Datavault AI acquired the SyncIN technology from Turner Global Media, not the entirety of the company, on July 7, 2025, according to multiple news reports. The acquisition involves Turner Global Media’s innovative audio QR technology, SyncIN, which enables smartphones to interact with broadcasts (TV, radio, and in-store) to facilitate Web 3.0 stablecoin transactions. This acquisition is expected to boost Datavault AI’s position in advertising and e-commerce, with revenue targets of 10-15 high-margin licensing deals in 2025 and a projected $40-50 million revenue goal by 2026.
Small position in Halliburton (HAL) 20.80; risk two bucks to make 5, but if it fills gap at 25, could see 30 again. Earnings on deck in a few weeks adds some risk. Oilfield services has been weak but I think it’s a reasonable trade.
As of March 31, 2025, Next Technology Holding Inc. (NXTT) had invested in approximately 5,833 Bitcoin, with an average purchase price of approximately $31,385 per Bitcoin.
baz22(@baz22)
July 10, 2025 3:01 pm
#47559
Just watching if BMGL gonna announce that $ 1 billion BTC proposal from May…?
Pendulum is swinging around BTC, ETH, SOL as companies are loading their crypto treasuries… Defi Development is making big moves… Kidz is rapidly increasing it’s SOL holdings
baz22(@baz22)
July 10, 2025 1:34 pm
#47554
Always such a delicate balance between a new company/technology and it’s stock
Northrop Grumman is a global aerospace and defense technology company. It focuses on designing, developing, and manufacturing a wide range of systems and products for both military and civilian clients. Key Areas of Operation: Aerospace: This includes aircraft like the B-21 Raider bomber, the F-35 center fuselage, and various unmanned aerial vehicles (UAVs) such as the Global Hawk. Defense Systems: Northrop Grumman produces missile defense systems, including the Ground Based Strategic Deterrent (Sentinel) and various missile defense components, as well as armaments like artillery and ammunition. Mission Systems: This segment encompasses a broad range of technologies, including C4ISR (Command, Control, Communications, Computers, Intelligence, Surveillance, and Reconnaissance), cyber warfare capabilities, and electronic warfare systems. Space Systems: Northrop Grumman is involved in various space programs, including satellite development, propulsion systems, and deep space exploration initiatives. Key Facts: Headquarters: Falls Church, Virginia. CEO: Kathy J. Warden. Founded: 1939 (as Northrop Aircraft, Inc.). Employee Count: Approximately 100,000. Global Presence: The company operates in the US and internationally. Major Products: B-21 Raider, F-35 center fuselage, Global Hawk, Sentinel, various missile defense systems. Key Customers: US Department of Defense, NASA, other government and commercial clients. ….. perhaps when Ascent Solar lets the news out…..
If going ETH, I believe SBET is much better…. The guiding hand at SBET is the Cofounder of Ethereum itself..The offering for the $ 500 million they just finished spending was in May…. I briefly posted it last week around $ 10… I was buying BTCS at $ 2.75 then
I think someone’s sniffing around Editas – EDIT… Possibly Pfizer….??
Remember the VERV deal a few weeks back… They had barely begun phase 2… Editas already completed phase 2 in ex vivo SCD, and the results were excellent…you know how it works – short em’ ( biotech ) into the ground before they reach the commercial market, then make an offer… Now the worm has turned… Risk asset’s are catching a bid
BUT this MLGO — the more positive news I see, the lower the stock price. There’s this inverse-correlation that my little brain can’t handle. It’s a Quantum effect.
China is not getting Any respect…!! But until it’s quantum project’s are commercialized, it will be tricky… However, in time……. Mlgo’s algorithms are in great use in the mainland ……did you get ‘ IREN ‘ at $ 10 a few weeks back..?
The FAA won’t issue Any final approvals until late 2026 or into 2027 for Any in the eVTOL sector…
Last edited 2 days ago by baz22
baz22(@baz22)
July 8, 2025 9:44 pm
#47533
May 2025… “Quince Therapeutics is advancing eDSP for Ataxia-Telangiectasia, leveraging strong prior data in the 6-9 age group and an innovative AIDE platform. Recent insider buying, new analyst coverage with high price targets, and robust patent protection highlight growing confidence and upside potential. Data readout for the NEAT Phase 3 trial is scheduled for early 2026, with all patients joining the open-label extension, and cash runway aligns with expected topline results. With a market cap near cash value and significant platform potential, I reiterate my Strong Buy rating ahead of readout…” SA..
SMMT: Astro Zeneca AZN is in discussion with SMMT, it is slightly up. Hope it goes up above $30.
baz22(@baz22)
July 8, 2025 5:41 pm
#47527
From January 2025…. “Why Rilparencel Could Be Huge For CKD Now, an interesting thing worth mentioning is that in Q4 2024, PROK mentioned that PROACT 1 could be enough to support approval for Rilparencel. The FDA itself mentioned this possibility, but obviously that remains contingent on them delivering good data that corroborates its previous trials. PROK also confirmed that there’s a possibility that they find a “surrogate” endpoint that could, in theory, expedite their regulatory pathway. If, for instance, the eGFR suggests the treatment is indeed effective, the FDA might grant it an accelerated approval pathway.”…..PRO……..
…… “2025 Will Be A Major Year For ProKidney’s Rilparencel In CKD Treatment
5
Save Comments (6) 2025 Will Be A Major Year For ProKidney’s Rilparencel In CKD Treatment Jan. 31, 2025 6:10 AM ETProKidney Corp. (PROK) StockPROK
Myriam Alvarez 2.65K Followers
5 Share
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(11min) Comments (6) About this article Ticker Analyst rating BUY Price at publication $1.68 Last price $3.73 Summary Rilparencel is ProKidney’s main candidate. It is intended as a therapy that stabilizes kidneys, making it potentially useful for CKD patients. We’ll have Rilparencel’s Phase 2 full data in 2025, as well as the potential confirmation about a “surrogate” endpoint for its Phase 3 trials. Currently, Rilparencel’s Phase 3 is planned to deliver full data by Q3 2027 if no surrogate endpoint is found that’s suitable for the FDA. The FDA confirmed in a meeting with PROK that its Phase 3 “could be sufficient” to support approval, and an accelerated pathway with a suitable surrogate endpoint is available. From a valuation perspective, PROK also seems relatively cheap and has multiple important catalysts for 2025. So, I rate it a “Buy” at these levels.
Jian Fan/iStock via Getty Images
ProKidney (NASDAQ:PROK) is a biotech that works on autologous cellular therapy for organs. In easier terms, PROK tries to preserve organs with its technology, and currently, its leading candidate is Rilparencel (React) for chronic kidney disease [CKD]. In particular, Rilparencel uses patients’ kidney cells to stabilize or slow down the progression of CKD. In fact, this IP has already received the FDA’s Regenerative Medicine Advanced Therapy [RMAT] designation because its last Phase 2 data was quite encouraging. Currently, they’re working on their final Phase 3 trials, which could also potentially uncover an accelerated pathway if they find a suitable “surrogate” endpoint. And from a valuation perspective, PROK seems relatively cheap as well, so I’m going to rate it a “Buy” for long-term biotech investors at these levels.
New Promise For CKD ProKidney was founded in 2015, and it’s currently headquartered in the US. In my view, PROK is quickly moving forward with its late-stage candidate, Rilparencel. This CKD therapy has shown great potential in its previous trials, and it’s now easily the company’s main value driver. At this point, the main catalysts to watch forward to in 2025 are the data from its Phase 2 REGEN-007 trial and a potential announcement of an accelerated pathway in its Phase 3 PROACT 1 study.
