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Bayer (BAYRY) Submits Applications for Heart Failure Drug
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Bayer AG (BAYRY - Free Report) announced that it has submitted regulatory applications seeking the approval of pipeline candidate, vericiguat, in the EU and Japan.
Vericiguat is an experimental once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%, who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization), in combination with available heart failure therapies.
The marketing authorization application (MAA) submitted to the European Medicines Agency (EMA) and the new drug application (NDA) submitted to the Ministry of Health, Labor and Welfare (MHLW) in Japan were based on positive data from the late-stage VICTORIA study.
The phase III study is investigating vericiguat compared to placebo when added to currently available heart failure therapies in these patients. Results showed that vericiguat 10 mg once daily significantly reduced the combined risk of heart failure hospitalization and cardiovascular death by 10% compared to placebo.
Bayer is developing the candidate in collaboration with Merck (MRK - Free Report) .
A potential approval will strengthen the company’s portfolio.
Shares of the company have declined 8.4% so far this year against the industry’s 1.3% growth.
Novartis’ (NVS - Free Report) Entresto is approved to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.
Bayer is undertaking several initiatives to strengthen its position across portfolios, enhance efficiency and accelerate structural measures, including the decision to exit the Animal Health business unit. The company had earlier announced the divestment of its Animal Health business to Elanco (ELAN - Free Report) . Meanwhile, the Monsanto acquisition in 2018 has strengthened Bayer's position.
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Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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Bayer (BAYRY) Submits Applications for Heart Failure Drug
Bayer AG (BAYRY - Free Report) announced that it has submitted regulatory applications seeking the approval of pipeline candidate, vericiguat, in the EU and Japan.
Vericiguat is an experimental once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45%, who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization), in combination with available heart failure therapies.
The marketing authorization application (MAA) submitted to the European Medicines Agency (EMA) and the new drug application (NDA) submitted to the Ministry of Health, Labor and Welfare (MHLW) in Japan were based on positive data from the late-stage VICTORIA study.
The phase III study is investigating vericiguat compared to placebo when added to currently available heart failure therapies in these patients. Results showed that vericiguat 10 mg once daily significantly reduced the combined risk of heart failure hospitalization and cardiovascular death by 10% compared to placebo.
Bayer is developing the candidate in collaboration with Merck (MRK - Free Report) .
A potential approval will strengthen the company’s portfolio.
Shares of the company have declined 8.4% so far this year against the industry’s 1.3% growth.
Novartis’ (NVS - Free Report) Entresto is approved to reduce the risk of death and hospitalization in people with certain types of long-lasting (chronic) heart failure.
Bayer is undertaking several initiatives to strengthen its position across portfolios, enhance efficiency and accelerate structural measures, including the decision to exit the Animal Health business unit. The company had earlier announced the divestment of its Animal Health business to Elanco (ELAN - Free Report) . Meanwhile, the Monsanto acquisition in 2018 has strengthened Bayer's position.
Zacks Rank
Bayer currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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