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Finally getting a bit of a boost.
whirlpool forming around the drain now....
Have you discussed your theories with financial planners?
Circling the drain. More rapidly now.
They missed their primary endpoint and have to shift the goalposts to find the positive results. Same thing happened in 2014 and it took 5 years to get to this point. Now the goalposts have shifted again.
Oh yeah, and the Company has no cash!
from another board
Total BETonMACE population (~2400 patients): Narrow miss on hitting the primary 3-point MACE endpoint: 18% Hazard Reduction (95% CI; 0.65-1.04) p=0.11. When excluding undetermined cause of death, there is a 21% Hazard Reduction (95% CI; 0.62-1.01) p=0.06. There was an early and sustained separation of the Kaplan-Meier survival curves. Breaking down the 3-point MACE composite, there was a 20% reduction in non-fatal MI (p=0.15) and 19% reduction in cardiovascular death (p=0.29). Forest plots show a trending improvements in hazard ratios for 11 out of 12 of pre-specified endpoints (no effect on stroke). Anticipated 7.5% 3-point MACE events per year in placebo, observed placebo rate was 5.8% per year (5.8 events per 100 patient years).
Congestive Heart Failure (CHF) in Total Population: In the total population, there was a 41% reduction for first hospitalization for CHF (95% CI; 0.38-0.94) p=0.03. Also 53% reduction for first and recurrent hospitalization for CHF. If stroke was replaced with first hospitalization for CHF in the 3-point MACE composite, there would have been a 24% reduction with p=0.02. DM mentioned that this is twice the effect of heart failure medication Entresto and that CHF market is twice that of the stroke market. An exploratory outcome composite of first hospitalization for CHF or cardiovascular death showed a 27% reduction (p=0.04). CHF partnering discussions ASAP, already initiated.
CKD population with baseline eGFR<60: In those patients with impaired renal function at baseline (eGFR<60; 124 patients apabetalone, 164 patients placebo), there was an incredible 50% Hazard Reduction in narrow 3-point MACE (95% CI; 0.26-0.96) p=0.03.
eGFR < 60 : 13/124 (10.4%) apabetalone vs. 35/164 (21.3%) placebo; HR 0.50 [95% CI (0.28 - 0.96)]
eGFR > 60: 112/1084 (10.3%) apabetalone vs. 114/1041 (11.0%) placebo; HR 0.94 (95% CI (0.73 – 1.22)]
This data is out of this world. You must view slides 21 to 29 for yourself to appreciate the robust and consistent effect on various cardiovascular outcomes in those patients with eGFR<60 compared to those with eGFR>60. It appears that the benefit is almost exclusively in those with eGFR <60 with little benefit in those with eGFR>60. All cardio data has an amplified benefit in this CKD sub-group! Renal partnering discussions planned ASAP.
Unfortunately, there was no mention of other CKD-substudy data (i.e. change in eGFR) other than the incredible MACE reduction. The only renal data shown is eGFR for the total population of ~2400 patients. At baseline, the apabetalone group had mean eGFR of 104.9 compared to 101.7 in the placebo group. At 100 weeks, the apbetalone group had mean eGFR of 104.3 compared to 105.2 in the placebo group. The data table indicates a -0.4 change in apabetalone group and a +2.1 change in placebo group, with p=0.03 for the group difference. These small changes in the total population seem clinically insignificant and in my opinion are nothing to worry about even though they are going in the wrong direction. The jury is still out on the CKD sub-study patients, who only represent ~10% of the total BETonMACE patients.
Below median LDL-C subgroup: Unexpected and yet to be understood and explained is the 40% Hazard Reduction for narrow 3-point MACE (95% CI; 0.42-0.86) p=0.02 in those with below median LDL-C at baseline. Similar to the data stratification for eGFR, it appears that most if not all of the benefit across various cardio endpoints is observed in those with below median LDL-C at baseline and little to no benefit in those with above median LDL-C at baseline. To be continued.....
