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

false 0001069530 0001069530 2025-12-15 2025-12-15

 

 

 

 

 

 

Pursuant to Section 13 or 15(d) of the

 

 

 

 

 

 

 

(Registrant’s telephone number, including area code)

 

 

 

 

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).

 

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. ☐

 

 

 

Following previously reported communications with the U.S. Food and Drug Administration (“FDA”) regarding Cassava Sciences, Inc.’s (“Cassava” or the “Company”) investigational new drug application (IND) and proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (“TSC”)-related epilepsy, on December 15, 2025, the Company received a formal letter from FDA confirming that the proposed clinical trial is on full clinical hold subject to the Company providing FDA with additional information, including additional pre-clinical data, and modifying the protocol design.

 

Cassava intends to work expeditiously to address the items identified in the letter, however, the Company no longer expects to initiate a proof-of-concept clinical trial for simufilam in TSC-related epilepsy in the first half of 2026 as previously disclosed. The updated timing for initiation of a clinical trial will depend on the Company’s ability to provide the requested information and on satisfactory completion of FDA’s review.

 

 

 

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.