acasti pharma phase 3
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“Compared to their baseline levels, the observed triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies,” said Dr. Dariush Mozaffarian, Professor at Tufts University and academic PI of the trial. Past performance is not necessarily a guide to future performance and forecasts are not a reliable indicator of future results.
We can see also in the chart that the RSI is not in the overbought 80 region but has risen from the key 50 line, almost text book like in fact and so indicates to us that should the Trilogy results be positive, that there is quite some way to run. Taking into consideration all of the analyses from TRILOGY once completed, we will seek to maximize the value of the CaPre® asset by continuing to explore a range of options available to us.”.
Chief Executive Officer
The Company and its board of directors has been and will continue to evaluate all strategic options and will provide updates on this process as warranted. December 23, 2019, 5:31 PM. As we can see in the tables below and also given recent commentary by COO Pierre Lemieux it looks to be highly probably that this end point will be met given the high Triglycerides readings in excess of 500mg/dL for all trial patients and the combination of treatment with statins too. Neither NASDAQ, the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release. We want to thank all of the investigators for their participation, and Acasti for sponsoring the Trilogy program.”, Jan D’Alvise, Chief Executive Officer of Acasti, stated, “We are very disappointed in the outcome of the Trilogy 2 study. Further catalysts aside from Trilogy 2 are the release of secondary and exploratory endpoints in March, presentation of the full dataset at “important” scientific meetings and, most importantly, the filing of an NDA to obtain FDA approval for release into the key US market. Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia Provided by GlobeNewswire. Align Research is authorised & regulated by the Financial Conduct Authority. Email: info@acastipharma.com Gaps don’t always get filled but when a stock price gets close it it then it generally acts as a magnet. CaPre was well tolerated in TRILOGY 2, with a safety profile similar to placebo, and consistent with the Company’s previously conducted Phase 2 and 3 studies. Align Research & a director of Align Research own shares in Acasti Pharma. Jan D’Alvise From a technical perspective we can see in the chart below that as the company re-rated during the summer, moving from sub $1 to near $3 given new coverage of the stock by a number of other analysts, that the shares have essentially spent the balance of the year consolidating these gains. Acasti Pharma Provides Update on Timing of Topline Results for TRILOGY 1 Phase 3 Trial of CaPre. Powered by Madgex Job Board Software. About Acasti Pharma. All rights reserved. Read full article. Your capital is at risk by investing in securities and the income from them may fluctuate. The marketability of some of the companies we cover is limited and you may have difficulty buying or selling in volume. We would not expect the company to remain independent going into 2021. As a result, the company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia, and does not plan to conduct additional clinical trials for CaPre. We have covered Acasti Pharmaceuticals extensively per HERE this last 2 years and the vast majority of that coverage has been focused around the key Phase (3) so called Trilogy 1 & 2 trial results for the company’s cholesterol lowering drug – Capre – and that are due out, in the former’s case, any day now with the latter following in early January 2020. “Compared to their baseline levels, the observed triglyceride reductions among patients taking CaPre were similar or larger than seen with prior omega-3 therapies,” said Dr. Dariush Mozaffarian, Professor at Tufts University and academic PI of the trial. The major part of November into early Dec seems to have been classic market maker manipulation to wring out the weak hands with a controlled decline to the $1.70 level. The forward-looking statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in Acasti’s public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including Acasti’s latest annual report on Form 10-K under the caption “Risk Factors”. This type of price action, whilst not infallible (anything can happen in the markets we have learnt over the years) does generally point to “parties in the know” accumulating. Terms of Service apply. December 30, 2019 | Posted by admin. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Acasti team and our clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2. This site is protected by reCAPTCHA and the Google We want to thank all of the investigators for their participation, and Acasti for sponsoring the Trilogy program.”, Jan D’Alvise, Chief Executive Officer of Acasti, stated, “We are very disappointed in the outcome of the Trilogy 2 study.
All forward-looking statements in this press release are made as of the date of this press release. We plan to now pool together the results from the two studies to see if we can better understand this phenomenon in post-hoc explorations. www.acastipharma.com, Investor Contact: “However, an unusual reduction in triglyceride levels in the placebo group meant that statistical significance was not achieved. Based on what we have seen in the preliminary topline data, we believe TRILOGY 2 was likely not affected by the same “Pre-Randomization Triglyceride Normalization” effect that we saw in TRILOGY 1. Forward-looking statements in this press release include, but are not limited to, information or statements about Acasti’s strategy, future operations, its review of strategic options, potential value for CaPre®, prospects and the plans of management. Full background on this opportunity can be found on the Acasti tab link above and we will not regurgitate the company’s operations here but look to provide those parties who have followed us from sub $1 with the observations we have made over the last few weeks from a technical perspective. Acasti Pharma Reports Topline Triglyceride Results from Phase 3 TRILOGY 2 Study of CaPre in Patients with Severe Hypertriglyceridemia Published: Aug 31, 2020 CaPre achieved a 30.4% median reduction in triglycerides at 12 weeks and 38.4% at 26 weeks, but did not achieve statistical significance for the primary endpoint Our own expectation is that if Trilogy 1 & 2 meet expectations that the market cap will be sitting closer to $1bn implying a stock price of around $10. The Acasti team and our clinical advisors will review the full dataset once it is available, and will complete the full data analyses as contemplated in the Statistical Analysis Plan, including the secondary and exploratory endpoints and the pooling of the data from TRILOGY 1 and 2.
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