– Patient perception improved 1.6 points on ADAS-Cog11 – Patient behavior improved 1.3 points on NPI –
AUSTIN, Texas, February 2, 2021 (GLOBE NEWSWIRE ) – Cassava Sciences, Inc. (Nasdaq: SAVA) today announced the results of an interim analysis of an open study of simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Patients’ cognitive and behavioral scores improved after six months of simufilam treatment without any safety issues.
In a clinical study funded by the National Institutes of Health and conducted by Cassava Sciences, six months of simufilam treatment improved ADAS-Cog11 cognitive scores 1.6 points, which corresponds to a mean improvement of 10% over the initial value up to the 6th month. In the same patients Simufilam In addition, dementia-related behavior such as anxiety, delusions and restlessness improved in the neuropsychiatric inventory by 1.3 points, which corresponds to an average improvement of 29% from the baseline by the 6th month.
Alzheimer’s is one progressive disease. Over time, a patient’s perception will always deteriorate. « Experience based on longitudinal studies of outpatients with mild to moderately severe Alzheimer’s disease suggests that ADAS tooth values decrease by 6 to 12 points per year, » says the FDA’s prescription information sheet for ARICEPT® (Donepezil ), one for the treatment of Alzheimer’s dementia type 1: « We couldn’t be more satisfied with these interim results, » said Remi Barbier, President of &, CEO. “We would have been happy to show that simufilam stabilizes cognition in patients for 6 months. Improvements in cognition and behavior show that this drug candidate has the potential to offer lasting treatment effects to people with Alzheimer’s disease. It’s an exciting development. «
The safety profile of simufilam in the interim analysis was consistent with previous human studies. There were no drug-related serious adverse events. Adverse events were mild and transient.
» Today’s data again suggest that Simufilam could be a transformative, novel therapeutic, « added Dr. med. Nadav Friedmann, Chief Medical Officer. » It appears that the drug’s unique mechanism of action may provide a treatment benefit after 6 months of dosing. «
Information on the Interim Analysis The ongoing one-year, open-label, multicenter study by Cassava Sciences is evaluating the long-term safety and tolerability of simufilam 100 mg twice daily in 100 patients with mild to moderate Alzheimer’s disease. This study began in March 2020 and is now approximately 80% enrolled. Today’s pre-planned interim analysis summarizes the clinical data in the middle the registration together, d. H. The first 50 patients who completed at least 6 months of drug treatment.
ADAS-Cog (Alzheimer’s Disease Assessment Scale-Cognitive Subscale) is a standard test for assessing changes in cognition in Alzheimer’s studies. NPI (Neuropsychiatric Inventory) is a widely used tool for measuring changes in dementia-related behavior. The Mini-Mental State Exam (MMSE) is a widely used test of cognitive function in the elderly. The interim analysis shows mean baseline values of 15.5 for ADAS-Cog11, 4.5 for NPI and 22.1 for MMSE.
A large part of the value of the open study is to collect data to determine the long-term safety profile of to support simufilam in patients. Intermediate efficacy data from an open-label study have limitations compared to efficacy data from a fully completed, large, randomized, controlled clinical trial or from a fully-included open-label study. However, previous clinical research by other sponsors on Alzheimer’s disease can serve as a context reference for estimates of an expected decrease in cognition in placebo patients:
In 2019, a randomized controlled trial of aducanumab (Biogen) was carried out in> 1,000 patients with Alzheimer’s disease. In this phase 3 study (EMERGE), placebo patients taking ADAS-Cog13 showed a mean decrease in cognition of approx. 1.4 points. This corresponds to a decrease of 6.3% from the initial value up to the 6th Month. The mean ADAS-Cog13 baseline was 22.2%. The mean baseline MMSE was 26.4.
