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Showing posts with label PTIE. Show all posts
Showing posts with label PTIE. Show all posts

Friday, June 26, 2026

===Filana Therapeutics (FLNA)

Pain Therapeutics, Inc. was a drug development company that rebranded as Cassava Sciences, Inc. in 2019. Following multiple regulatory rejections for its chronic pain drug Remoxy, the company shifted its focus to neurodegenerative diseases. In early 2026, the corporation further rebranded as Filana Therapeutics.
        

  • Origins (1998): Founded by Remi Barbier, the company originally focused on non-addictive pain therapies and abuse-deterrent opioids. 
  • Pain Programs: Its primary pipeline candidates included Remoxy (an abuse-deterrent oxycodone) and Oxytrex. After repeated Complete Response Letters (CRLs) from the FDA, the company abandoned its pain pipeline to focus on neurological conditions.
  • PTI-901 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.

  • Alzheimer's Drug Failure: The biotech discontinued all trials of simufilam for Alzheimer's disease after the drug missed all primary and secondary endpoints in late-stage Phase III studies.( late 2024).
  • Scrutiny and Investigations: The drug and its foundational data were subject to intense scrutiny. The SEC sued the company for allegedly publishing misleading data , and a federal grand jury indicted a former scientific advisor to the company for allegedly submitting false data regarding the drug's mechanism .
  • Corporate Settlement & Leadership Changes: Following the data controversy, several top executives—including former CEO Remi Barbier—resigned. Under new CEO Richard Barry, Cassava paid a $40 million fine to the SEC to settle misleading claims , and the DOJ subsequently closed its probe.
  • The company initially worked on three drugs: the pain drugs Oxytrex and Remoxy, and 

  • The Pivot to Filana Therapeutics: Shedding its troubled past, the company officially changed its name to Filana Therapeutics in March 2026. The biotech now trades under the ticker symbol "FLNA" and has shifted its developmental focus toward central nervous system (CNS) disorders, specifically exploring simufilam as a potential treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy.






  • Friday, February 7, 2025

    Cassava Sciences (SAVA)

    • March 27, 2019: Pain Therapeutics Inc. (PTIE) said it was changing its name and ticker to better reflect its focus on developing drugs for neurodegenerative diseases such as Alzheimer's..
    • The company was in a phase 2 testing of a drug candidate aimed at treating Alzheimer's, that did not seek to clear amyloid from the brain, but rather to stabilize a critical protein in the brain. It was also working to develop a biomarker/diagnostic to detect Alzheimer's using a simple blood test. 
     

    June 28, 2024
    Hoau-Yan Wang, a professor at the City University of New York (CUNY), was charged with fraud of over $16 million in grants.
    He co-wrote numerous articles with Cassava supporting the scientific rationale for Alzheimer’s drug candidate called simufilam. 
    The drug is currently undergoing late-stage testing as an Alzheimer’s treatment.

     

    Back when it was Pain Therapeutics, Cassava pushed an opioid called Remoxy. A 2022 New Yorker piece about CEO Remi Barbier and whistleblowers detailed some of its problems. Cassava’s clinical data was manipulated, a whistleblower said.
     

    • 7 months later:
    Feb 7, 2025