APPY Responds, AMGN Gets FDA Nod For Leukemia Drug, ARRY Surges After Hours

(RTTNews) - Amgen Inc.'s (AMGN) single-agent immunotherapy Blincyto has been approved by FDA for the treatment of patients with a rare form of acute lymphoblastic leukemia, Philadelphia chromosome-negative precursor B-cell acute lymphoblastic leukemia (B-cell ALL), 5 months ahead of the decision date of May 19, 2015.

Blincyto is approved under accelerated drug-approval process based on results of a phase II, multicenter, single-arm open-label study. Continued approval may be contingent upon verification of clinical benefit in subsequent trials, the company said.

AMGN closed Wednesday's trading at $168.07, down 0.71%.

Shares of Array BioPharma Inc. (ARRY) surged over 22 percent in after-hours Wednesday after the company agreed to regain full worldwide rights to cancer drug candidate Binimetinib, which is under phase III testing, from Novartis AG (NVS).

Invented by Array, Binimetinib was licensed to Novartis under a license agreement in 2010. In phase III trials, Binimetinib is being tested in the indications of low-grade serous ovarian cancer, NRAS mutant melanoma and BRAF V600 mutant melanoma.

Now that Novartis' global, exclusive license to Binimetinib will be terminated, Array will receive an upfront payment of $85 million from Novartis. The three ongoing phase III trials of Binimetinib, namely COLUMBUS, NEMO and MILO, will be funded by Novartis.

Array expects to file its first regulatory approval for Binimetinib during the first half of 2016.

ARRY closed Wednesday's trading at $3.91, down 1.01%. In after-hours, the stock rose 22.76% to $4.80.

Minerva Neurosciences Inc. (NERV) has completed the development and final selection of a once-daily dose formulation of MIN-101 for its schizophrenia program.

The new formulation, which has been developed to offer improved safety, tolerability and pharmacokinetic profile, will be used in the company's planned phase 2b clinical trial in schizophrenia, scheduled to begin in the first half of 2015.

NERV closed Wednesday's trading at $4.56, down 2.98%.

Organovo Holdings Inc. (ONVO) and Yale School of Medicine, Department of Surgery have formed a collaboration to develop bioprinted tissues for surgical transplantation research.

The Methuselah Foundation is donating at least $500,000 in direct funding to be divided among several institutions for Organovo bioprinter research projects.

Organovo commercially released its exVive3D Human Liver Tissue for preclinical drug discovery testing as recently as last month.

ONVO closed Wednesday's trading at $6.32, up 0.96%.

Venaxis Inc. (APPY) has filed its response to the FDA's Additional Information request related to the filing for APPY1 test seeking clearance. APPY1 Test is a rapid, multiple biomarker-based index assay for identifying patients that are at low risk for appendicitis.

The regulatory agency after initial review of the filing had sought additional data and information in July of this year. The company filed a 510(k) premarket submission for the APPY1 Test in March of 2014.

APPY closed Wednesday's trading at $1.52. In extended trading, the stock was up 5.26% to $1.60.