New Use For AMGN's Old Drug, BLUE In The Pink, Cellceutix Gets A Boost

(RTTNews) - Agios Pharmaceuticals Inc. (AGIO) touched another high on Monday, following positive phase I data in healthy volunteers for its investigational drug AG-348 that targets the underlying cause of pyruvate kinase deficiency.

In the phase I studies, dosing of AG-348 over 14-days in healthy volunteers resulted in a dose-dependent increase in the pyruvate kinase-R pathway as evidenced by a substantial increase in ATP and decrease in 2,3-DPG levels, which are key biomarkers of PKR activity and primary indicators of PK deficiency, according to the company.

The company has plans to initiate a phase II trial in patients with pyruvate kinase deficiency in the first half of 2015.

AGIO touched an all-time high of $113.82 on Monday before closing the day's trading at $107.30.

Amgen Inc. (AMGN) announced that its marketed drug XGEVA has received FDA approval for another indication - this time for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Hypercalcemia of malignancy, or HCM, is a serious complication in patients with advanced cancer, including those with hematologic malignancies, and indicates poor prognosis. The condition results from cancer-driven increases in bone resorption, and if untreated, can lead to renal failure, progressive mental impairment, coma and death.

XGEVA was first approved by the FDA in 2010 for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. Last year, the drug was approved by the FDA as the first-and-only treatment for adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

XGEVA raked in total revenue of $1.76 billion in 2013. In the nine months ended September 30, 2014, the drug has generated revenue of $1.61 billion.

AMGN touched a new high of $173.14 on Monday before closing the day's trading at $171.64.

BioDelivery Sciences International Inc. (BDSI) has completed the randomization of all patients in its ongoing initial pivotal phase III clinical trial for investigational Clonidine Topical Gel for the treatment of painful diabetic neuropathy. The top line results of the study are expected to be available by the end of March 2015.

BDSI closed Monday's trading at $14.59, down 0.75%.

Shares of bluebird bio Inc. (BLUE) touched another record high on Monday, following promising potential of its product candidate, LentiGlobin BB305, in beta-thalassemia major subjects.

Beta thalassemia is an inherited blood disease that reduces the production of hemoglobin. Treating beta-thalassemia includes frequent and lifelong blood transfusions, which deliver red blood cells to the body to correct the anemia.

LentiGlobin BB305 is under a phase 1/2 trial, dubbed Northstar Study, in subjects with beta-thalassemia major, and in another phase 1/2 trial, known as HGB-205 Study, in subjects with beta-thalassemia major and severe sickle cell disease.

According to the company, the first four beta-thalassemia major subjects treated with LentiGlobin who had at least three months of follow up are producing robust levels of beta-T87Q-globin and is transfusion-free. The data include the first five subjects treated in the ongoing Northstar Study and the first three subjects from its HGB-205 study.

The company remains on track to complete patient enrollment for the Northstar and HGB-205 studies in 2015.

BLUE closed Monday's trading at $48.89. In after-hours, the stock gained 43.18% to $70.

Cellceutix Corp. (CTIX.OB) touched a new high of $4.64 on Monday following the receipt of FDA's QIDP Designation for its investigational antibiotic Brilacidin.

Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity.

The company completed a phase 2b trial in September showing, amongst other things, a single dose of Brilacidin to be as effective in treatment of ABSSSI as a FDA-approved seven-day dosing regimen of Daptomycin.

CTIX.OB surged 34.03% on Monday to close at $4.49.

Shares of Epizyme Inc. (EPZM) rose more than 7 percent in extended trading on Monday after the company announced that its drug candidate EPZ015666 has demonstrated potent killing of cancer cells in vitro and efficacy in animal models of mantle cell lymphoma.

EPZM closed Monday's trading at $20.96, down 5.54%. In after-hours, the stock was up 7.40% at $22.51.

MEI Pharma Inc.'s (MEIP) drug candidate Pracinostat in combination with azacitidine (marketed as Vidaza by Celgene) has demonstrated significant clinical activity in elderly patients with newly diagnosed acute myeloid leukemia.

According to interim data from 33 evaluable patients in the phase II study, 15 to date have achieved the primary endpoint of complete response (CR) plus complete response with incomplete blood count recovery (CRi) plus morphologic leukemia-free state (MLFS).

The company expects top line data from the study to be reported in March 2015.

MEIP closed Monday's trading at $5.91, down 5.44%.

Merck & Co. Inc. (MRK) is all set to acquire antibiotics maker Cubist Pharmaceuticals Inc. (CBST) for $102 per share, which represents an equity value of $8.4 billion. Including $1.1 billion in net debt (based on projected cash balances) and other considerations, the total transaction value is approximately $9.5 billion.

Merck expects the acquisition to add more than $1 billion of revenue to its 2015 base. While the transaction will be neutral to non-GAAP EPS in 2015, Merck expects it to be significantly accretive to non-GAAP EPS in 2016 and beyond.

The transaction is expected to close in the first quarter of 2015.

MRK touched a new high of $62.20 on Monday before closing at $61.88.

TG Therapeutics Inc.'s (TGTX) investigational drug Ublituximab (TG-1101) in combination with Johnson & Johnson and Pharmacyclics' approved drug Imbruvica has demonstrated compelling clinical activity in patients with previously treated, high-risk chronic lymphocytic leukemia.

According to the company, the data not only shows Ublituximab can be safely combined with Imbruvica, but also can induce rapid and deeper responses compared to prior trials of Imbruvica alone.

TGTX closed Monday's trading at $13.76, down 0.29%. In after-hours, the stock rose 2.40% to $14.09.