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Cassava Sciences GAAP EPS of -$0.26

wpadmin — Thu, 12 Mar 2026 19:05:05 +0000

Cassava Sciences press release (FLNA): Q4 GAAP EPS of -$0.26.
Net cash used in operations was $32.3 million in 2025, consistent with previous guidance.

The Company met cash guidance for year-end 2025, reporting $95.5 million, and estimates cash at June 30, 2026 in a range from $47 to $50 million. The Company estimates net cash use in operations for first half of 2026 in a range from $14 to $17 million, plus a payment of a $31.25 million estimated loss contingency related to the potential settlement of certain securities litigation recorded in 2025.

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Cassava Sciences to rebrand to Filana Therapeutics

wpadmin — Tue, 10 Mar 2026 12:09:34 +0000

Cassava Sciences (SAVA) said it will change its name to Filana Therapeutics, reflecting its focus on developing drugs that target the filamin A protein to treat central nervous system disorders.

The company is working on therapies for conditions such as tuberous sclerosis complex-related epilepsy and other diseases linked to abnormal filamin A activity.

The company’s shares will begin trading under the new ticker FLNA on the Nasdaq Capital Market starting March 11, 2026.

“The launch of Filana Therapeutics represents a new beginning for our Company. Growing evidence suggests that filamin A is an important regulator of neuronal development and that modulating filamin A may provide a new approach to treating CNS disorders such as TSC-related epilepsy. Centering our identity on filamin A reflects our dedication to rigorous scientific discovery and to bringing new treatment options to patients and their families,” said Rick Barry, president and chief executive officer of Filana Therapeutics.

SAVA shares rose +2.4% premarket at $2.17.

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Cassava says DoJ has ended probe into research misconduct

wpadmin — Thu, 19 Feb 2026 13:42:09 +0000

Cassava Sciences (SAVA) announced on Thursday that the Fraud Section of the U.S. Department of Justice has closed an investigation into the company over allegations related to its research misconduct.

In July 2022, Reuters reported that the DoJ opened a criminal investigation into whether Austin, Texas-based Cassava (SAVA) manipulated research results for its experimental Alzheimer’s drug candidate, simufilam.

In 2024, a federal grand jury in Maryland indicted Hoau-Yan Wang, a company-paid consultant and CUNY School of Medicine professor, for fraudulently seeking NIH funds with falsified data related to simufilam.

The company said that the DOJ had dismissed the indictment with prejudice on Oct. 23.

Additionally, in September 2024, Cassava (SAVA) agreed to pay $40M to resolve allegations made by the SEC that the drug developer made misleading claims about Phase 2b trial data for simufilam in Alzheimer’s.

“The Company cooperated fully with both the DOJ and SEC investigations,” SAVA said, adding that “these outcomes end the investigations of the Company by the DOJ and SEC.”

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Cassava Sciences to pay $31.25M to settle securities class action suit

wpadmin — Tue, 23 Dec 2025 13:38:27 +0000

Cassava Sciences (SAVA) announced on Tuesday that it agreed to pay $31.25M to settle a class action lawsuit pending in a Texas District Court over the company’s alleged violations of the federal securities laws.
The case filed in the U.S. District Court for the Western District of Texas, Austin Division, in 2021 relied on allegations contained in Citizen Petitions submitted to the FDA regarding Cassava’s (SAVA) lead asset, simufilam.
In November 2024, the company suffered a late-stage trial setback for the once high-flying oral therapy targeted at Alzheimer’s disease.
“The settlement is not an admission of fault or wrongdoing by the Company,” Cassava (SAVA) said, adding that it has recorded a $31.25M provision in Q2 2025 to recognize a potential loss contingency related to the case.

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Cassava Sciences drops on delay for epilepsy study

wpadmin — Fri, 19 Dec 2025 12:27:38 +0000

Cassava Sciences (SAVA) fell ~14% in the premarket on Friday after the company said it will be forced to delay a clinical trial for its lead candidate, simufilam, for a form of epilepsy, as it moves to address several concerns raised by the U.S. FDA.

The setback relates to a proof-of-concept clinical trial for simufilam in tuberous sclerosis complex (“TSC”)-related epilepsy, for which the company has submitted an investigational new drug application seeking regulatory clearance for its initiation.

