Biotech_Forecast

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About Biotech_Forecast

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  1. Attached to this post is the worksheet for the Information Gathering Lesson. Biotech_Forecast_Trading_Worksheet.pdf
  2. "With positive clinical data from our pivotal registration trials that were presented at OARSI and the subsequent written indication from the FDA that the safety and efficacy data from the registration program for Zilretta are ‘acceptable to support filing of an NDA submission,' we moved forward in bolstering our commercial executive team and are now poised to submit an NDA with the FDA in the fourth quarter of this year. Our goal is to make Zilretta available to the many millions of knee osteoarthritis (OA) patients who lack good pain-relief options," said Michael Clayman, M.D., President and Chief Executive Officer of Flexion.
  3. The ongoing Phase Ib clinical study aims to evaluate the safety and effects of orally administered CCX872 when added to standard of care FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan and oxaliplatin) in patients with advanced non-resectable pancreatic cancer. Under the study protocol, patients may continue to receive CCX872 for an indefinite treatment period as long as there is no evidence of disease progression. The Company expects to report progression-free survival (PFS) by the end of 2016.
  4. SEATTLE, Aug. 08, 2016 (GLOBE NEWSWIRE) -- Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today provided a corporate update and reported financial results for the quarter ended June 30, 2016. "During the second quarter, we continued to accelerate the clinical development of our lead product candidate ONT-380, a promising small molecule for the treatment of advanced, metastatic HER2+ breast cancer," said Scott Myers, President and CEO of Cascadian Therapeutics. "Early clinical results with ONT-380 when combined with T-DM1 or capecitabine have suggested a favorable safety and tolerability profile, systemic activity in advanced disease and the potential to improve outcomes in patients with and without brain metastases. We're looking forward to reporting new data from the ongoing Phase 1b Triplet study expected later this year. In addition, we were granted Fast Track designation from the FDA for ONT-380 in HER2+ metastatic breast cancer."
  5. ANALYSIS OF 26 WEEK SAFETY DATA FROM STUDY QST-15-005 COMPLETED, NDA SUBMISSION REMAINS ON TRACK FOR FOURTH QUARTER 2016 EWING, NJ, September 22, 2016 -- Antares Pharma, Inc. (NASDAQ: ATRS) today announced safety results from the dose-blinded, multiple-dose, concentration-controlled, 26-week phase 3 study of QuickShot® Testosterone (QST) administered subcutaneously once each week to adult males with hypogonadism. The study, QST-15-005, included a screening phase, a titration phase and a treatment phase for evaluation of safety and tolerability, including laboratory assessments, adverse events and injection site assessments.