Pfizer, Inc (NYSE:PFE) 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 (OTC:HLUYY) , CRISPR Therapeutics AG (NASDAQ:CRSP) and Genomic Health Inc (NASDAQ:GHDX) , 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 (NASDAQ:AMZN)
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.
Pfizer Inc. (PFE): Free Stock Analysis Report
H Lundbeck A/S (HLUYY): Free Stock Analysis Report
Genomic Health, Inc. (GHDX): Free Stock Analysis Report
CRISPR THERAPTC (CRSP): Free Stock Analysis Report
Original post