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NVO's Etavopivat Hits Key Goals in Phase III Sickle Cell Disease Study
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Key Takeaways
Novo Nordisk's phase III HIBISCUS study met co-primary endpoints in sickle cell disease patients.
Etavopivat therapy showed 27% fewer VOCs and a delayed onset to 38.4 weeks vs 20.9 weeks on placebo.
NVO reported 48.7% Hb response with etavopivat vs 7.2% with placebo; regulatory filing planned in H2 2026.
Novo Nordisk (NVO - Free Report) announced meeting both co-primary endpoints in a late-stage study of its investigational candidate, etavopivat, for adults and adolescents with sickle cell disease (SCD). The data demonstrated that treatment with etavopivat resulted in superior reduction in vaso-occlusive crises (VOCs) and superior improvement in haemoglobin (Hb) response compared to placebo.
NVO’s etavopivat is an oral, once-daily activator of PKR currently being developed as a treatment for SCD, a genetic blood disorder caused by abnormal haemoglobin, leading to anaemia and painful VOCs. It affects approximately eight million people globally and is associated with severe complications, chronic pain and a lifespan shortened by about 30 years despite treatment advances.
The 52-week, pivotal phase III HIBISCUS study evaluated the safety and efficacy of etavopivat 400 mg compared to placebo in 385 patients aged 12 years or older with SCD. Participants were allowed to receive standard-of-care treatment throughout the study.
Year to date, Novo Nordisk shares have lost 20.4% compared with the industry’s 3.8% decline.
Image Source: Zacks Investment Research
NVO’s SCD Study Data in Detail
Per the data readout from Novo Nordisk’s phase III HIBISCUS study, etavopivat demonstrated a 27% reduction in the annualized rate of VOCs compared to placebo, highlighting a meaningful impact on one of the most debilitating aspects of SCD. The therapy also significantly delayed the onset of the first VOC, with a median time of 38.4 weeks compared to 20.9 weeks for placebo, underscoring its potential to improve disease control over time.
The candidate further showed a strong effect on Hb response, with 48.7% of treated patients achieving an increase of more than 1 g/dL at week 24, compared to just 7.2% in the placebo arm. This translated to an adjusted rate difference of 41.2%, reinforcing the therapy’s ability to address underlying anaemia. Additionally, exploratory findings indicated a significant reduction in the risk of blood transfusions among treated patients.
From a safety standpoint, etavopivat was generally well tolerated, with a profile consistent with earlier studies, suggesting no new safety concerns at this stage. The overall dataset supports a favorable benefit-risk profile as the therapy advances toward potential regulatory review.
Novo Nordisk is targeting its first regulatory submission for etavopivat in the second half of 2026, with detailed results from the HIBISCUS study expected to be presented at a scientific conference later in the year. If approved, etavopivat could emerge as a first- and best-in-class therapy, with the potential to significantly improve outcomes for people with SCD, who currently face limited treatment options.
Please note that etavopivat currently enjoys the FDA’s Fast Track, Rare Pediatric Disease and Orphan Drug designations in the United States for SCD. Additionally, the candidate also enjoys the Orphan Drug designation in the EU for the same indication. Etavopivat was added to Novo Nordisk’s portfolio following the acquisition of Forma Therapeutics in 2022.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have increased from $2.55 to $2.87. CPRX shares have gained 11.7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ADMA Biologics’ 2026 EPS have increased from 85 cents to 93 cents. ADMA shares have plummeted 40.4% year to date.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 32.2% year to date.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.
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NVO's Etavopivat Hits Key Goals in Phase III Sickle Cell Disease Study
Key Takeaways
Novo Nordisk (NVO - Free Report) announced meeting both co-primary endpoints in a late-stage study of its investigational candidate, etavopivat, for adults and adolescents with sickle cell disease (SCD). The data demonstrated that treatment with etavopivat resulted in superior reduction in vaso-occlusive crises (VOCs) and superior improvement in haemoglobin (Hb) response compared to placebo.
NVO’s etavopivat is an oral, once-daily activator of PKR currently being developed as a treatment for SCD, a genetic blood disorder caused by abnormal haemoglobin, leading to anaemia and painful VOCs. It affects approximately eight million people globally and is associated with severe complications, chronic pain and a lifespan shortened by about 30 years despite treatment advances.
The 52-week, pivotal phase III HIBISCUS study evaluated the safety and efficacy of etavopivat 400 mg compared to placebo in 385 patients aged 12 years or older with SCD. Participants were allowed to receive standard-of-care treatment throughout the study.
Year to date, Novo Nordisk shares have lost 20.4% compared with the industry’s 3.8% decline.
Image Source: Zacks Investment Research
NVO’s SCD Study Data in Detail
Per the data readout from Novo Nordisk’s phase III HIBISCUS study, etavopivat demonstrated a 27% reduction in the annualized rate of VOCs compared to placebo, highlighting a meaningful impact on one of the most debilitating aspects of SCD. The therapy also significantly delayed the onset of the first VOC, with a median time of 38.4 weeks compared to 20.9 weeks for placebo, underscoring its potential to improve disease control over time.
The candidate further showed a strong effect on Hb response, with 48.7% of treated patients achieving an increase of more than 1 g/dL at week 24, compared to just 7.2% in the placebo arm. This translated to an adjusted rate difference of 41.2%, reinforcing the therapy’s ability to address underlying anaemia. Additionally, exploratory findings indicated a significant reduction in the risk of blood transfusions among treated patients.
From a safety standpoint, etavopivat was generally well tolerated, with a profile consistent with earlier studies, suggesting no new safety concerns at this stage. The overall dataset supports a favorable benefit-risk profile as the therapy advances toward potential regulatory review.
Novo Nordisk is targeting its first regulatory submission for etavopivat in the second half of 2026, with detailed results from the HIBISCUS study expected to be presented at a scientific conference later in the year. If approved, etavopivat could emerge as a first- and best-in-class therapy, with the potential to significantly improve outcomes for people with SCD, who currently face limited treatment options.
Please note that etavopivat currently enjoys the FDA’s Fast Track, Rare Pediatric Disease and Orphan Drug designations in the United States for SCD. Additionally, the candidate also enjoys the Orphan Drug designation in the EU for the same indication. Etavopivat was added to Novo Nordisk’s portfolio following the acquisition of Forma Therapeutics in 2022.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) , ADMA Biologics (ADMA - Free Report) and Inovio Pharmaceuticals (INO - Free Report) . While CPRX and ADMA sport a Zacks Rank #1 (Strong Buy) each, INO carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have increased from $2.55 to $2.87. CPRX shares have gained 11.7% year to date.
Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.
Over the past 60 days, estimates for ADMA Biologics’ 2026 EPS have increased from 85 cents to 93 cents. ADMA shares have plummeted 40.4% year to date.
ADMA Biologics’ earnings beat estimates in one of the trailing three quarters, matched once and missed on the remaining occasion, with the average negative surprise being 1.79%.
Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 32.2% year to date.
Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.