Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a pharmaceutical company based in Los Altos, California, announced on Monday that it has amended its existing manufacturing and supply agreement with Shilpa Medicare Ltd., an India-based company. The amendment, effective as of Thursday, June 26, 2024, is in response to anticipated increased manufacturing needs for oxylanthanum carbonate (OLC), a drug compound under development.
Under the terms of the amendment, Unicycive has committed to a binding purchase order for OLC tablets, which Shilpa is expected to deliver by June 30, 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026. In support of the increased production, Unicycive will also fund the establishment of a new manufacturing line by Shilpa.
The original agreement between the two companies was signed on October 31, 2020, and outlined Shilpa's responsibilities in providing development, manufacturing, supply, and other chemistry, manufacturing, and controls (CMC)-related services for OLC. With the amendment, the initial term of the agreement is set to continue until the eighth anniversary of the U.S. Food and Drug Administration's (FDA) approval of Unicycive's New Drug Application (NDA) for OLC. Following this period, the agreement will automatically renew for successive four-year terms unless terminated earlier as per the agreement's provisions.
In other recent news, Unicycive Therapeutics has made several notable strides. The company doubled its authorized shares from 200 million to 400 million, a strategic move that could potentially facilitate capital raising, fund new research and development, or enable other corporate activities. In addition, Unicycive reported positive results from its pivotal clinical trial for Oxylanthanum Carbonate (OLC), a potential treatment for hyperphosphatemia in chronic kidney disease patients. The company's CEO, Dr. Shalabh Gupta, stated these results would support a New Drug Application (NDA) submission to the FDA, anticipated in Q3 2024.
The Annual Meeting of Stockholders resulted in the reelection of four directors and the approval of key proposals, including the Nasdaq 20% Issuance Proposal and the Authorized Share Increase Proposal. These developments could pave the way for future financings or corporate activities. Analyst attention towards Unicycive has been noteworthy, with Noble Capital maintaining its Outperform rating on Unicycive shares, and Piper Sandler initiating coverage on Unicycive, assigning an Overweight rating and establishing a price target of $9.00.
The company is expected to report top-line data from a 16-week Phase 2 trial evaluating OLC's tolerability in chronic kidney disease patients on dialysis in the late second quarter of 2024. Furthermore, a New Drug Application for OLC is anticipated by mid-2024, with potential approval by mid-2025. These are recent developments that could influence Unicycive Therapeutics' market position and investor interest.
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