- Shares of Cassava Sciences jumped as much as 16% on Monday on news that it successfully completed an end-of-phase two meeting with the FDA for its Alzheimer’s treatment Simufilam.
- The biotech company will be moving forward with a pivotal phase-three study in the second half of this year.
- Simufilam is a novel drug that targets “both neuroinflammation and neurodegeneration.
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Shares of Cassava Sciences jumped as much as 16% on Monday on news that the biotech company successfully completed an end-of-phase 2 meeting with the US Food and Drug Administration for Simufilam, its leading drug candidate for the treatment of Alzheimer’s disease. The meeting paved the way for a pivotal phase-three study in the second half of this year.
The Austin, Texas-based company surged toward an almost 10-year high, nearing a share price last seen in June 2011.
“For over 10 years we’ve been doing basic research and early drug development with simufilam,” Remi Barbier, President and CEO of the company said in a statement. “We believe the underlying science is solid, the drug appears safe and the clinical roadmap makes sense. We’ve crossed the Rubicon.
Simufilam is a novel drug that targets “both neuroinflammation and neurodegeneration,” the statement said.
The discussion during the meeting with the FDA, which took place in January, was supported by years of scientific and clinical data. This included positive results from a previously completed phase two clinical program.
More than five million Americans are living with the disease, according to the Alzheimer's Association.
Shares of Cassava Sciences traded at $59.07 at 12:20PM E.T. on Monday.