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Pfizer's Leukemia Candidate Gets Priority Review From FDA
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Pfizer, Inc (PFE - Free Report) announced that the FDA has granted a priority review to its new drug application (NDA) filed for the pipeline candidate glasdegib.
Pfizer is looking to get glasdegib approved for the first-line treatment of acute myeloid leukemia (AML) in combination with a chemotherapy treatment with respect to patients, ineligible for intensive chemotherapy.
Data from the phase II BRIGHT 1003 study showed that glasdegib, an oral smoothened inhibitor, led to a significant improvement in overall survival when added to low-dose cytarabine (LDAC) in comparison to LDAC alone in previously untreated patients with AML or high-risk myelodysplastic syndrome, who were ineligible for intensive chemotherapy. The findings from the study were presented at the 58th American Society of Hematology in 2016.
The FDA has set a Prescription Drug User Fee Act or PDUFA goal date in December 2018.
Earlier this year, Pfizer enrolled in a phase III BRIGHT AML 1019 trial (NCT03416179), evaluating glasdegib as an intensive/non-intensive chemotherapy on patients with newly diagnosed AML.
Per the company’s press release, AML, a rapidly progressing blood cancer, represents a market with huge demand for new treatment options.
Shares of Pfizer have inched up 0.3% year to date against the industry’s decline of 6.2%.
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the Large Cap Pharma and Biotech sectors are H Lundbeck A/S , CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has surged 34.1% year to date.
CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 150.4% year to date.
Genomic Health’s earnings estimates have been raised 46.9% for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 46.2% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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Pfizer's Leukemia Candidate Gets Priority Review From FDA
Pfizer, Inc (PFE - Free Report) announced that the FDA has granted a priority review to its new drug application (NDA) filed for the pipeline candidate glasdegib.
Pfizer is looking to get glasdegib approved for the first-line treatment of acute myeloid leukemia (AML) in combination with a chemotherapy treatment with respect to patients, ineligible for intensive chemotherapy.
Data from the phase II BRIGHT 1003 study showed that glasdegib, an oral smoothened inhibitor, led to a significant improvement in overall survival when added to low-dose cytarabine (LDAC) in comparison to LDAC alone in previously untreated patients with AML or high-risk myelodysplastic syndrome, who were ineligible for intensive chemotherapy. The findings from the study were presented at the 58th American Society of Hematology in 2016.
The FDA has set a Prescription Drug User Fee Act or PDUFA goal date in December 2018.
Earlier this year, Pfizer enrolled in a phase III BRIGHT AML 1019 trial (NCT03416179), evaluating glasdegib as an intensive/non-intensive chemotherapy on patients with newly diagnosed AML.
Per the company’s press release, AML, a rapidly progressing blood cancer, represents a market with huge demand for new treatment options.
Shares of Pfizer have inched up 0.3% year to date against the industry’s decline of 6.2%.
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the Large Cap Pharma and Biotech sectors are H Lundbeck A/S , CRISPR Therapeutics AG (CRSP - Free Report) and Genomic Health Inc , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
H Lundbeck’s earnings estimates have been revised 11.6% upward for 2018 and 4.3% for 2019 in the past 60 days. The stock has surged 34.1% year to date.
CRISPR Therapeutics’ loss per share estimates has been narrowed by 7.8% for 2018 and 9% for 2019 in the last 60 days. The stock has skyrocketed 150.4% year to date.
Genomic Health’s earnings estimates have been raised 46.9% for 2018 and 5.6% for 2019 in the past 60 days. The stock has soared 46.2% so far this year.
Wall Street’s Next Amazon
Zacks EVP Kevin Matras believes this familiar stock has only just begun its climb to become one of the greatest investments of all time. It’s a once-in-a-generation opportunity to invest in pure genius.
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