In an SEC filing on Thursday, the Austin, Texas-based biopharma added that the FDA has sent it a formal letter regarding the IND, noting that the proposed study is on full clinical hold pending further information, such as additional preclinical data from the company.

Cassava (SAVA) said it “intends to work expeditiously to address” the FDA’s concerns, and as a result, it no longer expects to begin the trial in H1 2026 as previously disclosed.

The company has already phased out its Alzheimer’s disease development program for simufilam following a late-stage trial setback for the oral therapy.

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Cassava Sciences hit with FDA request for more data on simufilam trial

wpadmin — Wed, 03 Dec 2025 12:21:54 +0000

Cassava Sciences (SAVA) said in a filing the FDA has asked for more information before allowing its investigational new drug application for simufilam in tuberous sclerosis complex-related epilepsy to move forward.
The agency needs additional details to evaluate potential risks and support the start of the proposed clinical study.
Cassava expects a formal letter outlining the FDA’s concerns and the steps required to address them. The company still aims to begin its proof-of-concept trial in the first half of 2026.
SAVA shares initially dropped as much as 13% premarket before recovering to trade up 1%.

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Cassava Sciences rises 10% after market close on CEO stock buy

wpadmin — Mon, 24 Nov 2025 22:51:38 +0000

Cassava Sciences has popped 10% in after-market-close trading Monday following an SEC filing indicated that CEO Richard Barry acquired a large number of shares on Nov. 20 worth ~$414K.
Through a trust, Barry purchased 150k shares at an average price of $4.76. He now owns just over 938K shares.

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Cassava Sciences spikes as CEO buys stock

wpadmin — Fri, 21 Nov 2025 12:37:56 +0000

Shares of Cassava Sciences (SAVA) added ~5% in the premarket on Friday after Richard Barry, President and Chief Executive Officer of the Alzheimer’s drug developer, purchased company stock after nearly two months.
Barry, who took over the company’s leadership in July 2024 following the resignation of former CEO Remi Barbier, has bought approximately 73.4K shares of Cassava (SAVA) for $2.75 apiece in a transaction worth nearly $201.8K, according to a regulatory filing on Thursday.
The deal conducted on Wednesday has raised Barry’s ownership stake in the company to more than 788K shares, following two other insider purchases in September for nearly 245.1K SAVA shares.
The Austin, Texas-based biotech has lost nearly 90% of its value over the past 12 months as the company moved to discontinue its research program for its lead asset, simufilam, in Alzheimer’s disease following multiple trial setbacks.

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Cassava Sciences files $200M mixed securities shelf

wpadmin — Thu, 13 Nov 2025 11:37:47 +0000

Cassava Sciences (SAVA) has filed a shelf registration statement with the SEC to offer up to $200 million worth of mixed securities, including common stock, preferred stock, depository shares, warrants, rights, debt securities, and units.
This registration statement also includes an “at the market offering” prospectus supplement covering the offering of up to $50M of SAVA common stock that may be issued and sold under a sales agreement with Cantor Fitzgerald & Co.

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Cassava says court dismisses criminal case against scientist

wpadmin — Fri, 24 Oct 2025 12:43:07 +0000

Cassava Sciences (NASDAQ:SAVA) shares rose as much as 6% premarket on Friday after a U.S. court dismissed a criminal case against Hoau-Yan Wang, a former scientific collaborator and advisor who conducted foundational research relating to the company’s investigational drug, Simufilam.

On October 23, 2025, the United States District Court for the District of Maryland granted the United States’ unopposed motion to dismiss with prejudice the criminal indictment against Wang. The order permanently terminates the case, and future charges related to the dismissed indictment cannot be refiled.

Wang was accused of submitting false information in grant applications to the U.S. National Institutes of Health (NIH) and manipulating research results, including Western Blot images.

The charges stemmed from a Maryland grand jury indictment that accused Wang, a CUNY School of Medicine professor and paid consultant to Cassava, of falsifying data related to Cassava’s lead asset, simufilam, which was then being studied for Alzheimer’s disease. The allegedly fabricated data was used to support applications for NIH grants, which resulted in Cassava receiving about $16 million in funding, according to the indictment.

The pharma firm announced plans to discontinue its research program for simufilam in Alzheimer’s disease by the end of the second quarter this year following a failure in a second late-stage trial for the oral small molecule. It has started preclinical studies for the drug in Tuberous Sclerosis Complex (TSC)-related epilepsy and is continuing cost reduction efforts.

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