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Alexion's New Formulation of Ultomiris Gets CHMP Backing
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Alexion Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris (ravulizumab)in the European Union.The company noted that the European Commission typically reaches a decision on approval in approximately two months of the CHMP recommendation. Hence, a decision on the same is expected in November 2020.
Ultomiris is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
PNH is a serious ultra-rare blood disorder and aHUS is an ultra-rare disease that can cause progressive injury to vital organs.
Shares of the company have gained 3.4% compared with the industry’s growth of 0.6%.
The CHMP positive opinion is based on a comprehensive chemistry, manufacturing and control (CMC) submission and a supplementary clinical data. Ultomiris 100 mg/mL would constitute an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment.
Alexion plans to submit regulatory filings in the United States and the EU in the third quarter of 2021 for an Ultomiris subcutaneous formulation and device combinations for PNH and aHUS that can be self-administered at home, after completion of the ongoing phase III study and collection of 12-month safety data.
Emergent’s earnings estimates have increased from $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 85.3% year to date.
Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 8.3% year to date.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 26.9% year to date.
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking. Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
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Alexion's New Formulation of Ultomiris Gets CHMP Backing
Alexion Pharmaceuticals, Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending marketing authorization for a new 100 mg/mL intravenous (IV) advanced formulation of Ultomiris (ravulizumab)in the European Union.The company noted that the European Commission typically reaches a decision on approval in approximately two months of the CHMP recommendation. Hence, a decision on the same is expected in November 2020.
Ultomiris is the first and only long-acting C5 inhibitor administered every eight weeks for the treatment of two ultra-rare diseases — paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
PNH is a serious ultra-rare blood disorder and aHUS is an ultra-rare disease that can cause progressive injury to vital organs.
Shares of the company have gained 3.4% compared with the industry’s growth of 0.6%.
The CHMP positive opinion is based on a comprehensive chemistry, manufacturing and control (CMC) submission and a supplementary clinical data. Ultomiris 100 mg/mL would constitute an advancement in the treatment experience for patients with aHUS and PNH by reducing average annual infusion times by approximately 60% compared to Ultomiris 10 mg/mL while delivering comparable safety and efficacy. With Ultomiris 100 mg/mL, most patients will spend six hours or less a year receiving treatment.
Alexion plans to submit regulatory filings in the United States and the EU in the third quarter of 2021 for an Ultomiris subcutaneous formulation and device combinations for PNH and aHUS that can be self-administered at home, after completion of the ongoing phase III study and collection of 12-month safety data.
Zacks Rank &Stocks to Consider
Alexion currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector include Emergent Biosolutions Inc. (EBS - Free Report) , Bio Techne Corp (TECH - Free Report) and Alimera Sciences Inc. (ALIM - Free Report) . While Emergent sports a Zacks Rank #1 (Strong Buy), Bio Techne and Alimera carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Emergent’s earnings estimates have increased from $4.23to $6.58 for 2020 and from $5.55 to $7.62 for 2021 over the past 60 days. Shares of the company have increased 85.3% year to date.
Bio Techne’s earnings estimates have increased from $5.33 to $5.48 for 2020 and from $6.41 to $6.50 for 2021 over the past 60 days. Shares of the company have increased 8.3% year to date.
Alimera’s loss per share estimates have narrowed from $2.33 to $1.31 for 2020 and from 63 cents to 52 cents for 2021 over the past 60 days. Shares of the company have decreased 26.9% year to date.
Alexion Pharmaceuticals, Inc. Price
Alexion Pharmaceuticals, Inc. price | Alexion Pharmaceuticals, Inc. Quote
These Stocks Are Poised to Soar Past the Pandemic
The COVID-19 outbreak has shifted consumer behavior dramatically, and a handful of high-tech companies have stepped up to keep America running. Right now, investors in these companies have a shot at serious profits. For example, Zoom jumped 108.5% in less than 4 months while most other stocks were sinking. Our research shows that 5 cutting-edge stocks could skyrocket from the exponential increase in demand for “stay at home” technologies. This could be one of the biggest buying opportunities of this decade, especially for those who get in early.
See the 5 high-tech stocks now>>