|Healthcare Review: Ariad Pharmaceuticals, Rosetta Genomics, Gilead Sciences, Acura, Infinity Pharmaceuticals|
|By Staff and Wire Reports|
|Monday, 09 December 2013 11:46|
Jefferies hikes its price target on Ariad Pharmaceuticals ($ARIA) to $4 from $2.50. Hold rating reiterated."Although timing of FDA's decision to return Iclusig to market remains uncertain, physicians expect a new label to be broader than just T315iM pts," analyst Eun Yang says.
Rosetta Genomics ($ROSG) soars 20% as the company says the New York State Department of Health has granted conditional approval for ROSG's kidney cancer test.
"With this approval, [we] can offer the Rosetta Kidney Cancer Test in all 50 U.S. states," the company says.
Fresh off FDA approval for the game-changing HCV treatment sofosbuvir, Gilead Sciences ($GILD) reports (at ASH) interim results from a Phase 2 study of the Syk inhibitor GS-9973 in relapsed or refractory hematologic malignancies. Results: 97% of CLL patients receiving at least eight weeks of therapy saw lymph node reduction, 20% saw a 50% or greater reduction in their tumors, and, regarding safety, in a population of 78 CLL and NHL patients receiving at least four weeks of therapy, 64% continued treatment. (PR)Also at ASH, GILD reported results from a Phase 2 study of the PI3K inhibitor idelalisib in refractory iNHL. OR rate: 57%, medium duration 12.5 months; CRs, 6%; 63% had a partial response. Median PFS: 11 months; median OS, 20.3 months.
Acura's ($ACUR) shares surge 5% after the FDA agrees to review the results of the failed Phase II trial of a painkiller that was made with the company's Aversion technology, which is designed to deter drug abuse. The results of the study showed that Acura's tablet did not significantly lower likability among abusers. The FDA has now agreed to provide a definitive response regarding the suitability of the study that will be used to consider authorization of Acura's product. The agency has requested extra data, although the company doesn't believe it will need to carry out additional studies.
Infinity Pharmaceuticals ($INFI) reports preclinical data that demonstrates the activity of IPI-145 (PI3K inhibitor) in models of DLBCL and T-ALL.INFI also says Phase 1 data in a NHL shows the treatment "led to a reduction in adenopathy" in three of eight DLBCL patients and two of three with Richter transformation.