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Cassava (NASDAQ: SAVA) says key DOJ and SEC probes are closed

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(High)
Filing Sentiment
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Form Type
8-K

Rhea-AI Filing Summary

Cassava Sciences, Inc. reported that the U.S. Department of Justice Fraud Section has closed its inquiry into the company regarding previously disclosed allegations of research misconduct connected to the case United States v. Wang, whose indictment was dismissed with prejudice on October 23, 2025. The company also highlighted that it had earlier resolved negligence-based disclosure charges with the U.S. Securities and Exchange Commission in September 2024 by paying a monetary penalty without admitting or denying the SEC’s allegations. These outcomes conclude the DOJ and SEC investigations of Cassava, allowing management to emphasize a continued focus on developing novel investigational treatments, including simufilam, for central nervous system disorders such as tuberous sclerosis complex-related epilepsy.

Positive

  • Major U.S. investigations concluded: The DOJ Fraud Section closed its inquiry into Cassava, and negligence-based disclosure charges with the SEC were previously settled, ending both agencies’ investigations into the company.
  • Strategic focus reaffirmed: With these matters resolved, Cassava emphasizes continued work on investigational CNS therapies, including simufilam for tuberous sclerosis complex-related epilepsy and potentially other indications.

Negative

  • None.

Insights

Key U.S. DOJ and SEC investigations into Cassava have now concluded.

Cassava Sciences states that the U.S. DOJ Fraud Section has closed its inquiry into allegations of research misconduct tied to the dismissed United States v. Wang indictment. It also previously settled negligence-based disclosure charges with the SEC in September 2024 by paying a monetary penalty without admitting or denying those allegations.

The end of both the DOJ and SEC investigations removes significant legal and regulatory uncertainty around the company’s past disclosures and research conduct, based strictly on the information provided. Management underscores a renewed focus on advancing investigational CNS treatments, including simufilam for tuberous sclerosis complex-related epilepsy, while standard drug development and regulatory risks described in its periodic reports continue to apply.

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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):  February 19, 2026

_______________________________

Cassava Sciences, Inc.

(Exact name of registrant as specified in its charter)

_______________________________

Delaware 001-4190591-1911336
(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification No.)

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

Austin, Texas 78731

(Address of Principal Executive Offices) (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:

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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, $0.001 par valueSAVANASDAQ Capital Market

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

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 7.01. Regulation FD Disclosure.

 

On February 19, 2026, Cassava Sciences, Inc. (the “Company” or “Cassava”) issued a press release related to the matters described in Item 8.01 of this Current Report on Form 8-K. A copy of the press release is attached as Exhibit 99.1 hereto and incorporated into this Item 7.01 by reference.

 

The information furnished in this Item 7.01 and Exhibit 99.1 attached hereto shall not be deemed to be “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of such section, nor shall such information be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.

 

Item 8.01. Other Events.

 

On February 19, 2026, Cassava announced that the U.S. Department of Justice Fraud Section (“DOJ”) informed the Company that it has closed the previously-disclosed inquiry into the Company regarding allegations of research misconduct as described in the indictment in United States v. Wang, 8:24-cr-000211-TDC (D. Md.), which was dismissed with prejudice by DOJ on October 23, 2025.

 

Item 9.01. Financial Statements and Exhibits.
   
Exhibit No. Description
   
99.1 Press Release issued by Cassava Sciences, Inc., dated February 19, 2026
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 

 

SIGNATURE

 

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.

 

 Cassava Sciences, Inc.
 a Delaware corporation
   
  
Date: February 19, 2026By: /s/ Eric J. Schoen        
  Eric J. Schoen
  Chief Financial Officer
  

 

EXHIBIT 99.1

Cassava Announces Closure of U.S. Department of Justice Investigation

AUSTIN, Texas, Feb. 19, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational treatments for central nervous system (CNS) disorders such as Tuberous Sclerosis Complex (TSC)-related epilepsy, today announced that the U.S. Department of Justice Fraud Section (DOJ) has closed its inquiry into the Company regarding allegations of research misconduct as described in the indictment in United States v. Wang, 8:24-cr-000211-TDC (D. Md.). That indictment was dismissed with prejudice by DOJ on October 23, 2025.

As previously disclosed, the Company reached a settlement with the U.S. Securities and Exchange Commission (SEC) of negligence-based disclosure charges in September 2024 and paid a monetary penalty without admitting or denying the SEC’s allegations.

The Company cooperated fully with both the DOJ and SEC investigations. These outcomes end the investigations of the Company by the DOJ and SEC.