Synergy with SGLT2 inhibitors: A critically important finding of apabetalone in BETonMACE is the synergy with the SGLT2 inhibitor class of diabetes drugs. ~12.3% of total patients (298 total patients; 150 apabetalone, 148 placebo) were on SGLT2 inhibitors. In this subgroup, there was a 60% Hazard Reduction in narrow 3-point MACE (95% CI; 0.16-1.00) p=0.05. Specifically in those patients taking Jardiance (Empagliflozin), there was a 66% Hazard Reduction (95% CI; 0.12-1.01) p=0.05. To put in perspective, SGLT2i by themselves in CANVAS and EMPA-REG elicited a 14% reduction in 3-point MACE. Importantly, this apabetalone effect is on top of the SGLT2i. Intellectual property has been filed, they now own IP on this moving forward. Additional patents in progress. SGLT2i partnering discussions have been initiated.
Safety: Safety is amazing. As expected, there were more patients with elevated liver enzymes in the apabetalone group; however, nothing else stands out. Amazing safety! 78/1212 apabetalone patients (6.4%) had ALT elevation of more than 3X above the upper limit of normal (ULN) compared to 18/1207 placebo patients (1.5%). Those with elevations 3X to 5X above ULN for ALT are sort of like a yellow caution flag. When specifically looking at those with greater elevations (>5X ULN), there were 40/1212 (3.3%) apabetalone patients compared to 9/1207 (0.9%) placebo patients. This rate is low and only 2.6% greater than placebo. Importanty, there was no Hy’s law cases reported indicated no liver damage. Lastly, only 35/1212 (2.9%) apabetalone patients had to discontinue due to liver enzyme elevations compared to 11/1207 (0.9%) of placebo patients. Overall, very good safety profile consistent with previous Phase 2 observations.
Cognition sub-study data: Under embargo and coming at CTAD Dec 5th. Will do webcast and update after this conference.
Near term commercialization steps: Breakthrough therapy status filings, both FDA and EMA, over the next 90-120 days. SGLT2i partnering discussions, one has already been initiated, key patent already filed. Renal partnering discussions ASAP. Congestive Heart Failure partnering discussions ASAP, already initiated. Orphan partnering discussions initially focused on PAH and HIV only at this time. PAH enrollment has already commenced. HIV funding being derived from a yet to be named US based organization.
hsCRP, apo-AI, triglyerides and other secondary endpoints: BETonMACE hsCRP data shown was only on a subset of patients at baseline and at 52 weeks. In this subset, there was no difference between placebo and apabetalone values at baseline or at 52 weeks. There was also no apo-AI data shown for baseline or on treatment. The lack of complete hsCRP data or any apo-AI data is very surprising to me. Baseline triglyceride values are shown (no difference between placebo and apabetalone); however, no on treatment triglyceride values are shown. I elaborated on these observations here. Additionally, there are some other secondary and exploratory endpoints mentioned in past trial design posters or publications that haven't been presented yet including fibrinogen, neutrophil to leukocyte ratio (NLR), platelet numbers, inflammatory cytokines, RNA profile in leukocytes. To be continued.....
Alkaline Phosphatase: In BETonMACE, AP went from 83.3 at baseline to 77.6 at 100 weeks in the apabetalone group (-4.8) compared to 81.9 at baseline to 84.2 at 100 weeks (+2.2) in the placebo group (p=0.003 apabetalone vs. placebo). Very interesting alkaline phosphatase (AP) story. They also presented a poster on AP today at AHA (see here) that is very similar to the poster at ASN earlier this month (see here). There were two other AP ASN posters too (see here and here). There is an interesting inter-relationship amongst AP, renal function, cognition, and cardiovascular disease. AP may end up being an incredibly useful biomarker. More on apabetalone and alkaline phosphatase here. Also, a new article recently came out Current Opinion in Nephrology and Hypertension from Resverlogix and members of the renal clinical advisory board: Pharmacologic epigenetic modulators of alkaline phosphatase in chronic kidney disease. AP is a hot topic!
That's all from me. Exciting stuff!
