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Idera Pharmaceuticals Inc. ($IDRA) received a positive boost as the FDA designated its Phase 2-stage IMO-2125 an Orphan Drug for the treatment of Stages IIB to IV melanoma. The  Orphan Drug status in the U.S. offers an additional seven-year period of market exclusivity for the indication, if approved. The company is currently evaluating IMO-2125’s safety, tolerability and clinical activity. The enrollment of the Phase 2 multicenter trial is expected to be completed in the second half of 2017 while overall response rate (ORR) data will likely be available in the first quarter of 2018.
The company stock jumped over 11 percent on the news. It is currently trading 28 percent up on YTD basis while its 1 year gain stands at 30 percent.

Portola Pharmaceuticals ($PTLA) received the FDA approval for its BEVYXXA (betrixaban) for the prevention of venous thromboembolism (VTE) in hospitalized at-risk adult patients. The company stock reacted positively to the news. The company claimed that BevyxXa is the first oral treatment and first extended duration treatment for this patient population. According to Thomson Reuters data, the analysts expect the drug to generate $313 million in revenue by 2020. The drug is designed for both hospital and in-home use.
The company stock soared over 46 percent on the news and touched its 52 weeks high of $57.90. The stock is now up 149 percent on YTD basis, while its 12 months gain stands at 142 percent.

 

Novo Nordisk ($NVO) plans to initiate a Phase 3 study next for its  once-weekly diabetes med semaglutide. The study will test to prove the drug’s effect in inducing and maintaining weight loss in obese people. Clinical trials assessing the GLP-1 analogue in type 2 diabetics showed an average weight loss of nearly 14% versus 2% for placebo, diet and exercise.
Karyopharm Therapeutics ($KPTI) announced updated data from a Phase 2b clinical trial SADAL assessing the company’s lead product candidate  selinexor (KPT-330) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL). The study showed a 33.3% (n=21/63) response rate.

AstraZeneca ($AZN) has received the positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use for its FASLODEX for the  treatment of hormone receptor-positive (HR+), locally advanced or metastatic breast cancer in postmenopausal women. The treatment is currently approved in Europe to treat estrogen receptor-positive (ER+) breast cancer.

Roche ($RHHBY) received the FDA approval for its fourth -generation HIV combination antigen-antibody assay, Elecsys HIV combi PT. The company claims that the combination format reduces the need for sample splitting and the use of additional analyzers.

 

Takeda Pharmaceuticals ($TKPHF) announced inking a new deal with Biological E. involving two licensing agreements for expediting the development and delivery of affordable vaccines. Biological E. will have the responsibility of commercializing the vaccine in India, China and other countries.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Jefferies Group LLC
Reiterates
Advanced Accelerator Applications S.A. (AAAP)
Buy
$50.00
Low
Stifel Nicolaus
Reiterates
Align Technology (ALGN)
Market Perform -> Buy
$145.00 -> $200.00
High
Deutsche Bank AG
Initiates
Amgen (AMGN)
Hold
$172.00
Medium
HC Wainwright
Reiterates
Antares Pharma (ATRS)
Buy -> Buy
$5.00
High
Chardan Capital
Initiates
Antares Pharma (ATRS)
Buy
$5.00
High
Piper Jaffray Companies
Reiterates
AVEO Pharmaceuticals (AVEO)
Positive

High
HC Wainwright
Reiterates
BioDelivery Sciences International (BDSI)
Buy
$4.00
Medium

Gainers (% price change) Last Trade Change Mkt Cap
Repligen Corporation RGEN 44.20 +4.11 (10.25%) 1.52B
Pacific Biosciences of PACB 3.71 +0.24 (6.92%) 406.58M
Antares Pharma Inc ATRS 3.21 +0.20 (6.64%) 510.70M
Oclaro, Inc. OCLR 10.01 +0.57 (6.04%) 1.66B
Keryx Biopharmaceuticals KERX 6.75 +0.36 (5.63%) 739.09M
Losers (% price change)
Arena Pharmaceuticals ARNA 14.88 -1.31 (-8.09%) 460.68M
Fluidigm Corporation FLDM 3.90 -0.20 (-4.88%) 121.67M
Omeros Corporation OMER 25.71 -0.85 (-3.20%) 1.13B
Seattle Genetics, Inc. SGEN 61.74 -1.51 (-2.39%) 8.78B
LifePoint Health Inc LPNT 65.50 -1.60 (-2.38%) 2.74B
Most Actives (dollar volume)
Amgen, Inc. AMGN 172.50 -1.32 (-0.76%) 128.68B
Gilead Sciences, Inc. GILD 70.54 +0.06 (0.09%) 96.25B
Johnson & Johnson JNJ 136.43 +0.37 (0.27%) 370.63B
Regeneron Pharmaceuticals REGN 517.33 -9.20 (-1.75%) 55.46B
Pfizer Inc. PFE 34.17 +0.11 (0.32%) 204.57B