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Cocrystal Pharma Inc. (COCP) stock soared more than 75% in Thursday’s pre-market trade after the company’s norovirus infection treatment received Fast Track designation from the U.S. Food and Drug Administration (FDA).
Cocrystal stated that the Fast Track designation for CDI-988 allows for the treatment’s accelerated development and expedited regulatory review.
Cocrystal stated that the Fast Track designation is aimed at facilitating the development of drugs that treat serious conditions and address unmet medical needs, while also accelerating their review process by the FDA.
As a result of this designation, Cocrystal will be able to communicate early and more frequently with the FDA throughout the development of CDI-988. The company stated that this will also allow for a rolling review of a New Drug Application (NDA).
CDI-988 may also qualify for Priority Review at the time of NDA submission.
“We are pleased that the FDA has granted Fast Track designation for CDI-988, marking a significant milestone for Cocrystal and a critical step toward helping patients with norovirus,” said Cocrystal’s co-CEO, Sam Lee.
Lee added that based on the data generated for CDI-988 so far, the company expects the treatment to potentially prevent as well as treat the norovirus infection.
Norovirus is a highly contagious virus that causes acute gastroenteritis. The infection can be serious due to rapid dehydration and is particularly dangerous for young children and the elderly.
“While most people recover within a few days, immunocompromised individuals can experience chronic, long-term norovirus infections that can persist for weeks to years,” Lee added.
Retail sentiment on Stocktwits around Cocrystal Pharma trended in the ‘bullish’ territory at the time of writing, with message volumes at ‘extremely high’ levels.
One bullish user on the platform termed the FDA Fast Track designation as a “big pharma type news for less than $5.”
COCP stock is up 4% year-to-date, but down 28% over the past 12 months. The Vanguard Total Stock Market Index Fund ETF (VTI) is up 17% over the past 12 months, while the Vanguard Extended Market Index Fund ETF (VXF) is up 20%.
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