Epizyme Inc.’s Phase I study, designed mainly to determine the safety of EPZ-5676, an inhibitor of the DOT1L histone methyltransferase (HMT) for the treatment of acute leukemia with rearrangements in the mixed lineage leukemia gene (MLL-r), ended up showing treatment effects in four of eight patients.
Synta Pharmaceuticals Corp.’s new money from a public offering – about $52.5 million in gross proceeds – will fuel an expanded Phase III push with the heat-shock protein 90 inhibitor ganetespib in non-small-cell lung cancer (NSCLC).
The FDA altered its view of Sarepta Therapeutics Inc.’s data with exon-skipping therapy eteplirsen for Duchenne muscular dystrophy (DMD) after Prosensa Holding NV’s failure with exon-skipper drisapersen for the condition, but Sarepta CEO Chris Garabedian hopes the agency can still be brought around.
Something of a mystery surrounds the Phase II dashed hopes with Zalicus Inc.’s oral calcium channel blocker Z160, which missed its primary endpoints in two pain indications, testing patients with lumbosacral radiculopathy and postherpetic neuralgia.
Salix Pharmaceuticals Ltd.’s $2.6 billion buyout of Santarus Inc. for $32 per share in cash provides entry into the primary care physician space, while bringing aboard more products – albeit a couple that are facing patent expirations fairly soon.
The Johnson & Johnson (J&J) Innovation Center, through J&J unit Janssen Pharmaceuticals Inc., is pledging up to $10 million up front per program, followed by as much as $145 million more for each, in a deal with Evotec AG that aims to find and target the true originators of Alzheimer’s disease (AD).
The FDA’s partial clinical hold on CUDC-427 because of a cancer patient’s death from liver failure overshadowed third-quarter earnings for Curis Inc., which is analyzing possible causes.
Keryx Biopharmaceuticals Inc.’s Zerenex (ferric citrate) may be poised to become the first oral iron booster that also provides phosphorous control in chronic kidney disease (CKD) patients, if new top-line data from a Phase II trial hold up.
Partnered with Adimab LLC for antibody development in dementia and Alzheimer’s disease (AD), Alector LLC raised an undisclosed amount of money in its Series A round, enough to last “two or three years, we think,” said CEO Arnon Rosenthal, who estimated “at least four years before we are in the clinic” with a drug that might succeed where so many others have not.
Two of five biomarkers found by Merrimack Pharmaceuticals Inc. ended up predictive of benefit from MM-121 in 34 percent of patients who took part in the company’s failed Phase II trial against ovarian cancer – a finding that took some of the sting out of the overall outcome.
