This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Acasti Announces Fiscal 2013 Results And Provides Update On Status Of Clinical Trials

Stocks in this article: ACST APO

Update on Status of Phase II Clinical Trials: Patient recruitment for COLT trial completed

Acasti continues to make good progress on its two Phase II clinical trials, designed to evaluate the effect of different daily doses of CaPre ® on patients with high to very high triglyceride levels. Patient recruitment for the open-label, dose ranging study (COLT) has now been completed and a final report is projected for this summer. Results for the double blind, placebo controlled study (TRIFECTA) are expected to be available during the first half of 2014.

Fiscal Year Milestones

  • Made significant progress in the clinical development of Acasti's drug candidate CaPre ®. To date, interim results of the COLT study confirm Acasti's confidence in CaPre's ® potential success, including an important and statistically significant triglyceride reduction as compared to standard of care. In addition to lowering triglycerides, Acasti's longer term objective is to also see the ability of CaPre ® to lower LDL (bad cholesterol) levels, while elevating HDL (good cholesterol), all of which are key in the management of chronic cardiovascular diseases. Moreover, a blind interim analysis in the TRIFECTA trial reported no safety concerns, indicating that CaPre ® is a safe product.
  • Continued to move forward to finalize plans for an Investigational New Drug filing with the U.S. Food and Drug Administration (FDA) for a Phase III clinical study in the USA. 
  • Expanded the commercialization of Acasti's medical food product Onemia™. Voluntary surveys conducted with the medical community have shown encouraging information regarding Onemia's™ efficacy in treating various cardiovascular conditions.
  • Invested strategically, announcing intention to make Acasti royalty free. Being royalty free under the license granted by Neptune would allow Acasti to preserve cash of at least $700,000 annually during the term of the licence, which is the current minimum royalty payment. It should also bring more flexibility and strength in negotiating deals with potential business partners and remove a valuation overhang.
  • Extended investor base and international presence by listing on the NASDAQ Capital Market.

"As we build on past successes and lay the groundwork for future growth, Acasti's position grows stronger and more promising each year," said Harlan Waksal, Executive Vice-President, Business & Scientific Affairs. "Going forward, we will continue to expand our presence in the biopharmaceutical market by investing strategically in R&D, protecting our intellectual property and building out our business to cement Acasti as a leader of pharmaceutical omega-3 phospholipids."

2 of 4

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 18,053.71 +23.50 0.13%
S&P 500 2,088.77 +6.89 0.33%
NASDAQ 4,806.8590 +33.3870 0.70%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs