Unicycive Therapeutics Inc Stock Price, News & Analysis

Unicycive Therapeutics (Nasdaq: UNCY) announced significant advancements in its product pipeline, focusing on Renazorb, a nanoparticle-based phosphate binder for Chronic Kidney Disease (CKD). The company is on track to file a New Drug Application (NDA) by the end of 2023 after signing a partnership with Lee’s Pharmaceutical for rights in China. Financially, Unicycive reported a net loss of $3.6 million for Q2 2022, with R&D expenses rising to $1.9 million. The company holds $10.6 million in cash as of June 30, 2022, ensuring funding for ongoing projects.

Unicycive Therapeutics, Inc. (Nasdaq: UNCY) has announced positive findings from a market research study indicating strong prescribing intent for its phosphate binder, Renazorb, pending FDA approval. Conducted by Reason Research, the study revealed nephrologists expect to prescribe Renazorb to 34% of dialysis patients needing phosphate binders. Key unmet needs identified include a lower pill burden and improved patient compliance, with Renazorb potentially addressing these issues. The hyperphosphatemia treatment market exceeds $1 billion in the U.S., presenting a significant commercial opportunity for Renazorb.

Unicycive Therapeutics has entered a partnership with Lee's Pharmaceutical to develop and market Renazorb® for hyperphosphatemia in patients with chronic kidney disease across Asia, including China. Unicycive will receive a $1 million upfront payment, potential milestone payments, and tiered royalties based on sales performance. The agreement capitalizes on Lee’s Pharm’s expertise in the region, where the renal disease market is expanding due to rising chronic kidney disease rates. Renazorb is designed to improve patient compliance by reducing pill burden, a critical factor for effective treatment.

Unicycive Therapeutics, a clinical-stage biotechnology company focused on kidney disease therapies, will present at the JMP Securities Life Sciences Conference on June 16, 2022, at 10:30 am ET. CEO Shalabh Gupta will showcase the company’s innovative treatments, including its lead drug Renazorb for hyperphosphatemia and the new entity UNI-494 for acute kidney injury. The event will be held in New York City, and the presentation will be available via live webcast on the company’s website.

Unicycive Therapeutics has initiated a pivotal clinical bioequivalence study for Renazorb, a phosphate binding agent, to treat hyperphosphatemia in patients with kidney disease. This single study, approved by the FDA, aims to demonstrate pharmacological efficacy compared to Fosrenol. The study will enroll 64 participants and evaluate urinary phosphate excretion changes. Previous trials showed Renazorb was safe and effective at reducing urine phosphate, addressing a significant unmet need in a market exceeding $1 billion. Unicycive is also preparing for commercialization.

Unicycive Therapeutics (Nasdaq: UNCY) reported its financial results for Q1 2022, revealing a net loss of $3.5 million ($0.24 per share), up from $1.0 million ($0.11 per share) in Q1 2021. Research and development expenses rose to $1.9 million, mainly due to ongoing drug development for Renazorb and UNI-494. The company is set to begin a bioequivalence study for Renazorb in Q2 2022 and anticipates filing a 505(b)(2) NDA. With $13.6 million in cash, Unicycive is adequately funded for upcoming milestones, including the clinical trial for UNI-494 planned for later in 2022.

Unicycive Therapeutics (Nasdaq: UNCY) announced a Key Opinion Leader (KOL) Event featuring Dr. Glenn Chertow from Stanford University on April 20, 2022. The event, titled “Novel Treatments in Kidney Disease,” aims to discuss innovative therapies for kidney disease, particularly hyperphosphatemia affecting over 500,000 chronic kidney disease patients in the U.S. Unicycive is developing Renazorb, a phosphate binder, and a pro-drug of nicorandil for treating both acute and chronic kidney conditions. The live webcast will be available for 90 days post-event.

Unicycive Therapeutics (Nasdaq: UNCY) reported its financial results for 2021, highlighting significant progress in clinical development. The FDA confirmed a regulatory pathway for its lead product, Renazorb, aimed at treating hyperphosphatemia in chronic kidney disease patients. The company plans to initiate a clinical bioequivalence study in healthy volunteers in Q2 2022. R&D expenses rose to $6.1 million from $1.0 million in 2020, while the net loss increased to $10.0 million, or $0.86 per share. Cash and equivalents stood at $16.6 million as of December 31, 2021.