Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) is one of the 11 Best All-Time Low Stocks to Buy According to Analysts. On July 12, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) announced that the FDA had issued a Complete Response Letter for its application to approve UX111.
UX111 is a gene therapy to treat patients with Sanfilippo syndrome type A. The CRL means the FDA cannot yet approve UX111. This is due to the issues related to Chemistry, Manufacturing, and Controls (CMC) and findings from facility inspections. These focus on the production process and manufacturing sites. Notably, the FDA did not find problems with the clinical trial data or the quality of the product itself.
A research team in a laboratory peering through microscopes at a biologic product.
Ultragenyx Pharmaceutical Inc. believes these facility and process observations can be addressed soon. The company has already fixed some issues and is working quickly to resolve the rest.
Ultragenyx Pharmaceutical Inc. is a biopharmaceutical company engaged in developing treatments for rare and ultra-rare genetic diseases.
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This article is originally published at Insider Monkey.
