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Arena (ARNA) Starts Phase II Study on Coronary Drug Temanogrel
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Arena Pharmaceuticals, Inc. announced that it has dosed the first patient in a phase II study evaluating its coronary candidate, temanogrel. The study is evaluating the safety, tolerability, and efficacy of two doses of the intravenous formulation of the candidate as a potential treatment for coronary microvascular obstruction (cMVO) in patients undergoing percutaneous coronary intervention (PCI).
The primary endpoint of the study will be measured by the change in Index of Microcirculatory Resistance on day 1 post-PCI compared to baseline. Data from the mid-stage study is expected in the second half of 2022. Previous data from pre-clinical and clinical data support the study evaluating the use of temanogrel in patients undergoing PCI to prevent cMVO.
The company stated that 40% to 60% of patients undergoing PCI for treating acute coronary syndrome fail to achieve full myocardial reperfusion, which can lead to cMVO and increase negative cardiovascular outcomes and mortality by two to three folds. With no FDA-approved therapy for the cMVO indication, the field represents a significant opportunity for the company, if successful.
Please note that the candidate enjoys Fast Track designation in the United States for cMVO. The company is developing the candidate as a potential treatment for Raynaud's phenomenon secondary to systemic sclerosis.
Shares of Arena have lost 20.8% so far this year compared with the industry’s 1.1% decrease.
Image Source: Zacks Investment Research
Meanwhile, the company is developing its lead pipeline candidate, etrasimod, for multiple indications. The candidate is in late-stage development as a potential treatment for active ulcerative colitis. The company is advancing the candidate to a phase III registrational program to evaluate it as a potential treatment for atopic dermatitis. A phase IIb/III study is evaluating etrasimod in patients with Crohn's disease. A mid-stage study was initiated during the last quarter to evaluate the candidate in patients with eosinophilic esophagitis.
However, a mid-stage study evaluating the company’s another key pipeline candidate, olorinab, in abdominal pain due to irritable bowel syndrome failed in March. The company is evaluating possible strategic options for the candidate and further development of the candidate is now subject to regulatory approval.
With no approved products, successful development of pipeline candidate is key to Arena’s prospects. Any pipeline setback going forward will likely have an adverse impact on the company’s shares.
Bellerophon’s loss per share estimates have narrowed from $2.75 to $2.69 for 2021 and from $2.31 to $2.27s for 2022 in the past 30 days.
Akero’s loss per share estimates have narrowed from $4.50 to $2.97 for 2021 and from $4.84 to $3.11 for 2022 in the past 30 days.
Repligen’s earnings per share estimates increased from $2.21 to $2.26 for 2021 and from $2.53 to $2.56 for 2022 in the past 30 days.
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The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Image: Bigstock
Arena (ARNA) Starts Phase II Study on Coronary Drug Temanogrel
Arena Pharmaceuticals, Inc. announced that it has dosed the first patient in a phase II study evaluating its coronary candidate, temanogrel. The study is evaluating the safety, tolerability, and efficacy of two doses of the intravenous formulation of the candidate as a potential treatment for coronary microvascular obstruction (cMVO) in patients undergoing percutaneous coronary intervention (PCI).
The primary endpoint of the study will be measured by the change in Index of Microcirculatory Resistance on day 1 post-PCI compared to baseline. Data from the mid-stage study is expected in the second half of 2022. Previous data from pre-clinical and clinical data support the study evaluating the use of temanogrel in patients undergoing PCI to prevent cMVO.
The company stated that 40% to 60% of patients undergoing PCI for treating acute coronary syndrome fail to achieve full myocardial reperfusion, which can lead to cMVO and increase negative cardiovascular outcomes and mortality by two to three folds. With no FDA-approved therapy for the cMVO indication, the field represents a significant opportunity for the company, if successful.
Please note that the candidate enjoys Fast Track designation in the United States for cMVO. The company is developing the candidate as a potential treatment for Raynaud's phenomenon secondary to systemic sclerosis.
Shares of Arena have lost 20.8% so far this year compared with the industry’s 1.1% decrease.
Meanwhile, the company is developing its lead pipeline candidate, etrasimod, for multiple indications. The candidate is in late-stage development as a potential treatment for active ulcerative colitis. The company is advancing the candidate to a phase III registrational program to evaluate it as a potential treatment for atopic dermatitis. A phase IIb/III study is evaluating etrasimod in patients with Crohn's disease. A mid-stage study was initiated during the last quarter to evaluate the candidate in patients with eosinophilic esophagitis.
However, a mid-stage study evaluating the company’s another key pipeline candidate, olorinab, in abdominal pain due to irritable bowel syndrome failed in March. The company is evaluating possible strategic options for the candidate and further development of the candidate is now subject to regulatory approval.
With no approved products, successful development of pipeline candidate is key to Arena’s prospects. Any pipeline setback going forward will likely have an adverse impact on the company’s shares.
Arena Pharmaceuticals, Inc. Price
Arena Pharmaceuticals, Inc. price | Arena Pharmaceuticals, Inc. Quote
Zacks Rank and Stocks to Consider
Arena currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the drug/biotech sector are Bellerophon Therapeutics, Inc. (BLPH - Free Report) , Akero Therapeutics, Inc. (AKRO - Free Report) and Repligen Corporation (RGEN - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Bellerophon’s loss per share estimates have narrowed from $2.75 to $2.69 for 2021 and from $2.31 to $2.27s for 2022 in the past 30 days.
Akero’s loss per share estimates have narrowed from $4.50 to $2.97 for 2021 and from $4.84 to $3.11 for 2022 in the past 30 days.
Repligen’s earnings per share estimates increased from $2.21 to $2.26 for 2021 and from $2.53 to $2.56 for 2022 in the past 30 days.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>