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From FirstWorldPharma:
“ Cassava's candidate for Alzheimer's hits the drug development graveyard
Elizabeth S. Eaton
PUBLISHED : MARCH 25, 2025
Ref: GlobeNewswire
Cassava Sciences put the final nail in simufilam's coffin after the Alzheimer's disease candidate demonstrated no treatment benefit in a second late-stage study.
The company shared topline data on Tuesday from the REFOCUS-ALZ trial — which had been terminated in November when another Phase III study, RETHINK-ALZ, missed its co-primary endpoints — demonstrating that simufilam failed to meet all primary, secondary and exploratory biomarker measures. The oral small molecule targets the filamin A protein.
The 76-week REFOCUS-ALZ study had enrolled 1125 patients with mild-to-moderate Alzheimer's to receive either simufilam or placebo; the topline readout was based on results from "a large portion of subjects… [who] completed their final study visit prior to the termination of the trial," Cassava said.
The trial's two primary endpoints evaluated change in cognition and function from baseline, as measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-COG12) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scales.
"We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease. These results were unambiguous," said CEO Rick Barry. "Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the programme by the end of Q2 2025."
The company's shares fell 32% on Tuesday to close at about $1.90. Cassava's valuation has now fallen more than 98% from its peak of $135.3 million in July 2021, when the company was riding high on data that suggested simufilam improved cognition and behaviour in patients with Alzheimer's, as well as a presentation at the Alzheimer's Association International Conference (AAIC) showing that the candidate significantly reduced plasma levels of altered filamin A and p-tau181 in patients after 28 days.
However, shares tumbled shortly afterward amid allegations that Cassava had manipulated its trial data, although the company denied all allegations. Specifically, a citizen's petition asked that the FDA order a halt of RETHINK-ALZ and REFOCUS-ALZ, highlighting "grave concerns about the quality and integrity" of lab-based studies on the oral drug, as well as a "long-standing pattern" of potential data manipulation in scientific papers and corporate disclosures. That petition was denied by the FDA in 2022.”
From FirstWorldPharma:
“ Cassava's candidate for Alzheimer's hits the drug development graveyard
Elizabeth S. Eaton
PUBLISHED : MARCH 25, 2025
Ref: GlobeNewswire
Cassava Sciences put the final nail in simufilam's coffin after the Alzheimer's disease candidate demonstrated no treatment benefit in a second late-stage study.
The company shared topline data on Tuesday from the REFOCUS-ALZ trial — which had been terminated in November when another Phase III study, RETHINK-ALZ, missed its co-primary endpoints — demonstrating that simufilam failed to meet all primary, secondary and exploratory biomarker measures. The oral small molecule targets the filamin A protein.
The 76-week REFOCUS-ALZ study had enrolled 1125 patients with mild-to-moderate Alzheimer's to receive either simufilam or placebo; the topline readout was based on results from "a large portion of subjects… [who] completed their final study visit prior to the termination of the trial," Cassava said.
The trial's two primary endpoints evaluated change in cognition and function from baseline, as measured by the Alzheimer's Disease Assessment Scale-Cognitive 12 (ADAS-COG12) and Alzheimer’s Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scales.
"We are disappointed that the results of REFOCUS-ALZ and RETHINK-ALZ showed no treatment benefit for patients with mild-to-moderate Alzheimer’s disease. These results were unambiguous," said CEO Rick Barry. "Cassava will discontinue all efforts to develop simufilam for Alzheimer’s disease and we expect to phase out the programme by the end of Q2 2025."
The company's shares fell 32% on Tuesday to close at about $1.90. Cassava's valuation has now fallen more than 98% from its peak of $135.3 million in July 2021, when the company was riding high on data that suggested simufilam improved cognition and behaviour in patients with Alzheimer's, as well as a presentation at the Alzheimer's Association International Conference (AAIC) showing that the candidate significantly reduced plasma levels of altered filamin A and p-tau181 in patients after 28 days.
However, shares tumbled shortly afterward amid allegations that Cassava had manipulated its trial data, although the company denied all allegations. Specifically, a citizen's petition asked that the FDA order a halt of RETHINK-ALZ and REFOCUS-ALZ, highlighting "grave concerns about the quality and integrity" of lab-based studies on the oral drug, as well as a "long-standing pattern" of potential data manipulation in scientific papers and corporate disclosures. That petition was denied by the FDA in 2022.”
$SAVA Cassava stops Alzheimer's program as simufilam fails another phase 3.
https://www.fiercebiotech.com/biotech/cassava-stops-alzheimers-program-simufilam-fails-another-phase-3
No one is ever going to recoup their investment through a class action suit. Pennies on the dollar years in the future at best.
Imminent data read out? Huge upside gap here. Short covering at least 6 days to cover. Heads up!
That's the press issuance posted today.
"Cash and assets 128 million."
Cash and assets 128 million.
About the only hope SAVA speculators have of recouping part of their stake:
https://ih.advfn.com/stock-market/NASDAQ/cassava-sciences-SAVA/stock-news/95399778/cassava-sciences-inc-securities-fraud-class-acti
$SAVA: How much cash do they still have ?
Or is it all gone ?💋
Don't trust what FINVIZ is saying................ anyone got update Cash On Hand numbers for $SAVA
Something's afoot.... I think it's called pump and dump.
Nervous? Just the messenger.. Volume suggests something's afoot imo.
Proven?? You sure about that?
Why would any proper pharma company buy a scammy company with a drug candidate proven to be ineffective?
I think we can all safely discount those “rumors”.
Biogen buyout rumors. Going to be a huge volume day here!
