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FDA meeting for zervimesine detailed by Cognition Therapeutics (CGTX)

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

Rhea-AI Filing Summary

Cognition Therapeutics, Inc. filed a current report to note that it has issued a press release about completing a Tye C meeting with the U.S. Food and Drug Administration for its drug candidate zervimesine in dementia with Lewy bodies. The company is furnishing this press release as an exhibit to the report, providing investors with an official update on this regulatory interaction.

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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): January 27, 2026

 

Cognition Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40886   13-4365359
(State or other jurisdiction of
incorporation or organization)
  (Primary Standard Industrial
Classification Code Number)
  (I.R.S. Employer
Identification No.)

 

2500 Westchester Ave.
Purchase
, NY
  10577
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code: (412) 481-2210

 

Not Applicable
(Former name or former address, if changed since last report)

 

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 (see General Instruction A.2. below):

 

¨ 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))

 

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

 

Title of Each Class   Trading Symbol   Name of Exchange on Which
Registered
Common Stock, par value $0.001 per share   CGTX   The Nasdaq Stock Market LLC

 

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

 

Emerging growth company x

 

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. ¨

 

 

 

 

 

 

Item 8.01 Other Events.

 

On January 27, 2026, Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the completion of its Tye C meeting with the U.S. Food and Drug Administration for zervimesine in dementia with Lewy bodies. A copy of the press release is being filed as Exhibit 99.1 hereto.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are being furnished herewith:

 

Exhibit
No.
  Document
99.1   Press Release, dated January 27, 2026
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.

 

  COGNITION THERAPEUTICS, INC.
Date: January 27, 2026    
  By: /s/ Lisa Ricciardi
  Name: Lisa Ricciardi
  Title: President and Chief Executive Officer

 

 

FAQ

What did Cognition Therapeutics, Inc. (CGTX) announce in this 8-K?

Cognition Therapeutics, Inc. reported that it issued a press release announcing the completion of its Tye C meeting with the U.S. Food and Drug Administration for zervimesine in dementia with Lewy bodies.

Which drug candidate is mentioned in Cognition Therapeutics, Inc. (CGTX)'s 8-K filing?

The filing refers to zervimesine, which is being studied for dementia with Lewy bodies.

What regulatory agency did Cognition Therapeutics, Inc. (CGTX) meet with?

The company completed a Tye C meeting with the U.S. Food and Drug Administration.

What exhibit did Cognition Therapeutics, Inc. (CGTX) attach to this 8-K?

The company attached Exhibit 99.1, which is a press release dated January 27, 2026, and Exhibit 104, the Cover Page Interactive Data File.

What is the subject of the press release furnished by Cognition Therapeutics, Inc. (CGTX)?

The press release discusses the completion of a Tye C meeting with the U.S. Food and Drug Administration for zervimesine in dementia with Lewy bodies.

Who signed the Cognition Therapeutics, Inc. (CGTX) 8-K report?

The report was signed by Lisa Ricciardi, President and Chief Executive Officer of Cognition Therapeutics, Inc.

COGNITION THERAPEUTICS INC

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