BDAZ
3 month drop is approaching 50% (again)
drop from the high is now over 98% (someone was right on target a few years ago)
ProMIS Neurosciences Announces Third Quarter 2019 Results
PR NEWSWIRE 6:30 AM ET 11/14/2019
Company continues to expand its portfolio of highly selective antibodies targeting root cause of Alzheimer's, ALS and Parkinson's disease
TORONTO and CAMBRIDGE, MA, Nov. 14, 2019 /PRNewswire/ - ProMIS Neurosciences, Inc.(ARFXF) , a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three and nine months ended September 30, 2019.
"Over the course of 2019, the breadth and depth of our unique discovery and development platform was further evidenced as ProMIS made considerable progress in expanding its portfolio of opportunities in neurodegenerative diseases," stated Dr. Elliot Goldstein, ProMIS President and CEO. "In the third quarter of this year, we continued to generate further data supporting our antibody candidates for Parkinson's disease (targeting toxic forms of alpha-synuclein), amyotrophic lateral sclerosis (targeting toxic aggregates of TDP-43) and for Alzheimer's disease (targeting toxic forms of tau)."
Narrated updates relating to ProMIS' unique approach and capabilities can be found on the ProMIS website by clicking on the links below:
Click here for strategy overview memorandum from Executive Chairman Eugene Williams: http://bit.ly/ProMIS102319
Click here for Chief Scientific Officer Dr. Neil Cashman's overview of ProMIS' unique capability to design and develop antibodies selectively targeting toxic mis-folded proteins that are root causes of neurodegenerative diseases: http://bit.ly/ProMIS2KQ88la
Click here for Chief Development Officer, Dr. Johanne Kaplan's narrated overview of "Best in Class" therapy for misfolded protein diseases: http://bit.ly/ProMIS110719
Corporate Highlights
On November 13, 2019, subsequent to period-end, the company announced a non-brokered private placement for gross proceeds of up to $6.5 million. A first closing in the amount of $2,055,000 gross proceeds will occur on November 15, 2019.
In July 2019, the Company announced the voting results of the Corporation's annual meeting of shareholders held on June 27, 2019 in Toronto, Ontario. All of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders. All Directors were elected, with each nominee receiving more than 75% of the votes cast.
In July 2019, supporting data for PMN310, the Company's lead antibody candidate for Alzheimer's disease (AD) were published in Scientific Reports, a journal of the Nature Research family. In the manuscript, "A Rationally Designed Humanized Antibody Selective for Amyloid Beta Oligomers in Alzheimer's Disease," the authors demonstrate PMN310's selectivity for toxic amyloid-beta oligomers (AßOs), a root cause of AD. The results of activity assays show that PMN310 inhibits both the spread and toxicity of AßOs in vitro, and, in mouse studies, that PMN310 prevents AßO-induced loss of memory formation and reduces both synaptic loss and inflammation. PMN310 compared favorably to other Aß-directed antibodies, showing a lack of adverse event-associated binding to Aß plaque.
In July 2019, the Company presented an update on PMN310 for Alzheimer's disease at the annual Alzheimer's Association International Conference® (AAIC) in Los Angeles. In an oral presentation, Chief Development Officer, Dr. Johanne Kaplan highlighted the therapeutic potential of PMN310 against the toxic oligomer form of AßO, a root cause of AD. Dr. Neil Cashman, ProMIS Chief Scientific Officer delivered data derived from ProMIS' preclinical program for ALS in a poster presentation demonstrating the role of toxic, misfolded TAR-DNA binding protein 43 (TDP-43) as a root cause of neurogenerative diseases such as ALS and frontotemporal dementia (FTD).
Scientific Advisory Board Appointment
In August 2019, the Company appointed Dr. Andre Strydom to its scientific advisory board (SAB). Dr. Strydom is a world-recognized expert in ageing-related issues in Down syndrome and his research has advanced understanding of AD in Down syndrome patients. His expertise and advocacy will help guide ProMIS development plans relating to treatment of AD in Down syndrome. He is a professor in the Institute of Psychiatry, Psychology and Neuroscience at King's College London, and Honorary Consultant psychiatrist, South London and the Maudsley NHS Trust.
