Acasti Pharma Submits FDA Meeting Request on Schedule, and FDA Meeting Expected in the Second Half of June [Canadian Business Journal (Canada)]
Acasti Pharma, Inc. (ACST)
Last acasti pharma, inc. earnings: 2/14 08:00 am
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Source: Canadian Business Journal
LAVAL, Québec, April 01, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia, today announced that it has filed its meeting request with the Food and Drug Administration (FDA). The meeting is intended to discuss TRILOGY 1 data, and gain alignment with the FDA on the interpretation of the results. The Company will also seek the FDA’s input on Acasti’s proposed revisions to the pre-specified TRILOGY 2 statistical analysis plan (SAP), and explore and agree on a plan for pooling the data from TRILOGY 1 and TRILOGY 2 in support of an NDA filing. Acasti remains blinded to the TRILOGY2 results, and intends to update the statistical analysis plan (SAP) with these revisions if the FDA agrees. As previously noted, upon submission of the meetin
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- Acasti Announces Corporate Name Change to Grace Therapeutics, Inc. [Canadian Business Journal (Canada)]Canadian Business Journal
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- Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.GlobeNewswire
- Acasti Pharma Inc. (NASDAQ: ACST) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $12.00 price target on the stock.MarketBeat
- Acasti Pharma Inc. (NASDAQ: ACST) had its price target raised by analysts at Craig Hallum from $6.00 to $8.00. They now have a "buy" rating on the stock.MarketBeat
ACST
Earnings
- 8/9/24 - Beat
ACST
Sec Filings
- 10/28/24 - Form 8-K
- 10/25/24 - Form 8-K
- 10/16/24 - Form EFFECT
- ACST's page on the SEC website