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Agios (AGIO) Gets FDA Nod for Rare Anemia Drug Mitapivat
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Agios Pharmaceuticals (AGIO - Free Report) announced that the FDA has approved its lead pipeline candidate, mitapivat, for the treatment of hemolytic anemia in adults with pyruvate kinase (“PK”) deficiency. The drug, to be marketed by the trade name of Pyrukynd, is the first disease-modifying therapy approved to treat this rare and debilitating blood disorder.
Shares of Agios were up 6.8% in after-hours trading on Thursday in response to the approval news. The stock has declined 10.4% so far this year compared with the industry’s decrease of 7.1%.
Image Source: Zacks Investment Research
The new drug application (NDA) for Pyrukynd was based on data from two pivotal phase III studies — ACTIVATE and ACTIVATE-T — which evaluated mitapivat for treating PK deficiency in adults who are not regularly transfused and those who are regularly transfused, respectively. Data from the studies have demonstrated that mitapivat significantly improves hemolysis (destruction of red blood cells) and anemia in PK deficiency,
A marketing authorization application seeking approval of mitapivat for PK deficiency was filed in Europe in June last year. A decision in Europe is expected by the end of this year.
With the approval of Pyrukynd, Agios gets its first marketed drug and should start generating product sales. The drug is expected to be launched in the United States in approximately two weeks’ time.
Apart from PK deficiency, mitapivat is also being developed for other hemolytic anemias including sickle cell disease (“SCD”) and thalassemia. Agios has initiated two phase III studies, ENERGIZE and ENERGIZE-T, to evaluate mitapivat for thalassemia in adults, with one segment being not regularly transfused while the other being regularly transfused. In December 2021, the company announced the initiation of the phase II/III RISE UP study evaluating mitapivat for SCD.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 60 days.
Earnings of Adaptimmune Therapeutics beat estimates in two of the last four quarters, missed the mark once and delivered in-line results in one, with the average surprise being 0.91%.
Vertex Pharmaceuticals’ stock has risen 12.5% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Repligen’s earnings per share estimates for 2022 have increased from $3.22 to $3.23 per share in the past 60 days.
Repligen beat earnings expectations in each of the last four quarters, with the average surprise being 49.2%
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Agios (AGIO) Gets FDA Nod for Rare Anemia Drug Mitapivat
Agios Pharmaceuticals (AGIO - Free Report) announced that the FDA has approved its lead pipeline candidate, mitapivat, for the treatment of hemolytic anemia in adults with pyruvate kinase (“PK”) deficiency. The drug, to be marketed by the trade name of Pyrukynd, is the first disease-modifying therapy approved to treat this rare and debilitating blood disorder.
Shares of Agios were up 6.8% in after-hours trading on Thursday in response to the approval news. The stock has declined 10.4% so far this year compared with the industry’s decrease of 7.1%.
Image Source: Zacks Investment Research
The new drug application (NDA) for Pyrukynd was based on data from two pivotal phase III studies — ACTIVATE and ACTIVATE-T — which evaluated mitapivat for treating PK deficiency in adults who are not regularly transfused and those who are regularly transfused, respectively. Data from the studies have demonstrated that mitapivat significantly improves hemolysis (destruction of red blood cells) and anemia in PK deficiency,
A marketing authorization application seeking approval of mitapivat for PK deficiency was filed in Europe in June last year. A decision in Europe is expected by the end of this year.
With the approval of Pyrukynd, Agios gets its first marketed drug and should start generating product sales. The drug is expected to be launched in the United States in approximately two weeks’ time.
Apart from PK deficiency, mitapivat is also being developed for other hemolytic anemias including sickle cell disease (“SCD”) and thalassemia. Agios has initiated two phase III studies, ENERGIZE and ENERGIZE-T, to evaluate mitapivat for thalassemia in adults, with one segment being not regularly transfused while the other being regularly transfused. In December 2021, the company announced the initiation of the phase II/III RISE UP study evaluating mitapivat for SCD.
Zacks Rank & Stocks to Consider
Agios currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the drug/biotech sector include Adaptimmune Therapeutics , Vertex Pharmaceuticals (VRTX - Free Report) and Repligen (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.
Adaptimmune Therapeutics’ loss per share estimates for 2022 have narrowed from 99 cents to 91 cents in the past 60 days.
Earnings of Adaptimmune Therapeutics beat estimates in two of the last four quarters, missed the mark once and delivered in-line results in one, with the average surprise being 0.91%.
Vertex Pharmaceuticals’ stock has risen 12.5% in the past year. Estimates for Vertex Pharmaceuticals’ 2022 earnings have gone up from $13.32 to $14.33 per share while those for 2023 have increased from $13.85 to $15.31 per share over the past 60 days.
Vertex Pharmaceuticals’ earnings performance has been strong with the company beating earnings expectations in each of the last four quarters. Vertex Pharmaceuticals has a four-quarter earnings surprise of 10.01%, on average.
Repligen’s earnings per share estimates for 2022 have increased from $3.22 to $3.23 per share in the past 60 days.
Repligen beat earnings expectations in each of the last four quarters, with the average surprise being 49.2%