Financial Results
Results of Operations – Three months ended September 30, 2019 and 2018
Net loss for the three months ended September 30, 2019 was $1,637,714 compared to a net loss of $2,911,981 for the three months ended September 30, 2018, respectively. Included in the net loss amount for the three months ended September 30, 2019 were non-cash expenses of $134,634, representing share-based compensation and amortization of an intangible asset, compared to $385,951 for the three months ended September 30, 2018. The decrease in the net loss in the three months ended September 30, 2019 reflects decreased costs associated with external contract research organizations for internal programs, consultant salaries and associated costs, patent costs and share-based compensation offset by increased general corporate expenditures.
Research and development expenses for the three months ended September 30, 2019 were $1,053,123, as compared to $1,867,648 in the three months ended September 30, 2018. The decrease in the research and development expenses for the three months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributed to decreased costs associated external contract research organizations for internal programs and patent costs offset by increased external consulting costs and share-based compensation.
General and administrative expenses for the three months ended September 30, 2019 were $584,602, as compared to $1,044,596 in the three months ended September 30, 2018. The decrease for the three months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributable to decreased consultant salaries and associated costs, general corporate expenditures and share-based compensation.
Results of Operations – Nine months ended September 30, 2019 and 2018
Net loss for the nine months ended September 30, 2019 was $5,942,821, compared to a net loss of $6,683,714 for the nine months ended September 30, 2018, respectively. Included in the net loss amount for the nine months ended September 30, 2019 were non-cash expenses of $551,968, representing share-based compensation and amortization of an intangible asset, compared to $888,506 for the nine months ended September 30, 2018. The decrease in the net loss in the nine months ended September 30, 2019 reflects decreased costs associated with external contract research organizations for internal programs, patent costs and share-based compensation offset by increased consultant salaries and associated costs and general corporate expenditures.
Research and development expenses for the nine months ended September 30, 2019 were $3,866,394, as compared to $4,096,729 in the nine months ended September 30, 2018. The decrease in the research and development expenses for the nine months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributed to decreased spending on external contract research organizations for internal programs and reduced patent expense offset by increased contracted research salaries and associated costs, external consulting expense and share-based compensation.
General and administrative expenses for the nine months ended September 30, 2019 were $2,076,463, as compared to $2,587,253 in the nine months ended September 30, 2018. The decrease for the nine months ended September 30, 2019, compared to the same periods ended September 30, 2018, is primarily attributable to decreased share-based compensation offset by increased consultant salaries and associated costs, general corporate expenditures and foreign exchange.
Outlook
The Company will continue to build on its unique, proprietary discovery and development platform to further characterize the potential benefits of its programs selectively targeting toxic aggregates of TDP-43 and SOD1 in ALS, toxic forms of alpha-synuclein ( in PD and other related disorders, and toxic forms of tau and amyloid beta in AD and other dementias to further support ongoing pharmaceutical partnering discussions.
About ProMIS Neurosciences, Inc.(ARFXF)
ProMIS Neurosciences, Inc. (ARFXF) is a development stage biotechnology company focused on discovering and developing antibody therapeutics selectively targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). The Company's proprietary target discovery platform is based on the use of two complementary thermodynamic, computational discovery engines -ProMIS and Collective Coordinates – to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision approach, the Company is developing novel antibody therapeutics for AD, ALS and PD. ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.
Company documents relating to the fiscal year 2018 annual report can be viewed on the System for Electronic Document Analysis and Retrieval (SEDAR) at the link below:
https://www.sedar.com/search/search_en.htm
Visit us at www.promisneurosciences.com or follow us on Twitter and LinkedIn
To learn more about the role of misfolded toxic oligomers in Alzheimer's disease, Parkinson's disease and ALS, tune into Saving Minds, at iTunes or Spotify.
The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/promis-neurosciences-announces-third-quarter-2019-results-300958025.html
SOURCE ProMIS Neurosciences Inc.(ARFXF)
"We are pleased to offer this private placement designed to afford a cash runway well into 2020. Proceeds of the offering will support further development of our programs targeting Parkinson's disease, amyotrophic lateral sclerosis (ALS) and Alzheimer's disease, each of which is the subject of ongoing partnering discussions with large biopharmaceutical companies," stated Dr. Elliot Goldstein, ProMIS President and CEO.
