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Acasti Pharma Inc. (ACST)
NasdaqCM - NasdaqCM Real Time Price. Currency in USD
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How high can this stock go when they announce phase 3 trials?
Yahoo! has been so bad lately - especially the ACST board. I like using (
) now instead for my daily research.
Great opportunity here. Can see this at $5 in coming months.
Time for analysts to increase price targets!!! Great call today
yes sometimes the manager drives to the ground because they want a payout. but they need to bring back what they had when this company first started . i mean 300 a share man . what was going back then thats not now . open your eyes company and get with the program . it is shameful to run a company like this .
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Only a matter of time until D’Alvise runs whatever is left to the ground…
Well..maybe in 10 years (if this company survive) I might get at least my money back LOL. lesson learned 80% down it is a joke #screwacst
we past the average volume on canadian side.
AWESOME NEWS for ACST.... BUY BUY BUY
why are they selling this is going up again tomorrow. it the summer high . where the grants at . 200 a share coming soon.
(TLIS) Price $1.30 has MEGA Cash of $8.70 per Share + Covid test approved =Unknown gem with 500%+ UPSIDEE
Something needs to happen cuz I’m way down with this one
I told you under 1.00$ is coming and it will…
Recent Q1, 2020 13F filings should be very interesting for Acasti investors. My prediction that Institutional Ownership should jump from 05.88% in Q4, 2019 to 10-15% in Q1, 2020. Shorts know that funds are accumulating ACST and covering during last 4 months: from 2,277,902 in 1/15/2020 to 322,116 in 4/15/2020.
Increased Positions 24 1,982,656
Decreased Positions 11 267,266
Also good sign.
Acasti management did very bad thing to retail investors: the results of TRILOGY 1 scared the majority of them and forced to sale shares with huge losses. They did it because of the articles that said:
"TRILOGY 1 results didn’t reach statistical significance against placebo. But CaPre actually worked. The issue was that the placebo worked nearly as well. Median triglyceride levels dropped 30.5% for patients receiving CaPre — and 27.5% in the placebo group. That latter performance doesn’t seem to make much sense. The placebo is just cornstarch, which should have zero effect. (That’s, of course, why cornstarch was chosen as a placebo in the first place.) In similar trials, the effect usually was in a range between -10% and +10%."
The first statement "results didn’t reach statistical significance against placebo" is false one. Specially designed to scare investors. They should said that both treated with CaPre arm and placebo arm showed very high TG level drop. Such drop of TG in placebo group can't be explained if patients got only starch pills but not additional treatment with other active compound that can alone significantly decrease TG level i.e. statins.
Authors of such articles did good job for funds/institutions: they helped them to buy very cheap Acasti shares. After CaPre approval by FDA funds will have huge gain.
The landscape has changed significantly since last Fall when ACST traded as high as $3 and as Amarin with its unanimous adcom vote was careening toward $10B and a certain BO. What followed next no one could have anticipated completely including AZ ending the Strength trial, Trilogy 1 Placebogate, a worldwide pandemic, and Amarin losing its patent battle and catering to $5. There were multiple articles calling for ACST to soon close the gap on AMRN and $20 price targets were considered conservative. But for those who've held on, or added and averaged down, ACST could rise like a phoenix from the ashes. Management is quietly optimistic following the audit and has promptly requested a meeting with the FDA. Oppenheimer's Leland Gershell thinks the stock will recover maintaining his buy rating and $7 price. Most however have dramatically lowered their expectations or have completely cut and run while all the authors have not surprisingly run out of ink. All things considered this could be the perfect set up for a significant upside surprise if the stars come back into alignment. Should the FDA extend them an olive branch and if the secondary endpoints demonstrate statistical significance the return to $3 or higher could be swift. On the downside we're just $0.36 away from the absolute bottom. I like the risk/reward ratio, I think management has a fair chance of salvaging the Trilogy study, and I believe this could become the turnaround story that no one ever expected. Cheers!
Don't worry about fund's scepticism about Acasti - they just removed stocks with declining pps from portfolio to show good numbers. One thing is important here - Acasti management knows exactly why placebo arm showed such phenomenal results (TG drop was similar as patients were dosed with Vascepa) and sent all data to FDA. It's very rare situation when both treated arm and placebo one showed very good results. Usually treated arm results are just slightly higher than standard medicine (non-inferior) but placebo also show some positive trend. So, statistics analysis can't show big difference. In TRILOGY 1 trial starch pills showed results similar to Vascepa i.e. impossible in real life. It's 100% that some placebo patients got active compound(s) that can significantly decrease TG (statins or increased insulin dosage for diabetics). Acasti management understands that if such mistakes revealed many holders with losses will try to sue the company for their losses. But also they know that CaPre approval by FDA will increase ACST pps 300-400% in one day. Pps will become higher than before drop and longs who didn't sell will be happy.
What the probability that FDA will allow to correct TRILOGY 1 and 2 results? If statins were reason for TG drop the probability of correction >90% (without additional Ph3). If the reason was increasing insulin dosage for diabetes patients during trial it's 100% that FDA will allow to remove them from analysis (see Exclusion criteria for Ph3).
Less than 20 days and we will know the reason. HOLD and add more.
The reason for unexpected placebo results at 5 sites: Patients with newly diagnosed type 1 diabetes or uncontrolled latent autoimmune diabetes of adults typically also have severe hypertriglyceridemia. We start these patients on basal bolus insulin regimen right away and that also brings their triglyceride levels from almost close to 500-1000 down to normal or near normal range. Unless otherwise indicated, we don’t necessarily start these patients on TG lowering agents other than statins. That’s because we expect their TG to come down drastically with insulin. Insulin activates Lipoprotein lipase; the enzyme that breaks down triglycerides. Patients like these should not have been included in the clinical trial conducted by ACST. This was a unintentional mistake at these 5 sites. FDA will understand this scientific basis of unexpected results in the placebo group. Provided Trilogy 2 results are favorable, we should expect an NDA filing in the fall. Thank you.
