Cassava Sciences Inc (NASDAQ: SAVA) reached an SPA (Special Protocol Assessment) agreement with the U.S. FDA on Tuesday morning for the phase 3 trial of its Alzheimer’s treatment, Simufilam.
Shares of the company, however, tanked about 30% this morning on a statement of concern that raised a question on the accuracy and integrity of Cassava’s Simufilam trial data late last night.
FDA requested to pause current Simufilam trials
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On top of challenging the integrity of western blot analyses and the validity of clinical biomarker data, the statement of concern also disputed the analyses of human brain tissue as it requested the drug regulator to pause the current Simufilam clinical trials.
On Wednesday, the biopharmaceutical company said the allegations were “false and misleadingâ€.
“As a science company, we champion facts that can be evaluated and verified. This helps people make informed choices. It is important for stakeholders to separate fact from fiction, which is why we wish to address allegations head-on,†CEO Remi Barbier said in a statement.
Cassava blasts all allegations as fiction
According to Cassava, the claims are baseless because an independent firm, Quanterix Corp, generated the data from Alzheimer’s patients and western blot was a foundational procedure that is widely used in labs to identify a protein of interest.
In its press release, the biotech company refuted all of the 15 claims made against the accuracy and integrity of its Simufilam trial data as fiction.
Casava Sciences has been popular among retail traders this year. The meme stock started the year at $7.0 a share and printed a high of $135 in the last week of July. Including the price action this morning, the $3.48 billion company is now exchanging hands at about $85 a share.
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