Each Unit will consist of one common share of the Company and one share purchase warrant of the Company (each a "Warrant"). Each Warrant will entitle the holder thereof to purchase one share at an exercise price of $0.35 per share at any time through the fifth anniversary of the offering.
Yes, I agree. Maybe some bad news will turn things around. I'm happy only that I have a few shares. I'm guessing this drop is either directly tied to MidasTouch (haha) or is anticipating some sort of raise in front of the rollout.
This stock has proven it can drop in any situation. I’m a buyer in the 6’s (up to a point) thinking acquisition is possible now.
Falling knife? RSI is still in the mid 40's...I could not resist a tiny position. This is looking very attractive to a few BP's
per our discussion the other day, this seems a good point to nibble.
Exactly....jump and dump. I wish I had sold all during the pre. Did take a little off though. Stock is undervalued
I guess now we will have to wait until RedHill shows significant revenue from Talicia.
This stock should be $20
U.S. FDA approves RedHill's bacterial infection treatment
REUTERS 5:38 AM ET 11/4/2019
Nov 4 (Reuters) - RedHill Biopharma Ltd's(RDHL) said on Monday its three-drug combination therapy to treat Helicobacter pylori bacterial infections had been approved by the U.S. Food and Drug Administration.
The drug, Talicia, is an oral capsule comprising two antibiotics, amoxicillin and rifabutin, as well as omeprazole, a common treatment for heartburn.
The Israel-based company said the drug was designed to address the high resistance of H. pylori bacteria to current clarithromycin-based standard-of-care therapies.
RedHill expects to launch Talicia in the United States in the first quarter next year.
Helicobacter pylori infection affects over 50% of the population worldwide, according to Redhill, and is one of the strongest risk factors in the development of gastric cancer. (Reporting by Manas Mishra in Bengaluru; Editing by Anil D'Silva and Shinjini Ganguli)
(c) Copyright Thomson Reuters 2019. Click For Restrictions - https://agency.reuters.com/en/copyright.html
Bunch of nonsense
Where is the FDA decision? waiting until the last minute as usual....
The is no indication to date that kevetrin is effective
I fully expect all remaining data on endpoints to be released at AHA.
ProMIS Neurosciences Is ProMIS’ Alzheimer’s Antibody Better Than Biogen’s?
ProMIS advances ALS Program. ProMIS Neurosciences yesterday announced it has generated antibody candidates for the treatment of neurodegenerative diseases known as amyotrophic lateral sclerosis and frontotemporal dementia. We believe this is a positive development as the company nears completion of preclinical development and prepares to start human clinical trials.
ProMIS' differentiation. ProMIS is developing a novel therapeutic approach targeting a distinctive molecular entity, known as toxic oligomers, which the scientific literature recognizes as the true culprits of neurodegenerative diseases such as ALS, FTD, Alzheimer’s and Parkinson’s diseases. In contrast, competitor Biogen’s aducanumab is targeting amyloid-beta plaques for the treatment of Alzheimer’s. ProMIS’ lead drug PMN310 does not bind amyloid-beta plaques.
Impact of Biogen’s news. In a reversal of fortunes, Biogen’s stock gained 25% over the last two trading sessions after the company announced that it plans to file for FDA approval of aducanumab for the treatment of Alzheimer’s. On March 21, 2019, Biogen’s stock lost 29% after the company discontinued two Phase III clinical trials on the use of aducanumab. In our view, the news is positive for the sector. However, we still believe that ProMIS’ PMN310 is a superior drug.
Reiterating Outperform Rating. We believe ProMIS’s currently deflated share price does not reflect the potential of its lead drug PMN310 and versatility of its antibody platform technology. In our opinion, PMN310 has a unique mechanism of action targeting the true culprit of Alzheimer's disease, which makes it potentially superior to aducanumab. We are reiterating our Outperform rating and $1.00 target price on the stock.