A randomized controlled study with ARICPET® (Donepezil, Eisai) was conducted in> 400 patients with mild to moderate Alzheimer’s disease.3 In this phase 3 study patients showed under placebo a mean decrease in cognition under ADAS- by about 1.9 points. Cog, a 7.3% decrease from baseline by week 24. The mean baseline ADAS-Cog was 26. The MMSE range was 10-26. Next Steps Cassava Sciences believes that today’s data and previous clinical results will advance simufilam into a Phase 3 clinical program support with Alzheimer’s. The initiation of a phase 3 study is still on schedule for the second half of 2021.
Cassava Sciences and the US Food and Drug Administration (FDA) recently held a successful meeting at the end of phase 2 (EOP2 ) for the Simufilam drug development program. Details of the EOP2 meeting will be announced in the first quarter of 2021 after the official minutes of the FDA meeting are finalized.
Based on today’s results and incoming demand from Alzheimer’s patients and their caregivers, the admission target for the open Study increased by up to 50 additional patients to a total target of approximately 150 patients. The company is currently in discussions with its scientific and clinical advisors about further possible improvements to the open label program.
About Alzheimer’s Disease Alzheimer’s disease is a progressive disorder of the brain that destroys memory and the ability to think. There are currently no drug therapies to stop Alzheimer’s disease, let alone reverse its course. In the US alone, there are currently about 5.8 million people living with Alzheimer’s disease, and in 2019, about 487,000 people aged 65 and over developed Alzheimer’s.4 The number of people with Alzheimer’s disease is expected to increase dramatically in the coming years, leading to an increase will lead to social and economic stress.5About SimufilamSimufilam is a proprietary, low molecular weight (oral) drug that restores the normal form and function of altered filamin A (FLNA), a scaffold protein, in the brain. An altered FLNA in the brain disrupts the normal function of neurons and leads to Alzheimer’s pathology, neurodegeneration and neuroinflammation. The underlying science for Simufilam is published in journals including the Journal of Neuroscience, Neurobiology of Aging, Journal of Biological Chemistry, Neuroimmunology and Neuroinflammation, and Journal of Prevention of Alzheimer’s Disease.
Cassava Sciences is also developing a pre-screening diagnostic called SavaDx to detect Alzheimer’s disease with a simple blood test.
Simufilam and SavaDx were both developed in-house. Both product candidates are funded primarily through peer-reviewed research grants from the National Institutes of Health (NIH). Cassava Sciences owns worldwide development and commercial rights to its research programs in Alzheimer’s disease and related technologies, with no royalties to third parties.
About Cassava Sciences, Inc. Cassava Sciences’ mission is to innovate in chronic neurodegenerative diseases discover and develop. For the past 10 years, Cassava Sciences has combined cutting-edge technology with new insights in neurobiology to develop novel solutions for Alzheimer’s disease. For more information, please visit: https://www.CassavaSciences.com
Cassava Sciences’ open-label study of simufilam in Alzheimer’s is funded by the National Institutes of Health (NIH / NIA) Clinical Research Grant # AG065152.
The contents of this press release are the sole responsibility of Cassava Sciences and do not necessarily represent the official views of the NIH / NIA.
Safe Harbor by Cassava SciencesThis press release contains forward-looking statements, including statements made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that address: our strategy and plans; the treatment of Alzheimer’s disease; the status of current and future clinical studies with simufilam, including the interpretation of an interim analysis of open study results; inherent limitations of the ADAS-Cog and NPI test batteries; planned enrollment and other changes to the open label program; our intention to initiate a clinical phase 3 program with simufilam in the second half of 2021; Results of our EOP2 meeting with the FDA and the timing of further announcements; oral comments from our staff; and, if applicable, potential advantages of our product candidates. These statements may be identified by words such as « may, » « anticipate, » « believe, » « could, » « expect, » « forecast, » « intend, » « plan, » « possible, » « potentially, » and « identified » there will be other words and terms of similar meaning. There is a high level of risk involved in drug development and commercialization and few research and development programs result in commercialization of a product. Our clinical results from previous clinical studies may not indicate complete results or results from later or larger clinical studies and do not warrant regulatory approval. You should not place undue reliance on these statements or scientific data that we present or publish.
