FDA Approves Odactra, JUNO Abandons Rocket, VRML Abuzz, No Tremors For NDRM

(RTTNews) - Celgene Corp. (CELG) and Agios Pharmaceuticals' (AGIO) New Drug Application for Enasidenib has been granted Priority Review by the FDA - with a decision date set for August 30, 2017.

The companies are seeking approval of Enasidenib for the treatment of patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 2 (IDH2) mutation.

AGIO closed Wednesday's trading at $51.74, up 6.81%.

A study from Exact Sciences Corp. (EXAS) and Mayo Clinic released by the American Association of Cancer Research shows promise for the development of a new blood-based lung cancer test.

The study involving 398 patients (311 controls and 87 cancers) demonstrated that biomarkers in plasma, in this case, four novel methylated DNA markers, achieved a sensitivity of 91-96 percent at a specificity of 90-94 percent.

EXAS closed Wednesday's trading at $22.15, up 2.93%. In after-hours, the stock was up 4.97% to $23.25.

Juno Therapeutics Inc. (JUNO) has decided to pull the plug on its phase II trial of JCAR015 in adult patients with r/r acute lymphoblastic leukemia, referred to as the ROCKET trial.

Last November, the trial was put on hold following two patient deaths. Juno conducted an investigation into the toxicity. Considering the fact that there are other product candidates in its pipeline, which are likely to provide improved efficacy and tolerability, Juno, in collaboration with partner Celgene, has made a strategic decision to cease development of JCAR015.

JUNO closed Wednesday's trading at $25.31, up 5.28%. In after-hours, the stock was down 7.94% to $23.30.

The FDA has approved Odactra, the first allergen extract, for house dust mite allergies. Odactra, which is to be administered under the tongue, is indicated for people 18 through 65 years of age.

Odactra is manufactured for Merck, Sharp & Dohme Corp., (a subsidiary of Merck and Co., Inc., Whitehouse Station, N.J.) by Catalent Pharma Solutions Limited, United Kingdom.

Shares of NeuroDerm Ltd. (NDRM) rose more than 26% on Wednesday, following positive results from its phase II trial of ND0612H for advanced Parkinson's disease.

The trial, dubbed Trial 006, demonstrated a statistically significant and clinically meaningful reduction in OFF-time and increase in proportion of patients "ON" by 8:00 am (primary and key secondary endpoints). The study also showed statistically significant reduction in troublesome dyskinesia and a complete reduction of OFF-time to zero hours in 66% of responders.

NDRM closed Wednesday's trading at $29.30, up 26.57%. In after-hours, the stock was up another 1.52% to $29.74.

Puma Biotechnology Inc. (PBYI) has a couple of catalyst to watch out for in the coming months.

The anticipated key milestones are :

-- Additional data from its Phase II CONTROL trial of Neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer using antidiarrheal prophylaxis with loperamide and other agents are expected in Q2, 2017. -- Interim Phase I/II data from NSABP FB-10 trial of Neratinib plus Kadcyla in HER2-positive metastatic breast cancer expected in Q2, 2017. -- Data from Phase II SUMMIT basket trial of Neratinib in patients with HER2 non-amplified solid tumors that have a HER2 mutation anticipated in Q2, 2017. -- Data from phase III trial in third-line HER2-positive MBC patients in the first half of 2017. -- Data from TBCRC-022 Phase II trial of Neratinib plus capecitabine in HER2-positive MBC patients with brain metastases expected in Q2, 2017. -- Data from phase II SUMMIT basket trial of Neratinib in HER2-negative breast cancer patients with HER2 mutations in Q2, 2017 -- Final 5-year disease free survival (DFS) data from ExteNET Phase III trial of Neratinib as an extended adjuvant treatment in HER2-positive early stage breast cancer slated for release during the second half of 2017. -- Regulatory decisions in the United States and European Union on Neratinib for the extended adjuvant treatment of patients with HER2-positive early stage breast cancer in the third quarter of 2017.

PBYI closed Wednesday's trading at $38.05, up 3.68%.

Sangamo Therapeutics Inc.'s (SGMO) SB-913, a genome editing product candidate for the treatment of Mucopolysaccharidosis Type II (MPS II), has been granted orphan drug designation by the FDA.

Sangamo is conducting a Phase 1/2 clinical trial evaluating SB-913 as an in vivo genome editing treatment for MPS II. Sangamo is also conducting Phase 1/2 studies this year evaluating in vivo genome editing treatments SB-318 for MPS I, another rare lysosomal storage disorder, and SB-FIX for hemophilia B, a rare blood disease.

Data from the above studies and from a clinical trial for a fourth lead program, SB-525, a gene therapy approach for hemophilia A, are expected in late 2017 or early 2018.

SGMO closed Wednesday's trading at $4.70, up 3.30%.

ASPiRA LABs, a Vermillion company (VRML), has signed a contracted in-network agreement with Blue Cross Blue Shield of Michigan for ovarian cancer risk assessment test OVA1. ASPiRA's OVA1 test is U.S. FDA cleared.

Blue Cross Blue Shield of Michigan serves over six million beneficiaries throughout Michigan and surrounding states.

VRML closed Wednesday's trading at $2.35, up 1.73%. In after-hours, the stock was up 17.02% to $2.75.