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Incyte (INCY) Announces Data on Monjuvi, FDA Approval for GVHD Drug
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Incyte (INCY - Free Report) announced that the late-stage inMIND study on tafasitamab met its primary and secondary endpoints.
This phase III study is evaluating the efficacy and safety of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with Revlimid and Rituxan compared to Revlimid and Rituxan alone in patients with relapsed or refractory follicular lymphoma (FL).
The trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. It also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population. In addition, the secondary endpoint of PFS results by the blinded independent review is consistent with investigator-based PFS results.
Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.
We note that the drug was granted accelerated approval by the FDA, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
On Aug 14, Incyte and partner Syndax Pharmaceuticals (SNDX - Free Report) obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
The candidate was approved under the brand name Niktimvo.
The FDA approval was based on positive data from the global AGAVE-201 study evaluating the safety and efficacy of Niktimvo in 241 adult and pediatric patients with refractory chronic GVHD who received at least two prior lines of systemic therapy. The trial met the primary endpoint across all cohorts receiving Niktimvo.
Niktimvo is Incyte’s second approved treatment for chronic GVHD.
Syndax and Incyte collaborated on the worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications in 2021.
The drug will be co-commercialized by Incyte and Syndax Pharmaceuticals in the United States, while Incyte has exclusive commercialization rights for Niktimvo outside of the country.
Incyte and Syndax will seek FDA approval to launch two smaller vial sizes to ease dosing. Following FDA approval of the new vial sizes, Incyte and Syndax expect to launch Niktimvo in the United States, no later than the early first quarter of 2025.
Approval of new drugs and a potential label expansion of additional drugs are important for Incyte as the company is heavily dependent on its lead drug, Jakafi (ruxolitinib), for its top-line growth.
Shares of Incyte have lost 1.8% year to date compared with the industry’s decline of 1.6%.
We note that Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, is also approved for acute GVHD, apart from polycythemia vera and myelofibrosis.
Axatilimab is also being evaluated in frontline combination trials in chronic GVHD, a phase II combination trial with ruxolitinib and a phase III combination trial with steroids. The studies are expected to begin by the end of this year. Axatilimab is also being studied in an ongoing phase II study in patients with idiopathic pulmonary fibrosis.
We remind investors that Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets. Novartis also has exclusive worldwide development and commercialization rights for lung cancer drug Tabrecta for which it pays royalties to Incyte.
The consensus estimate for Krystal Biotech’s 2024 earnings per share has decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.
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Incyte (INCY) Announces Data on Monjuvi, FDA Approval for GVHD Drug
Incyte (INCY - Free Report) announced that the late-stage inMIND study on tafasitamab met its primary and secondary endpoints.
This phase III study is evaluating the efficacy and safety of tafasitamab, a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, or placebo in combination with Revlimid and Rituxan compared to Revlimid and Rituxan alone in patients with relapsed or refractory follicular lymphoma (FL).
The trial met its primary endpoint of progression free survival (PFS) by investigator assessment in FL. It also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population. In addition, the secondary endpoint of PFS results by the blinded independent review is consistent with investigator-based PFS results.
Incyte gained worldwide exclusive global rights for tafasitamab from MorphoSys AG. Tafasitamab is marketed as Monjuvi in the United States and as Minjuvi in the ex-U.S. markets.
We note that the drug was granted accelerated approval by the FDA, in combination with Revlimid, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
On Aug 14, Incyte and partner Syndax Pharmaceuticals (SNDX - Free Report) obtained FDA approval for axatilimab-csfr, an anti-CSF-1R antibody, for the treatment of chronic graft-versus-host disease (GVHD) after the failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.
The candidate was approved under the brand name Niktimvo.
The FDA approval was based on positive data from the global AGAVE-201 study evaluating the safety and efficacy of Niktimvo in 241 adult and pediatric patients with refractory chronic GVHD who received at least two prior lines of systemic therapy. The trial met the primary endpoint across all cohorts receiving Niktimvo.
Niktimvo is Incyte’s second approved treatment for chronic GVHD.
Syndax and Incyte collaborated on the worldwide co-development and co-commercialization license agreement for axatilimab in chronic GVHD and any future indications in 2021.
The drug will be co-commercialized by Incyte and Syndax Pharmaceuticals in the United States, while Incyte has exclusive commercialization rights for Niktimvo outside of the country.
Incyte and Syndax will seek FDA approval to launch two smaller vial sizes to ease dosing. Following FDA approval of the new vial sizes, Incyte and Syndax expect to launch Niktimvo in the United States, no later than the early first quarter of 2025.
Approval of new drugs and a potential label expansion of additional drugs are important for Incyte as the company is heavily dependent on its lead drug, Jakafi (ruxolitinib), for its top-line growth.
Shares of Incyte have lost 1.8% year to date compared with the industry’s decline of 1.6%.
We note that Jakafi (ruxolitinib), a first-in-class JAK1/JAK2 inhibitor, is also approved for acute GVHD, apart from polycythemia vera and myelofibrosis.
Axatilimab is also being evaluated in frontline combination trials in chronic GVHD, a phase II combination trial with ruxolitinib and a phase III combination trial with steroids. The studies are expected to begin by the end of this year. Axatilimab is also being studied in an ongoing phase II study in patients with idiopathic pulmonary fibrosis.
We remind investors that Jakafi is marketed by Incyte in the United States and by Novartis (NVS - Free Report) as Jakavi in ex-U.S. markets. Novartis also has exclusive worldwide development and commercialization rights for lung cancer drug Tabrecta for which it pays royalties to Incyte.
Zacks Rank & a Stock to Consider
Incyte currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Krystal Biotech (KRYS - Free Report) , carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
The consensus estimate for Krystal Biotech’s 2024 earnings per share has decreased to $2.07 from $2.39 in the past 30 days. Shares of KRYS have surged 51.1% year to date.