Source: JPMorgan Presentation. January 2025.
As an overview, its pipeline hinges on autologous cellular therapies like Rilparencel. Note that Rilparencel targets CKD, which is a worldwide prevalent condition. However, Rilparencel’s particular focus is on CKD in type 2 diabetes [T2DM] patients at risk of kidney failure. Nonetheless, I do believe it’s a potentially revolutionary therapy that could also give hope to some sub-demographics with unmet medical needs in CKD.
Moreover, PROK’s process is relatively simple. It first requires tissue from patients, which obviously involves biopsy. But after that, PROK can use that biomaterial to isolate kidney cells and reproduce them in their labs. Eventually, they can use those cells as a form of kidney therapy. For this, PROK cryopreserves kidney cells to maintain them until they’re ready to be administered to CKD patients. At that point, PROK simply injects the cells back into the patient’s kidneys.
Why Rilparencel Could Be Huge For CKD Now, an interesting thing worth mentioning is that in Q4 2024, PROK mentioned that PROACT 1 could be enough to support approval for Rilparencel. The FDA itself mentioned this possibility, but obviously that remains contingent on them delivering good data that corroborates its previous trials. PROK also confirmed that there’s a possibility that they find a “surrogate” endpoint that could, in theory, expedite their regulatory pathway. If, for instance, the eGFR suggests the treatment is indeed effective, the FDA might grant it an accelerated approval pathway.
Source: JPMorgan Presentation. January 2025.
To be clear, that potential is inherently speculative, and the actual guidance for PROACT 1’s full data will be available in Q3 2027. Still, the eGFR endpoint alternative could be achieved faster than the survival rates or dialysis data. Plus, it’s encouraging to see that the FDA itself seems open to the idea of offering PROK an expedited pathway that could bring Rilparencel to market. Note that PROK disclosed that it intends to give us more details about potentially focusing on eGFR later this year, and if they confirm this, it could be a major milestone. After all, it would essentially pull forward Rilparencel’s potential submission to the FDA.
But still, remember that Rilparencel’s Phase 2 trials showed a substantially lower disease progression toward terminal CKD stages. And it demonstrated that Rilparencel indeed stabilized kidneys as measured by the eGFR. Note that eGFR stands for “Estimated Glomerular Filtration Rate” and basically measures how well kidneys filter blood. So, as you might expect, a higher eGFR implies healthier kidneys, and that makes it a fantastic proxy to assess how effective Rilparencel actually is. And if you look at Group 1’s data, it clearly shows that eGFR remains stable for 18 months after Rilparencel. In other words, Rilparencel seems like a viable treatment that could preserve kidney function in CKD patients. And the kicker is that there are no serious side effects that could derail its potential approval either (so far at least”
This is a biggie coming up… The next Alzheimer’s Association International Conference (AAIC) will be held from July 28 – August 1, 2024, in Philadelphia, USA and online, according to the Alzheimer’s Association. * tiny Cgtx has an FDA review on July 9
Last edited 3 days ago by baz22
Stev1183
July 7, 2025 9:37 pm
#47510
I do read this site every day, but rarely contribute. The first stock I own is Mux for the past 15 years. First time in all that time that I actually feel that mux is going to have an incredible 3 years going forward. I will do a write up this week. The 2nd stock i own is a stock nobody seems to discuss on this board…..Tesla. seems to me if you want to own one stock for the next 25 years, I can’t imagine anyone can beat this stock. The only thing that 8can stop this from going 10 fold in the next 25 years is when Elon jtalks. Put a muzzle on this man, and watch his accomplishments. This is a man that has huge flaws, but his ability to get things done is incredible. I also believe that elon thinks on a different level than everybody else. That being said, I would have no interest in becoming a friend of his. But I will let him make me money.
Totally agree… I bought MUX ( when it was US Gold ) in 2009..I bought at $ 0.93 cents… it ran to $ 9.00 in one year…Always have pushed Tesla here, but not much in the past 2 years…..did buy at $ 110 then.. ** I remember this ( US GOLD ) because I bought 5,000 shares in my hospital bed after knee replacement in January, 2009….!!! Good luck on both…
Tesla is a beast to trade. I am learning that there is a rhythm to it. I trade TSLA options. The volatility makes nice profit opportunities. Early on I got my ass handed to me, but lately I have been able to make it all back. Went long Sep 340 puts at 354 on Jun 23 and recently sold puts against it under 300. Bought a 310/315/320 Sept 19 butterfly yesterday for $0.13 a contract. No risk and off the charts reward if it comes in. I don’t know about holding TSLA stock. Eventually Musk will take SpaceX and xAI public. xAI is the stock that I would want to own. My point is that TSLA short term is a dog…lower sales, lots of competition in autonomous vehicle space. Optimus is a long long way from commercialization. Lyn Alden had a nice write up back in March… https://www.lynalden.com/march-2025-newsletter/ Musk is genius and I am grateful for his vision and unrelenting pursuit of things that everyone else is afraid to do but he is also a snake oil salesman.
*** Guys – it looks like it’s just going to be the original, existing members that blog here… Please, feel free to help contribute.. I need you’ guys’ insight’s
Last edited 4 days ago by baz22
baz22(@baz22)
July 7, 2025 7:28 am
#47499
July 2, 2025….. ” Klotho Neurosciences ($KLTO) has received FDA Orphan Drug Designation for its myotropic adeno-associated virus (AAVMYO2) gene therapy vector containing SKL and a muscle-specific promoter for the treatment of amyotrophic lateral sclerosis (ALS).  What this means: Orphan drug status is granted to drugs or biological products intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States. The designation provides certain incentives to the company, such as tax credits for qualified clinical trials, exemption from user fees, and potentially 7 years of market exclusivity after approval. “
I would keep an eye on BTCS… BMNR just rocked to $ 161.00 on news of Tom Lee’s COB appointment and plans for BMNR to buy $ 250 million in ETH… thus far, BTCS has purchased 14,600 ETH, with the CEO putting up big personal money ……… ” Ethereum serves as a prominent platform for various stablecoins. It enables the creation and operation of stablecoins through its smart contract functionality, facilitating the development of decentralized finance (DeFi) applications that rely on stable, pegged digital currencies. Here’s why Ethereum is a key platform for stablecoins: Smart Contracts: Ethereum’s smart contract capabilities allow for the development of complex financial instruments, including stablecoins, which are digital currencies pegged to a stable asset like the US dollar. DeFi Ecosystem: Ethereum’s decentralized finance (DeFi) ecosystem has greatly contributed to the growth and adoption of stablecoins. DeFi applications like lending platforms and decentralized exchanges rely on stablecoins for their operations. Secure and Transparent: Ethereum’s blockchain provides a secure and transparent environment for storing and managing stablecoins. The network of nodes ensures accurate and secure transaction recording. Popular Stablecoins: Many popular stablecoins, such as USDC, DAI, and Ethena USDe, are built on or operate on the Ethereum blockchain. Tokenization of Assets: Ethereum is also a platform for tokenizing traditional assets, including stablecoins. In essence, Ethereum’s infrastructure and functionalities make it a suitable foundation for the creation, management, and use of stablecoins within the broader cryptocurrency and DeFi landscape. …..
