Filana Therapeutics

Filana Therapeutics, Inc., formerly Cassava Sciences, Inc. and originally Pain Therapeutics, Inc., is an American pharmaceutical company headquartered in Austin, Texas. The company was founded in 1998 by Remi Barbier and initially concentrated on opioid-based treatments for chronic pain. Its early development portfolio included Oxytrex, a combination of oxycodone and naltrexone; Remoxy, an abuse-deterrent formulation of oxycodone; and PTI-901, a low-dose naltrexone candidate for irritable bowel syndrome. None of these programs became an approved commercial medicine. Remoxy was repeatedly rejected by the U.S. Food and Drug Administration, while Oxytrex failed Phase III testing. After the FDA’s 2018 rejection of Remoxy, the company reorganized around neuroscience and Alzheimer’s disease research. It adopted the name Cassava Sciences in 2019 and made simufilam its principal development program. Simufilam, previously designated PTI-125, was an oral small-molecule candidate intended to alter the conformation of filamin A, or FLNA, a scaffolding protein that the company linked to Alzheimer’s-related pathology. The company sponsored mid-stage and late-stage studies and reported biomarker and cognitive findings that attracted substantial investor attention. In 2021, its share price rose sharply and the company’s market value exceeded $5 billion, even though it had no approved medicine and no product revenue during the 2013–2021 period. The Alzheimer’s program became the subject of scientific criticism, a citizen petition to the FDA, media investigations, and regulatory and criminal proceedings. Critics questioned the biological basis of the FLNA hypothesis, the handling and presentation of clinical and laboratory data, and the disclosure of the role and interests of consultant and co-author Hoau-Yan Wang. The company rejected allegations that its research was unreliable. In June 2024, the U.S. Department of Justice charged Wang with fraud relating to research and grant applications. In September 2024, the Securities and Exchange Commission charged Cassava, Remi Barbier, Lindsay Burns, and Wang with securities-fraud-related violations. The company and the individual defendants settled the SEC matter without admitting or denying the allegations, agreeing to civil penalties; Barbier and Burns also accepted temporary officer-and-director bars. The DOJ later dropped its case against Wang shortly before a scheduled 2025 trial, without stating a reason. Barbier and Burns resigned in 2024. Richard J. Barry became executive chairman and subsequently chief executive officer, while Claude Nicaise became board chair. Simufilam failed to demonstrate clinical benefit in Phase III trials, and its development was discontinued in November 2024. The company later broadened its stated focus toward FLNA-targeted treatments for brain diseases and adopted the name Filana Therapeutics on March 10, 2026. Its history therefore spans opioid drug development, a highly valued but unsuccessful Alzheimer’s program, and a post-simufilam effort to reposition the business around neurological medicines. It remains a development-stage pharmaceutical company rather than a company with an established marketed product portfolio.

Filana Therapeutics was established in May 1998 by Remi Barbier as Pain Therapeutics, Inc. The company began in South San Francisco with an initial investment of $1 million and pursued opioid-related approaches to chronic pain. Barbier had become interested in the pharmaceutical potential of research associated with Stanley M. Crain of the Albert Einstein College of Medicine. The early portfolio comprised Oxytrex, Remoxy, and PTI-901. Oxytrex combined oxycodone with naltrexone and was designed to provide analgesia while potentially limiting opioid tolerance and withdrawal effects. The candidate failed Phase III trials. Remoxy was a twice-daily gel formulation of oxycodone intended to reduce abuse through its formulation properties. The FDA rejected the product multiple times, culminating in a 2018 rejection after an advisory discussion raised concerns about abuse risk. That decision helped prompt a strategic change. In August 2018, the company announced that it would reorganize around Alzheimer’s disease products and diagnostics, and in 2019 it became Cassava Sciences. The company’s new central program was PTI-125, later named simufilam. Cassava argued that Alzheimer’s disease could involve a pathological change in the shape or conformation of FLNA and that simufilam could restore the protein’s function. Open-label work began in 2020. An initial analysis of cerebrospinal-fluid biomarkers from a Phase IIb program was reported as unsuccessful in May 2020, but a later analysis by an outside laboratory was said to show biomarker and cognitive improvements. The laboratory was subsequently identified as the CUNY laboratory of Hoau-Yan Wang, a paid consultant and co-author with Lindsay Burns on relevant research. Interest in simufilam drove a dramatic increase in the company’s market value in 2021. The company had no approved product and no product revenue from 2013 through 2021, but its stock became one of the strongest performers of 2021. The program also attracted criticism from Alzheimer’s researchers and investors. In August 2021, a citizen petition submitted on behalf of whistleblowers asked the FDA to suspend the trials, citing alleged problems with experimental methods, data presentation, and possible manipulation. Cassava called the allegations unfounded and criticized the petition process. The share price fell sharply after the petition became public. Larger clinical studies began in late 2021, including planned Phase III trials with hundreds of participants. Enrollment was reportedly affected by the controversy. In June 2024, the DOJ indicted Wang in relation to alleged fraud involving simufilam research and NIH funding applications. Barbier and Burns resigned the following month. Richard J. Barry became executive chairman, was later named CEO, and Claude Nicaise became chairman of the board. In September 2024, the SEC brought charges against the company, Barbier, Burns, and Wang concerning alleged misleading statements and omissions about clinical results, data handling, and conflicts of interest. The defendants settled the SEC matter without admitting or denying the allegations and agreed to monetary penalties; the former executives also accepted bars from serving as officers or directors for specified periods. The DOJ later dismissed its case against Wang shortly before a scheduled 2025 trial, without providing a public explanation. Simufilam ultimately failed to show clinical benefit in Phase III trials, and development ended in November 2024. In April 2025, the company announced changes to its clinical-development leadership, including the planned departure of chief medical officer James W. Kupiec and the appointment of Jack Moore to oversee clinical development. On March 10, 2026, the company adopted the name Filana Therapeutics, signaling a renewed focus on FLNA-targeted therapies for brain diseases. The business remains a research-focused pharmaceutical company with no approved product identified in the supplied reference material.

