Home › Research › Laboratory science
SEC Charges Cassava Sciences and Former Top Executives with Securities Fraud Related to Alzheimer's Drug Clinical Trial
U.S. Securities and Exchange Commission. SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311), 2024-09-26
Topic: Amyloid, tau and blood-test diagnosis
In September 2024 the SEC announced that Cassava Sciences and three individuals tied to the company agreed to pay over $40 million combined to settle federal charges that they misled investors about a 2020 Phase 2 trial of simufilam. The SEC said the company falsely claimed the trial was properly blinded and touted a large cognitive-memory improvement, when the full unblinded dataset actually showed no measurable improvement in patients' episodic memory. None of the parties admitted or denied the allegations.
Key findings
- Cassava Sciences agreed to pay a $40 million penalty
- Former CEO Remi Barbier: $175,000 penalty; former SVP Lindsay Burns: $85,000 penalty; consultant Hoau-Yan Wang: $50,000 penalty
- SEC alleged the Phase 2 trial was not actually blinded as claimed, because Wang had access to unblinding information
- SEC alleged the company failed to disclose that the complete dataset showed no measurable improvement in episodic memory
- Settlement made without any party admitting or denying the SEC's allegations
Why it matters
The SEC alleged that Cassava Sciences falsely claimed its 2020 Phase 2 simufilam trial was properly blinded and touted a large cognitive-memory improvement, when the full unblinded dataset showed no measurable improvement in episodic memory. The company and three individuals settled for over $40 million combined without admitting or denying the allegations.
Study details
- Effect sizePenalties: Cassava Sciences $40 million; Remi Barbier $175,000; Lindsay Burns $85,000; Hoau-Yan Wang $50,000
- Evidence strengthHigh
Limitations
This is a civil securities settlement, not a scientific misconduct finding or criminal conviction of research fraud per se (a separate DOJ indictment of Wang for NIH grant fraud, reported in June 2024, is the criminal-fraud track); the settlement was made without admission or denial of wrongdoing by any party.
How this study scored 16/100
Regulatory decision — not a study. It scored 21 on the same rubric, but non-peer-reviewed sources are capped at 16, so it shows as 16. Scored zero for study design, sample size, studied in people, randomised / blinded and indexed in PubMed because the record does not state it. We have no data on times cited, citations per year, impact for its field and year, still being cited, senior author's track record, institution's track record, multi-centre collaboration and free to read, so those were left out: it earned 14 of the 66 points we could judge it on, which is 21 out of 100.
| Component | Points | Why |
|---|---|---|
| Journal tier | 2 / 10 | Tier 4 — not a peer-reviewed journal (SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311)) |
| Journal's citation record | 0 / 4 | Not a journal article, so the journal's record does not count |
| Study design | 0 / 12 | No study design recorded — scores zero, not guessed (not stated in the record — scored 0) |
| Strength of evidence | 5 / 5 | Rated “high” in our summary |
| Peer-review validation | 1 / 10 | Regulatory decision — not a study. Named source is a regulator (FDA / EMA / CMS / SEC). |
| How recent | 4 / 5 | 2024 — within 3 year(s) of the newest study here |
| Sample size | 0 / 4 | Participant count not stated — scores zero (not stated in the record — scored 0) |
| Effect reported | 2 / 3 | Effect reported as a number, without an interval or test |
| Studied in people | 0 / 3 | Not stated whether this was studied in people — scores zero (not stated in the record — scored 0) |
| Randomised / blinded | 0 / 2 | No randomisation or blinding stated — scores zero (not stated in the record — scored 0) |
| Times cited | — / 7 | No citation count (not found in OpenAlex) — left out of this score |
| Citations per year | — / 5 | No citation count or no year — left out of this score |
| Impact for its field and year | — / 6 | No field-weighted citation impact (OpenAlex has none yet) — left out of this score |
| Cited by studies here | 0 / 6 | No other study in this library cites it |
| Still being cited | — / 4 | No yearly citation counts — left out of this score |
| Senior author's track record | — / 4 | Senior author's record not available — left out of this score |
| Institution's track record | — / 3 | No institution listed in OpenAlex — left out of this score |
| Multi-centre collaboration | — / 3 | Institutions not listed — left out of this score |
| Indexed in PubMed | 0 / 2 | No PubMed ID and no DOI — scores zero (not stated in the record — scored 0) |
| Free to read | — / 2 | Access not recorded — left out of this score |
| Points | 14 / 66 | Scored on 12 of 20 parts. We have no data for the rest, so they are left out: 14 of the 66 points we could judge it on is 21 out of 100. |
| Total | 21 / 100 | Capped to 16 because this is not a peer-reviewed article. |
What each of these 20 components measures, and what this score is not →
Read the original
Free copy unknown: no free-copy check has an answer for this record yet. That does not mean it is paywalled.
Cite this study APA, Vancouver, BibTeX · download .bib or .ris
Built from the record alzhub holds for this paper, not looked up. This record has no DOI, so the citation leaves it out. Volume, issue and page numbers are not held in the record. Check the citation against the original before you use it.
APA 7th
Commission, U. S. a. E. (2024). SEC Charges Cassava Sciences and Former Top Executives with Securities Fraud Related to Alzheimer's Drug Clinical Trial. SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311).
Vancouver
Commission USaE. SEC Charges Cassava Sciences and Former Top Executives with Securities Fraud Related to Alzheimer's Drug Clinical Trial. SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311). 2024.
BibTeX
@article{commission2024-91a12b9f,
author = {Commission, U.S. Securities and Exchange},
title = {{SEC Charges Cassava Sciences and Former Top Executives with Securities Fraud Related to Alzheimer's Drug Clinical Trial}},
journal = {SEC Press Release / Administrative Order (Securities Act of 1933 Release No. 11311)},
year = {2024}
}
Related studies in Laboratory science
Also tagged “double-blind”
783 studies in the library carry the topic tag “double-blind”; these are this study's neighbours in a fixed, alphabetical-by-hash tour of them, not the closest in content. All 783 tagged studies.