AstraZeneca PLC’s (AZN - Free Report) wholly owned subsidiary, Alexion Pharmaceuticals, announced that it has discontinued the phase III study evaluating its long-acting C5 complement inhibitor, Ultomiris (ravulizumab), in adult patients with amyotrophic lateral sclerosis (“ALS”), a rare and fatal neurodegenerative disease.
The decision to stop the CHAMPION-ALS study was based on recommendation of the Independent Data Monitoring Committee (“IDMC”), following their review of data from a pre-specified interim analysis. The IDMC recommended that the study should be stopped owing to lack of efficacy.
Moreover, no new safety finding was observed, and the data was similar to the safety profile of Ultomiris.
The global placebo-controlled phase III CHAMPION-ALS study investigated the safety and efficacy of Ultomiris in a broad ALS patient population. The primary endpoint of the study was to see a change in the ALS functional rating scale-revised score.
Shares of AstraZeneca have rallied 18.4% so far this year, in line with the industry's growth.
We remind investors that Ultomiris was added to AstraZeneca’s portfolio following the acquisition of Alexion Pharmaceuticals in July 2021. The drug is approved for paroxysmal nocturnal hemoglobinuria (“PNH”) and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy in adult and pediatric (one month of age and older) patients.
Another company developing a treatment for ALS is Apellis Pharmaceuticals, Inc. (APLS - Free Report) .
The company is evaluating its sole marketed drug, Empaveli (pegcetacoplan), in the phase II MERIDIAN study for the treatment of ALS. Empaveli is approved as a monotherapy treatment for adult patients suffering from PNH.
In a separate press release, AstraZeneca announced positive data from the phase III PROVENT study evaluating its COVID-19 antibody combo, AZD7442.
Data from the study showed that treatment with AZD7442 led to a statistically significant reduction in the incidence of symptomatic COVID-19 – the primary endpoint. Treatment with AZD7442 reduced the risk of developing symptomatic COVID-19 infection by 77% as compared to placebo. Per the company, AZD7442 is the first long-acting antibody combination to prevent COVID-19 disease.
Also, no case of severe COVID-19 or COVID-19-related death was reported in the AZD7442 arm, while there were three cases of severe COVID-19 disease in the placebo arm, including two deaths.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 22.1% upward for 2021 and 17.9% upward for 2022 over the past 60 days. The stock has surged 35.5% year to date.
Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 6.4% upward for 2022 over the past 60 days.
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AstraZeneca PLC’s (AZN - Free Report) wholly owned subsidiary, Alexion Pharmaceuticals, announced that it has discontinued the phase III study evaluating its long-acting C5 complement inhibitor, Ultomiris (ravulizumab), in adult patients with amyotrophic lateral sclerosis (“ALS”), a rare and fatal neurodegenerative disease.
The decision to stop the CHAMPION-ALS study was based on recommendation of the Independent Data Monitoring Committee (“IDMC”), following their review of data from a pre-specified interim analysis. The IDMC recommended that the study should be stopped owing to lack of efficacy.
Moreover, no new safety finding was observed, and the data was similar to the safety profile of Ultomiris.
The global placebo-controlled phase III CHAMPION-ALS study investigated the safety and efficacy of Ultomiris in a broad ALS patient population. The primary endpoint of the study was to see a change in the ALS functional rating scale-revised score.
Shares of AstraZeneca have rallied 18.4% so far this year, in line with the industry's growth.
We remind investors that Ultomiris was added to AstraZeneca’s portfolio following the acquisition of Alexion Pharmaceuticals in July 2021. The drug is approved for paroxysmal nocturnal hemoglobinuria (“PNH”) and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy in adult and pediatric (one month of age and older) patients.
Another company developing a treatment for ALS is Apellis Pharmaceuticals, Inc. (APLS - Free Report) .
The company is evaluating its sole marketed drug, Empaveli (pegcetacoplan), in the phase II MERIDIAN study for the treatment of ALS. Empaveli is approved as a monotherapy treatment for adult patients suffering from PNH.
In a separate press release, AstraZeneca announced positive data from the phase III PROVENT study evaluating its COVID-19 antibody combo, AZD7442.
Data from the study showed that treatment with AZD7442 led to a statistically significant reduction in the incidence of symptomatic COVID-19 – the primary endpoint. Treatment with AZD7442 reduced the risk of developing symptomatic COVID-19 infection by 77% as compared to placebo. Per the company, AZD7442 is the first long-acting antibody combination to prevent COVID-19 disease.
Also, no case of severe COVID-19 or COVID-19-related death was reported in the AZD7442 arm, while there were three cases of severe COVID-19 disease in the placebo arm, including two deaths.
Zacks Rank & Stocks to Consider
AstraZeneca currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include Repligen Corporation (RGEN - Free Report) and Vertex Pharmaceuticals Incorporated (VRTX - Free Report) , both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Repligen’s earnings estimates have been revised 22.1% upward for 2021 and 17.9% upward for 2022 over the past 60 days. The stock has surged 35.5% year to date.
Vertex’s earnings estimates have been revised 10.2% upward for 2021 and 6.4% upward for 2022 over the past 60 days.
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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