“Klotho, a gene found on chromosome 13q12, is involved in a variety of processes and signaling pathways in the human body related to vitamin D metabolism; cardiovascular, renal, musculoskeletal, and skin diseases; and cancer biology. However, more importantly, it has been linked to beneficial effects related to anti-aging. The levels of soluble Klotho in the blood have been found to decline with age, increasing the risk of age-related diseases. When the Klotho gene was silenced or defective, it caused a shorter lifespan. However, when the gene was overexpressed, it resulted in a longer lifespan. Klotho has positive benefits on the neurological system by causing a higher representation of useful longevity genes, preventing further neuronal damage, and offering neuroprotection. Thus, it has the potential to become a new treatment for many age-related diseases that cause dementia, including multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease. In this review, we discuss the mechanisms of Klotho’s benefits and roles on various organ systems, specifically on nervous system disorders that lead to dementia” https://pmc.ncbi.nlm.nih.gov/articles/PMC10324629/#:~:text=Klotho%2C%20a%20gene,lead%20to%20dementia
Although I am forever Amazed the value put on One appointment of One man ( Lee – BMNR ) ) when Four of the best Minds in the world of biotech ( KLTO ) are guiding possible the future of meaningful living, and the stock doesn’t budge….
sp. correction….. One sq. Ft. of a Maxeon solar panel weighs 2.5 lbs., not 25 lbs… *** There are 453.5 grams in one pound…. as stated, there are just 8 grams weight in one Ascent panel, which is one sq. Ft…..
Lend your securities. Earn income.Fidelity’s Fully Paid Lending Program lets you earn incremental income on securities that you already own, just by lending them out
They said I can lend 4 stock from all stock I own and will get monthly income of $224 does anyone know? what is this?
AVXL had a nice move today. EMA decision likely mid-month? If today is any indication, then MAA approval likely. Baz, where would price go after MAA approval?
Hi Chris…. Good to hear from you again… Been awhile…. AVXL was Always high up on my ALZ list… Bill had discussed it before… Hope this tidbit helps… *** I’ll get more from the article later… “Summary Anavex Life Sciences’ OLE study demonstrates that its Alzheimer’s drug works for years beyond the clinical study. The OLE expands efficacy to include patients’ behavioral abilities. The Anavex drug may offer years of extra mental lucidity and greater self-sufficiency among Alzheimer’s patients. The EU’s approval of Blarcamesine could increase Anavex’s market value from $ 800 million to $ 8 billion “
This is from May……. ” “Anavex is working with J.P. Morgan to partner with a larger company in Europe to market Blarcamesine, as discussed in the recent earnings call. If an announcement is made that a large pharma company has partnered with Anavex, the stock price will spike. This could happen in weeks or months”
This is lengthy…. I would recommend highly that those truly interested in unbiased biotech analysis subscribe to SA……..
“Does Anavex’s Alzheimer’s Drug Actually Confer Benefit Over Three Years May 15, 2025 8:49 PM
Price at publication $8.44 Last price $10.57 Change since publication 25.24%
Summary Anavex Life Sciences’ OLE study demonstrates that its Alzheimer’s drug works for years beyond the clinical study. The OLE expands efficacy to include patients’ behavioral abilities. The Anavex drug may offer years of extra mental lucidity and greater self-sufficiency among Alzheimer’s patients. The EU’s approval of Blarcamesine could increase Anavex’s market value from $800 million to $8 billion.
akinbostanci/iStock via Getty Images
Last year, top researchers in Alzheimer’s Disease treatments published a scientific journal article describing how a new drug can slow the cognitive decline of Alzheimer’s patients by 36%, and by nearly 50% for people with a particular genotype. About 70% of humans have that particular genotype, so an enormous portion of the population would likely gain years of mental lucidity if they used this new drug.
The new drug is called Blarcamesine, and it was invented by Anavex Life Sciences (NASDAQ:AVXL). The European Medicines Agency has accepted Anavex’s application to market Blarcamesine as a daily pill for Alzheimer’s treatment. By the end of the year, Alzheimer’s patients around the world will know if the EU has ushered in a new hope for them.
The Phase 2b/3 clinical trial demonstrated that taking Blarcamesine over the course of 48 weeks slows cognitive-behavioral decline by 27% as measured by the CDR-SB. This performance equals that of the leading FDA-approved drug: Biogen’s Lecanemab.
Plus, Blarcamesine does not cause brain-bleeding, while Lecanemab does. And Blarcamesine took about thirty weeks less than Lecanemab to produce the impressive results.
And yet, for many whose family members suffer from Alzheimer’s Disease, a lingering question remains. Would Blarcamesine work beyond the first 48 weeks of treatment? A prolonged effect could mean the difference between months of extra mental lucidity and years of extra mental lucidity.
An Open-Label Extension (OLE) study of Blarcamesine attempted to answer that question.
The OLE Study The Open Label Extension Study for Anavex’s Blarcamesine drug went on for 144 weeks. It started after the original 48-week, double-blind Phase 2b/3 clinical trial ended.
In an early April presentation at the AD/PDTM 2025 Conference in Vienna, Austria, Dr. Timo Grimmer presented the results in a paper entitled, “Phase IIb/III ATTENTION-AD Study: Over Three Years of Continuous Treatment with Oral Blarcamesine Continues to Significantly Benefit Early Alzheimer’s Disease Patients.”
I agree that the OLE provided crucial evidence that Blarcamesine confers clinical benefits for three years or possibly close to four years.
Let me describe the OLE. Both the treatment group and the placebo group patients of the clinical trial were offered an opportunity to take Blarcamesine as a daily pill as part of the extension study.
The OLE patients were not unblinded, meaning, they were not told which group they belonged to in the original study — the placebo group or the treatment group. This means that the patients could not draw any definitive conclusions about whether the drug had an effect on them in the original drug trial. In this way, a proper comparison could be made between the two groups in the OLE study.
The OLE compared two groups: the early starters (the group who had taken the drug during the clinical trial) and the late starters (the former placebo group, who started taking the drug only at the start of the OLE).
How will the rate of cognitive decline of the early starters compare to that of the late starters after 144 weeks? Will the late starters “catch up” to the early starters in their cognitive abilities?
And can any conclusions be drawn about the performance of the drug in slowing cognitive decline in general?
Better to Start Taking Blarcamesine Earlier than Later All participants of the original clinical trial were composed of people diagnosed with Alzheimer’s Disease. They were in the earlier stages of disease progression — some suffered from Mild Cognitive Impairment (MCI) and some from Mild Dementia due to Alzheimer’s. Among the trial participants there were a disproportionate number of people who carry the APOE4 gene, a gene variant that causes earlier and more severe Alzheimer’s symptoms.
Anavex reported that the early starters declined cognitively at a slower pace than the late starters. The benefit of starting just 48 weeks earlier on Blarcamesine was rather great.
All of the findings were statistically significant at 192 weeks (the end of the study). The original study found that use of Blarcamesine slowed cognitive decline as measured by the ADAS-Cog13 by 36% over the course of 48 weeks. Of course, slowing decline by such a degree was extremely encouraging. The fact that the originally medicated patients widened its cognitive “lead” over the original placebo group over the course of an additional 144 weeks is meaningful.
Exactly how meaningful?
In the original clinical trial, the treatment group scored over 2 points “better” (a lower score) than the placebo on the ADAS-Cog13. That was after 48 weeks of treatment for the treatment group and 48 weeks of a placebo for the placebo group.
Then, during the OLE, both groups were treated daily with Blarcamesine. After an additional 144 weeks, the early starters extended their “lead” from 2.0 points to 3.83 points over the late starters. Even though the late starters had been treated for 144 weeks, the early starters nearly doubled their original “lead” over the late starters. The late starters not only did not catch up to the early starters, but they actually fell behind much further.
