stockrafter
17 hours ago
No, do not think they are going head to head, but it is in the same game, so keeping track on it, while waiting. The pic of the auto-injector was interesting. It is the same AI Biogen uses for the Plegridy Pen, fwiw.
Enough on that, check out the info below……it is eye opening information……
The beginning of the story…… https://news.northwestern.edu/stories/2019/01/a-new-approach-to-alzheimers-disease/
Developer of Sabirnetug.……smart dude…. https://neurobiology.northwestern.edu/people/core-faculty/klein-william.html
The website…check out the research and other links……good stuff…. https://kleinlab.org/
Write up on the impressive team……. https://news.weinberg.northwestern.edu/2024/01/29/neuroscientist-william-kleins-purpose-and-perseverance-continues-inspiring-a-new-wave-of-efforts-to-combat-alzheimers-disease/
“Acumen is among the foremost drug discovery companies attacking amyloid beta oligomers and its most promising therapeutic, ACU193, derives from an antibody program initiated in Klein’s research lab decades ago.”
So now even more perplexed on the share price..........but one of these days.....no doubt.......
stockrafter
5 days ago
Some interesting info from their partner on SC injection. The partner company reported signing a small volume AI deal with a company…Highly suspect it was Acumen…..It fits the timeline, since a deal needs to be signed before announcing the upcoming P2 SC trial, which will also be validating the AI SC IMO…..
Yet they can still beat the price down....so Perplexing to this small investor.......
New article on the P1 trial, more of the same but in detail....…. https://www.sciencedirect.com/science/article/pii/S2274580725000263
Interesting short video on the two current ALZ drugs….given by IV, 1x mn or 2x mn, at $25,000yr……All the more reason for SC injection in 3 seconds....…
https://www.kare11.com/article/news/health/another-treatment-those-affected-alzheimers-disease/89-d293e960-867f-4f71-9e61-91cf03d23a2a
stockrafter
2 weeks ago
Thanks the posts, it all sounds good, which is why it is so perplexing to me, as to who is selling all those shares over the past few months? It is easily noticeable on the Yahoo chart, that since the big drop back on 11/12/2024 the volume is relatively higher than past, and the price keeps falling. Roughly 400,000 for 40 days, is 16,000,000 shares, all below $2.50, with Yahoo Finance showing only 34 million in the float. Perplexing!
As a small investor, one can only buy so many shares, or risk a large percentage of the portfolio in one stock. Would have been nice, to have the technical skills, to surmise the SP would drop so low, certainly would have more share at a lower price. Still with an expected share price greatly exceeding my expectation of low teens, waiting will not be a problem. Unfortunately it is down today already, with high volume. Perplexing!
stockrafter
2 weeks ago
Well SotG that is some optimism, 200 bucks, I will be happy if it hits 10 bucks. I would be a millionaire at 200 bucks if I held all my shares till that happens. If sabirnetug showed some serious promise, I would suspect a larger company would buy ABOS before it reached such high price levels.
Agree there are a few drugs in progress, problem is that it appears Lilly is pushing theirs drug along fairly quickly, and they have the bucks to push thru as fast and far as they can.
The recent sells by a number of insiders, did not help, and did not look promising, no matter what their reasons.
Certainly not dropping out, will continue posting interesting news. Keep up the posting...........
From a recent article......."This trial aims to enroll approximately 540 individuals across multiple sites in the United States, Canada, the United Kingdom, and the European Union. If successful, sabirnetug could mark a significant breakthrough in neurodegenerative disease treatment."
stockrafter
2 weeks ago
Well there you go, suspect the story presented is correct, the problem appears to be the competition, its always the competition....well back to looking, holding, and hoping on Acumen.......with Lilly back in the race......
https://www.neurologylive.com/view/phase-3-trailrunner-alz-3-test-effects-igg1-monoclonal-antibody-remternetug-early-alzheimer-disease
https://www.beingpatient.com/remternetug-alzheimers-prevention-trial/
stockrafter
2 weeks ago
Well clearly there has to be something missing in the story Dr. Doherty presented in his enlightening informative discussion, otherwise the share price would not be on this relentless downward trend, IMO....Will continue looking, hoping, and holding, just seems the potential is there........not like I've never made a bad investment before.......
stockrafter
4 weeks ago
Guess they sell when they need to, and can.