Equity Research Cosme Ordonez, MD, Ph.D., Senior Life Sciences Analyst (561) 998-5487 cordonez@noblecapitalmarkets.com
Noble Capital Markets, Inc. Trading: (561) 998-5489 Sales: (561) 998-5491 www.noblecapitalmarkets.com
Why should any of the rumors be true? One explanation for the lack of urgency to release results is that the results aren’t good and they are looking for spin
Shorting onto news?
thanks
been in for a bit with a small position...
what are the chances this meets its primary endpoint?
arfxf
All the rumors of "just missed it" and wait until you see the Crestor subgroup, etc...are JUST THAT! Rumors.
Memorandum from Executive Chairman Eugene Williams:
https://promisneurosciences.com/wp-content/uploads/2019/10/final.chairmans-memorandum.Oct_.23.2019.pdf
ProMIS Neurosciences issues Chairman's update memorandum and white paper on Alzheimer's disease
PR NEWSWIRE 2:00 AM ET 10/24/2019
New resources detail positive impact of aducanumab pivotal trial results and recent progress of ProMIS pipeline programs
TORONTO and CAMBRIDGE, MA, Oct. 24, 2019 /PRNewswire/ - ProMIS Neurosciences, Inc. , a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, has issued a memorandum, compiled by its Executive Chairman of the Board, that provides context for the company's recent program progress as well as a white paper analysis of Biogen's October 22, 2019 decision to submit its amyloid-beta (Aß)-targeting drug candidate, aducanumab for Alzheimer's disease (AD) to the U.S. Food and Drug administration (FDA) in early 2020. The new resources detail how each development demonstrates strong momentum across the company's preclinical programs.
ProMIS Neurosciences Inc. (CNW Group/ProMIS Neurosciences Inc.)
On October 22, 2019, Biogen announced that the conclusions from aducanumab's interim analysis for futility, disclosed on March 21, 2019, were incorrect. Biogen also announced that analysis of additional trial data now indicates that aducanumab is effective in patients with longer term, high-dose exposure, and that they plan to file a marketing application with FDA early next year.
"We believe that over the coming months there will be a greater recognition of the likelihood that Biogen's aducanumab will be the first ever approved disease modifying therapy in Alzheimer's, although with a modest clinical benefit," said Eugene Williams, Executive Chairman, ProMIS Neurosciences(ARFXF). "It will change the thinking about amyloid generally, and more people will understand the growing body of scientific literature showing that the toxic oligomer of amyloid is the critical target. Selectivity for the toxic oligomer, as demonstrated preclinically with ProMIS' candidate antibody therapeutic PMN310, will increasingly be recognized as a critical differentiator, the basis of 'best in class'. Those expectations could be very positive for ProMIS."
In October 2019, the company announced significant progress on several of its antibody programs demonstrating the unique ability of its drug discovery and development platform to rapidly and cost-effectively discover, predict and validate antibody candidates that are highly selective for neurotoxic misfolded proteins. Each of these programs, briefly updated below, is the object of ongoing partnering discussions with several large pharmaceutical companies.
Parkinson's disease (PD) and Multiple System Atrophy (MSA)—preclinical in vitro studies, announced October 8, indicate that antibody candidates targeting toxic forms of alpha-synuclein, a root cause of PD and MSA, bind strongly to toxic alpha-synuclein aggregates derived from MSA-affected brain. The antibodies also protect cultured neurons from alpha-synuclein toxicity and spreading (propagation).
Amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD)—new data, announced October 22, show several antibody candidates demonstrate selectivity for toxic, misfolded intracellular aggregates of TDP-43, a root cause of ALS and FTD, with no binding to normal TDP-43 located in the cell nucleus.
Alzheimer's disease—new data, announced October 17, show several antibody candidates bind toxic forms of tau, a protein that can misfold and play a major role in disease progression. The antibodies also inhibit propagation of neurotoxic tau in a cellular model.
