Macrocure Ltd. shares (NASDAQ:MCUR) hit an all-time low on Thursday after a futility analysis of partial data from a pivotal phase III study revealed that the company's sole candidate, the cell therapy Curexcell, is unlikely to meet its primary endpoint of helping heal venous leg ulcers (VLU) faster than a placebo, leaving the company without one of the key trials expected to underpin an FDA biologics license application planned for the second half of 2016.
A head-to-head study pitting an implantable exenatide-filled osmotic pump developed by Intarcia Therapeutics Inc. against the blockbuster Januvia (sitagliptin, Merck & Co. Inc.) over a year of type 2 diabetes treatment proved the pump superior in reducing HbA1c levels and producing weight loss according to top-line data from the latest of several phase III studies the company has run, positioning Intarcia to file applications seeking approval of the drug-device combination, called ITCA-650, in the first half of 2016.
Omeros Corp. (NASDAQ:OMER) shares rose to a record high Tuesday, climbing 72 percent overall to close at $25.03 after the company said OMS721, a therapy it’s developing for the treatment of thrombotic microangiopathies (TMAs), continued to perform well in a small midstage trial.
Genentech Inc.'s most advanced immunotherapy candidate, atezolizumab, met its primary endpoint in a pivotal phase II study, shrinking tumors in people with locally advanced or metastatic non-small-cell lung cancer (NSCLC) whose disease expressed programmed cell death ligand-1 (PD-L1), and setting the stage for an early 2016 registration filing.
New data revealing the potential for Kempharm Inc.'s hydrocodone prodrug, KP-201 (benzhydrocodone), to deter abuse by yielding lower hydrocodone exposure when snorted vs. generic hydrocodone bitartrate moved the company closer to what it expects will be a fourth quarter FDA NDA filing.
Reviving hopes for its experimental dendritic cell-based vaccine, ICT-107, Immunocellular Therapeutics Ltd. said it expects to soon begin enrolling newly diagnosed glioblastoma patients in a registrational phase III trial under a special protocol assessment (SPA) freshly agreed with the FDA.
Eleven Biotherapeutics Inc., which saw its shares (NASDAQ:EBIO) crushed after lead candidate EBI-005 eye drops failed a phase III trial in dry eye disease earlier this year, dosed the first patients in a new phase III study testing the same drug for the treatment of moderate to severe allergic conjunctivitis (AC), sending shares up $1.75, or 74.8 percent, to close at $4.09 on Wednesday.
Orexigen Therapeutics Inc. reported higher-than-expected second quarter revenues, helped by royalties on U.S. sales of obesity drug Contrave (naltrexone and bupropion). Shares rose (NASDAQ:OREX) 35 cents, to $4.17 by Thursday's close as the company settled a dispute with its North American partner Takeda Pharmaceutical Co Ltd. and signed a new distribution deal for South Korea.
Ovid Therapeutics Inc. has completed an oversubscribed $75 million series B financing to support its work to advance the oral extrasynaptic GABA A agonist OV-101 (gaboxadol) into phase II as a potential treatment for both Angelman and fragile X syndromes, as well as development of other internal candidates and pipeline expansions.
Genome-editing start-up Editas Medicine Inc. has raised $120 million in an oversubscribed series B financing to advance its discovery-stage programs and platform in one of the year's biggest private financings.