Some recent news out there, good, and bad, but think the discussion in the interview answers some of the bad question the whiner, Pillar mentions in his article.
The bad, nothing is perfect, always someone trying to cheat. Fix it and move on.
https://www.almendron.com/tribuna/the-devastating-legacy-of-lies-in-alzheimers-science/
A GREAT interview, every investor, needs to listen to.....things start around 11 minutes, 25 minutes, and 28 minutes in..updates on trials towards end of interview....
The clinical trial...
https://clinicaltrials.eu/trial/study-on-the-effects-of-sabirnetug-for-patients-with-early-alzheimers-disease/
,
stockrafter
1 month ago
Yes, volume has been increasing these past few days/weeks, sadly the price is not doing the same.. Just a relentless downward trend, With only 32 million or so in the float, one would think the SP would start increasing with the increasing volume. Been looking new info but nothing pops up. Most are waiting for updates on clinical trials. But will hang in there, keep up the effort.....
stockrafter
1 month ago
Good PR, not much new, but still a good PR. Waiting for update on full enrollment of the Phase II/III Safety & Efficacy trial, an update on the completed P1 SC trial and plans for the P2 SC, which IMO will be using a HALO autoinjector.
Good call on the swing in share price, also as noted this is a more of a long term bet, with many ups and downs, but if all goes will it will be worth the wait, IMO.
INTERCEPT-AD, a phase 1 study of intravenous sabirnetug in participants with mild cognitive impairment or mild dementia due to Alzheimer's disease
https://www.sciencedirect.com/science/article/pii/S2274580724005971?via%3Dihub
stockrafter
2 months ago
Agree, a good investment at this price, with a potential upside worth the wait. You are probably right on the reason for the dip, did not expect it. Suppose its a good time to buy more at a ridiculous price.
The recent Evercore discussion highlights on a lot of good points, and worth listening to. Looking forward to updates next Q1 on results of current trials, and new trials.
"Video Journal of Dementia (VJDementia) " post ongoing videos on dementia, and has Acumen videos on the p-tau217 assay.
https://www.youtube.com/channel/UCYnoowKy7NI-5Gp58b_tUfA/videos
stockrafter
4 months ago
A marketed competitor, Lecanemab, is going the SC-AI route,
“EISAI COMPLETES ROLLING SUBMISSION TO US FDA FOR LEQEMBI® (LECANEMAB-IRMB) ”
https://media-us.eisai.com/2024-10-31-Eisai-Completes-Rolling-Submission-to-US-FDA-for-LEQEMBI-R-lecanemab-irmb-Biologics-License-Application-for-Subcutaneous-Maintenance-Dosing-for-the-Treatment-of-Early-Alzheimers-Disease-Under-the-Fast-Track-Status
Feeds suspicion Acumen is developing a triple combo, Sabirnetug-hyaluronidase-autoinjectior, with Halozyme.
An upcoming fireside chat might shed light on the next P2 clinical trial for SC sabirnetug….
