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NantKwest ($NK) reported that it has received the FDA approval for its NANT Cancer Vaccine IND application. The company plans to start its Phase ½ clinical trial with 80 subjects shortly. The co-primary endpoints are safety measures and objective response rate. According to the company, the NANT Cancer Vaccine induces immunogenic cancer cell death by activating the innate and adaptive immune system. Patrick Soon-Shiong, MD, Chairman and CEO of NantKwest noted, “Abraxane, a nanoparticle albumin-bound (Nab) paclitaxel, was the first protein-based drug to alter the survival of metastatic pancreatic cancer in over 20 years.”
The company stock gained over 9 percent in its previous trading session, trimming its Year to Date losses to 45 percent.

Array BioPharma ($ARRY) stock shot up as the company announced positive results from Part 2 of its Phase 3 COLUMBUS study assessing the combination of binimetinib and encorafenib for the treatment of patients with BRAF-positive advanced/unresectable/metastatic melanoma. The company says it plans to file its U.S. marketing application with the FDA in June or July. Array had acquired this BRAF inhibitor from Novartis in 2015. The company said that the patients receiving the combination, known as COMBO300, demonstrated median progression-free survival (PFS) of 12.9 months compared to 9.2 months for those treated with encorafenib alone with 23% less risk (hazard ratio = 0.77).
The company stock is up over 138 percent in the past 12 months so far.

 

AbbVie ($ABBV) reported that its preliminary results from a Phase 2 clinical trial CELEST, testing its upadacitinib (ABT-494) in adults with moderately to severely active Crohn's disease showed an encouraging treatment effect. The company intends to advance the JAK1 inhibitor into Phase 3 development. The estimated study completion date is April 2018.

Aytu BioSciences ($AYTU) reported that it has acquired Nuelle, which makes a personal care device for women under the brand name ‘Fiera’. Under the terms of the deal, Nuelle shareholders received 2.5M shares of Aytu common stock plus potential earn-out payments up to a maximum of $6.9 million based on net sales of up to $100 million.

Corbus Pharmaceuticals ($CRBP) reported that the FDA has rejected its request for Breakthrough Therapy status for anabasum (Resunab) for systemic sclerosis. The drug candidate already has Orphan Drug status for Fast Track review for the indication. The company expects to carry out a Phase III study in the fourth quarter.

Pulmatrix ($PULM) has been granted the U.S. Patent #9,642,798 by the USPTO. The patent covers the company’s lead candidate PUR0200 for the potential treatment of chronic obstructive pulmonary disease (COPD), the sixth U.S. patent protecting the product. In clinical studies, PUR0200 has been up to five times more efficient in delivering the drug to the lungs than currently marketed offerings.

 

Takeda Pharmaceuticals ($TKPYY) announced inking a strategic deal with GammaDelta Therapeutics Ltd. for developing its T cell platform to treat inflammatory autoimmune disorders and a range of cancers. The agreement provides for Takeda, along with venture capital outfit Abingworth, to commit up to $100 million to accelerate research and development of GammaDelta's T cells derived from human tissues. 

Cerus ($CERS) reported that the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority exercised additional options under its contract for the development of INTERCEPT red blood cells. The new options are valued at $46.6 million. The funds will support a Phase 3 study to assess the RBCs for the treatment of anemia in cardiovascular surgery patients. The funds will also be used for a UK-based study in patients undergoing exchange transfusion for sickle cell disease.

 

Mylan ($MYL) reported total revenue of $2.72 billion for the first quarter, up 24% compared to the prior year period. Its adjusted diluted earnings per ordinary share ("adjusted EPS") of $0.93, up 22% compared to $0.76 in the prior year period. The company reported its U.S. GAAP cash provided by operating activities at $452.9 million, up 463% compared to $80.5 million in the prior year period.
Titan Pharmaceuticals ($TTNP) reported a loss of $3 million in its first quarter. On per share basis, its loss stood at $0.16. The company earned $40,000 in revenue.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
HC Wainwright
Lowers Target
AEterna Zentaris (AEZS)
Buy
$7.50 -> $3.00
Low
Royal Bank of Canada
Raises Target
Allergan plc (AGN)
Outperform
$279.00 -> $284.00
Low
Goldman Sachs Group
Downgrades
Allergan plc (AGN)
Buy -> Neutral

Low
Cantor Fitzgerald
Reiterates
Cascadian Therapeutics (CASC)
Hold
$4.00
Low
Piper Jaffray Companies
Upgrades
Depomed (DEPO)
Underweight -> Neutral

Low
Royal Bank of Canada
Reiterates
Epizyme (EPZM)
Buy
$20.00
Low
Needham & Company LLC
Reiterates
Inogen (INGN)
Buy
$96.00
Low
Piper Jaffray Companies
Downgrades
Insys Therapeutics (INSY)
Overweight -> Neutral

Low

Gainers (% price change)Last TradeChangeMkt CapValeant PharmaceuticalsVRX12.05+2.34 (24.03%)3.98BNova MeasuringNVMI22.13+2.91 (15.14%)618.45MAlbany Molecular ResearchAMRI18.00+1.98 (12.36%)793.58MInsys Therapeutics IncINSY11.79+1.11 (10.39%)836.91MCorcept Therapeutics Inc.CORT10.25+0.97 (10.39%)1.15BLosers (% price change)NxStage Medical, Inc.NXTM22.95-4.06 (-15.01%)1.48BAcelRx PharmaceuticalsACRX2.60-0.25 (-8.77%)124.54MCytokinetics, Inc.CYTK14.30-1.35 (-8.63%)655.16MAntares Pharma IncATRS2.79-0.11 (-3.79%)421.04MSTAAR Surgical CompanySTAA9.75-0.35 (-3.47%)399.09MMost Actives (dollar volume)Valeant PharmaceuticalsVRX12.05+2.34 (24.03%)3.98BMerck & Co., Inc.MRK63.29-0.72 (-1.12%)173.62BBecton Dickinson and CoBDX180.66-1.96 (-1.07%)37.96BPfizer Inc.PFE33.38-0.07 (-0.21%)198.60BCelgene CorporationCELG120.10+1.74 (1.47%)90.67B