Jul. 2 at 8:57 PM
Maxim Group analysts released a research note on Unicycive Therapeutics (Nasdaq:
$UNCY) following the company’s Complete Response Letter (CRL) from the FDA regarding its oxylanthanum carbonate (OLC) application.
Unicycive Therapeutics is a B2i Digital Featured Company. View their comprehensive profile at https://b2idigital.com/unicycive.
According to Maxim analyst Jason McCarthy, while the CRL delays commercialization, it “could actually be viewed as a derisking event” because the FDA’s concerns were limited to third-party manufacturing compliance issues rather than the drug’s safety or efficacy data.
Key points from the Maxim analysis:
- The CRL was based solely on cGMP deficiencies at a third-party manufacturing vendor.
- No issues were raised regarding OLC’s preclinical, clinical, or safety data.
- Unicycive had already identified a backup manufacturing vendor as part of its redundancy strategy.
- The company expects to meet with the FDA in a Type A meeting during Q3 2025 to determine next steps.
McCarthy maintains a Buy rating with a
$30 price target, stating that “from a higher level perspective, it seems OLC should gain approval and that’s the key ‘derisking’ takeaway from the CRL.” In the analyst’s opinion, the manufacturing issue represents a regulatory hurdle rather than a fundamental problem with the drug candidate itself. However, the timeline for resolution remains uncertain pending the upcoming FDA meeting.
OLC targets hyperphosphatemia in patients with chronic kidney disease on dialysis, potentially offering a reduced pill burden compared to existing treatments through its proprietary nanoparticle technology. Unicycive’s pipeline also includes UNI-494 for the treatment of Acute Kidney Injury (AKI) which can occur due to complications from illness, infections, dehydration, or certain medications.
Led by CEO Dr. Shalabh Gupta, MD 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 dedicated to its mission of addressing unmet needs in kidney disease treatment.
Please visit Unicycive and B2i Digital to learn more and follow Unicycive as the company advances innovative treatments for kidney disease.
DISCLOSURE: Management of B2i Digital owns shares of unrestricted UNCY stock as of July 2, 2025. The opinions and points outlined in the Maxim Research note are solely those of the analyst. B2i Digital does not verify, validate, confirm or offer any opinions of its own. B2i Digital is solely sharing the highlights from the Maxim Research note as a convenience to interested parties. 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 full disclaimer in the Risks and Disclosures section of https://b2idigital.com/unicycive
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