”UBS Global Healthcare Conference on Wednesday, Nov. 13, 2024, at 1:15 p.m. PT (4:15 p.m. ET).”
https://investors.acumenpharm.com/news-releases/news-release-details/acumen-pharmaceuticals-participate-ubs-global-healthcare
On a side note a short video on the p-TAU-127 biomarker screening presentation has been posted…
https://www.neurologylive.com/view/acumen-pharmaceuticals-phase-2-advancements-ad-screening-todd-feaster-psyd
Which as noted earlier, sub-3 with be history after the presentation.....looking good so far......
stockrafter
4 months ago
The two current competitors….Kisunla and Leqembi
https://alzheimersweekly.com/how-to-choose-between-leqembi-vs-kisunla/
Good article on current and upcoming competitors…
......“Beginning a New Era of Precision Alzheimer’s Therapeutics”
https://www.insideprecisionmedicine.com/topics/translational-research/beginning-a-new-era-of-precision-alzheimers-therapeutics/
Prothena has several up and coming ALS drugs, comment on website gives more incentive for Acumen to develop SC sabirnetug along with an AI.
........Prothena Provides Updates on PRX012, PRX123, Birtamimab and Portfolio Programs
.......“Prothena is developing a molecule that we certainly hope will be delivered at home, once monthly, by subcutaneous administration and can be self-administered. I think that from a treatment burden perspective that allows us to start to think about the idea that any patient should have access to these types of approaches, and we think that that’s very important,” said Gene Kinney, PhD, Prothena CEO and president.”
https://www.prothena.com/pipeline/
Suspect days of sub 3 bucks will be history after the presentation later this week.
https://finance.yahoo.com/news/acumen-pharmaceuticals-deliver-breaking-presentation-120000342.html
stockrafter
4 months ago
Significant comments made in this discussion last week.......
Discussion is very good, best part is little more than 4:00 into discussion Siemers mentions Sabirnetug Efficacy is better and fewer side effects then the competition, Lecanemab , and Donanemab.....Cool......
"UNDERSTANDING ALZHEIMER’S AND THE PATH FORWARD, WITH ERIC SIEMERS, MD"
(Eric Siemers, MD, chief medical officer at Acumen Pharmaceuticals, )
"Early detection of Alzheimer's is vital for effective treatment, according to Eric Siemers, MD, who emphasizes the importance of caregiver support and proactive planning for families navigating the diagnosis."
https://www.theeducatedpatient.com/view/understanding-alzheimer-s-and-the-path-forward-with-eric-siemers-md
stockrafter
4 months ago
SP is looking good today, along with volume.....
A lot of news out there on the competition LEQEMBI, and Donanemab, giving insight on Sabirnetug potential.
Interesting news from a couple days on wasted volumes of the competition, giving insight into the cost of the drug and giving yet another reason for a prefilled AI.
https://www.uclahealth.org/news/release/smaller-vial-size-alzheimers-drug-could-save-medicare
"The researchers on the study, published(Link is external) October 14 in the peer-reviewed JAMA Internal Medicine, estimate that Medicare could waste up to $336 million annually due to discarded medication."
“However, we estimate lecanemab waste to be only 5.8%, rendering current policy ineffective, and sounding the bell that further policy changes are likely needed,” he said.
stockrafter
4 months ago
Lonza is on board, and will make a good CDMO partner.
"If The CDMO Shoe Fits, Wear It Now"
"In November of 2022, Acumen entered an agreement with Lonza that granted it a worldwide non-exclusive license to use Lonza’s glutamine synthetase gene expression system to manufacture and commercialize ACU193/sabirnetug."
"Although that predates his joining Acumen (in February of this year), Doherty says there had been an earlier round of work performed with a different set of providers, “but as we announced, we are working with Lonza moving forward.”
https://www.outsourcedpharma.com/doc/if-the-cdmo-shoe-fits-wear-it-now-0001
stockrafter
4 months ago
Yes, one of these days, but still accumulating so don't want it to move up too fast.
The presentation last week is worth listening to, and doing a thorough review of the PowerPoint info. They did a good job of explaining sabirnetug development and progress. An interesting (and exciting) detail is improvements were measured in a few biomarkers after only 3 doses.
Slide 68 show they are working with Halozyme for SC injection, completed Phase 1, and Phase 2 will start soon. IMO, they will develop an autoinjector for sabirnetug using Holzyme Enhanze and AI. At the end of the Q&A section the speaker mentions the difficulty of developing an AI.
