Acasti Pharma Inc ACST

Healthcare

Acasti Pharma Inc. is a Canada-based late-stage biopharma company with drug candidates addressing rare and orphan diseases. The Company is targeting three underserved orphan diseases: GTX-104, an intravenous infusion targeting subarachnoid hemorrhage (SAH), a rare and life-threatening medical emergency, in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull; GTX-102, an oral mucosal spray targeting ataxia-telangiectasia (A-T), a progressive, neurodegenerative genetic disease that primarily impacts children causing severe disability; and GTX-101, a topical spray, targeting postherpetic neuralgia, a persistent and often debilitating neuropathic pain caused by nerve damage from the varicella zoster virus (shingles). The Company’s clinical assets have each been granted Orphan Drug Designation by the FDA, which provides seven years of marketing exclusivity post-launch in the United States, and additional intellectual property protection.

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Comment by lscfaon Jan 02, 2020 12:46pm

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Post# 30511472

RE:Wow

Twisting the truth?

Seeking Alpha article:
While an outcome trial will unlikely be needed for a hypertriglyceridemia label, subsequent uptake in the marketplace likely will. During the 2020 Q2 conference call, ACST management had indicated that the likelihood of an outcomes trial was high.

Jan D’Alvise

Yes. Thanks, Leland. So let me respond and then Pierre you’re welcome to join in here if I miss anything. But I think that clearly we may ultimately need to conduct an outcome trial but we believe that if our Phase 3 results can replicate our Trifecta Effect as we saw in Phase 2, we believe based on our discussions with key opinion leaders and high volume prescribers that CaPre could gain significant market traction without a cardiovascular trial and really become a preferred omega-3 for patients with severe hypertriglyceridemia or patients with broader cardiometabolic disease, again, even without outcome data.