Spectrum Pharmaceuticals, Inc. (SPPI - Free Report) announced that it has withdrawn the biologics license application (“BLA”) seeking approval for its neutropenia candidate, Rolontis. The company stated that the withdrawal is due to the FDA’s request for additional manufacturing-related data for the drug. Moreover, though the additional data ar not likely to be a major amendment to the BLA, theexpected time to gather the requested data is likely to cross the 60-day review period ending Mar 29.
Shares of Spectrum Pharma fell more than 7% in pre-market trading on Mar 15. However, the company recovered most of the loss in normal trading and closed at 2.9% down on Mar 15. The company’s shares are up 14.1% so far this year compared with the industry’s growth of 19.1%.
Spectrum Pharma said the FDA also did not raise any concern related to the pre-clinical and clinical data submitted with the BLA or made any request to conduct additional studies. The company is in active discussion with the FDA and plans to file the updated BLA, including the requested information, as early as possible.
With the sale of the marketed portfolio in March, Spectrum Pharma has no steady product revenues. The company depends on the success of its pipeline development. Rolontis is the lead candidate, which has been evaluated for treating chemotherapy-induced neutropenia in patients undergoing myelosuppressive chemotherapy.
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.
Apart from Rolontis, the company is developing poziotinib for the treatment of metastatic non-small cell lung cancer with EGFR exon 20 mutations. In December 2018, the company had received a setback as the FDA did not grant Breakthrough Therapy designation to the candidate.
A marketing approval to pipeline candidates is necessary for future prospects of Spectrum Pharma. With the withdrawal of Rolontis BLA, commercialization of the candidate will also be delayed.
Zacks Rank & Stocks to Consider
Spectrum Pharma currently carries a Zacks Rank #4 (Sell). Better-ranked stocks in the same sector include Infinity Pharmaceuticals, Inc. (INFI - Free Report) and AIT Therapeutics, Inc. (AITB - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Infinity Pharma’s earnings estimates have been revised 10.5% upward for 2019 over the past 60 days. The stock has rallied 52.6% so far this year.
AIT Therapeutics’ earnings estimates have moved 18.8% north for 2019 over the past 60 days. The stock is up 6.2% year to date.
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