Cassava Sciences
Cassava Sciences is an American pharmaceutical company based in Austin, Texas. The company was developing simufilam, an oral-tablet drug candidate for the treatment of Alzheimer's disease. Development of simufilam was discontinued in November 2024 after it failed to show clinical benefit in phase III clinical trials.
In June 2024, the United States Department of Justice charged an advisor to Cassava Sciences, Hoau-Yan Wang, with [|fraud over research results related to the experimental drug]. Less than a month later, the president, chief executive officer and chairman of the board, Remi Barbier, resigned along with Lindsay Burns, his wife, who was a Cassava senior vice president and Wang's co-author. The U.S. Securities and Exchange Commission filed fraud charges in September 2024 against Cassava, Barbier, Burns and Wang. The parties did not admit wrongdoing, but agreed to pay fines of Cassava $40 million, Barbier $175,000, Burns $85,000, and Wang $50,000. The DOJ dropped the fraud charges against Wang shortly before trial was scheduled to begin in October 2025 without giving a reason.
Cassava was founded in 1998 by Remi Barbier as Pain Therapeutics, Inc., changing its name in 2019. The company initially worked on three drugs: the pain drugs Oxytrex and Remoxy, and PTI-901, which aimed to treat irritable bowel syndrome. The company had no drug approved as of 2021, and no product revenues between 2013 and 2021; with 25 employees, the company's stock was the sixth-best performing in 2021 before falling after concerns over simufilam research.
History
Founding
Cassava Sciences was founded by Remi Barbier in May 1998 as Pain Therapeutics, focusing on opioids and chronic pain. Barbier first heard of the research led by Stanley M. Crain at the Albert Einstein College of Medicine in New York City around 1993. Crain invited Barbier to his lab and explained the potential pharmaceutical and financial benefits. In 1998, Barbier started Pain Therapeutics, Inc. in South San Francisco, California, with an initial investment of $1 million.Name change
Following the fourth Food and Drug Administration rejection of one of its experimental pain drugs, Remoxy, Cassava announced in August 2018 it would reorganize the company to focus on products for treating and diagnosing Alzheimer's. In 2019, the company changed its name to Cassava Sciences.Corporate affairs
Leadership
Remi Barbier was Cassava's president, chief executive officer and chairman of the board until his abrupt July 2024 resignation, when Richard J. Barry was named executive chairman of the board. A CEO search was initiated, with the outgoing CEO, Barbier, to remain employed by Cassava until September 13, 2024 in a non-executive capacity, without duties or responsibilities. On September 9, Cassava announced that Barry was named CEO, and Claude Nicaise, who had served on the board since 2023, was appointed chairman of the board.Lindsay Burns the senior vice president for neuroscience and Barbier's wife also resigned in 2024 following the indictment of her co-researcher Wang on charges of fraud. She was replaced in May 2025 by Angélique Bordey.
Hoau-Yan Wang, a professor at City University of New York is a consultant who was on Cassava's advisory board. He is a co-author, with Burns, of many journal papers. The Wall Street Journal stated in 2021 that, along with Cassava's officers, he could receive bonuses based on Cassava's market performance; he was indicted in June 2024 for falsifying data related to Cassava's Alzheimer's drug in development, simufilam.
Other officers, as of July 2024, were James W. Kupiec, chief medical officer, and Eric Schoen, chief financial officer. In April 2025, Cassava announced that Kupiec would resign in May, and Jack Moore would become senior vice president of clinical development, responsible for developing simufilam for tuberous sclerosis-related epilepsy. Other senior vice presidents are: R. Christopher Cook, Michael Marsman, Michael Zamloot, and George Thornton.
According to Charles Piller, writing in Science, Barbier would not specify in 2022 who were the company's 2022 scientific advisers. Patrick Keefe wrote in The New Yorker in January 2022 that Cassava's bonus plan provides for potential cash bonuses tied to "specific valuations for twenty consecutive days". He added that the "full incentive scheme could exceed two hundred million dollars, and it was not pegged to F.D.A. approval or to the success of the drug—just to the share price. This appeared to create an incentive for the company to pump its own stock." The WSJ stated that, under this plan, Barbier's bonus could reach $108 million.
Financial
The company had no product revenues between 2013 and 2021.Cassava and its collaborators were awarded National Institutes of Health grants totalling $20 million between 2015 and 2021.
The WSJ wrote that, due to the promise of Simufilam, Cassava Sciences stock became the sixth-best stock of 2021, driving the company's value to over $US5 billion, with the stock price reaching $125 per share. Keefe noted that part of the increase in share price was driven by discussion and hype in online forums, making it a so-called meme stock. The share price fell to $42 after a petition was filed with the FDA in August 2021, questioning the company's research. After Wang's June 2024 indictment, the stock fell by 46% to a new low of about $10 per share.
