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Forma's (FMTX) Etavopivat Proves Safety Profile in SCD Study
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Forma Therapeutics Holdings, Inc. announced that its investigational pyruvate kinase-R (PKR) activator, etavopivat significantly improved anemia and red blood cell (RBC) health in patients with sickle cell disease (“SCD”). The candidate also demonstrated a favorable tolerability and safety profile in the given patient population.
The company is evaluating once-daily, oral etavopivat in the open-label cohort of a randomized, placebo-controlled phase I study. Data from the same showed that treatment with etavopivat (400 mg) for up to 12 weeks reduced anemia by significantly raising and sustaining hemoglobin levels. Also, treatment with etavopivat significantly increased the lifespan of RBCs and decreased hemolysis.
The results of this phase I study were presented in two oral sessions at the annual meeting of the American Society of Hematology.
Shares of Forma have plunged 58.1% so far this year compared with the industry’s decrease of 22.7%.
Image Source: Zacks Investment Research
The company is currently evaluating the safety and efficacy of etavopivat in the ongoing phase I/II Hibiscus study for treating patients with SCD. The study has two co-primary endpoints — hemoglobin and vaso-occlusive crises while secondary endpoints include quality of life and pharmaco-economic impacts.
We note that SCD is a chronic disorder associated with a decrease in the health and lifespan of RBCs. Per the company, around 100,000 people in the United States are affected by SCD. Hence, if successfully developed and upon potential approval, etavopivat can serve an area of high unmet medical need.
Many companies are developing treatments for SCD, which is likely to result in competition for Forma in the days ahead. Global Blood Therapeutics’ Oxbryta (voxelotor) was approved by the FDA as an oral once-daily treatment for SCD in patients aged 12 years and above in November 2019.
In September 2021, the FDA granted priority review to Global Blood Therapeutics’ supplemental new drug application for Oxbryta to treat SCD in children aged four to 11 years, as well as to the new drug application for a pediatric weight-based formulation of the drug. A decision is due on Dec 25, 2021.
Several other companies are also developing hematopoietic stem cell transplantation, cell therapies and gene-editing therapies to treat SCD.
Image: Shutterstock
Forma's (FMTX) Etavopivat Proves Safety Profile in SCD Study
Forma Therapeutics Holdings, Inc. announced that its investigational pyruvate kinase-R (PKR) activator, etavopivat significantly improved anemia and red blood cell (RBC) health in patients with sickle cell disease (“SCD”). The candidate also demonstrated a favorable tolerability and safety profile in the given patient population.
The company is evaluating once-daily, oral etavopivat in the open-label cohort of a randomized, placebo-controlled phase I study. Data from the same showed that treatment with etavopivat (400 mg) for up to 12 weeks reduced anemia by significantly raising and sustaining hemoglobin levels. Also, treatment with etavopivat significantly increased the lifespan of RBCs and decreased hemolysis.
The results of this phase I study were presented in two oral sessions at the annual meeting of the American Society of Hematology.
Shares of Forma have plunged 58.1% so far this year compared with the industry’s decrease of 22.7%.
The company is currently evaluating the safety and efficacy of etavopivat in the ongoing phase I/II Hibiscus study for treating patients with SCD. The study has two co-primary endpoints — hemoglobin and vaso-occlusive crises while secondary endpoints include quality of life and pharmaco-economic impacts.
We note that SCD is a chronic disorder associated with a decrease in the health and lifespan of RBCs. Per the company, around 100,000 people in the United States are affected by SCD. Hence, if successfully developed and upon potential approval, etavopivat can serve an area of high unmet medical need.
Many companies are developing treatments for SCD, which is likely to result in competition for Forma in the days ahead. Global Blood Therapeutics’ Oxbryta (voxelotor) was approved by the FDA as an oral once-daily treatment for SCD in patients aged 12 years and above in November 2019.
In September 2021, the FDA granted priority review to Global Blood Therapeutics’ supplemental new drug application for Oxbryta to treat SCD in children aged four to 11 years, as well as to the new drug application for a pediatric weight-based formulation of the drug. A decision is due on Dec 25, 2021.
Several other companies are also developing hematopoietic stem cell transplantation, cell therapies and gene-editing therapies to treat SCD.
Zacks Rank & Stocks to Consider
Forma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Sarepta Therapeutics, Inc. (SRPT - Free Report) and Editas Medicine, Inc. (EDIT - 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.
Sarepta Therapeutics’ loss per share estimates have narrowed 31.3% for 2021 and 26% for 2022 over the past 60 days.
Earnings of Sarepta Therapeutics have surpassed estimates in two of the trailing four quarters, and missed the same on the other two occasions.
Editas Medicine’s loss per share estimates have narrowed 11.2% for 2021 and 4.6% for 2022 over the past 60 days.
Editas Medicine’s earnings have surpassed estimates in two of the trailing four quarters and missed the same on the other two occasions.