Immunomedics Inc. (IMMU) is one of today’s notable stocks in decline, down as much as 45 percent following Belgium’s UCB announcement that its Phase 3 clinical trial program for Epratuzumab did not meet primary endpoint. Epratuzumab was licensed from Immunomedics.
“Although we are disappointed with the results from the Phase 3 program, our commitment to the lupus community remains. We are focused on developing new therapies for the treatment of immunological conditions including SLE and have another SLE drug in clinical development. We would like to express our sincere thanks to the patients and clinical investigators who made the EMBODY™ program possible. It has produced a comprehensive dataset and we look forward to sharing the findings with the scientific community,” said in a statement Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive VP, UCB.
Shares of SunPower Corporation (SPWR) are higher by 3.54% to $26.00 in pre-market trading on Tuesday after announcing the acquisition of 1.5 gigawatts of projects under development in 11 U.S. states from the Australian developer Infigen Energy. Terms were not disclosed.
Shares of Amedica Corporation (AMDA) were plunging, down 35.44% to $0.50 in pre-market trading Tuesday, after the biomaterial company announced the FDA has requested Amedica provide 24-month clinical performance data for pending 510(k) submission for the Valeo C Interbody with CsC Osteo-Conductive Scaffolding.
Amedica said that the FDA after reviewing the product’s clinical performance data, as well as indications for use and device description, has requested that the company provide 24-month clinical performance data before further clearance consideration. Separately, Salt Lake City, Utah-based Amedica today announced that it expects to report Q2/15 revenue in the range of $4.7 million and $4.9 million, as compared to $4.7 million during Q1/15.
Shares of Progenics Pharmaceuticals, Inc. (PGNX) are up $1.87, or over 20%, at $11.00, after the company this morning announced that the FDA has designated Azedra as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.