Cassava Sciences, Inc. - SAVA STOCK NEWS

Cassava Sciences has confirmed there is no evidence of data manipulation in a 2012 study regarding Alzheimer's treatment, as stated by the Journal of Neuroscience. This study supports the development of simufilam, their lead drug candidate. A duplicated figure was identified, but it did not affect the study's conclusions. The company continues its focus on a Phase 3 clinical program for simufilam. Additionally, a second Citizen Petition requesting FDA approval for simufilam has been submitted, although no engagement has occurred from the FDA.

Cassava Sciences (SAVA) has initiated its first Phase 3 study for simufilam, an investigational drug targeting Alzheimer’s disease. This study, named RETHINK-ALZ, will assess the safety and efficacy of simufilam over 52 weeks in approximately 750 patients. A second Phase 3 study, REFOCUS-ALZ, is expected to start by year-end, evaluating the drug over 78 weeks with around 1,000 patients. Both studies have received Special Protocol Assessments from the FDA, confirming their design features. The company's commitment to transparency and ethical standards in research is emphasized.

Cassava Sciences (Nasdaq: SAVA) announced top-line results from a 12-month interim analysis of its open-label study with simufilam, showing an average improvement of 3.2 points in ADAS-Cog scores (p<0.001). Conducted with funding from the NIH, 68% of participants improved significantly, while over 50% exhibited no neuropsychiatric symptoms by month 12. The FDA's Special Protocol Assessment for the upcoming Phase 3 program remains on track for Q4 2021. No serious adverse events related to the drug were reported, highlighting its safety profile.

Cassava Sciences (Nasdaq: SAVA), a biotechnology company dedicated to Alzheimer’s treatment, will present at the H.C. Wainwright’s 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will feature a fireside chat led by Vernon T. Bernardino, PhD, Managing Director of Biotechnology Equity Research.

The event starts on September 13 at 7:00 a.m. Eastern Time, and the chat will be available for replay on the company’s website for 90 days.

Austin-based Cassava Sciences, Inc. (Nasdaq: SAVA) has publicly addressed recent allegations regarding its Alzheimer's disease research, claiming these accusations are false. CEO Remi Barbier stated that the assertions about the company’s science being improbable or fraudulent are misleading. Cassava Sciences aims to defend its integrity and the interests of its stakeholders vigorously. The company has made its full statement available through an audio file and written transcript accessible online. Further details about their mission and developments can be found on their official website.

Cassava Sciences, Inc. (Nasdaq: SAVA) announced plasma p-tau analysis results from its Phase 2b clinical study on Alzheimer’s disease. The study's testing was conducted by Quanterix Corp., an independent laboratory, focusing on p-tau levels in plasma samples. CEO Remi Barbier emphasized data integrity, asserting that all testing was performed blind. Cassava Sciences has refuted allegations regarding scientific integrity made by a party holding a short position in its stock, insisting that claims are misleading and unfounded.

Cassava Sciences (Nasdaq: SAVA), a biotech firm focused on Alzheimer's disease, issued a response to recent online claims about its scientific integrity, labeling them as false and misleading. The company asserts that its biomarker data was independently generated and stands firm in the credibility of its research. Key clarifications include the accurate increase of plasma p-tau levels in a patient, the legitimacy of Western blot techniques, and FDA agreement on Phase 3 study protocols for simufilam. Cassava emphasizes the importance of distinguishing fact from fiction to uphold stakeholder trust.

Cassava Sciences announced the FDA's agreement under a Special Protocol Assessment (SPA) for its Phase 3 studies of simufilam in treating Alzheimer’s disease. This agreement validates the study protocols aimed at ensuring regulatory compliance and effective design. The company reaffirms its plan to initiate the Phase 3 program in Fall 2021. Two pivotal clinical studies will evaluate simufilam's safety and efficacy in subjects with mild-to-moderate Alzheimer's. CEO Remi Barbier emphasized that this milestone aligns the company with FDA requirements.

Cassava Sciences, focused on Alzheimer's disease, reported a net loss of $5.1 million for Q2 2021, translating to $0.13 per share, compared to a net loss of $1.1 million or $0.05 per share in Q2 2020. Cash and cash equivalents increased to $278.3 million as of June 30, 2021, with no debt. The expected cash usage for the full year is $20-25 million, driven by R&D and operational costs. R&D expenses surged to $3.9 million from $0.6 million year-over-year, reflecting a focus on clinical trial preparations.