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Cocrystal Pharma (NASDAQ: COCP) advances CDI-988 into Phase 1b norovirus human challenge study

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Cocrystal Pharma, Inc. reported that an Institutional Review Board at Emory University School of Medicine has approved initiation of a Phase 1b human challenge study with its compound CDI-988. The planned study is designed to evaluate CDI-988 both as a preventive and as a treatment for norovirus infections, a common cause of viral gastroenteritis. The company disclosed this development via a press release furnished as an exhibit to the report.

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Insights

IRB approval advances CDI-988 into a Phase 1b human challenge study for norovirus.

Cocrystal Pharma obtained Institutional Review Board approval at Emory University School of Medicine to start a Phase 1b human challenge study of CDI-988. A human challenge study intentionally exposes volunteers to a pathogen under controlled settings, which can generate detailed early data on how a candidate performs for both prevention and treatment.

The study focuses on CDI-988 in the context of norovirus infections, indicating continued progression of this program in the clinic. While no efficacy or safety results are provided, the step from earlier work to a Phase 1b design suggests the program met prior internal and regulatory prerequisites.

Future disclosures related to this Phase 1b study, including any interim or final data that the company may release in later filings or press releases, will be important to understand CDI-988’s potential role in preventing and treating norovirus.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): December 18, 2025

 

Cocrystal Pharma, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-38418   35-2528215

(State or other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

19805 N. Creek Parkway

Bothell, WA

  98011
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (877) 262-7123

 

(Former name or former address, if changed since last report.): n/a

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   COCP  

The Nasdaq Stock Market, LLC

(The Nasdaq Capital Market)

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On December 18, 2025, Cocrystal Pharma, Inc. (the “Company”) issued a press release announcing the approval from the Institutional Review Board at Emory University School of Medicine to initiate a Phase 1b human challenge study with CDI-988. This study aims to evaluate CDI-988 as both a preventive and treatment for norovirus infections. A copy of the press release is furnished as Exhibit 99.1.

 

The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities under such section, and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Exchange Act.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit   Description
99.1   Press Release dated December 18, 2025
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Cocrystal Pharma, Inc.
     
Date: December 18, 2025 By: /s/ James Martin
  Name: James Martin
  Title: Co-Chief Executive Officer and Chief Financial Officer

 

 

 

 

FAQ

What did Cocrystal Pharma (COCP) disclose in this 8-K filing?

Cocrystal Pharma reported that an Institutional Review Board at Emory University School of Medicine approved initiation of a Phase 1b human challenge study with its drug candidate CDI-988 for norovirus.

What is CDI-988 being studied for at Cocrystal Pharma (COCP)?

The Phase 1b human challenge study is designed to evaluate CDI-988 as both a preventive and a treatment for norovirus infections.

Which institution approved the CDI-988 Phase 1b human challenge study for Cocrystal Pharma (COCP)?

The Institutional Review Board at Emory University School of Medicine granted approval to initiate the Phase 1b human challenge study with CDI-988.

Does this Cocrystal Pharma (COCP) 8-K filing include clinical results for CDI-988?

No clinical results are described. The disclosure focuses on approval to initiate a Phase 1b human challenge study of CDI-988 for norovirus.

How did Cocrystal Pharma (COCP) communicate the CDI-988 update to the public?

The company issued a press release dated December 18, 2025, which is furnished as Exhibit 99.1 to the report.

Is the CDI-988 Phase 1b study information considered filed for liability purposes?

No. The company states that the information in Item 7.01, including Exhibit 99.1, is furnished and not deemed filed for purposes of Section 18 of the Exchange Act.

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