Hot Pharma stock to watch: Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI)

Free $50 Forex No-Deposit Bonus

Spectrum Pharmaceuticals, Inc. (NASDAQ: SPPI) stock surged over 30.1% on April 10th, 2018 (As of 1:14 PM GMT-4; Source: Google finance) driven by their positive results. They have updated poziotinib Phase 2 data in MD Anderson’s EGFR Exon 20 Mutant Non-Small Cell Lung Cancer study are available, based on longer follow-up.

The preliminary confirmed objective response rate and potential progression-free survival (PFS) benefit in EGFR Exon 20 Mutant Non-Small Cell Lung Cancer patients. In the first 11 patients, the confirmed objective response rate was 64%. This is a better than expected performance as they were initially aiming to get response rates in the range of 20% to 30%. The median PFS of these 11 patients has not been reached after a median follow up of 6.5 months. Moreover, the two most common adverse events observed in the study to date are skin rash and diarrhea, which are known EGFR inhibitor-related toxicities.

These early data from MD Anderson indicate that the poziotinib might have a meaningful impact on outcomes for patients who have limited treatment options. As one of the initial sites on the east coast for Spectrum’s ongoing multi-center Phase 2 study, they saw patients seeking us out from around the world.

 

Another major pipeline of the group is their ROLONTIS(eflapegrastim), a novel long-acting GCSF wherein a registrational Phase 3 study ADVANCE was initiated under an SPA with the FDA last year to evaluate ROLONTIS in the management of chemotherapy-induced neutropenia. The Company reported that the ADVANCE study met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and pegfilgrastim. The adverse event profile was similar between the two treatment arms. The Company finished enrolling RECOVER, an international Phase 3 trial that has a similar design. The Company expects to file the BLA in Q4 2018.

For 2018, they forecast the total revenue to be in the range of $90 to $110 million in 2018. The Gross margin is forecasted to enhance mainly as a result of enhancements to Evomela manufacturing. R&D expense is expected increase driven by additional spend on pipeline.

 

Copyright © 2018. All Rights Reserved. FXDailyReport.Com
Risk Warning: Trading CFDs is a high risk activity and you may lose more than your initial deposit. You should never invest money that you cannot afford to lose. FXDailyReport.com will not accept any liability for loss or damage as a result of reliance on the information contained within this website including data, quotes, charts and buy/sell signals. Please be fully informed regarding the risks and costs associated with trading the financial markets.