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Agios' (AGIO) Sickle Cell Disease Study Meets Primary Endpoint
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Agios Pharmaceuticals (AGIO - Free Report) announced that the phase II portion of the phase II/III RISE UP study of mitapivat in sickle cell diseasemet its primary endpoint of hemoglobin response rate in patients receiving both the 50-mg and 100-mg twice-daily doses of mitapivat.
The candidate is approved under the brand name Pyrukynd, to treat adults with pyruvate kinase (PK) deficiency, a rare and debilitating blood disorder.
The mid-stage, label expansion study evaluated the efficacy and safety of Pyrukynd (mitapivat) in sickle cell disease patients aged 16 years and older.
The data showed improvements in hemolysis and erythropoiesis markers, along with a decrease in the annualized rates of sickle cell pain crises when compared with the placebo group.
The study observed a hemoglobin response in 46.2% of patients who received 50-mg mitapivat and 50% of those on 100-mg mitapivat. This was in contrast to only 3.7% of patients in the placebo group.
Shares of Agios have lost 2.2% year to date against the industry’s 4.7% growth.
Image Source: Zacks Investment Research
The aforementioned findings are quite encouraging and provide a strong foundation for advancing to the phase III portion of the RISE UP study. The primary endpoints of this phase will include hemoglobin response and the annualized rate of sickle cell pain crises.
AGIO plans to enroll the first patient of the study in the fourth quarter of this year and aims to report the phase III data by 2025. If the results continue to be promising, the company may potentially receive FDA approval for mitapivat in 2026.
The observed safety profile for mitapivat in the mid-stage study was consistent with the previously reported data from studies on sickle cell disease and other hemolytic anemias.
In February 2022, it received FDA approval for Pyrukynd, for the treatment of hemolytic anemia in adult patients with PK deficiency.
The drug was also granted approval for adults with PK deficiency in the European Union in November 2022.
AGIO is enrolling patients in the late-stage clinical studies (ACTIVATE-kids and ACTIVATE-kidsT) of Pyrukynd for treating PK deficiency in pediatric patients. The company is also developing mitapivat for thalassemia (ENERGIZE and ENERGIZE-T). It expects multiple readouts for Pyrukynd’s late-stage studies during 2024-2025.
Successful development of Pyrukynd for the abovementioned indications can boost the company’s prospects in the coming years.
The Zacks Consensus Estimate for Novartis’ 2023 earnings has gone up from $6.56 per share to $6.74, in the past 90 days. Shares of Novartis have risen 9.7% year to date.
NVS’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 5.15%.
The consensus estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 15.8% year to date.
AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.49 per share to a loss of $2.05 for 2023 in the past 90 days. Shares of the company have rallied 6.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.
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Agios' (AGIO) Sickle Cell Disease Study Meets Primary Endpoint
Agios Pharmaceuticals (AGIO - Free Report) announced that the phase II portion of the phase II/III RISE UP study of mitapivat in sickle cell diseasemet its primary endpoint of hemoglobin response rate in patients receiving both the 50-mg and 100-mg twice-daily doses of mitapivat.
The candidate is approved under the brand name Pyrukynd, to treat adults with pyruvate kinase (PK) deficiency, a rare and debilitating blood disorder.
The mid-stage, label expansion study evaluated the efficacy and safety of Pyrukynd (mitapivat) in sickle cell disease patients aged 16 years and older.
The data showed improvements in hemolysis and erythropoiesis markers, along with a decrease in the annualized rates of sickle cell pain crises when compared with the placebo group.
The study observed a hemoglobin response in 46.2% of patients who received 50-mg mitapivat and 50% of those on 100-mg mitapivat. This was in contrast to only 3.7% of patients in the placebo group.
Shares of Agios have lost 2.2% year to date against the industry’s 4.7% growth.
Image Source: Zacks Investment Research
The aforementioned findings are quite encouraging and provide a strong foundation for advancing to the phase III portion of the RISE UP study. The primary endpoints of this phase will include hemoglobin response and the annualized rate of sickle cell pain crises.
AGIO plans to enroll the first patient of the study in the fourth quarter of this year and aims to report the phase III data by 2025. If the results continue to be promising, the company may potentially receive FDA approval for mitapivat in 2026.
The observed safety profile for mitapivat in the mid-stage study was consistent with the previously reported data from studies on sickle cell disease and other hemolytic anemias.
In February 2022, it received FDA approval for Pyrukynd, for the treatment of hemolytic anemia in adult patients with PK deficiency.
The drug was also granted approval for adults with PK deficiency in the European Union in November 2022.
AGIO is enrolling patients in the late-stage clinical studies (ACTIVATE-kids and ACTIVATE-kidsT) of Pyrukynd for treating PK deficiency in pediatric patients. The company is also developing mitapivat for thalassemia (ENERGIZE and ENERGIZE-T). It expects multiple readouts for Pyrukynd’s late-stage studies during 2024-2025.
Successful development of Pyrukynd for the abovementioned indications can boost the company’s prospects in the coming years.
Agios Pharmaceuticals, Inc. Price and Consensus
Agios Pharmaceuticals, Inc. price-consensus-chart | Agios Pharmaceuticals, Inc. Quote
Zacks Rank & Other Stocks to Consider
Agios currently carries a Zacks Rank #2 (Buy).
Some other top-ranked stocks in the overall healthcare sector are Novartis (NVS - Free Report) , Akero Therapeutics (AKRO - Free Report) and Omega Therapeutics (OMGA - Free Report) , each carrying a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis’ 2023 earnings has gone up from $6.56 per share to $6.74, in the past 90 days. Shares of Novartis have risen 9.7% year to date.
NVS’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 5.15%.
The consensus estimate for Akero Therapeutics has narrowed from a loss of $2.96 per share to a loss of $2.80 for 2023 in the past 90 days. Shares of Akero Therapeutics have nosedived 15.8% year to date.
AKRO’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 19.13%.
The consensus mark for Omega Therapeutics has narrowed from a loss of $2.49 per share to a loss of $2.05 for 2023 in the past 90 days. Shares of the company have rallied 6.1% year to date.
OMGA’s earnings beat estimates in two of the trailing four quarters, met the mark in one and missed in another, delivering an average surprise of 8.24%.