Cassava sciences fda approval. See why SAVA stock is a Hold.

Cassava sciences fda approval. Nov 14, 2024 · It’s time to correct one of the more egregious misconceptions about Cassava Sciences floating around the internet, @adamfeuerstein writes. (The report was requested by a person trying to profit if Cassava’s share price declines, and shared with Science by his colleague. . Mar 11, 2024 · The FDA report, disclosed under the Freedom of Information Act, raises new questions about the credibility of claims by Wang and Cassava about simufilam, a drug that has long been under scrutiny. Now, some experts want Cassava to get more heat from the FDA and have its clinical programs ground to a halt Simufilam (PTI-125) is an experimental medication for the treatment of Alzheimer's disease. Read what this means for SAVA stock here. Cassava Sciences owns exclusive, worldwide rights to its investigational product candidates and related technologies, without royalty obligations to any third party. Oct 9, 2024 · The FDA granted accelerated approval to the drug in 2021 but concerns were later raised about a lack of efficacy and alleged ‘missing data’ on the frequency of serious adverse events including brain oedema, microhaemorrhages, and superficial siderosis. May 1, 2025 · August 4, 2025 Cassava Sciences Reports Positive Preclinical Study Evaluating Simufilam for TSC-Related Epilepsy According to The New York Times, the FDA reprimanded Cassava Sciences for appearing to promote the unapproved drug. Development of simufilam was discontinued in November 2024 after it failed to show clinical benefit during phase III clinical trials. “Cassava Sciences is a small company doing cutting-edge research in neurosciences. Oct 4, 2024 · Cassava Sciences has faced a barrage of regulator scrutiny over alleged clinical impropriety in studies of an experimental Alzheimer’s candidate. Aug 24, 2021 · “The SPAs underscore our alignment with FDA on key scientific, clinical and regulatory requirements of our Phase 3 program of simufilam in Alzheimer’s disease. S. Over the past two years, Cassava Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Simufilam. Nov 25, 2024 · Cassava Sciences said that its drug did not significantly reduce cognitive decline in 1,900 people with mild to moderate Alzheimer’s disease. Most recently, Cassava shelled out millions to fend off corporate misconduct allegations from the U. The drug has since been pulled from the market. Nov 8, 2024 · Cassava Sciences' stock is highly shorted, with potential reward tied to the upcoming Phase 3 trial results for simufilam. Securities and Exchange Commission. Food and Drug Administration (FDA) has confirmed they could support an application for simufilam’s approval if the results are positive. Feb 8, 2024 · The two studies collectively enrolled 1,929 people with mild to moderate Alzheimer’s and the U. Now the FDA needs to act, @adamfeuerstein writes. 4 days ago · Cassava Sciences is nearing a Phase 3 readout for its Alzheimer's drug, lecanemab, despite facing a scandal involving the SEC. Cassava Sciences has chalked up one win in an ongoing battle over the integrity of its clinical trials for Alzheimer’s disease. ” Cassava Sciences also Jan 3, 2022 · Cassava Sciences could achieve 11x upside from the current price before FDA approval of Simufilam. See why SAVA stock is a Hold. Food and Drug Administration (FDA). [2][3] It was being developed by the American pharmaceutical firm Cassava Sciences. [9] Barbier accused the FDA of "math errors, material mistakes and misrepresentations", which the agency denied. Sep 16, 2025 · This section highlights FDA-related milestones and regulatory updates for drugs developed by Cassava Sciences (SAVA). Aug 24, 2021 · Cassava Sciences Inc (NASDAQ: SAVA) announced an agreement with the FDA under a Special Protocol Assessment (SPA) for both of its pivotal Phase 3 trials for oral simufilam in treating Alzheimer's Sep 30, 2024 · Cassava Sciences believes that simufilam interrupts amyloid-β42 binding to receptors in the brain and may affect the Alzheimer's disease process. Nov 25, 2024 · Simufilam’s problems began in 2021, when a law firm representing two whistleblowers, who stood to profit if Cassava’s stock fell, filed a citizen’s petition with the U. [4] The US Food and Drug Administration (FDA) received a citizen petition in August Oct 2, 2024 · Studies that once seemed to support the drug, simufilam, have been called into question, leading to retractions from scientific journals and resignations of top officials at Cassava Sciences, the Oct 2, 2024 · The SEC concluded that Cassava Sciences falsified data in its Alzheimer’s clinical trials. Mar 3, 2021 · After an FDA meeting, Cassava Sciences plans to launch pivotal studies of simufilam in treating mild-to-moderate Alzheimer's patients. 36kk alvm3c 0jrp 2n dwlts axsy 7ig hqwq adw k4rbh