Following the November 2024 announcement that simufilam had failed Phase III trials, Cassava stock fell to $4.29 per share, losing 84% of its value in one day.
Staffing
As of November 2021, Cassava had 25 employees.Research candidates
The company had no drug approved as of 2021.FLNA hypothesis
Filamin A is a protein that Cassava Sciences says becomes misshaped in people with Alzheimer's, leading to amyloid buildup in the brain contributing to the disease; Cassava journal papers, co-authored by Wang and Burns, suggest that the shape of FLNA in the brain can be restored. A 2022 article in The New York Times stated that none of the Alzheimer's experts they spoke with knew of any support for the FLNA hypothesis; Lawrence Sterling Honig, professor of neurology at Columbia University Irving Medical Center, said: "But in fact, all the evidence seems to be from this lab."Oxytrex, Remoxy and PTI-901
The company started with three drug candidates based on opioids: Oxytrex, Remoxy and PTI-901.Oxytrex was a mixture of two generic drugs, oxycodone and naltrexone that aimed to enhance analgesia while reducing opioid tolerance and withdrawal symptoms. The drug combination failed phase III clinical trials.
Remoxy was a twice-daily gel form of oxycodone intended to be abuse-deterrent. It was repeatedly rejected by the FDA, culminating in the final rejection in 2018 after an FDA advisory meeting raised concerns about a potential risk of abuse. According to The New York Times, the FDA reprimanded Cassava Sciences for appearing to promote the unapproved drug. Barbier accused the FDA of "math errors, material mistakes and misrepresentations", which the agency denied.
Alzheimer's disease
In August 2020, the chemical name simufilam was assigned to the company's experimental drug, previously called PTI-125, which Cassava Sciences says can restore misshaped FLNA in the brain. Open-label studies had started in March 2020, and Cassava Sciences had reported in May 2020 that initial biomarker analysis of cerebrospinal fluid samples from its phase IIb clinical trials of PTI-125 had failed, but reported in September 2020 that a new analysis by an "outside lab" showed improvements in biomarkers, adding that individuals with Alzheimer's also showed improvements in cognition with simufilam. It was later revealed that the outside lab was Wang's CUNY lab. In October 2021, larger trials were initiated; Cassava Sciences announced in December 2021 that the first phase III trial of simufilam would enroll about 750 participants, and the second 1,000. In the first quarter of 2022, 60 participants were enrolled; Stat stated that enrollment had slowed as of April 2022, as people were deterred from enlisting due to the prevailing controversies.Development of simufilam was discontinued in November 2024 after it failed to show clinical benefit in phase 3 clinical trials; it was Cassava's only drug undergoing clinical trials.
Allegations of research fraud
In June 2024, Wang was indicted by the United States Department of Justice for fraud and charged with falsifying data on $16 million in grant applications to the NIH related to simufilam.Reuters reported in July 2024 that the DOJ and the U.S. Securities and Exchange Commission were also investigating two senior Cassava employees. Barbier and Burns abruptly resigned in July 2024.
In September, the SEC charged Cassava, Barbier and Burns for "misleading statements... made in September 2020 about the results of a phase two clinical trial for Cassava's purported drug treatment for Alzheimer's", and charged Wang for "manipulating the trial results". According to Reuters, the company "failed to disclose that a full set of patient data actually showed 'no measurable cognitive improvement in the patients' episodic memory,' also failed to disclose Wang's role in the clinical trial and his personal, financial, and professional interests in the drug's success". The charges filed in the United States District Court for the Western District of Texas alleged that Cassava violated "antifraud provisions of the federal securities laws" and "reporting provisions of the federal securities laws" and the SEC stated in a press release that "without admitting or denying the allegations, Cassava, Barbier, and Burns... agreed to pay civil penalties of $40 million, $175,000, and $85,000, respectively. Barbier and Burns agreed to be subject to officer-and-director bars of three and five years, respectively." The settlement must be approved by the U.S. District Court.
According to Science journal's Piller, "CUNY itself found Wang had committed 'egregious' scientific misconduct" and the SEC "charged that Wang had been 'unblinded' for patient fluid samples 'negligently failed to fully disclose' that she had removed data from 40% of the volunteers in a phase 2 simufilam clinical trial after learning which ones received simufilam or the placebo." Piller wrote that the SEC complaint stated that Cassava had "raised more than $260 million from investors after that announcement", when in fact, "the complete data showed the drug failed to improve 'episodic' memory in Alzheimer's patients".
For a trial slated to begin in October 2025, CUNY released a report claiming scientific misconduct by Wang could not be proven. The DOJ dropped the charges shortly before trial was scheduled to begin, without giving a reason.