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Cassava Sciences, now Filana Therapeutics, reports developments around its biotechnology program for central nervous system disorders, with current focus on Tuberous Sclerosis Complex (TSC)-related epilepsy. Company updates center on simufilam, a proprietary investigational oral small molecule intended to modulate filamin A protein, including preclinical work, clinical-development planning, and publication of prior Phase 3 Alzheimer’s disease trial results.
Recurring news also covers financial results, cash-use updates, leadership and board changes, and legal or regulatory matters, including the closure of government inquiries and securities litigation updates. The completed name change and ticker transition are part of the company’s durable corporate-status history.
Cassava Sciences (SAVA) announced the appointment of Chris Cook as Senior Vice President and General Counsel, a newly created position aimed at enhancing operations and strategic initiatives. Cook has over 25 years of legal experience, previously serving as Global Head of Litigation at Alcon and holding senior roles at Walmart Central America and Jones Day. The company continues its Phase 3 clinical trials for simufilam, an investigational drug for Alzheimer's disease, with FDA Special Protocol Assessments granted for both studies involving approximately 1,750 patients.
Cassava Sciences (Nasdaq: SAVA) announced the launch of an open-label extension study for its investigational Alzheimer’s drug, simufilam, designed for patients completing ongoing Phase 3 studies. The study aims to enroll up to 1,600 participants, offering them no-cost access to simufilam over 52 weeks. This initiative will gather long-term safety and tolerability data for the drug at a dosage of 100 mg twice daily. Both ongoing Phase 3 trials have FDA Special Protocol Assessments. Enrollment for the open-label study begins in November 2022.
Cassava Sciences has announced its participation in the H.C. Wainwright 24th Annual Global Investment Conference in New York on September 13, 2022. President & CEO Remi Barbier will present in person from 3:30 PM to 4:00 PM Eastern Time. Institutional investors can request meetings through the conference's official site. A live webcast of the presentation will be available on Cassava's investors page, with an archived replay accessible for 90 days afterward. The company is focused on treating Alzheimer’s disease with its lead candidate simufilam.
Cassava Sciences, Inc. (Nasdaq: SAVA) announced that the Journal of Prevention of Alzheimer's Disease confirmed no evidence of data manipulation in a 2020 paper regarding its drug simufilam. This response comes after ongoing scrutiny and allegations against the company’s research. CEO Remi Barbier expressed optimism that the journal's statement will help dispel unfounded accusations. Previous investigations from various journals also found no evidence of misconduct related to simufilam. An ongoing investigation by The City University of New York is still pending a public response.
Cassava Sciences (SAVA) provided an update on its Phase 3 clinical trials for simufilam in Alzheimer’s disease, announcing over 400 patients are now enrolled. An interim analysis of 100 patients who completed 12 months of open-label treatment showed the drug was safe and well tolerated, with average ADAS-Cog11 scores improving by 1.5 points. Financially, the company reported a net loss of $19.3 million for Q2 2022, up from $5.1 million the previous year. As of June 30, 2022, Cassava had $197.2 million in cash and equivalents, supporting ongoing R&D efforts.
Cassava Sciences (SAVA) reaffirmed that no government agency has found evidence of research misconduct against the company. In a statement, CEO Remi Barbier emphasized that they are cooperating with inquiries linked to allegations made by short-sellers. Notably, no officer or director at Cassava has sold stock in over a decade, contrasting with short-sellers who have reportedly profited over $100 million from shorting SAVA. The company's mission remains focused on developing treatments for neurodegenerative diseases like Alzheimer’s.
Cassava Sciences, Inc. (Nasdaq: SAVA) reported financial results for Q1 2022, revealing a net loss of $17.5 million, or $0.44 per share, up from a loss of $3.5 million, or $0.09 per share, in Q1 2021. Cash and cash equivalents stood at $209.7 million with no debt. The company is advancing its Phase 3 clinical program for simufilam in Alzheimer’s disease, now enrolling over 120 patients across 115 sites. R&D expenses rose significantly to $14.9 million due to increased clinical activities, while G&A expenses reached $2.9 million, primarily from legal services.
Cassava Sciences, a clinical-stage biotechnology company focused on Alzheimer’s disease, announced its participation in B. Riley Securities’ Neuroscience Conference on April 27-28, 2022. Remi Barbier, CEO, will engage in a Q&A session on April 27 at 1:30 PM ET. The event will be streamed live, with a recording available for 90 days post-event on both the conference site and Cassava Sciences’ investor webpage.
The company is currently advancing its lead drug candidate, simufilam, through Phase 3 clinical studies for Alzheimer’s treatment.
Cassava Sciences, Inc. (Nasdaq: SAVA) will hold a webcast on April 5, 2022, at 9 AM ET, featuring President & CEO Remi Barbier and CFO Eric Schoen. Stakeholders are invited to listen via the provided webcast link. Although there will be no live Q&A, participants can submit questions beforehand via email. The event will also have an archived replay available on the company's website for 90 days. Cassava focuses on developing treatments for Alzheimer’s disease, particularly their lead drug candidate, simufilam, currently in Phase 3 clinical trials.
Cassava Sciences, a clinical-stage biotechnology firm focusing on Alzheimer's disease, announced a Q1 2022 update via a fireside chat with CEO Remi Barbier on April 5, 2022, at 9 AM ET. The public can access the event through a webcast. Stakeholders are invited to submit questions in advance. Cassava is actively developing its lead drug, simufilam, currently in Phase 3 clinical studies under FDA guidelines, alongside various other studies to evaluate its efficacy for Alzheimer's treatment.