Keep in mind the grand canyon gap on the chart. The reward to risk here favors upside including fomo momo.
No ideas on what catalyst could be in play but there's short covering and institutional buying back in. Last day of tax loss selling is also fueling the buys. The obv is clearly indicating accumulations. Just my take
Or maybe this is year end retail flush dump capitulation… has the company downsized the staff in Austin? Any idea what their next act is?
Based on what?
Short squeeze could be epic here.
Looks like bottom is in. Short squeeze could be epic here.
Majority of employees to be laid off?
Maybe they can save the company by saying they will turn into an AI drug discovery company and put their cash in BTC?
LOL
Yes, a company founded and run by fraudsters with a drug that doesn’t work.
What could possibly go wrong?
It's worth it to take a position here. There's a chance for rebound here.
In SEC 144 filing CFO using Morgan Stanley to sell SAVA stock . Saying he knows no material info!!!! Hmmm..
You are most welcome.
Maybe he is good at sniffing out security fraudsters and crooks because he knows how to think like them.
Regards...
THANKS for the reply
I cant stand that weirdo either
he just happened to make a good call on $SAVA whether it was really him or not
who knows
What about the director who poured millions into Cassava propping it up when it would crash from bad news? If this was a scam, wouldnt he have known about it?
That also baffled me. Many smart people had their money tied up here and somehow the share price recovered after the court cases in September. Id love to know more about the why.
They didnt see the forest for all the trees?
I can only agree. Shkreli still has friends in the industry that likely told him about all of his "DD" that he presented in this rink dink "paper" then earns the laurels.
98% of PH3 Alzheimer trials miss and this one had many sticks in the soup. --> managements history of lying and no peer reviewed literatue backing.
Unbelievable there is this laughable antihero worshipping around his persona. Nothing fabulous about this sociopath.
I made the same call repeatedly over the last 2 years but didn't get the love that the convicted fraudster is getting!
How long before indictments of former CEO and his wife? Class action suit? Who sold with inside info this past Friday?
I dont like him but he made a good pre P3 call
if somehow it passed P3 it could have went up slot
P3 fail it crashed
Im listening to him talk about shorting MSTR against BTC hedge/arbitrage
https://x.com/i/broadcasts/1LyxBgywQZkKN
Last call all aboard SAVA FDA fast track status Micro RNA novel prize cancer destruction RNAZ
When companies split in ways that put them this far above the minimum requirement they usually do so when they expect much more downside and when they want to cater to the low float crowd instead of real investors in the bio space.
Thank you. Someone forwarded this to me, else i wouldnt have anticipated something like that :)
Im not interested in ESPR right now as its really in no mans land. I dont "hold" many bios at all. The market has been brutal past few months. But there are some 70 stocks i monitor daily for action...
$PGHL. Wow! Ran 918% during market hours. AH down 87%.
The opposite of a bear raid.
Prada
9 hours ago
So what happened? I’ll tell you….
Short sellers need only be outside of margin compliance for a fraction of a second for brokers to force automatic buy-ins. Knowing this, offshore scam operators tightly control the float of all these issuers but sometimes leave borrow available to lure in short sellers...
When short sellers bite, the scam operators wash trade a spike in the stock, then keep bid/asks moving during the halt so no unhalt price can be settled upon during regular trading hours. Then, after hours, it unhalts as they rip the price 10x+, causing brokers to force-liquidate accounts that were short. Brokers buy-in to cover the short sales as scam artists sell into the artificially high price.
This can lead to short accounts being wiped out instantly and can even lead to broker losses. The same liquidation scam playbook had been executed previously with other Nasdaq offshore scam tickers such as $ZJYL.
So much for that former insider/fraudster of KBI*O then turned into another turd HYG*N. But altogether, SAVA has been a scam, any public company that works with Maxim is a scam. Period.
Exactly.
Nice chatting with you Janice.
Yes, I was surprised to learn kidney beans are somewhat toxic. Toxic enough that you should never cook them in the water you soaked them in. I wouldn't have known were I not an inveterate reader of packaging.
Cassava, from what i have seen, is ingrained into the cultures of Mexican / African / South American diets and they are proud of it.
Their persistence, imo comes from a lack of alternatives and again a culture practice of growing a usable and edible product. Visiting some places in Mexico / Brazil you begin to understand people are just in "survival" mode - use what's available.
The toxicity issue is also common in legume crops such as lima / red kidney beans which are also common in these cultural diets.
And it was first done by pretty primitive people.
Cocoa beans taste pretty crappy before you run them through a 15 step process to get chocolate...Another case of " how did they get from this raw stuff to that?"
Yes, it was an unusual choice of name. Though it's a popular carbohydrate in Central and South America, perhaps the most popular. I've always wondered how many people died before they figured out how to prepare it. And why they were so persistent.
Interesting, just like cassava, which when raw, contains cyanide and is toxic.
https://www.medicalnewstoday.com/articles/323756#is-it-toxic
The name picked by scammers for scammers - how suitable!
Now let's see , where is cassava grown? Mexico / Costa Rica / South America. Insiders probably went straight to the airport after the reverse split, never to be seen again, unless of couse Karma catches up to them, amen.
Appreciate the "scam force" here on Ihub - H Bear too.
Hello again! I found this one remarkable because it was KNOWN that the most important insiders were scammers. And people seem simply to have discounted that, somehow imagining what they produced would be a winner.
Why, hello janice!
Our paths have not crossed for a long time.
Yes, investors still gett'in burnt, will it ever end !? i think not, even i , have had to learn a few lessons from my foolish juvenile days. (lol)
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