Such statements are based largely on our current expectations and projections of future events. Such statements speak only as of the date of this press release and are subject to a number of risks, uncertainties, and assumptions including, but not limited to, the risks associated with the ability to conduct or complete clinical trials on anticipated schedules to demonstrate the specificity, safety, The effectiveness or potential health benefits of our product candidates, the severity and duration of healthcare precautions in the face of the COVID-19 pandemic, any unexpected impact the pandemic has on our business operations, and including those in the « Risk Factors » section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and future reports to be filed with the SEC. The foregoing identifies many, but not all, of the factors that could cause actual results to differ from those anticipated in any forward-looking statement. Given these risks, uncertainties, and assumptions, the forward-looking statements and events discussed in this press release are inherently uncertain and cannot occur. Actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Accordingly, you should not rely on forward-looking statements as predictions of future events. Except as required by law, we disclaim any intention or responsibility for updating or revising any forward-looking statements contained in this press release. Investors can find more information about these and other risks associated with our business in our filings with the SEC, which are available on the SEC’s website at www.sec.gov.
This press release may also contain statistical and drug information. based on independent industry publications or other publicly available information. We have not independently verified the accuracy or completeness of the data contained in these publicly available data and information sources. Accordingly, we do not make any representations regarding the correctness or completeness of such data or information. You are advised not to give excessive weight to such data.
1 Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020690s042,021720s014,022568s011lbl.pdf (2018) 2Source: Biogen, EMERGE Phase III study, slide 24, https://investors.biogen .com / static-files / 8e58afa4-ba37-4250-9a78-2ecfb63b1dcb (2020) 3Source: https://www.accessdata.fda.gov / drugsatfda_docs / label / 2018 / 020690s042,021720s014,022568s011lbl, 5 Source: Alzheimer’s Association. Disease facts and figures. https://www.alz.org/media/documents/alzheimers-facts-and-figures-2019-r.pdf
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Let’s talk portfolio defense. After manipulating the Social Flash Mob Market over the past week, this topic should not be ignored. That doesn’t mean the markets are collapsing. After losing 2% to close last week’s Friday session, this week’s trading started on a positive tone as the S&P 500 rose 1.5% and the Nasdaq rose 2.5%. The underlying bullish factors – a more stable political scene steadily driving COVID vaccination programs – still play a role, even if not quite as strong as investors had hoped. While heightened volatility might linger with us for a while, it’s time to consider defensive stocks. And that will bring us to dividends. By providing a steady stream of income regardless of market conditions, a reliable dividend stock provides a pad for your investment portfolio when the stock stops growing in value. With that in mind, we used the TipRanks database to get three dividend stocks that yield 8%. However, that’s not all they offer. Each of these stocks received enough street praise to earn a consensus rating of « Strong Buy ». New Residential Investment (NRZ) First we examine the REIT sector, Real Estate Investment Trusts. These companies have long been known for dividends that are both high-yielding and reliable. Due to the company’s tax compliance, REITs are required to return a certain percentage of profits directly to shareholders. NRZ, a medium-sized company with a market capitalization of $ 3.9 billion, has a diverse portfolio of residential mortgages, original loans, and mortgage loan service rights. The company is based in New York City. NRZ has a $ 20 billion investment portfolio that has generated dividends of $ 3.4 billion since its inception. The portfolio has proven resilient in the face of the corona crisis, and after a difficult first quarter last year, NRZ posted rising gains in the second and third quarters. The most recently reported third quarter showed GAAP earnings of $ 77 million, or 19 cents per share. Although this EPS was lower than in the previous year, it was a strong trend reversal compared to the 