RMTI Cruises Ahead, ALNY, CELG Touch New Highs, BIOD Progresses

(RTTNews) - The Supplemental New Drug Application for Eliquis, an oral anti-clotting drug jointly developed by Bristol-Myers Squibb Co. (BMY) and Pfizer Inc. (PFE) for prophylaxis of deep vein thrombosis following hip or knee replacement surgery has been accepted for review by FDA. The regulatory agency is scheduled to announce its decision on the expanded indication of Eliquis on March 15, 2014.

Eliquis is already approved to reduce the risk of stroke, blood clots in patients with non-valvular atrial fibrillation in the United States, European Union, Japan and a number of other countries around the world. In the E.U. and a number of other countries around the world, the drug is also approved for prevention of venous thromboembolic events in adult patients who have undergone elective hip or knee replacement surgery.

BMY is up 1.74% at $45.63.

A phase III study of Celgene Inc.'s (CELG) blockbuster cancer drug REVLIMID in combination with Dexamethasone in patients newly diagnosed with multiple myeloma, dubbed FIRST, has met its primary endpoint of progression-free survival.

The company said it will commence discussions with regulatory authorities and submit dossiers for registration in the US, Europe and other markets.

CELG touched a new high of $136.36 today, and is currently trading 7.22% higher at $134.11.

RedHill Biopharma Ltd. (RDHL) said Wednesday it has commenced the first of two supplementary pharmacokinetic studies with its investigational drug RHB-102 and that it will begin the second study next month. Results from both studies are expected by October 2013.

RHB-102 is a proprietary, extended release, once-daily oral formulation of Ondansetron, a leading drug for the prevention of nausea and vomiting in cancer patients.

Rockwell Medical Inc.'s (RMTI) investigational drug SFP has met the primary and key secondary endpoints in a phase III efficacy study, known as CRUISE-1, as a treatment for iron replacement in chronic kidney disease patients on dialysis. Another phase III efficacy study of SFP, dubbed CRUISE-2, is underway, and results from this trial are expected in Q4-2013.

RMTI is up 25% trading at $4.72.

Shares of Alnylam Pharmaceuticals Inc. (ALNY) touched a new high of $43.63 today after the company reported positive top-line results from an on ongoing phase I trial of its investigational product ALN-TTRsc for the treatment of TTR-mediated amyloidosis.

The company plans to start a phase II clinical study of ALN-TTRsc in familial amyloidotic cardiomyopathy patients in late 2013. If all goes well as planned, a pivotal phase III trial for ALN-TTRsc in FAC patients will commence in 2014.

Biodel Inc. (BIOD) announced Wednesday that dosing in its phase II clinical trial of BIOD-123, an investigational ultra-rapid-acting injectable mealtime insulin therapy, has been completed.

The phase II study compares BIOD-123 to Eli Lilly's Humalog on measures of HbA1c, postprandial glucose excursions, glycemic variability, hypoglycemic event rates and weight changes. The top-line results from this trial are expected to be released by the end of this quarter.

BIOD is trading 1.20% higher at $4.19.