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Omeros (OMER) Announces Data on Narsoplimab in COVID-19 Patients
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Omeros Corporation (OMER - Free Report) announced encouraging preliminary results from the second cohort of critically ill COVID-19 patients treated with lead candidate, narsoplimab.
Narsoplimab is an inhibitor of mannan-binding lectin-associated serine protease 2 (MASP-2), the effector enzyme of the lectin pathway of complement.
The patients in the cohort were part of the "second surge" of COVID-19 in Italy and sicker than those in the first cohort of patients treated with narsoplimab. The patients were suffering from significant acute respiratory distress syndrome (ARDS), with 90% of them intubated at the start of narsoplimab treatment. The majority of patients had multiple comorbidities and risk factors for poor outcomes and all had failed other therapies (steroids).
The results showed that 80% of the patients recovered, survived and were discharged. However, there were two deaths.
Per the company, narsoplimab targets the inflammatory endothelial disease — a central driver across variants — unlike other drugs for COVID-19.
The candidate is being evaluated in the I-SPY COVID-19 trial, an adaptive platform clinical study enrolling critically ill COVID-19 patients. The trial is sponsored by Quantum Leap Healthcare Collaborative and funded in part by the U.S. government through the Biomedical Advanced Research and Development Authority (BARDA).
Omeros’ stock has increased 6.1% so far this year compared with the industry’s rise of 4.3%.
Image Source: Zacks Investment Research
We remind investors that narsoplimab enjoys Breakthrough Therapy and Orphan Drug designations in both hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and IgA nephropathy. The company recently announced that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of HSCT-TMA. The new target action date is Oct 17, 2021. The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request. The FDA has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review.
The FDA has given Emergency Use Authorization (EUA) to Regeneron’s (REGN - Free Report) antibody cocktail, casirivimab and imdevimab, administered together (REGEN-COV) for the treatment of mild to moderate COVID-19.
Earnings estimates for Repligen for 2021 are up by 40 cents.
Earnings estimates for Zoetis for 2021 are up by 7 cents.
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Image: Bigstock
Omeros (OMER) Announces Data on Narsoplimab in COVID-19 Patients
Omeros Corporation (OMER - Free Report) announced encouraging preliminary results from the second cohort of critically ill COVID-19 patients treated with lead candidate, narsoplimab.
Narsoplimab is an inhibitor of mannan-binding lectin-associated serine protease 2 (MASP-2), the effector enzyme of the lectin pathway of complement.
The patients in the cohort were part of the "second surge" of COVID-19 in Italy and sicker than those in the first cohort of patients treated with narsoplimab. The patients were suffering from significant acute respiratory distress syndrome (ARDS), with 90% of them intubated at the start of narsoplimab treatment. The majority of patients had multiple comorbidities and risk factors for poor outcomes and all had failed other therapies (steroids).
The results showed that 80% of the patients recovered, survived and were discharged. However, there were two deaths.
Per the company, narsoplimab targets the inflammatory endothelial disease — a central driver across variants — unlike other drugs for COVID-19.
The candidate is being evaluated in the I-SPY COVID-19 trial, an adaptive platform clinical study enrolling critically ill COVID-19 patients. The trial is sponsored by Quantum Leap Healthcare Collaborative and funded in part by the U.S. government through the Biomedical Advanced Research and Development Authority (BARDA).
Omeros’ stock has increased 6.1% so far this year compared with the industry’s rise of 4.3%.
We remind investors that narsoplimab enjoys Breakthrough Therapy and Orphan Drug designations in both hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) and IgA nephropathy. The company recently announced that the FDA will require additional time to review the Biologics License Application (BLA) for narsoplimab for the treatment of HSCT-TMA. The new target action date is Oct 17, 2021. The BLA was accepted for filing in January 2021 under the FDA’s Priority Review program with an action date of Jul 17, 2021. Omeros recently submitted a response to an FDA information request. The FDA has classified the response as a major amendment, which requires additional time to review as part of the ongoing BLA Priority Review.
The FDA has given Emergency Use Authorization (EUA) to Regeneron’s (REGN - Free Report) antibody cocktail, casirivimab and imdevimab, administered together (REGEN-COV) for the treatment of mild to moderate COVID-19.
Omeros currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the healthcare sector include Repligen Corporation (RGEN - Free Report) and Zoetis Inc. (ZTS - Free Report) . While Repligen sports a Zacks Rank #1 (Strong Buy), Zoetis carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Earnings estimates for Repligen for 2021 are up by 40 cents.
Earnings estimates for Zoetis for 2021 are up by 7 cents.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.
See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>