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Investing.com - Unicycive Therapeutics Inc (NASDAQ:UNCY) announced that the FDA plans to issue a complete response letter (CRL) for its Oxylanthanum Carbonate (OLC) New Drug Application (NDA). The news has intensified pressure on the stock, which has declined over 31% in the past week, according to InvestingPro data.
The company stated it will immediately seek a Type A meeting with the FDA to align on the best strategy to resolve the remaining issues identified in the CRL. This development follows a June 10 disclosure that an FDA manufacturing inspection of a third-party contractor for its CDMO identified deficiencies in cGMP compliance.
Unicycive previously clarified that the inspection findings did not relate to the Unicycive drug substance itself. The company noted that these compliance issues must be resolved before final labeling discussions with the Agency can begin.
The healthcare technology firm reported it has already produced OLC drug product with a backup vendor that has a long history of successful FDA and international regulatory inspections. This alternative production could potentially support the resolution of the Chemistry, Manufacturing, and Controls (CMC) issues identified in the CRL.
Unicycive disclosed it currently has an unaudited cash balance of approximately $20.7 million, which the company projects will sustain operations into the second half of 2026. With a market capitalization of $62.57 million and a "Weak" overall financial health score according to InvestingPro, investors should closely monitor the company’s cash burn rate.
In other recent news, Unicycive Therapeutics received a Complete Response Letter from the FDA for its Oxylanthanum Carbonate (OLC) treatment, citing deficiencies at a third-party manufacturing vendor. The FDA did not raise concerns about the drug’s pre-clinical, clinical, or safety data. Unicycive has identified a second vendor to address these manufacturing issues and plans to request a Type A meeting with the FDA to discuss next steps. The company reported an unaudited cash balance of approximately $20.7 million, expected to fund operations into the second half of 2026. Additionally, Unicycive announced a 1-for-10 reverse stock split to meet Nasdaq’s minimum bid price requirement, effective June 18, 2025. H.C. Wainwright analysts reiterated a Buy rating on Unicycive stock, maintaining a $9.00 price target despite the manufacturing compliance issue. The analysts noted that they do not foresee a challenge to their core thesis and would consider buying the stock on any weakness. Unicycive remains confident in the potential of OLC, based on extensive clinical and preclinical data, despite the FDA’s current concerns.
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