21 cent loss reported in the previous quarter. The rising income has enabled NRZ to raise the dividend. The Q3 payment was 15 cents per common share; The dividend for the fourth quarter was increased to 20 cents per common share. At this rate, the dividend annualizes to 80 cents, making an impressive 8.5%. In a further move to return profits to investors, the company announced in November that it had approved share buybacks of $ 100 million. BTIG analyst Eric Hagen is impressed with New Residential – especially the company’s solid balance sheet and liquidity. “[We] like the ability to potentially build capital through retained earnings while maintaining a competitive payout. We believe the dividend increase underscores the company’s liquidity position. We believe that NRZ has been able to release capital as it has raised approximately $ 1 billion in securitized debt for its MSR portfolio through two separate transactions since September, ”said Hagen. In line with his comments, Hagen rates NRZ as a buy and its target price of $ 11 implies an upward movement of 17% for the year ahead. (To see Hagen’s track record, click here.) It’s not often that all analysts agree on a stock. When this happens, take note of it. NRZ’s consensus rating for strong buy is based on unanimous 7 purchases. The stock’s average target price of $ 11.25 indicates an upward movement of ~ 20% from the current stock price of $ 9.44. (See NRZ stock analysis on TipRanks) Saratoga Investment Corporation (SAR) With the next stock we switch to the investment management area. Saratoga specializes in mid-market debt, capital appreciation and equity, with over $ 546 million under management. Saratoga’s portfolio is broad, including industry, software, waste disposal and home security. Saratoga has seen a slow but steady recovery from the corona crisis. The company’s sales declined in the first quarter of 20 and have grown slowly since then. The report for the third quarter of the fiscal year, published in early January, showed $ 14.3 million. Adjusted for taxes before taxes, Saratoga’s net investment income of 50 cents per share exceeded its 47-cents forecast by 6%. They say the race is slowly and steadily winning, and Saratoga has shown investors a generally stable hand over the past year. The stock has rallied 163% from its low after the corona last March. And the dividend, which the company cut in the second quarter, has increased twice since then. The current dividend of 42 cents per common share was declared for payment on February 10 last month. The annualized payment of $ 1.68 gives a return of 8.1%. The analyst Mickey Schleien from Ladenburg Thalmann is optimistic about Saratoga and writes: “We believe that the SAR portfolio is relatively defensive and focuses on software, IT services, education services and the CLO. SAR’s CLO remains up-to-date and the company is seeking refinancing / appreciation that we believe could positively affect our guidance. The analyst continued, « Our model assumes that SAR will use cash and SBA debt to fund net portfolio growth. We believe the Board of Directors will continue to increase the dividend given the performance of the portfolio, the existence of undistributed taxable income and the economic benefits of the Covid-19 vaccination program. “To this end, Schleien rates SAR a Buy along with a price target of USD 25. This number implies an upward trend of 20% from the current level. (To see Schleien’s track record, click here.) Wall Street analysts approve of Schleien on this stock. The other three registered ratings are buys, and the analyst consensus rating is a strong buy. Saratoga’s shares trade for $ 20.87 with an average target price of $ 25.50, indicating an upward movement of 22% over the next 12 months. (See SAR stock analysis on TipRanks) Hercules Capital (HTGC) Last but not least, Hercules Capital is a venture capital company. Hercules provides early stage funding support to small client businesses with a scientific background. Hercules’ customers are Life Life, Technology and Financial SaaS. Since its inception in 2003, Hercules has invested over $ 11 billion in more than 500 companies. The quality of the Hercules portfolio is evident from the company’s recent performance. The stock has fully rebounded from last winter’s corona crisis, rebounding 140% from its low last April. The result has also recovered. For the first nine months of 2020, HTGC posted net investment income of $ 115 million, or 11% more than the same period in 2019. For dividend investors, the key point is that net investment income covered the distribution – in fact, it was 106% of the Base distribution. The company was confident