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Shares of Cassava Sciences Inc. tumbled 73.2% in trading on Friday after the company said its investigational Alzheimer's disease treatment failed a mid-stage trial. The experimental drug, PTI-125, did not meet the primary endpoint (reducing cerebrospinal fluid (CSF) levels of tau protein) in the Phase 2b study; however, it did meet a secondary endpoint, reducing CSF levels of another biomarker, IL1-beta. The therapy was being tested in people with mild and moderate forms of Alzheimer's. "Today's top-line results disappoint and are not consistent with previous clinical experience for reasons that are unclear at the moment," CEO Remi Barbier said in a news release. Cassava's stock is down 60% year-to-date. The SPDR S&P Biotech Exchange-Traded Fund has gained 4.2%.

Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that The Journal of Prevention of Alzheimer’s Disease (JPAD), a peer-reviewed journal for the research community, published results from the Company’s Phase 2a study demonstrating that its lead drug candidate, PTI-125, reduced biomarkers of disease in Alzheimer’s patients. This publication provides clinical insights into how our lead drug candidate, PTI-125, could make an important difference for patients living with Alzheimer’s disease.

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Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced clinical updates and business progress across its pipeline of product candidates under development. Cassava Sciences is building a leading position in Alzheimer’s R&D by focusing on the development of a first-in-class program for treating and detecting Alzheimer’s disease. The Company’s scientific approach for the treatment of Alzheimer’s disease seeks to simultaneously improve both neurodegeneration and neuroinflammation.

Cassava Sciences (SAVA) saw a big move last session, as its shares jumped more than 8% on the day, amid huge volumes.

Companies In The News Are: LLY, SAVA, FLR, LYTS

The Zacks Analyst Blog Highlights: Agile Therapeutics, Air Industries, Dermira, Microbot Medical and Cassava Sciences

Investing in micro-cap biotechs is a risky business. Although 2020 has seen a host of small biotech companies’ valuations soar on the back of promising trial data for a COVID-19 vaccine or treatment, it’s easy to forget just how devastating negative results can be. Bring results of a failed clinical trial to the public‘s attention, and the stock gets dropped faster than you can say “primary endpoint.”Case in point: Cassava Sciences (SAVA). The Austin, Texas-based company shed 74% of its value in Friday’s session following the release of disappointing results from a Phase 2 study evaluating Cassava's lead investigational drug, PTI-125, in Alzheimer's disease (AD).The candidate failed to meet the primary endpoint, which was to produce a meaningful improvement in a number of AD biomarkers, when compared to the placebo.Targeting an altered form of filamin A, a scaffolding protein present in the body, PTI-125 is a small molecule designed to reduce the protein’s effects. Present in the brains of AD patients, the extremely toxic form of the protein interferes with the normal function of neurons, thereby, causing neuroinflammation and neurodegeneration.The company has noted that the high variability in biomarkers may have masked the drug’s effect, with it planning to further analyze the data.Although Maxim's Jason McCarthy notes there were positives to take away from the data, they are not enough to dissuade the analyst from changing his model for Cassava.McCarthy said, “The data failed to meet the primary endpoint of significant improvement in AD biomarkers from baseline to Day 28 in treatment groups compared to placebo. A significant reduction in CSF levels, however, was noted in neuroinflammation biomarker IL1-beta, a secondary endpoint (p<0.035). Nonetheless, a miss is a miss and the path forward for PTI-125 is unclear.”Accordingly, the analyst downgraded SAVA to Hold and removed the previous $12 price target “while the company further evaluates the data and path forward.” (To watch McCarthy’s track record, click here)Only one other analyst has reviewed Cassava over the past three months, assigning the stock a Hold rating. Therefore, the micro-cap biotech has a Hold consensus rating. To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.

During the Q4 investors' call, Cassava Sciences (SAVA) is likely to provide an update on its lead candidate PT-125, which is being developed for the treatment of Alzheimer's disease.

This study did not meet its primary endpoint. The pre-specified primary endpoint was a statistically significant effect of PTI-125 versus placebo on cerebrospinal fluid (CSF) levels of tau protein and other biomarker assessments from baseline to Day 28. PTI-125 significantly reduced a secondary endpoint, CSF levels of IL1-beta (p<0.035), a core biomarker of neuroinflammation, from baseline to Day 28.

Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...

-Top-Line Results of a Phase 2b in Alzheimer’s On Track for Mid-Year 2020 -- Cash Balance Exceeds $26 Million at January 31, 2020 -- $5 Million Net Cash Use Expected in 2020 -.

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Zacks.com featured highlights include: Cassava Sciences, Rubicon Project, Talos Energy, Teekay Tankers and Karyopharm Therapeutics

Cassava Sciences shares drop after its candidate treatment for Alzheimer's disease missed its key endpoint in a Phase IIb trial.

Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced it has initiated dosing for the last patient in a Phase 2b study of PTI-125. This completes patient enrollment in a randomized, double-blind, placebo-controlled, Phase 2b study of PTI-125, Cassava Sciences’ investigational drug to treat Alzheimer’s disease. “This study again brought together leaders from the research community who share our commitment to improving outcomes for patients with Alzheimer’s disease,” said Remi Barbier, President & CEO.

- Anticipates Early Data Readout for Phase 2b Study of PTI-125 in Alzheimer’s Disease - - Approximately $2.9 Million in NIH Research Grants Awarded in 2020 - - Open-Label.

Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced the initiation of an open-label extension study to evaluate PTI-125 in patients with Alzheimer’s disease. The Company’s lead investigational drug, PTI-125, seeks to improve both neurodegeneration and neuroinflammation in patients with Alzheimer’s disease. “We believe the ability of our drug to improve multiple functions in the brain represents a new, different and crucial approach to treat Alzheimer’s disease,” said Remi Barbier, President & CEO.

Cassava Sciences, Inc. (SAVA), a clinical-stage biotechnology company focused on Alzheimer’s disease, today announced that it has been awarded a new $2.5 million research grant award from the National Institutes of Health (NIH). This new research grant will support the on-going clinical evaluation of PTI-125, the Company’s lead investigational drug.