Cocrystal Pharma, Inc. (NASDAQ:COCP) shares are trading higher Thursday after the company announced that it has received Fast Track designation from the FDA for its CDI-988, the first oral antiviral candidate being developed for treatment and prophylaxis of norovirus infection.
- Cocrystal shares are climbing with conviction. Why are COCP shares rallying?
FDA Fast Track Designation Accelerates Development Path
The company said the FDA's Fast Track designation is intended to facilitate development and expedite regulatory review for drugs that treat serious conditions and address unmet medical needs.
The designation allows for more frequent communication with the FDA, rolling review of a New Drug Application and potential eligibility for Priority Review.
CDI-988 is a direct-acting oral protease inhibitor designed to target a highly conserved region of noroviruses, coronaviruses and other 3CL viral proteases.
A Phase 1b norovirus challenge study is currently underway at Emory University School of Medicine to evaluate the candidate for both prevention and treatment of infection.
"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 President and co-CEO Sam Lee.
Norovirus is responsible for an estimated 685 million cases globally each year and carries an approximately $60 billion economic impact, according to the company.
Cocrystal Shares Rise
COCP Price Action: At the time of publication, Cocrystal shares are trading 57.84% higher at $1.61, according to data from Benzinga Pro.
This illustration was generated using artificial intelligence via Midjourney.
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