Pharmaceutical

Esperion Therapeutics (NASDAQ:ESPR) shares increased by more than 10% after investors learned that the FDA will not require a long-term outcomes study prior to its potential approval of the company’s cholesterol-lowering drug.

Esperion Therapeutics (NASDAQ:ESPR) shares increased by more than 10% after investors learned that the FDA will not require a long-term outcomes study prior to its potential approval of the company’s cholesterol-lowering drug.
According to Fierce Biotech:

Investors and analysts have been fretting over exactly what the FDA will do with ETC-1002, an LDL-lowering pill that is angling for a share of a blockbuster market many believe lies in wait for a new class of PCSK9 drugs. While the oral ETC-1002 may not be as effective as the PCSK9 drugs, including the newly-approved Praluent from Regeneron ($REGN) and Sanofi ($SNY) as well as a rival Amgen ($AMGN) drug, it also has a shot at grabbing a significant share of the market with a less expensive and more easily managed drug that could do everything many patients in this huge market require.
Overhanging all of these drugs has been a persistent fear that regulators would require a long-running cardiovascular outcomes trial to prove the therapy works as expected in improving patients’ health. But according to Esperion, the agency says it’s ready to give it a green light for a relatively narrow market–which still amounts to a patient pool of 9 million people–and then hold back on a broader approval until after the CVOT data comes in later.

Click here to read the entire article on Fierce Biotech.

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