For access to the Chairman's Update please click on: http://bit.ly/ProMIS102319
The white paper is available by clicking on: http://bit.ly/ProMISWP102319
To learn more about the role of amyloid beta in Alzheimer's disease including evidence implicating the toxic oligomer, tune into Saving Minds, at iTunes or Spotify.
No question. This is an opportunity to accumulate.
"The momentum behind each of our programs is palpable," said Elliot Goldstein, MD, ProMIS Neurosciences(ARFXF) President and CEO. "In the past 30 days, we've announced data advancing our development programs selectively targeting toxic misfolded proteins for treatment of Alzheimer's and Parkinson's disease and Multiple System Atrophy (MSA), ALS and FTD. Yesterday, Biogen's decision to submit its amyloid-beta targeting drug candidate, aducanumab, for FDA approval signaled a milestone shift in the promise of next-generation amyloid-beta targeting drugs. Our lead program, PMN310, offers sniper-like precision for the toxic, misfolded form of amyloid beta, a key feature that offers important potential advantages compared to aducanumab. We will continue to support the patient community by advancing our programs, in particular PMN310 for Alzheimer's disease, leveraging our proprietary, drug discovery platform."
The only institution listed in the latest report holds 2000 shares. Worth a little over $180.
Lots of excitement today at Promis.
Savvy investment of 180 bucks....
Innovation Pharmaceuticals Inc, Inst Holders, 3Q 2019 (IPIX)
DOW JONES & COMPANY, INC. 2:55 AM ET 10/21/2019
The following table shows the largest shareholders in INNOVATION PHARMACEUTICALS INC COM (IPIX) for the quarter ended September 30, 2019, listed by holding size. The list represents up to 50 of the largest holders in the company.
Note: Unless otherwise mentioned the reporting date is 09/30/2019
Institution Shares Shares % Last
Held Changed Held Report
IFP Advisors Inc. 2,000 2,000 0.001 03/31
13F data provided by: Factset Research Systems Inc.;
Please send questions to ownership@factset.com.
Copyright, Factset Research Systems, 2019. All Rights Reserved.
(END) Dow Jones Newswires
10-21-190355ET
Nine cents says it all
There is no evidence to date that Kevetrin is effective.
RedHill Biopharma Announces $36 Million Strategic Investment by Cosmo Pharmaceuticals and U.S. Rights to Approved Travelers’ Diarrhea Drug AEMCOLO
TEL-AVIV, Israel and RALEIGH, N.C., October 18, 2019 RedHill Biopharma Ltd. (Nasdaq: RDHL) (Tel-Aviv Stock Exchange: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on the development and commercialization of clinical late-stage, proprietary drugs for the treatment of gastrointestinal diseases, today announced that it has entered into a strategic collaboration with Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”).
The strategic collaboration includes an exclusive license agreement for the U.S. rights to Aemcolo® (rifamycin) and a simultaneous private investment by Cosmo of $36.3 million in RedHill at $7.00 per American Depositary Share (ADS), representing approximately 13.5% over the closing price on October 17, 2019, with a 180-day transfer restriction.
Following this transaction, RedHill will maintain a debt-free balance sheet with approximately $59 million of cash and cash equivalents and will be well-positioned to launch RHB-105 (Talicia®)1 for H. pylori infection in the U.S. with an expanded sales force, if approved by the Food and Drug Administration (FDA). The New Drug Application (NDA) for RHB-105 (Talicia®) is under priority review by the FDA, with an assigned target Prescription Drug User Fee Act (PDUFA) action date of November 2, 2019.
Aemcolo® (rifamycin), containing 194mg of rifamycin as delayed-release tablets, is a minimally absorbed antibiotic that is delivered to the colon, approved by the FDA in 2018 for the treatment of travelers’ diarrhea caused by non-invasive strains of E. coli in adults (“Travelers’ Diarrhea”).
1 RHB-105 (Talicia®) is an investigational new drugs, not available for commercial distribution. Talicia® is a proposed tradename and is subject to FDA review and approval
Roughly $10,000 in trading so far today...any chance there will be any action here near-term?
I got a few cheap ones. Also in at 7 and 650. Breaking my rule about averaging down but relatively small position