“We welcome the resolution of these investigations and remain dedicated to maintaining the trust of all our stakeholders. As we move forward, we will continue to focus our efforts on developing a novel treatment for TSC-related epilepsy,” said Richard J. Barry, President and Chief Executive Officer of Cassava.

About Cassava Sciences, Inc.

Cassava Sciences, Inc. (NASDAQ: SAVA), is a biotechnology company focused on developing novel, investigational treatments, including simufilam, for central nervous system disorders, such as tuberous sclerosis complex (TSC)-related epilepsy, and potentially other indications.

For more information, please visit: https://www.CassavaSciences.com

For More Information Contact:
Investors
Sandya von der Weid
svonderweid@lifesciadvisors.com

Company
Eric Schoen, Chief Financial Officer
(512) 501-2450
ESchoen@CassavaSciences.com
IR@cassavasciences.com

Cautionary Note Regarding Forward-Looking Statements: add a few notes on the paper

This news release contains forward-looking statements. Forward-looking statements may be identified by words such as “anticipate”, “before”, “believe”, “could”, “expect”, “forecast”, “intend”, “may”, ”pending”, “plan”, “possible”, “potential”, “prepares for”, “will”, and other words and terms of similar meaning.

Such statements are based on our current expectations and projections about future events. Such statements speak only as of the date of this news release and are subject to a number of risks, uncertainties and assumptions, including, but not limited to, those risks inherent in drug discovery and development or specific to Cassava Sciences, Inc., as described in the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2024 and Quarterly Report on Form 10-Q for the period ended September 30, 2025, and subsequent reports periodically filed and to be filed with the SEC. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from expectations in any forward-looking statement. In light of these risks, uncertainties and assumptions, the forward-looking statements and events discussed in this news release are inherently uncertain and may not occur, and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely upon forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements. For further information regarding these and other risks related to our business, investors should consult our filings with the SEC, which are available on the SEC's website at www.sec.gov.

All of our pharmaceutical assets under development are investigational product candidates. These have not been approved for use in any medical indication by any regulatory authority in any jurisdiction and their safety, efficacy or other desirable attributes, if any, have not been established in any patient population. Consequently, none of our product candidates is approved or available for sale anywhere in the world.

Our clinical results from earlier-stage clinical trials or preclinical studies may not be indicative of future results from later-stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements or any scientific data we present or publish.

We are in the business of new drug discovery and development. Our research and development activities are long, complex, costly and involve a high degree of risk. Holders of our common stock should carefully read our Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q and any other SEC filings in their entirety, including the risk factors therein. Because risk is fundamental to the process of drug discovery and development, you are cautioned to not invest in our publicly traded securities unless you are prepared to sustain a total loss of the money you have invested.

FAQ

What did Cassava Sciences (SAVA) announce about the DOJ investigation?

Cassava Sciences announced that the U.S. Department of Justice Fraud Section has closed its inquiry into the company regarding allegations of research misconduct. The matter related to an indictment in United States v. Wang, which DOJ dismissed with prejudice on October 23, 2025.

How did the United States v. Wang case relate to Cassava Sciences (SAVA)?

The DOJ inquiry into Cassava concerned allegations of research misconduct described in the indictment in United States v. Wang, 8:24-cr-000211-TDC (D. Md.). That indictment was dismissed with prejudice by the DOJ on October 23, 2025, and the inquiry into Cassava has now been closed.

What was the outcome of Cassava Sciences’ (SAVA) SEC investigation?

Cassava previously reached a settlement with the SEC in September 2024 over negligence-based disclosure charges. The company paid a monetary penalty without admitting or denying the SEC’s allegations, and this resolution, together with the DOJ closure, ends those federal investigations.

Are all DOJ and SEC investigations into Cassava Sciences (SAVA) now resolved?

Yes. Cassava states that the DOJ Fraud Section has closed its inquiry, and it earlier settled negligence-based disclosure charges with the SEC. According to the company, these outcomes end the investigations of Cassava by both the DOJ and the SEC.

What is Cassava Sciences’ (SAVA) business focus after resolving these investigations?

Cassava Sciences remains focused on developing novel, investigational treatments for central nervous system disorders. This includes simufilam and a program targeting tuberous sclerosis complex-related epilepsy, while drug development risks described in its Form 10-K and Form 10-Q filings continue to apply.

Did Cassava Sciences (SAVA) admit wrongdoing in its SEC settlement?

No. Cassava’s disclosure states it settled negligence-based disclosure charges with the SEC in September 2024 by paying a monetary penalty without admitting or denying the SEC’s allegations, following cooperation with both the DOJ and SEC investigations.

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