Unicycive Therapeutics Enters Alignment With FDA On Path To File New Drug Application For Oxylanthanum Carbonate (OLC)
Portfolio Pulse from Benzinga Newsdesk
Unicycive Therapeutics is planning to file a New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) using the 505(b)(2) regulatory pathway. This pathway allows Unicycive to reference the currently approved drug, Fosrenol.
October 23, 2023 | 11:04 am
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POSITIVE IMPACT
Unicycive Therapeutics' decision to file an NDA for OLC could potentially boost the company's stock as it indicates progress in their drug development pipeline.
The filing of an NDA is a significant step in the drug development process. It indicates that Unicycive believes their drug has enough evidence of being safe and effective to warrant review by the FDA for commercial sale. This progress could be seen positively by investors, potentially leading to an increase in the company's stock price.
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