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Cassava Sciences shares are plunging in premarket trading and are losing most of their value after the biotech firm said its experimental Simufilam drug aimed at treating Alzheimer’s disease failed to show a “significant reduction in cognitive or functional decline” during the Phase 3 trial of the treatment.
Cassava Sciences shares are plunging in premarket trading and are losing most of their value after the biotech firm said its experimental Simufilam drug aimed at treating Alzheimer’s disease failed a late-stage study.
The drug was aimed at treating patients with mild-to-moderate Alzheimer’s.
A second late-stage trial for the drug Simufilam has also been discontinued.
Cassava Sciences (SAVA) shares are plunging in premarket trading and are losing most of their value after the biotech firm said its experimental Simufilam drug—aimed at treating Alzheimer’s disease (AD)—failed to show a “significant reduction in cognitive or functional decline” during the Phase 3 trial of the treatment.
The drug was aimed at treating patients with mild-to-moderate Alzheimer’s, which the Mayo Clinic describes as the most common cause of dementia.
“The results are disappointing for patients and their families who are living with this disease and physicians who have been looking for novel treatment options,” Chief Executive Officer (CEO) Rick Barry said in a statement.
“We took careful measures to enroll patients with mild-to-moderate AD. Despite that, the loss of cognition in the placebo group was less pronounced than was previously reported in other placebo-controlled studies in AD,” he added.
Barry said that the failure of the late-stage trial for Simufilam means that the company would discontinue another late-stage study and open-label study of the drug. An open-label or nonblinded study is where both the health providers and the patients are aware of the drug or treatment being given, according to the National Cancer Institute.
The company in September agreed to a $40 million settlement with the Securities and Exchange Commission (SEC) over charges that it manipulated clinical trial data related to its Alzheimer’s disease drug.
Cassava Sciences shares are tumbling 80% in premarket trading, bringing their year-to-date gain to around 18%.
Health care stocks were edging higher premarket Monday as the Health Care Select Sector SPDR Fund was up 0.5% and the iShares Biotechnology ETF recently advanced by 0.9%.
Cassava Sciences shares plunged by 84% after the company said its late-stage trial of simufilam in mild-to-moderate Alzheimer's disease did not meet the co-primary endpoints of cognitive and functional improvement.
Biohaven shares fell past 10% after the company said a study of its experimental drug for spinal muscular atrophy did not achieve a "statistically significant difference" compared with placebo and standard of care at 48 weeks.
Alnylam Pharmaceuticals shares were up over 2% after the company said the US Food and Drug Administration has accepted its supplemental new drug application for vutrisiran, an investigational RNAi therapeutic for the treatment of ATTR amyloidosis with cardiomyopathy.
US equity futures rose before Monday's opening bell as traders looked ahead to the minutes from the Federal Reserve's most recent policy-setting meeting as well as a key inflation metric due for release later in the week.
Dow Jones Industrial Average futures rose 0.8%, S&P 500 futures increased 0.6%, and Nasdaq futures were up 0.6%.
The Federal Open Market Committee will release the minutes from its latest meeting Tuesday.
The Personal Consumption Expenditures price index, the Fed's preferred measure of inflation, will be released Wednesday.
US stock markets will be closed Thursday for the Thanksgiving Day holiday, and will also close early at 1 pm ET the following day.
Oil prices were lower, with front-month global benchmark North Sea Brent crude down 0.4% at $74.34 per barrel and US West Texas Intermediate crude down 0.4% at $70.93 per barrel.
The Dallas Federal Reserve's manufacturing business index is scheduled for release at 10:30 AM ET.
In other world markets, Japan's Nikkei closed 1.3% higher, Hong Kong's Hang Seng ended 0.4% lower, and China's Shanghai composite finished 0.1% lower. Meanwhile, UK's FTSE gained 1.4%, Germany's DAX index increased 0.4%, France's CAC 40 was up 0.1% and Spain's IBEX 35 was up 0.9% in Europe's early afternoon session.
In equities, shares of Tesla were 2.4% higher pre-bell following a Bloomberg report that the electric car manufacturer reached a conditional settlement deal with Rivian Automotive over allegations of stealing employees and trade secrets.
On the losing side, Cassava Sciences shares fell 85% after the company said its late-stage trial of a treatment candidate for Alzheimer's disease missed its co-primary endpoints of cognitive and functional improvement.
Health care stocks were edging higher premarket Monday as the Health Care Select Sector SPDR Fund (XLV) was up 0.6% and the iShares Biotechnology ETF (IBB) recently advanced by 1.1%.
Cassava Sciences shares plunged by over 84% after the company said its late-stage trial of simufilam in mild-to-moderate Alzheimer's disease did not meet the co-primary endpoints of cognitive and functional improvement.
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