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Cassava Sciences, Inc. (NASDAQ: SAVA) is a clinical-stage biotechnology company dedicated to the development of innovative solutions for the treatment and detection of Alzheimer's disease. The company's primary focus is on two groundbreaking product candidates: simufilam and SavaDx.
Simufilam is an oral therapeutic designed to treat Alzheimer's disease. It is currently undergoing two randomized, placebo-controlled Phase 3 clinical trials to assess its efficacy in patients with Alzheimer's dementia. This novel treatment aims to improve cognitive function and slow down the progression of the disease.
SavaDx, the company's investigational diagnostic product, represents a significant advancement in the early detection of Alzheimer's disease. This innovative diagnostic tool can potentially identify the presence of Alzheimer's years before symptoms become apparent, using a small sample of blood.
In addition to its clinical trials, Cassava Sciences recently announced a major financial achievement. The company secured over $125 million from the exercise of warrants, reflecting strong investor confidence. These funds will support the ongoing development and potential commercialization of their innovative products.
Cassava Sciences' mission is to address the urgent unmet medical needs of Alzheimer's patients and their families through rigorous scientific research and development. With its dedicated team and promising product pipeline, the company is well-positioned to make a significant impact on the landscape of Alzheimer's treatment and diagnosis.
For the latest updates on Cassava Sciences’ projects, partnerships, and financial performance, investors can refer to the company's filings with the Securities and Exchange Commission (SEC). For more detailed information, contact Eric Schoen, Chief Financial Officer, at (512) 501-2450 or ESchoen@CassavaSciences.com.
Cassava Sciences, Inc. (Nasdaq: SAVA) announced the completion of drug administration in the open-label study of simufilam for Alzheimer’s disease. Designed to assess long-term safety and cognitive changes over 12 months, around 200 patients participated. Independent biostatisticians will analyze the data, with results expected by year-end 2022. The company is also conducting two Phase 3 studies involving over 1,700 patients to evaluate simufilam's efficacy. The CEO expressed optimism about the study's progress and the need for innovation in Alzheimer's treatment.
Cassava Sciences, a clinical-stage biotechnology firm, has completed a registered direct offering of 1,666,667 shares of common stock at $30 per share, raising approximately $50 million in gross proceeds. The net proceeds, estimated at $47.3 million after expenses, will primarily fund working capital and support the development of simufilam, its lead drug candidate for Alzheimer’s disease. H.C. Wainwright & Co. was the exclusive placement agent for this offering, which was facilitated through an effective SEC registration statement.
Cassava Sciences (Nasdaq: SAVA), a biotechnology company focused on Alzheimer’s disease, has finalized an agreement to sell 1,666,667 shares at $30 each, generating approximately $50 million in gross proceeds. This registered direct offering is anticipated to close on November 22, 2022, subject to standard conditions. Proceeds will be allocated for working capital and advancing the development of the company's lead drug candidate, simufilam. H.C. Wainwright & Co. is the exclusive placement agent for this transaction.
Cassava Sciences (Nasdaq: SAVA) reported Q3 2022 financial results and updated on its Phase 3 program for simufilam in Alzheimer’s disease. The company has enrolled over 650 patients in its clinical trials, a significant increase from 150 six months prior. For Q3 2022, net loss was $20.3 million ($0.51 per share), up from a $9.6 million loss in Q3 2021. Cash and cash equivalents stood at $174.7 million with no debt. R&D expenses surged to $18.5 million due to increased clinical activities. The company expects full-year cash use to be around $80-$90 million.
Cassava Sciences, Inc. (Nasdaq: SAVA) has initiated a lawsuit against individuals involved in a "short and distort" campaign that allegedly harmed the company's stock price and delayed Alzheimer’s treatment development. The complaint cites over 1,000 false statements made by the defendants, including submissions to the FDA, which contributed to a significant market cap decline. Cassava has retained a prominent litigation attorney to represent the company. The filing underscores the company's commitment to defending its reputation and shareholder interests while combating misinformation.
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.