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Incyte (INCY) Down on FDA Nod for Another Myelofibrosis Drug
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Shares of Incyte Corporation (INCY - Free Report) are down 4.86% after the FDA approved another JAK1/JAK2 inhibitor for myelofibrosis.
The FDA approved GSK plc’s (GSK - Free Report) momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia. Ojjaara is a once-a-day oral JAK1/JAK2 and activin A receptor type 1 inhibitor.
Incyte’s lead drug, Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, is also approved for myelofibrosis.
Per GSK, Ojjaara is the only approved drug for both newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms and splenomegaly.
The approval of another JAK1/JAK2 inhibitor for the same indication will pose competition for Jakafi, particularly given Ojjaara’s comprehensive labeling. Investors seemed wary of the same; therefore, shares were down.
Myelofibrosis, a type of blood cancer, affects approximately 25,000 patients in the United States, leading to severely low blood counts, including anemia and thrombocytopenia, as well as constitutional symptoms such as fatigue, night sweats, bone pain and splenomegaly.
The FDA approval of momelotinib is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with anemia from the SIMPLIFY-1 phase III trial. SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received prior JAK-inhibitor therapy. The efficacy of momelotinib in treating patients with myelofibrosis in SIMPLIFY-1 was based on spleen volume response (reduction by 35% or greater).
Shares of Incyte have lost 25.9% in the year-to-date period compared with the industry’s decline of 14.6%.
Image Source: Zacks Investment Research
Increasing competition for Jakafi will be a matter of concern for Incyte.
We note that Jakafi is also approved for refractory acute graft-versus-host disease.
Incyte suffered a setback earlier in the year after the FDA issued a complete response letter (CRL) for ruxolitinib extended-release tablets. The CRL stated that the FDA could not approve the new drug application (NDA) in its present form. The regulatory body acknowledged that the study submitted in the NDA met its objective of bioequivalence based on the area under the curve parameters but identified additional requirements for approval. Shares fell on the news.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.
Shares of EXEL have gained 33.1% year to date. Earnings estimates for 2023 have risen by 9 cents to 98 cents.
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Incyte (INCY) Down on FDA Nod for Another Myelofibrosis Drug
Shares of Incyte Corporation (INCY - Free Report) are down 4.86% after the FDA approved another JAK1/JAK2 inhibitor for myelofibrosis.
The FDA approved GSK plc’s (GSK - Free Report) momelotinib under the brand name Ojjaara for the treatment of intermediate or high-risk myelofibrosis, including primary myelofibrosis or secondary myelofibrosis (post-polycythemia vera and post-essential thrombocythaemia), in adults with anemia. Ojjaara is a once-a-day oral JAK1/JAK2 and activin A receptor type 1 inhibitor.
Incyte’s lead drug, Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, is also approved for myelofibrosis.
Per GSK, Ojjaara is the only approved drug for both newly diagnosed and previously treated myelofibrosis patients with anemia that addresses the key manifestations of the disease, namely anemia, constitutional symptoms and splenomegaly.
The approval of another JAK1/JAK2 inhibitor for the same indication will pose competition for Jakafi, particularly given Ojjaara’s comprehensive labeling. Investors seemed wary of the same; therefore, shares were down.
Myelofibrosis, a type of blood cancer, affects approximately 25,000 patients in the United States, leading to severely low blood counts, including anemia and thrombocytopenia, as well as constitutional symptoms such as fatigue, night sweats, bone pain and splenomegaly.
The FDA approval of momelotinib is supported by data from the pivotal MOMENTUM study and a subpopulation of adult patients with anemia from the SIMPLIFY-1 phase III trial. SIMPLIFY-1 was designed to evaluate the efficacy and safety of momelotinib versus ruxolitinib in myelofibrosis patients who had not received prior JAK-inhibitor therapy. The efficacy of momelotinib in treating patients with myelofibrosis in SIMPLIFY-1 was based on spleen volume response (reduction by 35% or greater).
Shares of Incyte have lost 25.9% in the year-to-date period compared with the industry’s decline of 14.6%.
Image Source: Zacks Investment Research
Increasing competition for Jakafi will be a matter of concern for Incyte.
We note that Jakafi is also approved for refractory acute graft-versus-host disease.
Incyte suffered a setback earlier in the year after the FDA issued a complete response letter (CRL) for ruxolitinib extended-release tablets. The CRL stated that the FDA could not approve the new drug application (NDA) in its present form. The regulatory body acknowledged that the study submitted in the NDA met its objective of bioequivalence based on the area under the curve parameters but identified additional requirements for approval. Shares fell on the news.
Jakafi is marketed by Incyte in the United States and by Novartis as Jakavi outside the country.
Zacks Rank and Stocks to Consider
Incyte currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Exelixis (EXEL - Free Report) , each currently carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Loss estimates for Dynavax for 2023 have narrowed to 24 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pegged at 3 cents per share.
Shares of EXEL have gained 33.1% year to date. Earnings estimates for 2023 have risen by 9 cents to 98 cents.