Welcome to our dedicated page for Cassava Sciences news (Ticker: SAVA), a resource for investors and traders seeking the latest updates and insights on Cassava Sciences stock.
Cassava Sciences, Inc. (NASDAQ: SAVA) is a clinical-stage biotechnology company based in Austin, Texas that reports extensively on its efforts to develop simufilam, a proprietary, investigational oral small molecule for central nervous system (CNS) disorders. Recent news emphasizes a strategic shift toward tuberous sclerosis complex (TSC)-related epilepsy, following the discontinuation of its Alzheimer’s disease program after two Phase 3 trials did not meet their pre-specified endpoints.
News updates for SAVA commonly cover preclinical and clinical development milestones. Cassava has announced preclinical studies in mouse models of TSC-related epilepsy and focal cortical malformations, reporting that simufilam reduced seizure activity and alleviated neuronal abnormalities. The company also highlights presentations at scientific meetings, such as the TSC International Research Conference, where it shared data on seizure reduction and human safety findings from prior Alzheimer’s Phase 3 studies.
Regulatory and corporate developments are another key theme in Cassava’s news flow. Items include disclosures about the FDA placing the proposed proof-of-concept trial of simufilam in TSC-related epilepsy on full clinical hold pending additional data and protocol changes, as well as updates on the timing implications for clinical trial initiation. Investors also see announcements about leadership appointments in neuroscience and clinical development, board changes, participation in investor conferences, and financial results with commentary on cash resources and expense management.
Litigation and legal matters feature in Cassava’s news as well. The company has reported a binding term sheet to settle a consolidated securities class action for $31.25 million, subject to court approval, and has discussed related loss contingencies in its financial communications. For anyone tracking SAVA, this news page provides ongoing coverage of scientific publications, regulatory interactions, corporate governance changes, and financial and legal updates related to Cassava’s CNS drug development programs.
Cassava Sciences (SAVA) reported its financial results for the year ended December 31, 2020, highlighting a cash position of approximately $280 million as of February 2021. The company revealed that its lead drug candidate, simufilam, showed potential in improving cognition scores in Alzheimer’s patients after 6 months of treatment. The company plans to announce more data from a 12-month study mid-2021 and expects to initiate pivotal Phase 3 clinical trials later this year. Financially, the net loss for 2020 was $6.3 million, with a significant increase in cash from stock sales and NIH grants.
Cassava Sciences (Nasdaq: SAVA) has entered a drug supply agreement with Evonik Industries for simufilam, a treatment candidate for Alzheimer’s disease. The agreement facilitates the supply of large-scale, clinical-grade simufilam as Cassava progresses in its mission to develop solutions for chronic neurodegenerative diseases. The partnership highlights a commitment to enhancing the quality of life for Alzheimer's patients. Evonik, a leading contract development and manufacturing organization, aims to leverage its expertise to support Cassava's goals.
Cassava Sciences (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, is set to present at the H.C. Wainwright Global Life Sciences Conference on March 9-10, 2021. The management team will engage in virtual one-on-one meetings with analysts and investors. The presentation will be available on-demand from 7:00 AM ET on March 9 through the conference portal. Their lead drug candidate, Simufilam, aims to restore normal function of disrupted brain proteins associated with Alzheimer's.
For more details, visit www.CassavaSciences.com.
AUSTIN, Texas, Feb. 23, 2021 – Cassava Sciences (Nasdaq: SAVA) has been invited to present at the 10th Annual SVB Leerink Global Healthcare Conference. Remi Barbier, President & CEO, and Eric Schoen, CFO, are scheduled to present on February 25 at 2:20 PM Eastern time. Investors can access the live webcast on CassavaSciences.com, with replay available until May 26, 2021. The company is focusing on Alzheimer’s disease and its lead drug candidate, Simufilam, which aims to restore brain function and combat neurodegeneration.
Cassava Sciences (SAVA) has successfully completed an End-of-Phase 2 meeting with the FDA regarding simufilam, its Alzheimer’s disease candidate. The FDA agreed on key elements for a pivotal Phase 3 clinical program, set to start in the latter half of 2021. The Phase 3 studies will assess both disease-modifying effects and symptomatic improvement in approximately 1,600 Alzheimer’s patients. Key endpoints include ADAS-Cog and ADCS-ADL. Previous Phase 2 data showed promising results with no safety issues, setting a solid foundation for the upcoming trials.
Cassava Sciences (Nasdaq: SAVA) announced the closing of a direct offering of 4,081,633 shares of common stock at $49.00 per share, generating approximately $200 million in gross proceeds. After fees, the net proceeds are expected to be around $189.7 million, intended for working capital, general corporate purposes, and development of simufilam, its lead Alzheimer’s drug. The offering was conducted under an automatic shelf registration statement filed on February 10, 2021, with the SEC.
Cassava Sciences, Inc. (Nasdaq: SAVA) has announced a registered direct offering of 4,081,633 shares at $49.00 each, totaling approximately $200 million. The offering is set to close around February 12, 2021, pending customary conditions. Proceeds will be allocated for general corporate purposes and the development of simufilam, targeted for Alzheimer’s treatment. The offering is conducted under an automatic shelf registration statement filed with the SEC on February 10, 2021.
Cassava Sciences (Nasdaq: SAVA) announced progress in its Alzheimer’s disease programs, specifically the drug candidate simufilam. The company plans to expand an ongoing open-label clinical study, increasing enrollment to a total of 150 patients. They expect to initiate a Phase 3 program in the second half of 2021, following a successful meeting with the FDA. Key milestones include a second interim analysis and a Cognition Maintenance Study. Cassava anticipates using approximately $20-25 million in cash for operations in 2021, with about $93 million in cash available at year-end 2020.
Cassava Sciences, Inc. (Nasdaq: SAVA) announced the appointment of James Kupiec, MD as Chief Clinical Development Officer to spearhead the Phase 3 development of simufilam, an investigational drug for Alzheimer’s disease. Dr. Kupiec brings over 30 years of experience from leading firms like Pfizer and Sanofi. The company aims to advance its clinical pipeline and collaborate with research leaders and regulators. Alzheimer’s affects approximately 5.8 million people in the U.S., highlighting the urgency for innovative treatments like simufilam, which aims to restore neuron function disrupted by altered filamin A.
Cassava Sciences, Inc. (Nasdaq: SAVA) announces that the World Health Organization has advised the United States Adopted Names Council to change the name of its lead drug candidate for Alzheimer’s disease to simufilam. This decision was made to avoid trademark conflicts with another drug available in the Far East. The USAN has accepted this name change, ensuring that all future references to the Alzheimer’s drug will be under the name simufilam. This indicates progress in the drug's development and branding for market readiness.