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Alexion Graft-Versus-Host Disease Drug Wins Orphan Status
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Alexion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation (ODD) to its pipeline candidate, ALXN1007, for the treatment of acute graft-versus-host disease (GVHD).
The FDA, through its Office of Orphan Products Development, grants this status to candidates that are being developed to treat, prevent or diagnose rare diseases or disorders affecting less than 200,000 people in the U.S. This status makes ALXN1007 eligible for certain benefits and incentives including a period of marketing exclusivity in the U.S., following an approval for GVHD.
We note that ALXN1007 is a novel anti-inflammatory monoclonal antibody that targets complement protein C5a. It is currently being evaluated in a phase II study for the treatment of patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD). Moreover it was granted ODD in the EU for the same indication in Aug 2016.
We are encouraged by the FDA granting ODD to ALXN1007. Per Alexion’s press release, GI-GVHD affects roughly 10% of patients who receive an allogeneic hematopoietic stem cell transplant or bone marrow transplant. Patients with severe, acute GI-GVHD have a 30–40% mortality rate within the first six months of transplant.
Considering that there are limited treatment options for acute GI-GVHD, there exists significant unmet need for treatments targeting this severe and life-threatening rare autoimmune disease.
Alexion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and has remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’s loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
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Alexion Graft-Versus-Host Disease Drug Wins Orphan Status
Alexion Pharmaceuticals, Inc. announced that the FDA has granted orphan drug designation (ODD) to its pipeline candidate, ALXN1007, for the treatment of acute graft-versus-host disease (GVHD).
The FDA, through its Office of Orphan Products Development, grants this status to candidates that are being developed to treat, prevent or diagnose rare diseases or disorders affecting less than 200,000 people in the U.S. This status makes ALXN1007 eligible for certain benefits and incentives including a period of marketing exclusivity in the U.S., following an approval for GVHD.
We note that ALXN1007 is a novel anti-inflammatory monoclonal antibody that targets complement protein C5a. It is currently being evaluated in a phase II study for the treatment of patients with newly diagnosed acute GVHD of the lower gastrointestinal tract (GI-GVHD). Moreover it was granted ODD in the EU for the same indication in Aug 2016.
We are encouraged by the FDA granting ODD to ALXN1007. Per Alexion’s press release, GI-GVHD affects roughly 10% of patients who receive an allogeneic hematopoietic stem cell transplant or bone marrow transplant. Patients with severe, acute GI-GVHD have a 30–40% mortality rate within the first six months of transplant.
Considering that there are limited treatment options for acute GI-GVHD, there exists significant unmet need for treatments targeting this severe and life-threatening rare autoimmune disease.
ALEXION PHARMA Price
ALEXION PHARMA Price | ALEXION PHARMA Quote
Zacks Rank & Stocks to Consider
Alexion carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare sector include Infinity Pharmaceuticals, Inc. , BioMarin Pharmaceutical Inc. (BMRN - Free Report) and Exelixis, Inc. (EXEL - Free Report) . All the three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infinity’s loss estimates narrowed from $3.84 to $3.79 for 2016 and has remained stable for 2017 over the last 60 days. The company has posted a positive surprise in all the four trailing quarters with an average beat of 67.62%.
BioMarin’s loss estimates narrowed from 28 cents to 25 cents for 2016 and from $1.16 to $1.11 for 2017 over the last 60 days.
Exelixis’s loss estimates narrowed from 71 cents to 63 cents for 2016 and from 19 cents to earnings of 3 cents for 2017 over the last 60 days. The company has posted a positive surprise twice in the four trailing quarters with an average beat of 9.1%. Its share price has skyrocketed over 100% year to date.
Confidential from Zacks
Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>