Cassava Sciences Discontinues Alzheimer’s Program After Simufilam Fails Second Phase 3 Trial

Cassava Sciences announced that simufilam failed to meet primary endpoints in the Phase 3 REFOCUS-ALZ trial for mild-to-moderate Alzheimer's disease25.

The drug did not show significant reduction in cognitive or functional decline compared to placebo over 76 weeks2.

This failure follows a similar negative result from the previous RETHINK-ALZ Phase 3 trial in November 202423.

Cassava will discontinue all efforts to develop simufilam for Alzheimer's disease and phase out the program by the end of Q2 202557.

The company's stock plummeted by over 80% following the announcement39.

Simufilam demonstrated a favorable safety profile in clinical trials, despite its lack of efficacy27.

Cassava Sciences has been embroiled in controversy, including allegations of data manipulation and an SEC settlement for misleading investors69.

The company is pivoting to evaluate simufilam for TSC-related epilepsy in preclinical studies25.

As of December 31, 2024, Cassava maintained approximately $128.6 million in cash and cash equivalents25.

Sources:

2. https://www.stocktitan.net/news/SAVA/cassava-sciences-reports-topline-phase-3-refocus-alz-hcaw3xrcj2xs.html

3. https://www.biospace.com/drug-development/cassavas-shares-plunge-as-alzheimers-drug-fails-phase-3

5. https://www.biospace.com/drug-development/cassava-finally-ends-alzheimers-program-for-embattled-simufilam

6. https://www.science.org/content/article/controversial-alzheimer-s-drug-cassava-sciences-fails-clinical-testing

7. https://in.benzinga.com/general/biotech/25/03/44475019/cassava-sciences-discontinues-developing-simufilam-for-alzheimers-after-another-phase-3-trial-flop

9. https://www.ainvest.com/news/cassava-sciences-halts-alzheimer-trials-drug-fails-show-promise-stock-plummets-2503/