Anavex described the results in this manner:
The delayed-start analysis for ADAS-Cog13 showed a significant difference between early start and late start treatment groups up to Week 192 (LS mean difference -3.83, P = 0.0165), favoring the early start group. Together these results suggest that participants who initiated treatment with blarcamesine earlier in their disease progression showed greater stability of cognitive function compared to those who did not initiate blarcamesine until ~1 year later.
To put it another way, the group of patients who took Blarcamesine for 192 weeks scored a good deal better on the ADAS-Cog13 than the group of patients who took Blarcamesine for only 144 weeks. This way of looking at it makes it sound like taking Blarcamesine for just 48 weeks longer makes a huge difference. And that may very well be true.
It may also be true that taking Blarcamesine 48 weeks earlier in one’s disease progression is of vast importance. That is the conclusion that Anavex drew from the OLE study, except without the “vast” descriptor.
What is very interesting is that the graph in Anavex’s presentation shows that the late starters did indeed “catch up” to the early starters at “Week 96” on the graph (Week 48 of the OLE). So, after just 48 weeks of treatment during the OLE, the late-starters were approximately equal to the early-starters in their ADAS-Cog13 scores, despite the late starters having taken the drug for 48 weeks fewer than the early starters. What does this mean? It might mean that the first 48 weeks of treatment are quite powerful and that the second 48 weeks of treatment are not as powerful.
Over the next 96 weeks (Week 96 to Week 192 on the graph), the early starters pulled ahead by a great deal, speeding nearly 4 points “ahead” of the late-starters on the ADAS-Cog13 scores.
Interestingly, there was a subset of patients who had a much smaller delay between the original trial study and the OLE, specifically less than 19 days. This group, which enjoyed almost continuous access to Blarcamesine, actually sped ahead to a 4.2 point lead over the late-starters. So, those who had little or no interruption in their treatment opened up a 4.2 point lead over the late-starters, versus a 3.8 point lead for the entire group of early-starters. This indicates that uninterrupted intake of Blarcamesine has benefits over interrupting one’s intake of the drug. To characterize the degree of the “lead,” those who took Blarcamesine with little or no interruption more than doubled their already-large lead over the late starters.
All of the above-mentioned findings further demonstrate the efficacy of Blarcamesine to slow cognitive decline.
ADCS-ADL Results The participants in the original trial took the ADCS-ADL test to measure their behavioral habits — how well were they taking care of themselves and doing daily activities. The ADCS is based on caretaker interviews.
In the placebo-controlled original trial, the treatment group slowed their behavioral deterioration by 0.775 points compared to the placebo group. This 10% slowing of behavioral decline was not statistically significant. However, during the OLE, this 0.775 point “lead” that the treatment group held over the placebo group ballooned to 4.3 points. This was statistically significant, and represents a 5.5X multiplication of the original “gap” of .775 points.
For those who suffered little or no interruption in treatment, the multiple was 7.4X! The gap or “lead” was 5.75 points. To give some context, the original placebo group deteriorated by over 7.5 points during the 48-week clinical trial, and the treatment group deteriorated by over 6.7 points during that period. So, the gap that opened up between the two groups over 196 weeks (5.75 points) represents a major slowdown in behavioral decline for the early starters. It represents something like a 9-month delay in behavioral decline for the late-starters.
For further context, a typical Alzheimer’s patient loses about 4 points per year on the ADCS-ADL, according to one journal article.
Share Statistics (from yahoo)Avg Vol (3 month) 931.05k Avg Vol (10 day) 1.13M Shares Outstanding 85.37M Implied Shares Outstanding 85.37M Float 82.53M % Held by Insiders 3.33% % Held by Institutions 37.67% Shares Short (6/13/2025) 25.21M Short Ratio (6/13/2025) 28.32 Short % of Float (6/13/2025) 30.54% Short % of Shares Outstanding (6/13/2025) 29.53% Shares Short (prior month 5/15/2025) 24.1M
Share stats don’t instill confidence
Pharma Bro says EMA likely to reject Blarcamesine, pointing to flaws in development like relying on trial populations that aren’t based in the U.S.
… anything is possible…but Anavex working with JP Morgan to find a European partner is proactive.. Can they not include results from their European trials ?…. ” Anavex Life Sciences is conducting clinical trials in Europe for their drug blarcamesine (ANAVEX®2-73), specifically for Alzheimer’s disease and Rett syndrome. They have also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine. Here’s a more detailed breakdown: Alzheimer’s Disease: Anavex has been conducting a Phase IIb/III trial for blarcamesine in early Alzheimer’s disease, with sites in Australia, Canada, and Europe. They also recently reported positive long-term data from the Open-Label Extension (OLE) of this trial.”…
Correction…” can they not include results from their US trials ,( not European ) ” ? Possibly, but the US data most likely cannot be registered as proof, negative or positive
May 30, 2025…. “Summary I’m initiating a Strong Buy rating on Asset Entities due to its massive $750M PIPE funding and transformative merger with Strive Asset Management. The company is evolving from a social media tech play into a diversified entity targeting distressed Bitcoin assets and undervalued biotech firms. Institutional investors are buying in at a 121% premium, signaling strong confidence; I expect a short-term upside to $12-13 as momentum builds. Volatility will remain high, but with the new funding secured, I see a compelling short-term opportunity for investors at the current $8 level” SA
Datavault AI acquired the SyncIN technology from Turner Global Media, not the entirety of the company, on July 7, 2025, according to multiple news reports.
The acquisition involves Turner Global Media’s innovative audio QR technology, SyncIN, which enables smartphones to interact with broadcasts (TV, radio, and in-store) to facilitate Web 3.0 stablecoin transactions.
This acquisition is expected to boost Datavault AI’s position in advertising and e-commerce, with revenue targets of 10-15 high-margin licensing deals in 2025 and a projected $40-50 million revenue goal by 2026.
https://finance.yahoo.com/news/datavault-ai-joins-ibm-partner-120700883.html
Small position in Halliburton (HAL) 20.80; risk two bucks to make 5, but if it fills gap at 25, could see 30 again. Earnings on deck in a few weeks adds some risk. Oilfield services has been weak but I think it’s a reasonable trade.
https://dailyhodl.com/2025/07/09/bitwise-cio-reveals-4000x-prediction-says-ethereum-xrp-solana-and-others-will-be-impacted-from-one-booming-trend/
At this point I’m thinking BTC will keep making new high after new high to $ 125k
It Holds over 5,800 Bitcoin…. already bought in previous years… NXTT
As of March 31, 2025, Next Technology Holding Inc. (NXTT) had invested in approximately 5,833 Bitcoin, with an average purchase price of approximately $31,385 per Bitcoin.
Just watching if BMGL gonna announce that $ 1 billion BTC proposal from May…?
Pendulum is swinging around BTC, ETH, SOL as companies are loading their crypto treasuries… Defi Development is making big moves… Kidz is rapidly increasing it’s SOL holdings
Always such a delicate balance between a new company/technology and it’s stock
Northrop Grumman is a global aerospace and defense technology company. It focuses on designing, developing, and manufacturing a wide range of systems and products for both military and civilian clients.
Key Areas of Operation:
Aerospace:
This includes aircraft like the B-21 Raider bomber, the F-35 center fuselage, and various unmanned aerial vehicles (UAVs) such as the Global Hawk.
