By Dhirendra Tripathi
Investing.com – Cassava stock (NASDAQ:SAVA) plunged 20% Wednesday on reports the Securities and Exchange Commission is investigating claims that the company manipulated research results of simufilam, its experimental drug for Alzheimer’s.
The company disclosed Monday in an SEC filing it is cooperating with government investigations. It said an investigation isn’t a sign any wrongdoing occurred. It did not the name any agency probing it.
The National Institutes of Health, which awarded $20 million in grants to Cassava and its academic collaborators since 2015 for drug development, is also examining the claims, The Wall Street Journal said, quoting the company’s chief executive officer.
The accusations surfaced in August when two physicians petitioned the Food and Drug Administration to order suspension of Cassava’s clinical trials.
Disputing the validity of Cassava’s clinical biomarker data and the integrity of Western Blot Analysis, the petition’s authors said they doubted the company’s research claiming it included images that appeared manipulated.
Cassava said the biomarker data of Alzheimer’s patients was generated by Quanterix (NASDAQ:QTRX), an independent company, and presented at the recent Alzheimer’s Association International Conference.
The company said Western Blot Analysis is foundational to the biotechnology industry and is a standard lab technique used worldwide to detect a protein of interest.
Cassava’s proposed drug for Alzheimer’s aims to restore a protein, filamin A, that its scientists say is misshaped in the blood of patients suffering from the fatal illness.
Earlier this month, the Journal of Neuroscience said it had found no evidence of data manipulation in an article it published in July 2012 describing a new approach to treating Alzheimer's disease.
Cassava’s lead drug candidate for treating Alzheimer’s is currently in a phase-3 clinical program.