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PFE Gets FDA Nod for Expanded Use of Hemophilia Drug Hympavzi
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Key Takeaways
Pfizer gained FDA approval to expand Hympavzi use in additional hemophilia A and B populations.
Hympavzi is now approved for routine prophylaxis in patients aged six and older with or without inhibitors.
PFE's expanded label for Hympavzi is backed by phase III BASIS and BASIS KIDS study data.
Pfizer (PFE - Free Report) announced that the FDA has approved its anti-TFPI inhibitor Hympavzi (marstacimab) for the treatment of two additional hemophilia A or B patient populations. The latest approval now includes the treatment of hemophilia A or B in patients aged 12 years and above with inhibitors, as well as pediatric patients aged six to 11 years with or without inhibitors.
Following the latest FDA nod, HYMPAVZI is now approved in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged six years and older with hemophilia A with or without factor VIII inhibitors, or hemophilia B with or without factor IX inhibitors.
With this approval, Hympavzi has now become the first subcutaneous non-factor therapy available for treating pediatric patients with hemophilia B aged six to 11 years, addressing a significant medical need for the given patient population.
The European Commission recently approved Hympavzi for patients aged 12 years and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) FIX inhibitors.
PFE Stock Performance
Year to date, shares of Pfizer have rallied 6.4% compared with the industry’s rise of 5.8%.
Image Source: Zacks Investment Research
More on Pfizer’s Hympavzi Label Expansion
The latest approval of Hympavzi for adolescents and adults aged 12 years and older with hemophilia A or B who have inhibitors was based on data from the phase III BASIS study.
The study showed that Hympavzi significantly reduced bleeding episodes, lowering the average annualized bleeding rate by 93% compared with on-demand intravenous treatment using bypassing agents.
Meanwhile, the approval for Hympavzi in children aged six to 17 years with hemophilia A or B, regardless of inhibitor status, was based on interim results from the phase III BASIS KIDS study.
In February 2026, the FDA accepted and granted Priority Review to the supplemental biologics license application (sBLA) seeking approval for Hympavzi for expanded use in the given patient population.
A rare genetic blood disorder, hemophilia is caused by a missing clotting protein (FVIII in case of hemophilia A and FIX in case of hemophilia B), which prevents normal blood clotting. If the blood does not clot properly, it can lead to painful bleeding inside the joints that can cause scarring and damage.
Hympavzi targets tissue factor pathway inhibitor (TFPI), which is a natural anticoagulation protein that functions to prevent the formation of blood clots.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV shares have risen 4.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 85.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 19.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.
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PFE Gets FDA Nod for Expanded Use of Hemophilia Drug Hympavzi
Key Takeaways
Pfizer (PFE - Free Report) announced that the FDA has approved its anti-TFPI inhibitor Hympavzi (marstacimab) for the treatment of two additional hemophilia A or B patient populations. The latest approval now includes the treatment of hemophilia A or B in patients aged 12 years and above with inhibitors, as well as pediatric patients aged six to 11 years with or without inhibitors.
Following the latest FDA nod, HYMPAVZI is now approved in the United States for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and pediatric patients aged six years and older with hemophilia A with or without factor VIII inhibitors, or hemophilia B with or without factor IX inhibitors.
With this approval, Hympavzi has now become the first subcutaneous non-factor therapy available for treating pediatric patients with hemophilia B aged six to 11 years, addressing a significant medical need for the given patient population.
The European Commission recently approved Hympavzi for patients aged 12 years and older weighing at least 35 kg with hemophilia A (congenital factor VIII [FVIII] deficiency) FVIII inhibitors or hemophilia B (congenital factor IX [FIX] deficiency) FIX inhibitors.
PFE Stock Performance
Year to date, shares of Pfizer have rallied 6.4% compared with the industry’s rise of 5.8%.
Image Source: Zacks Investment Research
More on Pfizer’s Hympavzi Label Expansion
The latest approval of Hympavzi for adolescents and adults aged 12 years and older with hemophilia A or B who have inhibitors was based on data from the phase III BASIS study.
The study showed that Hympavzi significantly reduced bleeding episodes, lowering the average annualized bleeding rate by 93% compared with on-demand intravenous treatment using bypassing agents.
Meanwhile, the approval for Hympavzi in children aged six to 17 years with hemophilia A or B, regardless of inhibitor status, was based on interim results from the phase III BASIS KIDS study.
In February 2026, the FDA accepted and granted Priority Review to the supplemental biologics license application (sBLA) seeking approval for Hympavzi for expanded use in the given patient population.
A rare genetic blood disorder, hemophilia is caused by a missing clotting protein (FVIII in case of hemophilia A and FIX in case of hemophilia B), which prevents normal blood clotting. If the blood does not clot properly, it can lead to painful bleeding inside the joints that can cause scarring and damage.
Hympavzi targets tissue factor pathway inhibitor (TFPI), which is a natural anticoagulation protein that functions to prevent the formation of blood clots.
PFE's Zacks Rank & Stocks to Consider
Pfizer currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Indivior Pharmaceuticals (INDV - Free Report) , Liquidia Corporation (LQDA - Free Report) and Immunocore (IMCR - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share (EPS) have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV shares have risen 4.2% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Liquidia’s 2026 EPS have increased to $2.97 from $1.50. Over the same period, EPS estimates for 2027 have risen to $4.81 from $2.91. LQDA shares have surged 85.3% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Immunocore’s 2026 have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR shares have lost 19.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 46.66%.