Defense Systems:
Northrop Grumman produces missile defense systems, including the Ground Based Strategic Deterrent (Sentinel) and various missile defense components, as well as armaments like artillery and ammunition.
Mission Systems:
This segment encompasses a broad range of technologies, including C4ISR (Command, Control, Communications, Computers, Intelligence, Surveillance, and Reconnaissance), cyber warfare capabilities, and electronic warfare systems.
Space Systems:
Northrop Grumman is involved in various space programs, including satellite development, propulsion systems, and deep space exploration initiatives.
Key Facts:
Headquarters: Falls Church, Virginia.
CEO: Kathy J. Warden.
Founded: 1939 (as Northrop Aircraft, Inc.).
Employee Count: Approximately 100,000.
Global Presence: The company operates in the US and internationally.
Major Products: B-21 Raider, F-35 center fuselage, Global Hawk, Sentinel, various missile defense systems.
Key Customers: US Department of Defense, NASA, other government and commercial clients.
….. perhaps when Ascent Solar lets the news out…..
I cautiously add CGTX to the watching
https://www.stocktitan.net/news/CGTX/cognition-therapeutics-completes-end-of-phase-2-meeting-with-fda-for-ht9gtj52o96n.html
July 8th I got 5000 at 0.54
Got BMNR 300 at $51.50 and I am under right now
If going ETH, I believe SBET is much better…. The guiding hand at SBET is the Cofounder of Ethereum itself..The offering for the $ 500 million they just finished spending was in May…. I briefly posted it last week around $ 10… I was buying BTCS at $ 2.75 then
I think someone’s sniffing around Editas – EDIT… Possibly Pfizer….??
Remember the VERV deal a few weeks back… They had barely begun phase 2… Editas already completed phase 2 in ex vivo SCD, and the results were excellent…you know how it works – short em’ ( biotech ) into the ground before they reach the commercial market, then make an offer… Now the worm has turned… Risk asset’s are catching a bid
I hope so about edit
i have 100 call that expire in January 2026 and i just turn positive in it
Big beautiful bill also has nice incentives for biotech
EDIT…..
What?
Bubba…. https://finance.yahoo.com/news/microalgo-inc-announces-development-grover-130000542.html
$MLGO — Cheers Bubba. Hope your summer is going well. Hot as Hell out there most of the time. Thanks for the link.
What was Cramer’s quip from years’ ago : “Thank goodness stock prices do stop at Zero!!!”
…… 😂 …… But ♾️ for shorts on the wrong highway..!!!
I’ve got some stuff that’s OK/Fair (ARKK, CRWV, IONQ, MP, NLR, RDDT, XME)
& some Not-so-Much (RGTI, UAMY, PYPL)
BUT this MLGO — the more positive news I see, the lower the stock price. There’s this inverse-correlation that my little brain can’t handle. It’s a Quantum effect.
China is not getting Any respect…!!
But until it’s quantum project’s are commercialized, it will be tricky… However, in time……. Mlgo’s algorithms are in great use in the mainland
……did you get ‘ IREN ‘ at $ 10 a few weeks back..?
PLUG +25% BLOOM +16% BALLARD POWER +15%
Some impulse trading in green energy//hydrogen.
Yes… FCEL is tempting
Like the partnership EVTL has with Honeywell… State of art electronic systems… Low entry areas available
The FAA won’t issue Any final approvals until late 2026 or into 2027 for Any in the eVTOL sector…
May 2025… “Quince Therapeutics is advancing eDSP for Ataxia-Telangiectasia, leveraging strong prior data in the 6-9 age group and an innovative AIDE platform.
Recent insider buying, new analyst coverage with high price targets, and robust patent protection highlight growing confidence and upside potential.
Data readout for the NEAT Phase 3 trial is scheduled for early 2026, with all patients joining the open-label extension, and cash runway aligns with expected topline results.
With a market cap near cash value and significant platform potential, I reiterate my Strong Buy rating ahead of readout…” SA..
….. https://finance.yahoo.com/news/oppenheimer-predicts-840-surge-2-104600881.html
SMMT: Astro Zeneca AZN is in discussion with SMMT, it is slightly up. Hope it goes up above $30.
From January 2025…. “Why Rilparencel Could Be Huge For CKD
Now, an interesting thing worth mentioning is that in Q4 2024, PROK mentioned that PROACT 1 could be enough to support approval for Rilparencel. The FDA itself mentioned this possibility, but obviously that remains contingent on them delivering good data that corroborates its previous trials. PROK also confirmed that there’s a possibility that they find a “surrogate” endpoint that could, in theory, expedite their regulatory pathway. If, for instance, the eGFR suggests the treatment is indeed effective, the FDA might grant it an accelerated approval pathway.”…..PRO……..
…… “2025 Will Be A Major Year For ProKidney’s Rilparencel In CKD Treatment
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2025 Will Be A Major Year For ProKidney’s Rilparencel In CKD Treatment
Jan. 31, 2025 6:10 AM ETProKidney Corp. (PROK) StockPROK
Myriam Alvarez
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About this article
Ticker
Analyst rating
BUY
Price at publication
$1.68
Last price
$3.73
Summary
Rilparencel is ProKidney’s main candidate. It is intended as a therapy that stabilizes kidneys, making it potentially useful for CKD patients.
We’ll have Rilparencel’s Phase 2 full data in 2025, as well as the potential confirmation about a “surrogate” endpoint for its Phase 3 trials.
Currently, Rilparencel’s Phase 3 is planned to deliver full data by Q3 2027 if no surrogate endpoint is found that’s suitable for the FDA.
The FDA confirmed in a meeting with PROK that its Phase 3 “could be sufficient” to support approval, and an accelerated pathway with a suitable surrogate endpoint is available.
From a valuation perspective, PROK also seems relatively cheap and has multiple important catalysts for 2025. So, I rate it a “Buy” at these levels.
Jian Fan/iStock via Getty Images
ProKidney (NASDAQ:PROK) is a biotech that works on autologous cellular therapy for organs. In easier terms, PROK tries to preserve organs with its technology, and currently, its leading candidate is Rilparencel (React) for chronic kidney disease [CKD]. In particular, Rilparencel uses patients’ kidney cells to stabilize or slow down the progression of CKD. In fact, this IP has already received the FDA’s Regenerative Medicine Advanced Therapy [RMAT] designation because its last Phase 2 data was quite encouraging. Currently, they’re working on their final Phase 3 trials, which could also potentially uncover an accelerated pathway if they find a suitable “surrogate” endpoint. And from a valuation perspective, PROK seems relatively cheap as well, so I’m going to rate it a “Buy” for long-term biotech investors at these levels.
New Promise For CKD
ProKidney was founded in 2015, and it’s currently headquartered in the US. In my view, PROK is quickly moving forward with its late-stage candidate, Rilparencel. This CKD therapy has shown great potential in its previous trials, and it’s now easily the company’s main value driver. At this point, the main catalysts to watch forward to in 2025 are the data from its Phase 2 REGEN-007 trial and a potential announcement of an accelerated pathway in its Phase 3 PROACT 1 study.
Source: JPMorgan Presentation. January 2025.
As an overview, its pipeline hinges on autologous cellular therapies like Rilparencel. Note that Rilparencel targets CKD, which is a worldwide prevalent condition. However, Rilparencel’s particular focus is on CKD in type 2 diabetes [T2DM] patients at risk of kidney failure. Nonetheless, I do believe it’s a potentially revolutionary therapy that could also give hope to some sub-demographics with unmet medical needs in CKD.