Will be waiting for the current ALTITUDE trial update, a good update will move the SP, and planning on being all in by then.
"Expected Phase 1 subcutaneous topline results 1Q25"
"Expected completion of enrollment of ALTITUDE-AD 1H25"
https://investors.acumenpharm.com/static-files/c6a0d4a6-b7ec-421c-9230-d245ec96f9b4
tw0122
4 months ago
Add in $2.30s ready to go one of these days .. Sabirnetug is the first humanized monoclonal antibody to clinically demonstrate selective target engagement of AßOs in AD patients. Soluble AßOs are a highly toxic form of Aß that begin to accumulate before a clinical diagnosis of AD and are an early and persistent trigger of synaptic dysfunction and neurodegeneration. Acumen is developing sabirnetug as a potential next generation antibody treatment for early AD. Acumen is currently enrolling patients in the ALTITUDE sabirnetug -AD study, a Phase 2 clinical trial designed to evaluate the clinical efficacy and safety of intravenous sabirnetug in patients with early AD. Acumen is also evaluating a subcutaneous formulation of sabirnetug in a Phase 1 pharmacokinetic comparison study in healthy volunteers.
The extended collaboration builds upon an existing successful relationship between the two companies, in which Lonza provides DS manufacturing for the Phase 2 clinical supply of sabirnetug. Under the terms of the extended agreement, Lonza will manufacture cGMP DP of sabirnetug for the ongoing and future clinical phases and support the potential commercial launch at its industry-leading state-of-the-art DP manufacturing facility in Visp, Switzerland. Lonza will also provide quality control and stability testing as part of the collaboration.
Peter Droc, Head of Drug Product Services, Lonza, commented: “Our team of experts has extensive experience in supporting the clinical and commercial manufacture of drug products. In line with our strategy to offer an integrated end-to-end offering for biologics manufacturing, we are looking forward to collaborating with Acumen to advance its innovative and promising drug candidate in the clinic and beyond.”
James Doherty, President and Chief Development Officer, Acumen Pharmaceuticals, added: “The extension of our collaboration comes at a time when we’re advancing our clinical programs for sabirnetug with more than 50 Phase 2 sites activated across the U.S., Canada, U.K. and EU. We look forward to continuing our work with Lonza and delivering a potential next-generation treatment for early Alzheimer’s disease.”
About Sabirnetug (ACU193)
Sabirnetug (ACU193) is a humanized monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble amyloid beta oligomers (AßOs), which are a highly toxic and pathogenic form of Aß, relative to Aß monomers and amyloid plaques. Soluble AßOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function and induce neurodegeneration. By selectively targeting toxic soluble AßOs, sabirnetug aims to address the hypothesis that soluble AßOs are an early and persistent underlying cause of the neurodegenerative process in Alzheimer’s disease (AD). Sabirnetug has been granted Fast Track designation for the treatment of early AD by the U.S. Food and Drug Administration and is currently being evaluated in a Phase 2 study in patients with early AD.
About Acumen Pharmaceuticals, Inc.
Acumen Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic that targets toxic soluble amyloid beta oligomers (AßOs) for the treatment of Alzheimer’s disease (AD). Acumen’s scientific founders pioneered research on AßOs, which a growing body of evidence indicates are early and persistent triggers of Alzheimer’s disease pathology. Acumen is currently focused on advancing its investigational product candidate, sabirnetug (ACU193), a humanized monoclonal antibody that selectively targets toxic soluble AßOs, in its ongoing Phase 2 clinical trial ALTITUDE-AD (NCT06335173) in early symptomatic Alzheimer’s disease patients, following positive results in its Phase 1 trial INTERCEPT-AD. The company is headquartered in Newton, Mass. For more information, visit www.acumenpharm.com.
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Monksdream
2 months ago
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