重大事件即時報告 8-K 2026-05-21

Cognition Therapeutics完成FDA會議，推進zervimesine治療路易體痴呆精神病臨床開發

AI 繁中摘要

Cognition Therapeutics（納斯達克代號：CGTX）於2026年5月21日提交8-K表格，宣佈已完成與美國FDA就zervimesine用於治療伴隨精神病症狀的路易體痴呆（DLB）患者的會議。公司同日發佈新聞稿詳細說明會議結果。

zervimesine是Cognition Therapeutics開發的候選藥物，針對神經退行性疾病中的突觸毒性機制。本次FDA會議為該藥物在DLB合併精神病患者中的臨床開發路徑提供監管意見，有助於釐清後續研究設計及潛在加速審批方向。管理層認為，與FDA的積極溝通是推進該適應症的重要里程碑，有望降低開發不確定性。

對投資者而言，此8-K顯示公司核心管線獲得監管機構關注，若未來臨床數據正面，zervimesine有機會填補DLB精神病治療的未滿足需求。惟仍需注意臨床試驗風險及資金需求。公司為新興成長型企業，採用較長過渡期遵守新會計準則。

展開英文正文

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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): May 21, 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)
  
 (Commission File 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 May 21, 2026,
Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the completion of its meeting with the
U.S. Food and Drug Administration for zervimesine in dementia with Lewy bodies patients with psychosis. A copy of the Company’s
press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits
are being furnished herewith:

 

 
 Exhibit

No.
  
 Document

 
 99.1
  
 Press Release, dated May 21, 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: May 21, 2026
  
  

 
  
 By:
 /s/ Lisa Ricciardi

 
  
 Name:
 Lisa Ricciardi

 
  
 Title:
 President and Chief Executive Officer