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The going has been rough for Incyte (INCY - Free Report) of late. While it recently won two back-to-back FDA approvals after suffering a setback earlier, investors do not seem much impressed.
The FDA has approved a label expansion of its JAK1/JAK2 inhibitor, Jakafi (ruxolitinib). The drug can now be used for the treatment of chronic graft-versus-host disease (GVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years of age and older. The regulatory body also approved the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD). Ruxolitinib cream has been approved under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older.
However, the FDA’s recent update on warnings about increased risks of serious heart-related events, cancer, blood clots, and death for JAK inhibitors like Pfizer’s (PFE - Free Report) Xeljanz and Xeljanz XR and AbbVie’s (ABBV - Free Report) Rinvoq, among others, that treat certain chronic inflammatory conditions seem to dampen hopes of other JAK inhibitors. While JAK inhibitors, Jakafi and Bristol Myers' (BMY - Free Report) Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and are not part of the updates required for prescribing information for other inhibitors, there is a cloud of uncertainty regarding the same.
Earlier, the FDA also issued a Complete Response Letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or are intolerant of platinum-based chemotherapy.
Jakafi is already approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. It is also approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years of age and older.
On a positive note, Jakafi sales recorded growth in the second quarter after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well. Earlier, Incyte and partner MorphoSys obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
But Incyte is heavily dependent on Jakafi for growth. Hence, if the label expansion does not contribute to sales or the company faces any slowdown in overall Jakafi sales, it will be detrimental to its prospects in the future.
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Incyte's (INCY) Going Gets Rough Despite Recent Approvals
The going has been rough for Incyte (INCY - Free Report) of late. While it recently won two back-to-back FDA approvals after suffering a setback earlier, investors do not seem much impressed.
The FDA has approved a label expansion of its JAK1/JAK2 inhibitor, Jakafi (ruxolitinib). The drug can now be used for the treatment of chronic graft-versus-host disease (GVHD) after the failure of one or two lines of systemic therapy in adult and pediatric patients 12 years of age and older. The regulatory body also approved the cream formulation of ruxolitinib for the treatment of mild to moderate atopic dermatitis (AD). Ruxolitinib cream has been approved under the brand name Opzelura for the short-term and non-continuous chronic treatment of mild to moderate AD in non-immunocompromised patients 12 years of age and older.
However, the FDA’s recent update on warnings about increased risks of serious heart-related events, cancer, blood clots, and death for JAK inhibitors like Pfizer’s (PFE - Free Report) Xeljanz and Xeljanz XR and AbbVie’s (ABBV - Free Report) Rinvoq, among others, that treat certain chronic inflammatory conditions seem to dampen hopes of other JAK inhibitors. While JAK inhibitors, Jakafi and Bristol Myers' (BMY - Free Report) Inrebic (fedratinib), are not indicated for the treatment of arthritis and other inflammatory conditions and are not part of the updates required for prescribing information for other inhibitors, there is a cloud of uncertainty regarding the same.
Earlier, the FDA also issued a Complete Response Letter (CRL) for the biologics license application (BLA) for its intravenous PD-1 inhibitor, retifanlimab, for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal (SCAC) who have progressed on, or are intolerant of platinum-based chemotherapy.
Jakafi is already approved for the treatment of polycythemia vera (PV) in adults who have had an inadequate response to or are intolerant of hydroxyurea, intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF and post-essential thrombocythemia MF in adults. It is also approved for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years of age and older.
On a positive note, Jakafi sales recorded growth in the second quarter after a soft first quarter. The uptake of Pemazyre is also gaining traction. The company’s efforts to diversify its revenue base are encouraging as well. Earlier, Incyte and partner MorphoSys obtained the European Commission’s approval for tafasitamab under the brand name Minjuvi for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
But Incyte is heavily dependent on Jakafi for growth. Hence, if the label expansion does not contribute to sales or the company faces any slowdown in overall Jakafi sales, it will be detrimental to its prospects in the future.