1. 2026Rebranded as Filana Therapeutics

   Cassava Sciences adopted the Filana Therapeutics name and emphasized FLNA-targeted brain-disease research.

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2. 2024Leadership changes and federal charges

   The company’s top leadership changed amid DOJ and SEC proceedings related to simufilam research disclosures.

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3. 2024Simufilam program discontinued

   Phase III trials failed to show clinical benefit, ending development of the company’s only clinical-stage drug.

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4. 2021FDA petition challenges research

   A citizen petition requested that the FDA halt simufilam trials over alleged research and data-integrity concerns.

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5. 2020PTI-125 renamed simufilam

   The company assigned the chemical name simufilam to its principal Alzheimer’s candidate.

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6. 2019Rebranded as Cassava Sciences

   Pain Therapeutics changed its name to Cassava Sciences.

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7. 2018Strategic shift after Remoxy rejection

   Following another FDA rejection of Remoxy, the company announced a reorganization centered on Alzheimer’s disease products and diagnostics.

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8. 1998Pain Therapeutics founded

   Remi Barbier founded Pain Therapeutics to develop medicines for chronic pain and opioid-related conditions.

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Development-stage pharmaceutical company pursuing small-molecule treatments for neurological disease, particularly therapies involving filamin A biology.

• SimufilamAlzheimer’s disease investigational drug2020

  An oral small-molecule candidate formerly known as PTI-125. The company developed simufilam on the theory that abnormal FLNA conformation contributes to Alzheimer’s pathology and that the drug could restore the protein’s function. The program included mid-stage and Phase III studies, but it failed to demonstrate clinical benefit in Phase III trials and was discontinued in November 2024.

• RemoxyAbuse-deterrent opioid investigational drug

  A twice-daily gel formulation of oxycodone intended to make abuse more difficult than with conventional formulations. The FDA rejected Remoxy repeatedly, with the final rejection occurring in 2018 after concerns about abuse risk and product performance. It was never identified as an approved commercial medicine.

• OxytrexChronic-pain investigational drug

  A combination of oxycodone and naltrexone designed to provide analgesia while potentially reducing opioid tolerance and withdrawal symptoms. The program advanced to Phase III but failed its clinical trials and did not become an approved product.

• PTI-901Irritable-bowel-syndrome investigational drug

  A low-dose naltrexone candidate investigated for irritable bowel syndrome during the company’s earlier Pain Therapeutics period. The supplied reference material does not identify a successful late-stage outcome or approval.

• 2026Adopt the Filana Therapeutics identityStrategy

  After ending simufilam development, the company sought to frame its future around FLNA-targeted medicines for neurological disease.

  What changed. Cassava Sciences changed its name to Filana Therapeutics on March 10, 2026.

  Aftermath. The corporate identity shifted away from the Cassava Sciences name and toward a platform-oriented neuroscience positioning.

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• 2024End simufilam developmentGeneration change

  Simufilam was the company’s only drug in clinical trials, but Phase III testing did not show clinical benefit.

  What changed. The company discontinued the Alzheimer’s drug program in November 2024.

  Aftermath. The company moved toward a broader FLNA-targeted brain-disease strategy and later adopted the Filana Therapeutics name.

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• 2018Reorient the company toward Alzheimer’s diseaseStrategy

  Repeated FDA rejection of Remoxy weakened the original opioid-focused strategy.

  What changed. Pain Therapeutics announced a reorganization around Alzheimer’s disease products and diagnostics.

  Aftermath. The company changed its name to Cassava Sciences in 2019 and made simufilam its principal program.

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• 2024Research-fraud and securities-fraud proceedingsControversy

  The DOJ charged adviser Hoau-Yan Wang over alleged falsification connected with simufilam research and NIH grant applications. The SEC separately charged the company, Wang, Remi Barbier, and Lindsay Burns over alleged misleading statements and omissions concerning trial data and interests in the program. The SEC matter was settled without admissions of wrongdoing, while the DOJ later dropped its case against Wang.

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• 2021Scientific criticism and FDA citizen petitionControversy

  Whistleblowers and outside scientists questioned the reliability of preclinical work, reported biomarker findings, image handling, and disclosures about the laboratory that performed a key reanalysis. A petition asked the FDA to halt clinical trials; Cassava rejected the allegations.

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• 2026Company adopts Filana Therapeutics name

  Cassava Sciences changed its corporate name to Filana Therapeutics as it repositioned around FLNA-targeted medicines for brain diseases.

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• 2024Simufilam development discontinued

  The company stopped developing simufilam after Phase III trials failed to show clinical benefit.

  Product launchProduct generation
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• 2020Simufilam receives chemical name

  The company’s PTI-125 Alzheimer’s candidate was assigned the name simufilam.

  Product generation
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• 2019Company adopts Cassava Sciences name

  Pain Therapeutics rebranded as Cassava Sciences while shifting its focus toward Alzheimer’s disease research.

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1. Filana Therapeutics
2. Cassava Sciences corporate website