Esperion Therapeutics Inc (NASDAQ:ESPN) was top riser on Nasdaq Monday, with shares up over 48% as it received welcome feedback from the powerful US FDA on its cholesterol-lowering drug candidate.
The regulatory body said the firm's late-stage clinical program would be enough to support approval for the candidate.
The drug is aimed specifically as a supplementary treatment to statin therapy in patients with high cardiovascular disease risk.
Esperion plans to apply for FDA approval by the first half of 2019, with results from a phase 3 trial expected by the second quarter of 2018.
Tim Mayleben, chief executive of the biotech, said: "We are very pleased to have achieved clarity from FDA regarding Esperion’s LDL-C lowering development program.
"Our experienced lipid management team has worked closely with regulatory authorities and our key advisors to achieve this encouraging outcome.
"We continue to believe that bempedoic acid has the potential to provide physicians with a complementary and convenient oral treatment option that’s cost-effective for their patients with hypercholesterolemia who require additional LDL-C lowering.
"We remain focused on completing the global pivotal Phase 3 program for bempedoic acid and reporting top-line results from our long-term safety and tolerability study by Q2 2018 and top-line results from our ongoing Phase 3 LDL-C lowering efficacy studies by mid-2018."
Shares gained 48.2% to stand at $34.58 a pop.