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Cassava Sciences (SAVA) Up More Than 600% YTD: Here's Why

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Shares of Cassava Sciences, Inc. (SAVA - Free Report) have risen sharply in the year so far. The stock has skyrocketed 663.2% against the industry’s decrease of 4%.

price chart for SAVA


The company has made rapid progress in the development of its Alzheimer’s disease (“AD”) candidate, simufilam, in this time frame. This has pushed up Cassava Sciences’ share price.

Last month, the company successfully completed an end-of-phase II (EOP2) meeting with the FDA authorities for simufilam for the treatment of AD. Per the meeting, the FDA and Cassava Sciences agreed on key elements for a pivotal phase III program, which will support a new drug application filing for simufilam in AD.

The company plans to initiate two phase III studies to evaluate simufilam for AD in the second half of 2021. The phase III program for simufilam will consist of two large, double-blind, placebo-controlled studies evaluating simufilam in patients with mild-to-moderate AD dementia.

The first phase III study will evaluate disease-modifying effects of the candidate in AD patients. The goal of this study is to show a slower rate of decline in cognition and daily function in patients treated with simufilam versus those who receive placebo. The other study will evaluate simufilam for symptomatic improvement in AD patients. The goal of this study is to show improvement in cognition and daily functions in patients treated with simufilam as compared to those who receive placebo.

Meanwhile, in February 2021, Cassava Sciences announced encouraging interim data from the open-label study of simufilam. Both cognition and behavior scores of patients improved following six months of treatment with simufilam, with no safety issue observed. Shares of the company rose substantially back then.

We note that Cassava Sciences has no approved product in its portfolio at the moment. Therefore, pipeline development remains a key focus for the company. If successfully developed and upon potential approval, simufilam can lend a big boost to the company as there is no approved drug for treating AD.

Although several other companies are developing treatments for this disease, there is no success as of yet. Biogen (BIIB - Free Report) is one of the leading players in the AD segment with multiple candidates being tested for treating AD. Meanwhile, in January 2021, Biohaven’s (BHVN - Free Report) troriluzole failed to achieve statistical improvement in primary endpoints of phase II/III study on AD patients.

Zacks Rank & Stock to Consider

Cassava Sciences currently carries a Zacks Rank #3 (Hold). A better-ranked in the same sector is Catalyst Pharmaceuticals, Inc. (CPRX - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Catalyst Pharmaceuticals’ earnings estimates have been revised 5.6% upward for 2021 over the past 60 days. The stock has rallied 10.8% year to date.

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