aibioFDA grants Fast Track designation to CDI-988 for norovirus
Tickers COCP
The oral antiviral candidate gains earlier FDA contact and a possible path to Priority Review, Cocrystal said in an April 2, 2026 release.
Key facts
- Company
- Cocrystal Pharma, Inc. (NASDAQ: COCP)
- News type
- Company Updates
- Primary source
- Cocrystal Pharma, Inc. 8-K (2026-04-02)
Cocrystal Pharma, Inc. (Nasdaq: COCP) said on April 2, 2026 that the U.S. Food and Drug Administration has granted Fast Track designation to CDI-988, its oral, direct-acting protease inhibitor. The release describes CDI-988 as the first oral antiviral candidate being developed for the treatment and prophylaxis of norovirus infection.
What the designation means
According to the release, Fast Track designation is intended to facilitate development and accelerate review for drugs that treat serious conditions and address unmet medical needs. The designation enables early and frequent communication with the FDA throughout development. It allows rolling review of a New Drug Application, and it may qualify a product for Priority Review when the application is submitted. The designation is a regulatory status granted on the basis of the condition and the unmet need. It is not an approval and not a finding that the drug works, and the release says nothing about the FDA's view of the data.
Sam Lee, Ph.D., President and co-Chief Executive Officer, says the company looks forward to more frequent interactions with the FDA. The stated goal is to deliver the first therapeutic and preventive medicine to treat norovirus infections. In the release he says: "Based on compelling data generated to date, we believe that CDI-988 has the potential to both prevent and treat norovirus infection." The release does not present any of that data, and no results from the Phase 1b study are reported.
The clinical program
A Phase 1b norovirus challenge study is underway at Emory University School of Medicine to evaluate CDI-988 in both prevention and treatment. The release says the study will enroll up to 40 healthy adults, a small study. The primary endpoint is a reduction in the incidence of clinical symptoms. The secondary endpoints assess viral shedding, disease severity, safety and pharmacokinetics.
The release says CDI-988 was designed with the company's structure-based drug discovery technology, and that the designation further validates that approach for pan-viral antivirals. CDI-988 was designed as an inhibitor of a highly conserved region of noroviruses, coronaviruses and other 3CL viral proteases.
The disease
The release says norovirus is a leading cause of acute gastroenteritis and is responsible for an estimated 685 million global cases each year, with approximately $60 billion in worldwide economic impact. In the United States, the virus is associated with 21 million infections annually, resulting in around 109,000 hospitalizations, 465,000 emergency department visits and 900 deaths. The release describes norovirus as highly contagious. Dr. Lee also says most people recover within a few days.
In developing nations, the release says, norovirus contributes to as many as 1.1 million hospitalizations and 218,000 pediatric deaths each year. Lee notes that while most people recover within a few days, immunocompromised individuals can have chronic infections that persist for weeks to years.
Financial position
The XBRL data in the company's annual report show research and development expense of $5.1 million for the year ended December 31, 2025, compared with $12.5 million for 2024. The net loss was $8.8 million in 2025, compared with $17.5 million in 2024. Cash used in operations was $8.2 million in 2025, compared with $16.5 million in 2024.
Cash and cash equivalents were $7.0 million at December 31, 2025, compared with $9.9 million at December 31, 2024. That balance is below the $8.2 million used in operations in 2025. The release does not state a cash balance after that date.
What comes next
The release says the company expects more frequent interactions with the FDA as the program moves forward. It also says the Phase 1b study continues. The release does not give dates for an NDA submission or for topline results. It also does not say when the Phase 1b study will complete.