The wording with regards to statins can easily be misinterpreted and I believe the problem at the 5 sites lies there. Read carefully: 'Isolated hypertriglyceridemia, with triglycerides ≥500 mg/dL and <1500 mg/dL (≥5.7 mmol/L and <17.0 mmol/L) OR Mixed hyperlipidemia, with serum triglycerides ≥500 and <1500 mg/dL treated with a statin, CAI or PCSK9I inhibitor, alone or in combination, that has been stable for 6 weeks prior to randomization. If the subject is not being treated and not contraindicated, a statin and/or CAI treatment may be initiated at the discretion of the Investigator AT TIME OF SCREENING.'
The way the trial was designed was to allow for statins to be initiated 8-9 weeks BEFORE randomization in order for them to reach full effect on lipid profile and stabilize lipid profile before randomization. However it may have been interpreted at some sites that the physician would decide at the time of screening if patient would be initiated on statins, but those physicians would have instructed patients to start statins treatment only at randomization (when trial starts), therefore increasing response in both placebo AND CaPre arm, which is what has been seen. Also supports the fact that most of the placebo effect was seen in the first 4 weeks, which would be normal if placebo patients had just started statins.
On track to report topline results for TRILOGY 1 in December 2019 and TRILOGY 2 in January 2020
More than 90% of randomized patients have completed the studies
Data clean-up for TRILOGY 1 is 95% completed
Plan to present full data set including results for key secondary and exploratory endpoints of interest such as
non-HDL-C, LDL-C, VLDL, HDL-C and HbA1c at important scientific meetings beginning in the first quarter of
Approximately $25.8 million of cash and cash equivalents as at September 30, 2019; fully funded beyond
completion of Phase 3 studies
Awarded $750,000 in grants from the Government of Canada
Partnered with Aker BioMarine to provide supply of raw krill oil to support product launch and
Jan D’Alvise, president and CEO of Acasti Pharma, commented, “We continue on track to announce our Phase 3
TRILOGY 1 topline results in December 2019 and TRILOGY 2 topline results in January 2020. We eagerly await the
completion of the results from our two TRILOGY clinical studies for a number of reasons, including: (a) the large
patient population in our Phase 2 trials (675 patients) demonstrated both a significant reduction of triglycerides and
also indicated that CaPre may have a positive effect on other major lipid markers such as VLDL, LDL-C, and HDL-C
(“Trifecta Effect”), as well as HbA1c in patients with diabetes; (b) patients enrolled in our Phase 3 trials have higher
baseline triglyceride levels (above 500 mg/dl) versus our Phase 2 studies, where most had baseline triglycerides
significantly below 500 mg/dl; and (c) a favorable dose response was reported in the Phase 2 studies, in which
patients received a range of doses (1 gram, 2 grams and 4 grams per day for only 8 to 12 weeks), which we believe
bodes well for our Phase 3 trials, in which all patients randomized to CaPre received 4 grams per day and will
remain on drug for 6 months.”
“Assuming our TRILOGY trials replicate our Phase 2 data, we believe CaPre has the potential to become a best-inclass omega-3, due to both the Trifecta Effect and greater bioavailability, especially in patients that follow the
standard physician-recommended, restricted low-fat diet. We believe these benefits are due to our unique
composition of phospholipids, EPA and DHA as compared to "esterified" pharmaceutical omega-3s derived from fish
oils. Additionally, in all studies conducted to date, CaPre has shown no negative side effects or safety concerns.”
“We are also ramping up our commercialization efforts. Most recently, we announced a supply agreement with Aker
BioMarine to provide raw krill oil (RKO) to Acasti, under a two-year, fixed price supply agreement, which we believe
will ensure an adequate raw material supply to meet our anticipated needs through at least mid-2021, including
scale-up of production to build future inventory for anticipated commercial launch. At the same time, we are in active
discussions with a number of pharma companies regarding potential commercialization partnerships in several
countries around the world, and we look forward to providing further updates if and when developments unfold.”
Both TRILOGY trials have achieved 100% patient randomization and more than 90% of the patients have now
completed their 6-month plan. As a result, the “last patient, last visit” in the TRILOGY 1 study remains on track to
take place in November with topline results expected in December 2019 and the “last patient, last visit” in the
TRILOGY 2 study remains on track to take place in early January with topline results expected towards the end of
January 2020. Topline results will include a readout of the primary endpoint, which is intended to show CaPre’s
overall impact on lowering triglycerides (TGs) after 12 weeks compared to placebo. The TRILOGY studies are
designed to provide at least 90% statistical power to detect a difference of at least a 20% reduction from baseline in
TGs between CaPre and placebo. As previously disclosed, the placebo used in the TRILOGY trials is cornstarch,
which is inert, and consequently is expected to have a neutral effect on key biomarkers of patients in the placebo
group, and has been shown to not interfere with statin absorption and efficacy.
The Company has shared the statistical analysis plan (SAP) for the analysis and reporting of the TRILOGY results
with the FDA and will finalize the SAP prior to final database lock of TRILOGY 1, which Acasti expects to occur
shortly. Subject to any input from the FDA, Acasti currently intends to report topline TRILOGY results independently
for each study as Acasti receives results and these topline results will include the primary endpoint of TG reduction
at Week 12 compared to placebo. Safety and tolerability (e.g. overall adverse events (AE) and serious AE rate, any
discontinuation due to AEs, and AEs of special interest such as gastrointestinal events) will also be reported.
The Company currently expects that topline results will not include a
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