FDA grants breakthrough therapy designation to Spruce's MPS IIIB drug By Investing.com

Spruce Biosciences' tralesinidase alfa received Breakthrough Therapy Designation from the FDA, marking a significant step in treating Sanfilippo syndrome, a rare genetic disorder.

• The U.S. Food and Drug Administration granted Breakthrough Therapy Designation to Spruce Biosciences' enzyme replacement therapy, tralesinidase alfa, on Monday, emphasizing its potential for treating Sanfilippo syndrome.
• Sanfilippo syndrome, also known as MPS IIIB, is a rare genetic disorder that impacts the body's ability to break down certain sugars, leading to severe neurological decline.
• Tralesinidase alfa targets the underlying enzyme deficiency in patients, aiming to improve cerebrospinal fluid levels and overall health outcomes for those affected by MPS IIIB.
• Spruce Biosciences, based in South San Francisco, has a market capitalization of approximately $5 million, positioning it as a small-cap biotech firm within the pharmaceutical landscape.