Moreover, PROK’s process is relatively simple. It first requires tissue from patients, which obviously involves biopsy. But after that, PROK can use that biomaterial to isolate kidney cells and reproduce them in their labs. Eventually, they can use those cells as a form of kidney therapy. For this, PROK cryopreserves kidney cells to maintain them until they’re ready to be administered to CKD patients. At that point, PROK simply injects the cells back into the patient’s kidneys.
Why Rilparencel Could Be Huge For CKD
Now, an interesting thing worth mentioning is that in Q4 2024, PROK mentioned that PROACT 1 could be enough to support approval for Rilparencel. The FDA itself mentioned this possibility, but obviously that remains contingent on them delivering good data that corroborates its previous trials. PROK also confirmed that there’s a possibility that they find a “surrogate” endpoint that could, in theory, expedite their regulatory pathway. If, for instance, the eGFR suggests the treatment is indeed effective, the FDA might grant it an accelerated approval pathway.
Source: JPMorgan Presentation. January 2025.
To be clear, that potential is inherently speculative, and the actual guidance for PROACT 1’s full data will be available in Q3 2027. Still, the eGFR endpoint alternative could be achieved faster than the survival rates or dialysis data. Plus, it’s encouraging to see that the FDA itself seems open to the idea of offering PROK an expedited pathway that could bring Rilparencel to market. Note that PROK disclosed that it intends to give us more details about potentially focusing on eGFR later this year, and if they confirm this, it could be a major milestone. After all, it would essentially pull forward Rilparencel’s potential submission to the FDA.
But still, remember that Rilparencel’s Phase 2 trials showed a substantially lower disease progression toward terminal CKD stages. And it demonstrated that Rilparencel indeed stabilized kidneys as measured by the eGFR. Note that eGFR stands for “Estimated Glomerular Filtration Rate” and basically measures how well kidneys filter blood. So, as you might expect, a higher eGFR implies healthier kidneys, and that makes it a fantastic proxy to assess how effective Rilparencel actually is. And if you look at Group 1’s data, it clearly shows that eGFR remains stable for 18 months after Rilparencel. In other words, Rilparencel seems like a viable treatment that could preserve kidney function in CKD patients. And the kicker is that there are no serious side effects that could derail its potential approval either (so far at least”
Editas (EDIT) up 20% today
https://www.cnbc.com/quotes/EDIT
Probably just a few shorts leaving. There are a lot of them
Holding this for a few years, glad to see it in action.
Same here. Started buying in 2022. My last buy was earlier this year @ 0.99. Still a bit under water but expect a nice profit sooner or later-
All top executives at Editas ( CEO, CMO, CSO, previous CEO and COB ) worked at Biogen… I would think , if there is a buyout, Biogen would be the acquirer… The latest hire…. https://ir.editasmedicine.com/news-releases/news-release-details/editas-medicine-strengthens-executive-leadership-team-0#:~:text=CAMBRIDGE%2C%20Mass.%20%2C%20July%2024,Chief%20Executive%20Officer%2C%20Editas%20Medicine%20.
This is a biggie coming up… The next Alzheimer’s Association International Conference (AAIC) will be held from July 28 – August 1, 2024, in Philadelphia, USA and online, according to the Alzheimer’s Association.
* tiny Cgtx has an FDA review on July 9
I do read this site every day, but rarely contribute. The first stock I own is Mux for the past 15 years. First time in all that time that I actually feel that mux is going to have an incredible 3 years going forward. I will do a write up this week. The 2nd stock i own is a stock nobody seems to discuss on this board…..Tesla. seems to me if you want to own one stock for the next 25 years, I can’t imagine anyone can beat this stock. The only thing that 8can stop this from going 10 fold in the next 25 years is when Elon jtalks. Put a muzzle on this man, and watch his accomplishments. This is a man that has huge flaws, but his ability to get things done is incredible. I also believe that elon thinks on a different level than everybody else. That being said, I would have no interest in becoming a friend of his. But I will let him make me money.
Totally agree… I bought MUX ( when it was US Gold ) in 2009..I bought at $ 0.93 cents… it ran to $ 9.00 in one year…Always have pushed Tesla here, but not much in the past 2 years…..did buy at $ 110 then.. ** I remember this ( US GOLD ) because I bought 5,000 shares in my hospital bed after knee replacement in January, 2009….!!!
Good luck on both…
Tesla is a beast to trade. I am learning that there is a rhythm to it. I trade TSLA options. The volatility makes nice profit opportunities. Early on I got my ass handed to me, but lately I have been able to make it all back. Went long Sep 340 puts at 354 on Jun 23 and recently sold puts against it under 300. Bought a 310/315/320 Sept 19 butterfly yesterday for $0.13 a contract. No risk and off the charts reward if it comes in. I don’t know about holding TSLA stock. Eventually Musk will take SpaceX and xAI public. xAI is the stock that I would want to own. My point is that TSLA short term is a dog…lower sales, lots of competition in autonomous vehicle space. Optimus is a long long way from commercialization. Lyn Alden had a nice write up back in March… https://www.lynalden.com/march-2025-newsletter/ Musk is genius and I am grateful for his vision and unrelenting pursuit of things that everyone else is afraid to do but he is also a snake oil salesman.
SpaceX worth as much as Home Depot…
https://finance.yahoo.com/news/spacex-valuation-hit-around-400-184152092.html
Did not have your patience, I sold it a while back at a loss. TSLA looks interesting at below $300.
Was first posted last week… This is today’s news…https://www.investing.com/news/stock-market-news/artelo-biosciences-stock-soars-after-promising-depression-treatment-data-93CH-4124821
*** Guys – it looks like it’s just going to be the original, existing members that blog here… Please, feel free to help contribute.. I need you’ guys’ insight’s
July 2, 2025….. ” Klotho Neurosciences ($KLTO) has received FDA Orphan Drug Designation for its myotropic adeno-associated virus (AAVMYO2) gene therapy vector containing SKL and a muscle-specific promoter for the treatment of amyotrophic lateral sclerosis (ALS). 
What this means:
Orphan drug status is granted to drugs or biological products intended to treat a rare disease or condition that affects fewer than 200,000 people in the United States.
The designation provides certain incentives to the company, such as tax credits for qualified clinical trials, exemption from user fees, and potentially 7 years of market exclusivity after approval. “
I would keep an eye on BTCS… BMNR just rocked to $ 161.00 on news of Tom Lee’s COB appointment and plans for BMNR to buy $ 250 million in ETH… thus far, BTCS has purchased 14,600 ETH, with the CEO putting up big personal money
……… ” Ethereum serves as a prominent platform for various stablecoins. It enables the creation and operation of stablecoins through its smart contract functionality, facilitating the development of decentralized finance (DeFi) applications that rely on stable, pegged digital currencies.
Here’s why Ethereum is a key platform for stablecoins:
Smart Contracts:
Ethereum’s smart contract capabilities allow for the development of complex financial instruments, including stablecoins, which are digital currencies pegged to a stable asset like the US dollar.
DeFi Ecosystem:
Ethereum’s decentralized finance (DeFi) ecosystem has greatly contributed to the growth and adoption of stablecoins. DeFi applications like lending platforms and decentralized exchanges rely on stablecoins for their operations.
Secure and Transparent:
Ethereum’s blockchain provides a secure and transparent environment for storing and managing stablecoins. The network of nodes ensures accurate and secure transaction recording.
Popular Stablecoins:
Many popular stablecoins, such as USDC, DAI, and Ethena USDe, are built on or operate on the Ethereum blockchain.
