Pre-Open Stock Movers 12/26: (IMMU) (SPPI) (SBPH) (QGEN) (MBOT)
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Immunomedics (NASDAQ: IMMU) +2.4%; today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response. The PDUFA target action date of the resubmitted BLA is June 2, 2020.
Spectrum Pharma (NASDAQ: SPPI) -54%; today reported that its pre-specified primary endpoint in its Phase 2 clinical trial evaluating poziotinib in previously treated non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations was not met in Cohort 1. The company also announced that the Biologics License Application (BLA) for ROLONTIS® (eflapegrastim) was accepted for review by the U.S. Food and Drug Administration (FDA) and set a Prescription Drug User Fee Act (PDUFA) date of October 24, 2020.
Spring Bank Pharmaceuticals (NASDAQ: SBPH) -43%; today announced that the company has stopped dosing and enrolling patients in its Phase 2b CATALYST trials, which are examining the use of inarigivir soproxil 400mg for the treatment of chronic hepatitis B virus (HBV). In addition, the company has stopped dosing and enrollment in all other studies of inarigivir in subjects with chronic HBV.
Qiagen (NYSE: QGEN) -27%; announces that it has concluded the previously announced review of potential strategic alternatives, and has determined the execution of its current stand-alone business plan represents the best opportunity to drive future value creation.
Microbot Medical (NASDAQ: MBOT) -21% ; today announced that it has entered into definitive agreements with certain institutional investors for the purchase in a registered direct offering of 912,858 shares of its common stock, at a purchase price per share of $10.50, priced at-the-market under Nasdaq rules.
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