Cassava Sciences warns of potential clinical hold on simufilam in recent 10-K filing
Cassava Sciences (SAVA +2.4%) has warned that it may face a clinical hold on its trials for simufilam after the U.S. FDA imposed them this year on two competitors that are also working on Alzheimer's candidates.
The notification was tucked away in Cassava's (SAVA +2.7%) 10-K annual report filing on Feb. 28.
The company noted the holds on Cortexyme (CRTX +5.4%) and Denali Therapeutics (DNLI +0.4%) in regards to their Alzheimer's candidates, both done in January.
Cortexyme (CRTX +5.4%) said it would provide updates after further engagement with the agency and Denali (DNLI +0.4%) did not provide details behind its hold.
"A clinical hold may require us to spend significant resources over many months to address the root causes of FDA's concerns," Cassava (SAVA +2.7%) said in the filing. "We may not find and successfully address such root causes, which could adversely affect our business. "
"If we are on clinical hold for 1 year or longer, the FDA may consider our IND for simufilam to fall into Inactive Status, which may result in termination of the clinical program for simufilam," the company added. "To the extent we are not successful in lifting an FDA clinical hold, our results of operations and business will be materially adversely affected."
The FDA in February denied a citizen petition alleging improprieties in some simufilam studies.