Tokenization of Assets:
Ethereum is also a platform for tokenizing traditional assets, including stablecoins.
In essence, Ethereum’s infrastructure and functionalities make it a suitable foundation for the creation, management, and use of stablecoins within the broader cryptocurrency and DeFi landscape.
…..
** BTCS has secured $ 57 million for ETH purchases
Also think this would be an excellent strategic investment for Coinbase or such..
Or, Jack Dorsey
SBET – 1 $ Billion ETH buy ?
https://blockchain.news/flashnews/ethereum-eth-whales-accumulate-1-49m-eth-as-treasury-stock-sbet-plunges-70
“Klotho, a gene found on chromosome 13q12, is involved in a variety of processes and signaling pathways in the human body related to vitamin D metabolism; cardiovascular, renal, musculoskeletal, and skin diseases; and cancer biology. However, more importantly, it has been linked to beneficial effects related to anti-aging. The levels of soluble Klotho in the blood have been found to decline with age, increasing the risk of age-related diseases. When the Klotho gene was silenced or defective, it caused a shorter lifespan. However, when the gene was overexpressed, it resulted in a longer lifespan. Klotho has positive benefits on the neurological system by causing a higher representation of useful longevity genes, preventing further neuronal damage, and offering neuroprotection. Thus, it has the potential to become a new treatment for many age-related diseases that cause dementia, including multiple sclerosis, Alzheimer’s disease, and Parkinson’s disease. In this review, we discuss the mechanisms of Klotho’s benefits and roles on various organ systems, specifically on nervous system disorders that lead to dementia”
https://pmc.ncbi.nlm.nih.gov/articles/PMC10324629/#:~:text=Klotho%2C%20a%20gene,lead%20to%20dementia
Although I am forever Amazed the value put on One appointment of One man ( Lee – BMNR ) ) when Four of the best Minds in the world of biotech ( KLTO ) are guiding possible the future of meaningful living, and the stock doesn’t budge….
https://www.klotho.com/
I am watching the future now… https://www.benzinga.com/partner/news/25/07/46217826/ascent-solar-technologies-collaborates-with-nasa-to-advance-development-of-thin-film-pv-power-beamin
For reference, Maxeon makes the most. Efficient earth bound panels, and produce the highest watts per square foot – that power is 20 .8 watts per square. Ft… One sq. Ft. of Maxeon solar panel weighs 25 lb…
….. Now, Ascent solar panels are 1 sq. Ft… They produce 15.2 watts of power per sq. Ft…However, their weight per sq. Ft. is only 8 grams….and are deep space radiation resistant..and, flexible….
sp. correction….. One sq. Ft. of a Maxeon solar panel weighs 2.5 lbs., not 25 lbs…
*** There are 453.5 grams in one pound…. as stated, there are just 8 grams weight in one Ascent panel, which is one sq. Ft…..
https://www.stocktitan.net/news/ARTL/artelo-biosciences-announces-positive-first-in-human-data-for-art26-txkdgnt4jgy6.html
This is something new to me,
fidelity said to me.
Lend your securities. Earn income.Fidelity’s Fully Paid Lending Program lets you earn incremental income on securities that you already own, just by lending them out
They said I can lend 4 stock from all stock I own and will get monthly income of $224
does anyone know? what is this?
You can earn money by lending your stock for shorting:
https://www.interactivebrokers.com/en/pricing/stock-yield-enhancement-program.php
AVXL had a nice move today. EMA decision likely mid-month? If today is any indication, then MAA approval likely. Baz, where would price go after MAA approval?
Hi Chris…. Good to hear from you again… Been awhile…. AVXL was Always high up on my ALZ list… Bill had discussed it before… Hope this tidbit helps… *** I’ll get more from the article later… “Summary
Anavex Life Sciences’ OLE study demonstrates that its Alzheimer’s drug works for years beyond the clinical study. The OLE expands efficacy to include patients’ behavioral abilities.
The Anavex drug may offer years of extra mental lucidity and greater self-sufficiency among Alzheimer’s patients.
The EU’s approval of Blarcamesine could increase Anavex’s market value from $ 800 million to $ 8 billion “
This is from May……. ” “Anavex is working with J.P. Morgan to partner with a larger company in Europe to market Blarcamesine, as discussed in the recent earnings call. If an announcement is made that a large pharma company has partnered with Anavex, the stock price will spike. This could happen in weeks or months”
This is lengthy…. I would recommend highly that those truly interested in unbiased biotech analysis subscribe to SA……..
“Does Anavex’s Alzheimer’s Drug Actually Confer Benefit Over Three Years
May 15, 2025 8:49 PM
Price at publication
$8.44
Last price
$10.57
Change since publication
25.24%
Summary
Anavex Life Sciences’ OLE study demonstrates that its Alzheimer’s drug works for years beyond the clinical study. The OLE expands efficacy to include patients’ behavioral abilities.
The Anavex drug may offer years of extra mental lucidity and greater self-sufficiency among Alzheimer’s patients.
The EU’s approval of Blarcamesine could increase Anavex’s market value from $800 million to $8 billion.
akinbostanci/iStock via Getty Images
Last year, top researchers in Alzheimer’s Disease treatments published a scientific journal article describing how a new drug can slow the cognitive decline of Alzheimer’s patients by 36%, and by nearly 50% for people with a particular genotype. About 70% of humans have that particular genotype, so an enormous portion of the population would likely gain years of mental lucidity if they used this new drug.
The new drug is called Blarcamesine, and it was invented by Anavex Life Sciences (NASDAQ:AVXL). The European Medicines Agency has accepted Anavex’s application to market Blarcamesine as a daily pill for Alzheimer’s treatment. By the end of the year, Alzheimer’s patients around the world will know if the EU has ushered in a new hope for them.
The Phase 2b/3 clinical trial demonstrated that taking Blarcamesine over the course of 48 weeks slows cognitive-behavioral decline by 27% as measured by the CDR-SB. This performance equals that of the leading FDA-approved drug: Biogen’s Lecanemab.
Plus, Blarcamesine does not cause brain-bleeding, while Lecanemab does. And Blarcamesine took about thirty weeks less than Lecanemab to produce the impressive results.
And yet, for many whose family members suffer from Alzheimer’s Disease, a lingering question remains. Would Blarcamesine work beyond the first 48 weeks of treatment? A prolonged effect could mean the difference between months of extra mental lucidity and years of extra mental lucidity.
An Open-Label Extension (OLE) study of Blarcamesine attempted to answer that question.
The OLE Study
The Open Label Extension Study for Anavex’s Blarcamesine drug went on for 144 weeks. It started after the original 48-week, double-blind Phase 2b/3 clinical trial ended.
In an early April presentation at the AD/PDTM 2025 Conference in Vienna, Austria, Dr. Timo Grimmer presented the results in a paper entitled, “Phase IIb/III ATTENTION-AD Study: Over Three Years of Continuous Treatment with Oral Blarcamesine Continues to Significantly Benefit Early Alzheimer’s Disease Patients.”
I agree that the OLE provided crucial evidence that Blarcamesine confers clinical benefits for three years or possibly close to four years.
Let me describe the OLE. Both the treatment group and the placebo group patients of the clinical trial were offered an opportunity to take Blarcamesine as a daily pill as part of the extension study.
The OLE patients were not unblinded, meaning, they were not told which group they belonged to in the original study — the placebo group or the treatment group. This means that the patients could not draw any definitive conclusions about whether the drug had an effect on them in the original drug trial. In this way, a proper comparison could be made between the two groups in the OLE study.
