22:10 , Aug 3, 2018 |  BC Extra  |  Politics & Policy

ICER announces preliminary 2019 topics

The Institute for Clinical and Economic Review (ICER) released Thursday a preliminary list of drugs and other healthcare interventions that it may review in 2019. ICER's selection criteria include the projected timing and likelihood of...
21:08 , Aug 2, 2018 |  BC Extra  |  Company News

Management tracks: Omeros, EdiGene

Omeros Corp. (NASDAQ:OMER) hired Eckhard Leifke as CMO and VP of clinical development. He was global project head/VP of early project and external opportunities - cardiovascular and metabolism and global head/VP of late-stage development diabetes...
16:13 , Mar 16, 2018 |  BC Week In Review  |  Clinical News

Omeros reports Phase II OS data for OMS721 in thrombotic microangiopathy

Omeros Corp. (NASDAQ:OMER) reported data from 18 patients with hematopoietic stem cell transplant (HSCT)-associated thrombotic microangiopathy (HCT-TMA) in a Phase II trial and one HCT-TMA patient treated under a compassionate use program showing that once-weekly...
22:19 , Jan 5, 2018 |  BC Week In Review  |  Clinical News

Omeros to start Phase III trial of OMS721 to treat IgA nephropathy

Omeros Corp. (NASDAQ:OMER) said it reached an agreement with FDA on the design of a Phase III trial to test OMS721 in patients with IgA nephropathy. The company expects to begin enrollment early February. The double-blind,...
23:02 , Nov 10, 2017 |  BC Extra  |  Company News

Omeros soars on single Phase III plan for OMS721

Omeros Corp. (NASDAQ:OMER) soared $4.08 (29%) to $18.17 Friday after announcing late Thursday that FDA will accept a single Phase III trial with a primary endpoint of proteinuria reduction to support approval of OMS721 to...
19:51 , Aug 18, 2017 |  BC Week In Review  |  Financial News

Omeros raises $68.3M in follow-on

On Aug. 15, Omeros Corp. (NASDAQ:OMER) raised $68.3 million through the sale of 3 million shares at $22.75 in a follow-on underwritten by Cantor Fitzgerald, H.C. Wainwright, JonesTrading Institutional Services and Maxim Group. Omeros' OMS721 is...
21:03 , Aug 15, 2017 |  BC Extra  |  Financial News

Omeros, Oxford Immunotec fall after pricing follow-ons

Shares of Omeros Corp. (NASDAQ:OMER) and Oxford Immunotec Global plc (NASDAQ:OXFD) both slipped on Tuesday after the companies priced follow-ons, raising over $108 million total. Omeros raised $68.3 million through the sale of 3 million shares...
22:23 , Aug 11, 2017 |  BioCentury  |  Regulation

Foundation for inclusion

Hosting a patient-focused drug development workshop was the National Kidney Foundation Inc.’s first step in assuming the role of facilitator to collect patient perspectives that will shape R&D for kidney disease. On Aug. 4, the advocacy...
17:10 , Jun 15, 2017 |  BC Week In Review  |  Clinical News

Omeros' IgA nephropathy candidate gets FDA breakthrough designation

FDA granted breakthrough therapy designation to OMS721 from Omeros Corp. (NASDAQ:OMER) to treat IgA nephropathy. Omeros is evaluating the human mAb against mannan binding lectin serine peptidase 2 (MASP2) in a Phase II trial to...
22:15 , Feb 1, 2017 |  BC Week In Review  |  Clinical News

OMS721: Ph II data

Data from 2 patients with IgA nephropathy in an open-label, U.S. Phase II trial showed that OMS721 significantly reduced mean UACR to 525 mg/g at week 12 from 1,264 mg/g at baseline (p=0.011). Additionally, OMS721...