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Mesoblast (MESO) Up on Deal With BMT CTN to Develop GVHD Drug
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Mesoblast Limited (MESO - Free Report) announced that it has partnered with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to develop a pivotal phase III study of MESO’s lead product candidate, Ryoncil (remestemcel-L), to treat adults with steroid-refractory acute graft versus host disease (SR-aGvHD).
The BMT CTN is a body formed with a conglomeration of centers that collectively conduct approximately 80% of all the U.S. allogeneic blood and marrow transplants. The BMT CTN is funded by the United States National Institutes of Health.
Both parties are gearing up to initiate the pivotal phase III study of Ryoncil in this indication shortly.
The company’s stock rose 10.7% on Wednesday, in response to the encouraging collaboration agreement. Year to date, shares of Mesoblast have plunged 58.4% compared with the industry’s 23.7% fall.
Image Source: Zacks Investment Research
In its September 2023 draft guidance to the industry for the development of aGvHD treatment therapies, the FDA stated that a regulatory filing might be supported by positive results from a single-arm study in a population with refractory aGvHD where there are no available therapies.
In the planned pivotal phase III study, BMT CTN intends to evaluate Ryoncil in patients aged 12 years and older, who are refractory to both corticosteroids and a second-line agent, such as Incyte Corporation’s (INCY - Free Report) Jakafi (ruxolitinib). There are currently no approved therapies for such patient population.
Before initiation, the pivotal study protocols will be reviewed by two independent committees appointed by the National Heart, Lung and Blood Institute.
After the completion of such formalities, Mesoblast will submit the final protocol to the FDA for approval of the pivotal study design, as agreed at the Type A meeting with the regulatory body in September.
The company has already been denied marketing approval by the FDA for Ryoncil twice in the treatment of pediatric SR-aGvHD. The regulatory body argued that there were deficiencies in clinical and manufacturing data, asking for more data to support marketing approval of Ryoncil in this indication, including potency assay or clinical data.
Currently, there are no approved therapies in the United States for patients under 12 years of age suffering from aGvHD, which provides Mesoblast with a significant market opportunity, subject to the success of the pivotal phase III study of Ryoncil in this indication.
MESO is also currently developing Ryoncil in mid-late-stage studies in two additional indications, such as inflammatory bowel disease and acute respiratory distress syndrome.
Jakafi, Incyte’s lead drug, is a first-in-class JAK1/JAK2 inhibitor. It is currently the only approved treatment of SR-aGvHD in adult and pediatric patients aged 12 years or older in the United States. Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi. Jakafi is marketed by Incyte in the United States and Novartis as Jakavi outside the country.
Incyte’s Jakafi was initially approved in the United States for the treatment of patients with polycythemia vera (PV), who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has increased from $5.10 to $5.33. During the same time frame, the estimate for Ligand’s 2024 earnings per share has increased from $4.59 to $4.64. Year to date, shares of LGND have lost 12.5%.
LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 67.19%.
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Mesoblast (MESO) Up on Deal With BMT CTN to Develop GVHD Drug
Mesoblast Limited (MESO - Free Report) announced that it has partnered with the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) to develop a pivotal phase III study of MESO’s lead product candidate, Ryoncil (remestemcel-L), to treat adults with steroid-refractory acute graft versus host disease (SR-aGvHD).
The BMT CTN is a body formed with a conglomeration of centers that collectively conduct approximately 80% of all the U.S. allogeneic blood and marrow transplants. The BMT CTN is funded by the United States National Institutes of Health.
Both parties are gearing up to initiate the pivotal phase III study of Ryoncil in this indication shortly.
The company’s stock rose 10.7% on Wednesday, in response to the encouraging collaboration agreement. Year to date, shares of Mesoblast have plunged 58.4% compared with the industry’s 23.7% fall.
Image Source: Zacks Investment Research
In its September 2023 draft guidance to the industry for the development of aGvHD treatment therapies, the FDA stated that a regulatory filing might be supported by positive results from a single-arm study in a population with refractory aGvHD where there are no available therapies.
In the planned pivotal phase III study, BMT CTN intends to evaluate Ryoncil in patients aged 12 years and older, who are refractory to both corticosteroids and a second-line agent, such as Incyte Corporation’s (INCY - Free Report) Jakafi (ruxolitinib). There are currently no approved therapies for such patient population.
Before initiation, the pivotal study protocols will be reviewed by two independent committees appointed by the National Heart, Lung and Blood Institute.
After the completion of such formalities, Mesoblast will submit the final protocol to the FDA for approval of the pivotal study design, as agreed at the Type A meeting with the regulatory body in September.
The company has already been denied marketing approval by the FDA for Ryoncil twice in the treatment of pediatric SR-aGvHD. The regulatory body argued that there were deficiencies in clinical and manufacturing data, asking for more data to support marketing approval of Ryoncil in this indication, including potency assay or clinical data.
Currently, there are no approved therapies in the United States for patients under 12 years of age suffering from aGvHD, which provides Mesoblast with a significant market opportunity, subject to the success of the pivotal phase III study of Ryoncil in this indication.
MESO is also currently developing Ryoncil in mid-late-stage studies in two additional indications, such as inflammatory bowel disease and acute respiratory distress syndrome.
Jakafi, Incyte’s lead drug, is a first-in-class JAK1/JAK2 inhibitor. It is currently the only approved treatment of SR-aGvHD in adult and pediatric patients aged 12 years or older in the United States. Incyte has a collaboration agreement with Swiss pharma giant Novartis (NVS - Free Report) for Jakafi. Jakafi is marketed by Incyte in the United States and Novartis as Jakavi outside the country.
Incyte’s Jakafi was initially approved in the United States for the treatment of patients with polycythemia vera (PV), who have had an inadequate response to or are intolerant to hydroxyurea. It is also approved for the treatment of patients with intermediate or high-risk myelofibrosis (MF), including primary MF, post-PV MF and post-essential thrombocythemia MF.
Mesoblast Limited Price and Consensus
Mesoblast Limited price-consensus-chart | Mesoblast Limited Quote
Zacks Rank and Stock to Consider
Mesoblast currently has a Zacks Rank #3 (Hold).
A better-ranked stock worth mentioning is Ligand Pharmaceuticals (LGND - Free Report) , sporting a Zacks Rank #1 (Strong Buy) at present.
You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Ligand’s 2023 earnings per share has increased from $5.10 to $5.33. During the same time frame, the estimate for Ligand’s 2024 earnings per share has increased from $4.59 to $4.64. Year to date, shares of LGND have lost 12.5%.
LGND’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 67.19%.