Spectrum Pharma Files BLA for Neutropenia Candidate Rolontis

Spectrum Pharmaceuticals, Inc.SPPI 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 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 BSTC and Hikma Pharmaceuticals Plc HKMPF , 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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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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