BYSI - BeyondSpring CTI BioPharma gain ahead of FDA decision for key drugs

Clinical stage biopharma companies BeyondSpring (NASDAQ:BYSI) and CTI BioPharma (NASDAQ:CTIC) have gained ~4.9% and ~4.5% in the pre-market, respectively on below-average volume as investors await the FDA decision on two of their product candidates. BeyondSpring (BYSI) has Nov. 30 as Prescription Drug User Fee Act (PDUFA) target action date for the company’s marketing application for plinabulin in combination with granulocyte colony-stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN). Today is also the PDUFA date for CTI BioPharma’s (CTIC) New Drug Application (NDA) for pacritinib in myelofibrosis patients with severe thrombocytopenia. The commercial launch of the drug is expected by the end of the year, the company said in August. In the same month, BeyondSpring (BYSI) reached a two-year high after the company said that Plinabulin and docetaxel (DP) combination met the primary endpoint in a late-stage trial in patients with non-small cell lung cancer.

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BeyondSpring, CTI BioPharma gain ahead of FDA decision for key drugs