[8-K] CASSAVA SCIENCES INC Reports Material Event

Rhea-AI Filing Summary

Cassava Sciences, Inc. reports that the U.S. Food and Drug Administration has placed its proposed proof-of-concept clinical trial of simufilam in tuberous sclerosis complex (TSC)-related epilepsy on a full clinical hold. FDA’s letter requires Cassava to provide additional information, including more pre-clinical data, and to modify the trial’s protocol design before the study can proceed. Cassava plans to work expeditiously to address FDA’s comments, but it no longer expects to start this TSC-related epilepsy trial in the first half of 2026 as previously disclosed. The timing for starting a trial will depend on the company’s ability to provide the requested information and on FDA completing its review to the agency’s satisfaction.

Positive

• None.

Negative

• FDA full clinical hold on TSC-related epilepsy trial – FDA has placed Cassava’s proposed proof-of-concept clinical trial of simufilam in TSC-related epilepsy on full clinical hold pending additional information and protocol changes.
• Delay to previously expected 2026 trial start – Cassava no longer expects to initiate the TSC-related epilepsy simufilam trial in the first half of 2026; future timing depends on providing FDA’s requested data and completion of FDA’s review.

Insights

Biopharma regulatory and clinical development analyst

FDA full clinical hold delays Cassava’s simufilam trial in TSC-related epilepsy.

Cassava Sciences discloses that FDA has placed its planned proof-of-concept trial of simufilam in TSC-related epilepsy on a full clinical hold. FDA is asking for additional information, including more pre-clinical data, and changes to the protocol design before the study can begin. A full clinical hold means the trial cannot start until FDA’s concerns are resolved.

The company states it intends to work expeditiously to address FDA’s letter, but it no longer expects to initiate the TSC-related epilepsy trial in the first half of 2026 as previously disclosed. The new start date will depend both on how quickly Cassava can generate and submit the requested information and on FDA’s subsequent review and determination.

For investors focused on the breadth of simufilam’s development program, this update signals that the TSC-related epilepsy indication faces additional regulatory and scientific work before clinical testing can proceed. Future company disclosures around satisfying FDA’s information requests and any change in the clinical hold status will be important markers for the status of this specific program.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 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) December 15, 2025

Cassava Sciences, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-41905	91-1911336
(State or other jurisdiction of incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

6801 N Capital of Texas Highway, Building 1; Suite 300

Austin, Texas 78731

(Address of principal executive offices, including zip code)

(512) 501-2444

(Registrant’s telephone number, including area code)

(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 communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17CFR 240.14d-2(b))
☐	Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17CFR 240.13e-4(c))

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

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.001 par value		SAVA		NASDAQ Capital Market

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. ☐

Item 8.01. Other Events.

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.

SIGNATURE

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.

	CASSAVA SCIENCES, INC.
	a Delaware corporation
Date: December 18, 2025
	By:	/s/ Eric J. Schoen
		Eric J. Schoen
		Chief Financial Officer

FAQ

What did Cassava Sciences (SAVA) announce about its simufilam trial in TSC-related epilepsy?

Cassava Sciences reported that the U.S. Food and Drug Administration placed its proposed proof-of-concept clinical trial of simufilam in TSC-related epilepsy on a full clinical hold, based on a formal FDA letter received on December 15, 2025.

Why did FDA place Cassava Sciences’ TSC-related epilepsy trial on full clinical hold?

FDA’s letter states that the trial is on full clinical hold subject to Cassava providing additional information, including more pre-clinical data, and modifying the protocol design for the proposed proof-of-concept study.

How does the FDA clinical hold affect the timing of Cassava Sciences’ TSC-related epilepsy trial?

Due to the full clinical hold, Cassava no longer expects to initiate the proof-of-concept simufilam trial in TSC-related epilepsy in the first half of 2026 as it had previously disclosed.

What needs to happen before Cassava Sciences can start the simufilam TSC-related epilepsy trial?

Cassava must provide the additional information requested by FDA, including extra pre-clinical data, and modify the protocol design. The trial’s initiation will then depend on satisfactory completion of FDA’s review of those materials.

What is Cassava Sciences’ stated plan in response to FDA’s full clinical hold?

Cassava states that it intends to work expeditiously to address all items identified in FDA’s letter so that a proof-of-concept clinical trial of simufilam in TSC-related epilepsy can potentially proceed after FDA review.

Does this update affect Cassava Sciences’ status as a public company?

No structural listing changes are disclosed. The filing notes that Cassava Sciences’ common stock, par value $0.001 per share, trades on the NASDAQ Capital Market under the symbol SAVA.