The OLE compared two groups: the early starters (the group who had taken the drug during the clinical trial) and the late starters (the former placebo group, who started taking the drug only at the start of the OLE).
How will the rate of cognitive decline of the early starters compare to that of the late starters after 144 weeks? Will the late starters “catch up” to the early starters in their cognitive abilities?
And can any conclusions be drawn about the performance of the drug in slowing cognitive decline in general?
Better to Start Taking Blarcamesine Earlier than Later
All participants of the original clinical trial were composed of people diagnosed with Alzheimer’s Disease. They were in the earlier stages of disease progression — some suffered from Mild Cognitive Impairment (MCI) and some from Mild Dementia due to Alzheimer’s. Among the trial participants there were a disproportionate number of people who carry the APOE4 gene, a gene variant that causes earlier and more severe Alzheimer’s symptoms.
Anavex reported that the early starters declined cognitively at a slower pace than the late starters. The benefit of starting just 48 weeks earlier on Blarcamesine was rather great.
All of the findings were statistically significant at 192 weeks (the end of the study). The original study found that use of Blarcamesine slowed cognitive decline as measured by the ADAS-Cog13 by 36% over the course of 48 weeks. Of course, slowing decline by such a degree was extremely encouraging. The fact that the originally medicated patients widened its cognitive “lead” over the original placebo group over the course of an additional 144 weeks is meaningful.
Exactly how meaningful?
In the original clinical trial, the treatment group scored over 2 points “better” (a lower score) than the placebo on the ADAS-Cog13. That was after 48 weeks of treatment for the treatment group and 48 weeks of a placebo for the placebo group.
Then, during the OLE, both groups were treated daily with Blarcamesine. After an additional 144 weeks, the early starters extended their “lead” from 2.0 points to 3.83 points over the late starters. Even though the late starters had been treated for 144 weeks, the early starters nearly doubled their original “lead” over the late starters. The late starters not only did not catch up to the early starters, but they actually fell behind much further.
Anavex described the results in this manner:
The delayed-start analysis for ADAS-Cog13 showed a significant difference between early start and late start treatment groups up to Week 192 (LS mean difference -3.83, P = 0.0165), favoring the early start group. Together these results suggest that participants who initiated treatment with blarcamesine earlier in their disease progression showed greater stability of cognitive function compared to those who did not initiate blarcamesine until ~1 year later.
To put it another way, the group of patients who took Blarcamesine for 192 weeks scored a good deal better on the ADAS-Cog13 than the group of patients who took Blarcamesine for only 144 weeks. This way of looking at it makes it sound like taking Blarcamesine for just 48 weeks longer makes a huge difference. And that may very well be true.
It may also be true that taking Blarcamesine 48 weeks earlier in one’s disease progression is of vast importance. That is the conclusion that Anavex drew from the OLE study, except without the “vast” descriptor.
What is very interesting is that the graph in Anavex’s presentation shows that the late starters did indeed “catch up” to the early starters at “Week 96” on the graph (Week 48 of the OLE). So, after just 48 weeks of treatment during the OLE, the late-starters were approximately equal to the early-starters in their ADAS-Cog13 scores, despite the late starters having taken the drug for 48 weeks fewer than the early starters. What does this mean? It might mean that the first 48 weeks of treatment are quite powerful and that the second 48 weeks of treatment are not as powerful.
Over the next 96 weeks (Week 96 to Week 192 on the graph), the early starters pulled ahead by a great deal, speeding nearly 4 points “ahead” of the late-starters on the ADAS-Cog13 scores.
Interestingly, there was a subset of patients who had a much smaller delay between the original trial study and the OLE, specifically less than 19 days. This group, which enjoyed almost continuous access to Blarcamesine, actually sped ahead to a 4.2 point lead over the late-starters. So, those who had little or no interruption in their treatment opened up a 4.2 point lead over the late-starters, versus a 3.8 point lead for the entire group of early-starters. This indicates that uninterrupted intake of Blarcamesine has benefits over interrupting one’s intake of the drug. To characterize the degree of the “lead,” those who took Blarcamesine with little or no interruption more than doubled their already-large lead over the late starters.
All of the above-mentioned findings further demonstrate the efficacy of Blarcamesine to slow cognitive decline.
ADCS-ADL Results
The participants in the original trial took the ADCS-ADL test to measure their behavioral habits — how well were they taking care of themselves and doing daily activities. The ADCS is based on caretaker interviews.
In the placebo-controlled original trial, the treatment group slowed their behavioral deterioration by 0.775 points compared to the placebo group. This 10% slowing of behavioral decline was not statistically significant. However, during the OLE, this 0.775 point “lead” that the treatment group held over the placebo group ballooned to 4.3 points. This was statistically significant, and represents a 5.5X multiplication of the original “gap” of .775 points.
For those who suffered little or no interruption in treatment, the multiple was 7.4X! The gap or “lead” was 5.75 points. To give some context, the original placebo group deteriorated by over 7.5 points during the 48-week clinical trial, and the treatment group deteriorated by over 6.7 points during that period. So, the gap that opened up between the two groups over 196 weeks (5.75 points) represents a major slowdown in behavioral decline for the early starters. It represents something like a 9-month delay in behavioral decline for the late-starters.
For further context, a typical Alzheimer’s patient loses about 4 points per year on the ADCS-ADL, according to one journal article.
”
Thanks Baz !
Share Statistics (from yahoo)Avg Vol (3 month) 931.05k
Avg Vol (10 day) 1.13M
Shares Outstanding 85.37M
Implied Shares Outstanding 85.37M
Float 82.53M
% Held by Insiders 3.33%
% Held by Institutions 37.67%
Shares Short (6/13/2025) 25.21M
Short Ratio (6/13/2025) 28.32
Short % of Float (6/13/2025) 30.54%
Short % of Shares Outstanding (6/13/2025) 29.53%
Shares Short (prior month 5/15/2025) 24.1M
Share stats don’t instill confidence
Pharma Bro says EMA likely to reject Blarcamesine, pointing to flaws in development like relying on trial populations that aren’t based in the U.S.
… anything is possible…but Anavex working with JP Morgan to find a European partner is proactive..
Can they not include results from their European trials ?….
” Anavex Life Sciences is conducting clinical trials in Europe for their drug blarcamesine (ANAVEX®2-73), specifically for Alzheimer’s disease and Rett syndrome. They have also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for blarcamesine.
Here’s a more detailed breakdown:
Alzheimer’s Disease:
Anavex has been conducting a Phase IIb/III trial for blarcamesine in early Alzheimer’s disease, with sites in Australia, Canada, and Europe. They also recently reported positive long-term data from the Open-Label Extension (OLE) of this trial.”…
Correction…” can they not include results from their US trials ,( not European ) ” ?
Possibly, but the US data most likely cannot be registered as proof, negative or positive
EMA ‘ Conditional Approval ‘ is possible
Editas (EDIT) showing signs of life
Last | 11:20 AM EDT
2.73 +0.48 (+21.11%)
May 30, 2025…. “Summary
I’m initiating a Strong Buy rating on Asset Entities due to its massive $750M PIPE funding and transformative merger with Strive Asset Management.
The company is evolving from a social media tech play into a diversified entity targeting distressed Bitcoin assets and undervalued biotech firms.
Institutional investors are buying in at a 121% premium, signaling strong confidence; I expect a short-term upside to $12-13 as momentum builds.
Volatility will remain high, but with the new funding secured, I see a compelling short-term opportunity for investors at the current $8 level”
SA