Cognition Therapeutics提交8-K:称FDA就路易体痴呆三期研究关键要素确认一致
8-K - COGNITION THERAPEUTICS INC (0001455365) (Filer)
Cognition Therapeutics于2026年10月22日宣布,已收到美国食品药品监督管理局(FDA)的书面反馈,确认双方就路易体痴呆三期研究的关键要素达成一致。公司将相关新闻稿作为8-K附件提交;本材料未列出研究方案细节。
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): October 22, 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 Results of Operations and Financial Condition.
On October 22, 2026, Cognition Therapeutics, Inc. (the “Company”) issued a press release announcing the receipt of written feedback from the U.S. Food and Drug Administration (the “FDA”) confirming alignment on key elements of a Phase 3 study in dementia with Lewy bodies. 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 October 22, 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: October 22, 2026 | ||
| By: | /s/ Lisa Ricciardi | |
| Name: | Lisa Ricciardi | |
| Title: | President and Chief Executive Officer | |
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