Pfizer Inc. PFE announced that its Biologics License Application (BLA) for leukemia candidate inotuzumab ozogamicin has been accepted for priority review by the FDA.
Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
With the FDA granting priority review, a response should be out by Aug 2017.
Pfizer’s share price increased 3.5% year- to -date compared with the Zacks classified Large Cap Pharmaceuticals industry’s gain of 4.4%.
Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. The submission was based on phase III study -INO-VATE ALL or Study 1022. The open-label, randomized study evaluated the safety and efficacy of the candidate, in comparison to investigator-choice chemotherapy, in adults (n=326) with relapsed or refractory CD22-positive ALL.
The study had two primary endpoints – complete response with or without hematologic remission and overall survival (OS). Data from the study revealed an improvement over chemotherapy on a number of measures that included complete hematologic remission and progression-free survival (PFS). The study met its first primary endpoint of complete response, but failed to reach statistical significance in its second primary endpoint.
However, the second primary endpoint of OS demonstrated a strong trend toward longer OS. A Marketing Authorization Application (MAA) for inotuzumab ozogamicin for the same indication is alreadyunder review in Europe.
Pfizer, Inc. Price
Pfizer, Inc. Price | Pfizer, Inc. Quote
Zacks Rank & Key Picks
Pfizer currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Sunesis Pharmaceuticals SNSS, Exact Sciences Corp. EXAS, and GlaxoSmithKline plc GSK. While Sunesis carries a Zacks Rank#1 (Strong Buy), Exact Sciences and GlaxoSmithKline carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
Sunesis’ loss estimates narrowed by 5.06% and 8.80% for 2016 and 2017, respectively, over the past 30 days. The company recorded a positive earnings surprise in three of the last four quarters, the average being 0.54%.
GlaxoSmithKline’s earnings estimates increased from $2.64 to $2.76 for 2017 and from $2.78 to $2.85 for 2018 over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 11.03%. Its share price increased 4.4% year to date.
Exact Sciences’ loss estimates narrowed by 1.17% and 3.57% for 2016 and 2017, respectively, over the past 60 days. The company recorded a positive earnings surprise in all of the last four quarters, the average being 14.12%.
Zacks' Top Investment Ideas for Long-Term Profit
How would you like to see our best recommendations to help you find today’s most promising long-term stocks? Starting now, you can look inside our portfolios featuring stocks under $10, income stocks, value investments and more. These picks, which have double and triple-digit profit potential, are rarely available to the public. But you can see them now. Click here >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Pfizer, Inc. (PFE): Free Stock Analysis Report
GlaxoSmithKline PLC (GSK): Free Stock Analysis Report
Exact Sciences Corporation (EXAS): Free Stock Analysis Report
Sunesis Pharmaceuticals, Inc. (SNSS): Free Stock Analysis Report
To read this article on Zacks.com click here.
Zacks Investment Research