus has always been on enhancing the lives of people with hyperphosphatemia, as evidenced by the promising new data presented at ASN Kidney Week 2025 that showcase OLC’s differentiated clinical profile and reduced pill burden compared to currently available phosphate binders.
See today’s press release at https://ir.unicycive.com/news/detail/114/unicycive-therapeutics-announces-third-quarter-2025.
Unicycive Therapeutics is a clinical-stage biotechnology company developing innovative therapies for kidney diseases. The company’s lead investigational treatment, oxylanthanum carbonate, is a novel phosphate-binding agent for treating hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Its second program, UNI-494, targets conditions related to acute kidney injury and has received FDA orphan drug designation for preventing delayed graft function in kidney transplant patients.
Led by CEO Dr. Shalabh Gupta, MD Gupta and a seasoned executive team including CFO John Townsend, EVP Doug Jermasek, EVP Pramod Gupta, Dr. Atul Khare, Ph.D., M.B.A., and Dr. Guru Reddy, Unicycive is committed to addressing unmet needs in kidney disease treatment. Learn more at Unicycive (https://unicycive.com/) and B2i Digital (https://b2idigital.com/).
Disclosure: David Shapiro, CEO of B2i Digital, personally purchased in the open market and currently owns shares of unrestricted UNCY stock, in line with B2i Digital’s practice of investing alongside its Featured Companies. This post is not intended to solicit the sale of UNCY or any security, and it is not intended to offer any opinion on UNCY as an investment. Conduct your own research and consult with your own professional advisors prior to making any investment decisions. See the complete Disclosure in the Risks and Disclosures section of https://b2idigital.com/disclaimer.