With the FDA telling Sunesis Pharmaceuticals Inc. it wants additional clinical evidence on the experimental acute myeloid leukemia (AML) drug Qinprezo (vosaroxin) before backing submission of a new drug application (NDA), the company said it will "evaluate and refine" its U.S. plans while pursuing marketing approval for the drug in Europe, where regulators appear receptive to moving ahead with existing data.
Xoma Corp. highlighted its early stage pipeline Wednesday as its lead product candidate gevokizumab added another clinical failure to the record, which already included midstage busts in erosive osteoarthritis and type 2 diabetes.
Eiger Biopharmaceuticals Inc., a start-up seeking to develop a cure for chronic hepatitis delta virus (HDV), is on the verge of closing a series B financing that will help it advance its lead candidate, lonafarnib, while also broadening its portfolio to include multiple phase II, orphan-designated programs.
Cytrx Corp. shares (NASDAQ:CYTR) fell 20 percent, or 76 cents, to close at $3.04 as the cancer drug developer priced a 9.1 million share offering at $2.75 per share, a 27.6 percent discount to Monday's close. Reaction to the offering, which will raise gross proceeds of about $25 million to support pre-commercial preparations for aldoxorubicin and other programs, made Tuesday the company's second most active trading day year to date.
Five Prime Therapeutics Inc. has agreed to pay Inhibrx LLC $10 million for global rights to use antibodies that bind to glucocorticoid-induced tumor necrosis factor receptor (GITR) either alone or, more likely in combination with potential immuno-oncology therapies, such as its own phase I FPA-008, targeting tumor-associated macrophages.
Protagonist Therapeutics Inc. has raised $40 million in an oversubscribed series C financing to move its first oral peptide candidate, PTG-100, into phase I testing as a potential oral therapy for inflammatory bowel diseases (IBD) by the end of this year, likely in November or December.
Following a midstage trial showing its fast skeletal muscle activator, tirasemtiv, delivered respiratory and muscular benefits to patients with amyotrophic lateral sclerosis (ALS) despite missing its primary endpoint, Cytokinetics Inc. is launching a phase III trial of the drug to measure its impact on those factors and others, after conversations with regulators gave it confidence to pursue approval.
Ohr Pharmaceutical Inc. shares (NASDAQ:OHRP) snapped out of a months-long amble, jumping 62.6 percent to $3.69 Monday after a small midstage study showed that its lead candidate, OHR-102 (squalamine lactate ophthalmic solution 0.2 percent) eye drops, helped certain patients with macular edema receiving Lucentis (ranibizumab, Genentech Inc./Roche AG) achieve greater visual acuity gains than patients receiving Lucentis alone.
As the realities of building a million-person research group for the federal Precision Medicine Initiative come into clearer focus, the thorny issues of data privacy, security and control moved to the fore during the second day of a National Institutes of Health-sponsored workshop on participant engagement and health equity.
