Lexicon Pharmaceuticals Inc. plans to deploy its sales force Friday and have its first approved product, Xermelo (telotristat ethyl, previously LX-1032/LX-1606), available Monday for dispensing through its specialty pharmacies following the oral drug's approval by the FDA to treat carcinoid syndrome diarrhea in patients living with metastatic neuroendocrine tumors, or mNETs. Read More
Neuroderm Ltd. shares (NASDAQ: NDRM) climbed 26.6 percent Wednesday to $29.30 on word that a 24-hour regimen of its continuous delivery levodopa/carbidopa (LD/CD) candidate, ND0612H, significantly decreased the amount of time in which Parkinson's disease (PD) patients faced a reemergence of PD symptoms on medication, eliminating it altogether for some patients. Read More
Liquid biopsy startup Grail Inc. said it has raised more than $900 million through the first close of its series B round, putting it on the path to develop a blood-based test for cancer screening. The Menlo Park, Calif.-based company is slated to bring in more than $1 billion in the round and could close on the remainder of the investment prior to the end of the first quarter. Read More
Silica-coated iron oxide nanoparticles that can be used for the rapid warming of frozen tissues could pave the way for cryopreservation of organs, if the warming method can be scaled up sufficiently. Researchers from the University of Minnesota, Clemson University and Tissue Testing Technologies LLC, published their findings in the March 1, 2017, issue of Science Translational Medicine. Read More
XTL Biopharmaceuticals Ltd., of Raanana, Israel, said it regained compliance with Nasdaq listing requirements, with the closing price of its shares (NASDAQ:XTLB) closing above $1 for the 10 consecutive days from Feb. 10 to Feb. 24. Read More
Aytu Bioscience Inc., of Englewood, Colo., completed its tender offer to amend and exercise certain categories of warrants issued to investors that participated in its May 2016 and October 2016 financings. The company said gross proceeds were approximately $2.2 million, with net proceeds totaling approximately $2 million. The company did not disclose specific use of proceeds. On Wednesday, the company's shares (OTCQX:AYTU) lost 1 cent to close at 93 cents. Read More
Omeros Corp., of Seattle, reported additional data from the ongoing phase II trial testing OMS721 in the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (HCT-TMA) at the combined annual meetings of the Center for International Blood & Marrow Transplant Research and the American Society for Blood and Marrow Transplantation in Orlando, Fla. Consistent with previously reported results, statistically significant and clinically meaningful improvements in TMA disease activity were observed over the course of treatment, specifically in mean platelet count, mean LDH and mean haptoglobin. Mean creatinine also improved but did not reach statistical significance. Omeros plans to meet with regulators to design a phase III program for OMS721, a MASP-2-targeting drug. Read More
Keryx Biopharmaceuticals Inc., of Boston, reported U.S. product sales of Auryxia (ferric citrate) totaling $2.8 million in the fourth quarter, up 70 percent over the fourth quarter of 2015, despite the three-month supply interruption from August to November. Full-year sales of the hyperphosphatemia drug totaled $27.2 million, up 170 percent year over year. Total revenues were $9.5 million and $32 million for the quarter and full year, respectively. Keryx posted a fourth-quarter net loss of $33.8 million, or 32 cents per share. Consensus estimates had predicted a loss of 25 cents per share. For the full year, the net loss was $161.1 million, or $1.52 per share. The company ended the year with about $111.8 million on its balance sheet. Shares of Keryx (NASDAQ:KERX) closed Wednesday at $4.84, down 19 cents. (See BioWorld Today, Aug. 2, 2016.) Read More
Lack of a quorum stalled Wednesday's confirmation vote in the U.S. Senate Finance Committee for Seema Verma as the new administrator for the Centers for Medicare and Medicaid Services. Noting that Verma's nomination didn't stir the contention in the committee that other nominees had, Committee Chairman Orrin Hatch (R-Utah) said he hoped to see at least a few of his Democratic colleagues vote in favor of Verma. Those hopes appeared to be dashed when Ranking Member Ron Wyden (D-Ore.) decried the vagueness of Verma's written answers following last month's hearing. "What I read was a lot of health care happy-talk that didn't amount to much substance," he said. An unofficial proxy vote Wednesday showed only one Democrat supporting her nomination, and that senator has reportedly indicated he will likely go with his party when the official vote is taken. (See BioWorld Today, Feb. 17, 2017.) Read More
