- Esperion Therapeutics Inc (NASDAQ:ESPR) announced the full results from the CLEAR Outcomes trial, a global study of nearly 14,000 patients with or at risk for cardiovascular disease who were unable to maximize or tolerate a statin.
- The study showed that Nexletol (Bempedoic acid) significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, compared to placebo.
- Related: Esperion Therapeutics Reports Sooner Than Expected Positive Data From Nexletol Trial.
- The company remains on track to submit regulatory filings to the FDA and EMA in 1H 2023.
- The company anticipates regulatory filings in 1H 2023. It expects to receive up to $440 million in partner milestone payments upon including cardiovascular risk reduction data in applicable labels and the achievement of other regulatory milestones.
- The company expects full-year 2023 operating expenses to be approximately $225 million to $245 million.
- Price Action: ESPR shares are down 19.09% at $5.13 during the premarket session on the last check Monday.
- Photo Via Company
AstraZeneca Announced Tezspire Approved in Japan for Severe Asthma
AstraZeneca's Tezspire (tezepelumab) has been approved in Japan for the treatment of bronchial asthma in patients with severe or refractory disease in whom asthma symptoms cannot be controlled with mid- or high-dose inhaled corticosteroids and other long-term maintenance therapies.1
