The CEO noted that the findings also impact the company’s second Phase 3 trial, ReFocus-ALZ, which has now been discontinued alongside an Open Label Extension study.
Cassava Sciences Inc. ($SAVA) saw its stock plummet over 80% pre-market on Monday following the failure of a pivotal Phase 3 trial for its Alzheimer’s disease drug, simufilam.
Trading was briefly halted earlier as the company revealed that the trial did not meet its primary endpoints for improving cognitive or functional decline at week 52, based on the DAS-COG12 and ADCS-ADL scales.
Despite maintaining a favorable safety profile, the drug’s inability to demonstrate efficacy has dashed hopes for an alternative to existing Alzheimer’s treatments.
CEO Rick Barry acknowledged the setback.
"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,” he said.
“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. We are working to understand this better.”
He noted that the findings also impact the company’s second Phase 3 trial, ReFocus-ALZ, which has now been discontinued alongside an Open Label Extension study.
The company plans to release a comprehensive 52-week dataset, along with partial 76-week results, and will present its findings at an upcoming medical meeting.
Retail sentiment on Stocktwits, where Cassava has a dedicated following of nearly 54,000, has taken a dramatic hit.
Sentiment dropped to ‘extremely bearish,’ (9/100) — the lowest score in a year.
Polls show a split among investors, with 34% remaining long on the stock while 33% have exited their positions entirely.
Simufilam, which aims to address Alzheimer’s by targeting the shape of the protein Filamin A rather than amyloid plaques, had drawn significant interest for its novel approach.
However, the latest development adds to a turbulent year for Cassava, which had already doled out a $40 million SEC settlement over misleading trial claims.
Cassava’s stock, which had gained 17.6% year-to-date through Friday, faces the prospect of erasing a bulk of those gains.
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