It is not that often that you see biotech or biohealth stocks moving north of 50% in one trading session. If you do it is usually due to merger news or a rumor about a merger. In the case of Acasti Pharma Inc. (NASDAQ: ACST), the company’s shares were last seen trading up 73% at $2.17 after a drug study update.
Acasti Pharma announced on Wednesday that its bridging study for novel drug candidate CaPre (omega-3 phospholipid) has successfully met its objectives. The company said that this supports its strategy of pursuing the U.S. Food and Drug Administration’s (FDA) regulatory pathway for approval.
Acasti noted that the company is developing CaPre for the treatment of patients with severe hypertriglyceridemia. The 505(b)(2) regulatory pathway allows Acasti to streamline the overall development program required to support a New Drug Application by relying on the safety data of an approved drug.
Hypertriglyceridemia is a metabolic condition that contributes to increased risk of cardiovascular disease and pancreatitis. CaPre is a novel composition of omega-3 phospholipids sourced from krill.
Investors should understand that a 73% is hard to ignore. Still, they better keep in mind that Acasti’s market cap is just under $23 million. That means this was a mere $13.35 million or so in market cap before the news was released. Acasti Pharma has a 52-week trading range of $1.20 to $3.70.
Jan D’Alvise, president and CEO of Acasti Pharma, said:
We are confident that the results of this study support the 505(b)(2) regulatory pathway chosen by Acasti to gain marketing approval of CaPre. With this momentum, we look forward to working with the FDA to confirm the pathway and optimize the design of our Phase 3 program, which will seek to demonstrate the safety and efficacy of CaPre in patients with severe hypertriglyceridemia.
Roderick Carter, M.D., chairman of Acasti Pharma, said:
The CaPre bioavailability study has reinforced the compound’s unique attributes in comparison with the leading pharmaceutical agent for hypertriglyceridemia. CaPre demonstrates clinically meaningful effects on many key markers of cardio-metabolic health. With high rates of obesity and diabetes fueling the number of patients with elevated triglycerides and cholesterols, CaPre could fill the need for a best-in-class omega-3 medication that addresses the full lipid profiles of these patients.