Cassava Sciences Inc. filed SEC Form 8-K: Other Events

false 0001069530 0001069530 2025-11-26 2025-11-26

 

 

 

 

 

 

 

 

Pursuant to Section 13 or 15(d) of the

 

 

 

 

 

 

 

 

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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):

 

 

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

 

 

 

Indicate by check mark whether the registrant is an emerging growth company as defined in 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).

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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. ☐

 

 

 

As previously reported, Cassava Sciences, Inc. (the “Company”) has submitted an investigational new drug (“IND”) application to the U.S. Food and Drug Administration (“FDA”) in support of a proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (“TSC”)-related epilepsy.

 

Following an initial notification on November 26, 2025, FDA informed the Company on December 2, 2025, that the agency requires additional information in order to assess the risks to human subjects and to provide sufficient support for the initiation of the proposed clinical study. The Company expects to receive a formal letter from FDA with detailed information regarding the issues identified by FDA and the steps that would need to be taken to address those issues. 

 

Cassava will work collaboratively with FDA to provide the agency with the information it requests. The Company continues to prepare to initiate the proof-of-concept study in the first half of 2026.

 

 

 

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