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ImmunoCellular Therapeuticals (NYSEMKT:IMUC) stock jumped 25% in the Monday trading session as the company announced the latest data for the phase 2 trial of ICT-107 in patients with newly diagnosed glioblastoma. The updated immune response data from the phase 2 trial showed that treatment with ICT-107 resulted in the development of a measurable anti-tumor T cell response in some patients, which was associated with survival.
The ongoing phase 3 registrational trial of ICT-107 is designed as a randomized, double-blind, placebo-controlled study of HLA-A2+ subjects. The test is being conducted at about 120 sites in the US, Canada and the EU, with plans to randomize at least 500 patients with newly diagnosed glioblastoma. Overall survival is the primary endpoint in the trial. Secondary endpoints are progression-free survival and safety and overall survival in the two pre-specified MGMT subgroups.

Rosetta Genomics (NASDAQ:ROSG) announced inking a new research agreement with Sheba Medical Center based out of Israel. The agreement deals with the development of a microRNA-based signature for predicting response to Bristol-Myers Squibb's Opdivo (nivolumab). The company will also use its proprietary microarray design and qRT-PCR platform for identifying miRNAs associated with response.
The primary endpoint of the study is prediction of Objective Response Rate which will be measured by tumor radiologic response. The secondary endpoint relates to the prediction of survival benefit (overall survival) in patients suffering from advanced non-small cell lung cancer treated with nivolumab.

FDA lifts partial clinical hold on AstraZeneca H&N studies
AstraZeneca (NYSE:AZN) announces that the FDA has lifted the partial clinical hold on the enrollment of new patients with head and neck squamous cell carcinoma ("HNSCC") for clinical trials of durvalumab as monotherapy and in combination with tremelimumab or other potential medicines.
Zosano Pharma gets new Owners
Zosano Pharma (NASDAQ:ZSAN) reports that, on November 14, it inked a Stock Purchase Agreement with 18 foreign investors for the sale of 10,016,973 shares of common stock representing 99.9% of the issued and outstanding common shares of the company. The information was disclosed in 8-K filed by the company. It also announced the resignation by CEO and President Dr. Konstantine Alataris.

FDA approves Novo's Xultophy for type 2 diabetes
The FDA gave its approval to Novo Nordisk's (NYSE:NVO) Xultophy 100/3.6 (insulin degludec and liraglutide injection), a once-daily combination of Tresiba (insulin degludec injection) and Victoza (liraglutide), as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are inadequately controlled on less than 50 units of basal insulin or equal to 1.8 mg of liraglutide per day.
The company is expected to launch the medication in the first half of the next year.
FDA approves the expanded use of Darzalex
The FDA approves the use of Janssen Biotech's (NYSE:JNJ) DARZALEX (daratumumab), in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma (MM) who have received at least one prior line of therapy.

No patents to report.

Magellan Health buys Veridicus Holdings for $74.5M
Magellan Health (NASDAQ:MGLN) acquired Veridicus Holdings, LLC for $74.5M. The privately held firm is based out of Salt Lake City, UT. It is a pharmacy benefits manager (PBM) which uses proprietary analytics and clinical software for integrating pharmacy, medical and laboratory data to drive more effective therapeutic interventions and lower costs. Veridicus' also acts as a fully licensed insurance company.

 

No secondary offerings to report.

No IPOs to report.

• Biostar Pharmaceuticls (NASDAQ:BSPM) reported its third quarter EPS at -$0.71. Its revenue for the quarter stood at $0.64 million, down 84.8% on year over year basis.
• Enanta Pharmaceuticals (NASDAQ:ENTA) reported its fourth quarter loss at $0.09 per share, in comparison to consensus estimate of $0.14 per share in loss. Its revenue at $12.8 million, lagged behind expectations of $13.2 million.
• Corium (NASDAQ:CORI) announced its fourth quarter earnings at -$0.42 per share, missing market expectation by $0.03. Its revenue for the quarter was reported at $7.92 million.

• Barclays initiates coverage of Myovant Sciences Price Target $18
• H.C. Wainwright initiates coverage of Kite Pharma Price Target $78
• BMO Capital's Ian Smaiya rates Ra Pharmaceuticals as Outperform Price Target $26

None to report.

Gainers (% price change) Last Trade Change Mkt Cap
ImmunoCellular IMUC 3.3 +0.68 (25.95%) 424.89M
Momenta Pharmaceuticals MNTA 14.52 +0.97 (7.20%) 1.06B
Zogenix, Inc. ZGNX 12.85 +0.75 (6.20%) 318.56M
Spectrum Pharmaceuticals SPPI 4.52 +0.25 (5.85%) 364.12M
Cutera, Inc. CUTR 15.5 +0.85 (5.80%) 207.12M
Losers (% price change)
Henry Schein, Inc. HSIC 148.55 -8.41 (-5.36%) 11.81B
Acorda Therapeutics Inc ACOR 20.4 -0.90 (-4.23%) 942.95M
Oclaro, Inc. OCLR 9.5 -0.35 (-3.55%) 1.64B
Ariad Pharmaceuticals ARIA 13.61 -0.45 (-3.20%) 2.89B
Nektar Therapeutics NKTR 13.5 -0.44 (-3.16%) 2.06B
Most Actives (dollar volume)
Celgene Corporation CELG 124.16 +2.19 (1.80%) 96.16B
Pfizer Inc. PFE 31.57 +0.09 (0.29%) 190.07B
Johnson & Johnson JNJ 115 -0.36 (-0.31%) 309.61B
Bristol-Myers Squibb Co BMY 56.73 -0.03 (-0.05%) 94.94B
UnitedHealth Group Inc UNH 150.41 +0.96 (0.64%) 141.91B