Spectrum Pharmaceuticals, Inc. announced that it has submitted a biologics license application (BLA) to the FDA, looking for an approval of Rolontis (eflapegrastim), the company’s novel, long-acting granulocyte colony-stimulating factor (G-CSF), for the treatment of chemotherapy-induced neutropenia in patients with breast cancer.
The BLA was based on positive data from two phase III studies, namely ADVANCE and RECOVER. In both programs, Rolontis demonstrated non-inferiority to Amgen’s (AMGN - Free Report) Neulasta (pegfilgrastim) in improving duration of severe neutropenia.
Both analyses met the primary and all secondary endpoints.
Shares of Spectrum declined almost 7% on Thursday following this news as investors are probably not too bullish on the sales prospects of Rolontis. The Spectrum stock has tumbled 53.2% year to date, wider than the industry’s decline of 18.2%.
We remind investors that earlier this month, the FDA did not grant a breakthrough therapy designation to Spectrum’s another pipeline candidate, poziotinib, for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 mutations. The decision was based on subset of data from the ongoing phase II study at MD Anderson. Shares of Spectrum dropped significantly back then.
Zacks Rank & Stocks to Consider
Spectrum currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include BioSpecifics Technologies Corp and Hikma Pharmaceuticals Plc (HKMPF - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has rallied 29.7% so far this year.
Hikma’s earnings estimates have moved 17.9% north for 2018 and 14.8% for 2019 over the past 60 days. The stock has surged 39.1% year to date.
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Spectrum Pharmaceuticals, Inc. announced that it has submitted a biologics license application (BLA) to the FDA, looking for an approval of Rolontis (eflapegrastim), the company’s novel, long-acting granulocyte colony-stimulating factor (G-CSF), for the treatment of chemotherapy-induced neutropenia in patients with breast cancer.
The BLA was based on positive data from two phase III studies, namely ADVANCE and RECOVER. In both programs, Rolontis demonstrated non-inferiority to Amgen’s (AMGN - Free Report) Neulasta (pegfilgrastim) in improving duration of severe neutropenia.
Both analyses met the primary and all secondary endpoints.
Shares of Spectrum declined almost 7% on Thursday following this news as investors are probably not too bullish on the sales prospects of Rolontis. The Spectrum stock has tumbled 53.2% year to date, wider than the industry’s decline of 18.2%.
We remind investors that earlier this month, the FDA did not grant a breakthrough therapy designation to Spectrum’s another pipeline candidate, poziotinib, for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 mutations. The decision was based on subset of data from the ongoing phase II study at MD Anderson. Shares of Spectrum dropped significantly back then.
Zacks Rank & Stocks to Consider
Spectrum currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the same sector include BioSpecifics Technologies Corp and Hikma Pharmaceuticals Plc (HKMPF - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
BioSpecifics’ earnings estimates have been revised 9.6% upward for 2018 and 16.8% for 2019 over the past 60 days. The stock has rallied 29.7% so far this year.
Hikma’s earnings estimates have moved 17.9% north for 2018 and 14.8% for 2019 over the past 60 days. The stock has surged 39.1% year to date.
Will You Make a Fortune on the Shift to Electric Cars?
Here's another stock idea to consider. Much like petroleum 150 years ago, lithium power may soon shake the world, creating millionaires and reshaping geo-politics. Soon electric vehicles (EVs) may be cheaper than gas guzzlers. Some are already reaching 265 miles on a single charge.
With battery prices plummeting and charging stations set to multiply, one company stands out as the #1 stock to buy according to Zacks research.
It's not the one you think.
See This Ticker Free >>
Zacks Names "Single Best Pick to Double"
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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