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Pfizer's Xtandi Gets FDA Nod for Expanded Patient Group
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Pfizer, Inc. (PFE - Free Report) and partner Astellas announced that the FDA has approved its supplemental new drug application (sNDA) looking for label expansion of its cancer drug, Xtandi in men with metastatic castration-sensitive prostate cancer (mCSPC).
Until now, Xtandi was approved to treat metastatic and non-metastatic castration-resistant prostate cancer. With data from ARCHES study approved to be included in the label of Xtandi, it can treat a broader prostate cancer patient population. Xtandi is now approved for three indications in advanced prostate cancer – non-metastatic and metastatic CRPC and mCSPC.
mCSPC is a form of prostate cancer that has spread to other parts of the body but still responds to a medical or surgical treatment to lower testosterone levels.
The sNDA was based on data from the phase III ARCHES study, data from which demonstrated that Xtandi in combination with androgen deprivation therapy (“ADT”) significantly reduced the risk of radiographic progression or death by 61% compared to ADT alone. The sNDA is also supported by data from an Astellas-supported study, ENZAMET, which also met the primary endpoint of overall survival. A similar application is also under review in the EU and Japan.
Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside the U.S. markets. Pfizer recorded Xtandi alliance revenues of $594 million in the first nine months of 2019.
In a separate press release, the board of directors of Pfizer declared a dividend of 38 cents per share for first-quarter of 2020. The quarterly dividend amounts to an annual dividend of $1.52 per share, which represents an increase of almost 6% from the previous annual dividend of $1.44 per share (quarterly dividend of 36 cents). The dividend is payable on Mar 6, 2020 to shareholders of record at the close of business on Jan 31, 2020.
Pfizer’s shares were up more than 2% on Monday, in response to the positive news. Pfizer’s shares have declined 10.4% this year so far against an increase of 8.9% for the industry.
Shares of Roche have gained 24.2% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 1.2% over the past 60 days.
Bristol-Myers’ earnings estimates have increased 4.4% and 11.8%, respectively, for 2019 and 2020 over the past 60 days. The stock is up 22.1% this year so far.
Merck’s stock is up 16.8% this year so far. Its earnings estimates have risen 5.1% for 2019 and 2.6% for 2020 over the past 60 days.
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This pioneering tech ticker had soared to all-time highs and then subsided to a price that is irresistible. Now a pending acquisition could super-charge the company’s drive past competitors in the development of true Artificial Intelligence. The earlier you get in to this stock, the greater your potential gain.
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Pfizer's Xtandi Gets FDA Nod for Expanded Patient Group
Pfizer, Inc. (PFE - Free Report) and partner Astellas announced that the FDA has approved its supplemental new drug application (sNDA) looking for label expansion of its cancer drug, Xtandi in men with metastatic castration-sensitive prostate cancer (mCSPC).
Until now, Xtandi was approved to treat metastatic and non-metastatic castration-resistant prostate cancer. With data from ARCHES study approved to be included in the label of Xtandi, it can treat a broader prostate cancer patient population. Xtandi is now approved for three indications in advanced prostate cancer – non-metastatic and metastatic CRPC and mCSPC.
mCSPC is a form of prostate cancer that has spread to other parts of the body but still responds to a medical or surgical treatment to lower testosterone levels.
The sNDA was based on data from the phase III ARCHES study, data from which demonstrated that Xtandi in combination with androgen deprivation therapy (“ADT”) significantly reduced the risk of radiographic progression or death by 61% compared to ADT alone. The sNDA is also supported by data from an Astellas-supported study, ENZAMET, which also met the primary endpoint of overall survival. A similar application is also under review in the EU and Japan.
Xtandi was added to Pfizer’s portfolio with the acquisition of Medivation in September 2016. While Pfizer sells Xtandi in the United States in partnership with Astellas, the latter owns the marketing right outside the U.S. markets. Pfizer recorded Xtandi alliance revenues of $594 million in the first nine months of 2019.
In a separate press release, the board of directors of Pfizer declared a dividend of 38 cents per share for first-quarter of 2020. The quarterly dividend amounts to an annual dividend of $1.52 per share, which represents an increase of almost 6% from the previous annual dividend of $1.44 per share (quarterly dividend of 36 cents). The dividend is payable on Mar 6, 2020 to shareholders of record at the close of business on Jan 31, 2020.
Pfizer’s shares were up more than 2% on Monday, in response to the positive news. Pfizer’s shares have declined 10.4% this year so far against an increase of 8.9% for the industry.
Pfizer currently carries a Zacks Rank #2 (Buy). Some other top-ranked large-cap pharma stocks are Roche Holding AG (RHHBY - Free Report) , Bristol-Myers (BMY - Free Report) and Merck (MRK - Free Report) , all with a Zacks Rank #2. You can see the complete list of today’s Zacks #1 Rank stocks here.
Shares of Roche have gained 24.2% this year so far. Earnings estimates for 2019 have risen 0.8% while that for 2020 have increased 1.2% over the past 60 days.
Bristol-Myers’ earnings estimates have increased 4.4% and 11.8%, respectively, for 2019 and 2020 over the past 60 days. The stock is up 22.1% this year so far.
Merck’s stock is up 16.8% this year so far. Its earnings estimates have risen 5.1% for 2019 and 2.6% for 2020 over the past 60 days.
Free: Zacks’ Single Best Stock Set to Double
Today you are invited to download our latest Special Report that reveals 5 stocks with the most potential to gain +100% or more in 2020. From those 5, Zacks Director of Research, Sheraz Mian hand-picks one to have the most explosive upside of all.-
This pioneering tech ticker had soared to all-time highs and then subsided to a price that is irresistible. Now a pending acquisition could super-charge the company’s drive past competitors in the development of true Artificial Intelligence. The earlier you get in to this stock, the greater your potential gain.
See 5 Stocks Set to Double>>