Good news flowed in at Regeneron Pharmaceuticals (REGN) when the FDA cleared the company’s highly successful injectable eye drug for macular edema following retinal vein occlusion (RVO), a common retinal vascular disorder. Approval for the broad RVO indication includes sub-indications like, macular edema following branch retinal vein occlusion (BRVO) and macular edema following central retinal vein occlusion (CRVO). We remind investors that Eylea is already … Continue reading Biotech Stock News: Regeneron’s Eylea Gets An Important Approval From FDA

Shares of Sunesis Pharmaceuticals, Inc (SNSS) plunged significantly after the company announced that its phase III trial, VALOR, failed to meet its primary endpoint. The randomized, double-blind, placebo-controlled trial (n=711) evaluated the efficacy of Qinprezo (vosaroxin) and cytarabine in patients suffering from first relapsed or refractory acute myeloid leukemia (AML). The trial failed to reach its primary endpoint of a statistically significant improvement in overall … Continue reading Sunesis Pharmaceuticals Stock Down : Biotech Trial Failure

The oft-trodden path for a startup biotech is to aim for either a buyout or an IPO—or at minimum, a partnership with a big pharmaceutical company—before dealing with the hefty price tag of a Phase 3 study. One local biotech, however, took on the risk of bucking that trend—and succeeded. That story and much more below. Boston and Hayward, CA-based Intarcia turned heads earlier this … Continue reading Biotech Stocks: A Look At the Most Promising Biotech Stocks

Here we have a close look at some of the major Biotech Stocks which have shown tremendous promise over the past few weeks. Investors are all recommended to closely monitor these stocks over the coming months as some movement is expected from these stocks. Portola Pharmaceuticals (PTLA), a biopharmaceutical company, develops product candidates in the fields of thrombosis and hematology. This stock closed up 4.1% … Continue reading Biotech Stocks in News: Major Biotech Stocks to Focus On

Mergers and acquisitions were back in the news last week with Auxilium Pharmaceuticals (AUXL) being the target this time around. The company, which is looking to acquire QLT Inc (QLTI), received a proposal from Endo International plc (ENDP). Other updates last week include the usual regulatory and pipeline-related news. Gilead remained in the news thanks yet again to its hepatitis C virus (HCV) treatment, Sovaldi. … Continue reading Biotech Stock News: A Weekly Analysis of Major Biotech Stocks

Halozyme Therapeutics, Inc (HALO) announced that the FDA has lifted the clinical hold from a phase Ib/II study (Study S1313). The study is evaluating PEGPH20 (PEGylated recombinant human hyaluronidase) in combination with a modified FOLFIRINOX chemotherapy (mFOLFIRINOX) in patients suffering from metastatic pancreatic adenocarcinoma. The Study S1313, which is being sponsored and conducted by SWOG (a cancer research cooperative group funded primarily by the National … Continue reading Halozyme’s Clinical Hold Lifted by FDA : Biotech