enough to kickstart sales with an additional 2 cents payment. The combined payout results in an annualized payment of $ 1.28 per common share and a yield of 8.7%. In yet another vote of confidence, Hercules completed a $ 100 million investment grade bond offering in November, raising capital for debt repayments, new investments and corporate purposes. The bonds were offered in two tranches, each valued at $ 50 million. The bonds mature in March 2026. Analyst Crispin Love covers Piper Sandler stock and sees plenty to love in HTGC. “We continue to believe that HTGC’s focus on fast-growing technology and life science companies positions the company well in the current environment. In addition, Hercules is not dependent on a COVID recovery as it does not invest in « vulnerable » sectors. Hercules also has a strong liquidity position which should allow the company to act quickly when it finds attractive investment opportunities, « commented Love. All of the above convinced Love to rate HTGC as an outperform (i.e. buy). In addition to the call, he also set a target price of $ 16, indicating upside potential of 9%. (To see Love’s track record, click here.) The stock’s recent appreciation has pushed Hercules stock up to its average target price of $ 15.21 and only ~ 4% above the trading price of $ 14.67 calmly. Wall Street doesn’t seem to mind, however, as the analysts’ consensus rating is a unanimous strong buy based on 6 recent buy-side ratings. (See HTGC stock analysis on TipRanks.) To find great ideas for trading dividend stocks at attractive valuations, visit TipRanks ‘Best Stocks to Buy, a newly launched tool that brings together all of TipRanks’ stock insights. Disclaimer: The opinions expressed in this article are solely those of the presented analysts. The content is intended to be used for informational purposes only. It is very important that you do your own research before making any investment.
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General Electric Company (NYSE: GE) stocks traded a little higher on Monday after a Wall Street analyst took an in-depth look at the company’s free cash flow outlook. GE Analyst: Bank of America analyst Andrew Obin reiterated his buy recommendation on GE and raised his price target from $ 13 to $ 14. See Also: Buying Bank of America Stock The GE Thesis: GE stocks rose last week after the company posted better-than-expected industrial free cash flow of $ 4.37 billion and an industrial FCF between Jan. , $ 5 billion, and $ 4.5 billion respectively on Monday, Obin said GE’s 3% year-over-year fourth-quarter drop in orders was also a pleasant surprise, as orders were down 28% in the previous quarter. The midpoint of GE’s commercial FCF forecast for 2021 of $ 3.5 billion was also slightly above Bank of America’s target of $ 3.3 billion. Obin said investors don’t seem to be fully appreciating GE’s multi-year effort to reduce factoring, which was a $ 3.2 billion outflow in 2020. That process is now coming to an end, and Obin says investors can expect working capital to gradually normalize. Related Link:, 000, 5 Years Later: How Much Would General Electric Stock Be Worth? Obin is aware of the caution towards GE amid the uncertain economic outlook and the company’s rough recent track record, but believes the company is overly cautious with its aviation sales projections for 2021. In the meantime, Obin said, GE has a lot of financial flexibility in the short term and could actually benefit from rising interest rates. Rising interest rates would help reduce GE’s pension liability by $ 25.5 billion and GE Capital’s pension liability by $ 21.3 billion. « Higher discount rates would lower the value of these long-lived debt, » Obin said. Gasoline Gas Take: GE appears to have stopped the bleeding by aggressively addressing its liquidity and balance sheet issues, and it has implemented a long-term turnaround plan. Obin, however, is forecasting just 62 cents for earnings per share in 2023, which suggests GE is already trading at 17.2 times earnings in 2023, even if the company hits Obins’ growth targets over the next two years . Photo Credit: Momoneymoproblemz, via Wikimedia Commons Latest Reviews For GE DateFirmActionFromTo Jan 2021Morgan StanleyMaintainsOverweight Dec 2020DZ BankUpgradesSellHold Dec 2020Morgan StanleyMaintainsOverweight See More Analyst Ratings For GE See The Latest Analyst Ratings For More Info From BenzingaClick Would Be Worth General Stock Options Here From BenzingaClick Here For Options Trades From Benzinga Electric? © 2021 Benzinga.com. Benzinga does not offer investment advice. All rights reserved.
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