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Roche Holding AG ($RHHBY) received breakthrough therapy designation from the U.S. Food And Drug Administration (FDA) for its Rituxan (rituximab) drug, which is being developed by its subsidiary Genentech. The drug is for treating Pemphigus Vulgaris (PV), a rare disease which has limited treatment options. The designation comes with several benefits such as expedited review of a drug. Rituxan secured the status based on the results of a trial supported by Genentech’s parent company Roche.
Roche stock is up 11 percent this year so far while its 12 months gain stands at 5 percent. The results achieved in the study indicate that Rituxan has the potential to offer substantial improvement in pemphigus vulgaris remission rates.

Insys Therapeutics Inc. ($INSY) announced that the Drug Enforcement Agency has issued an interim final rule that would result in Syndros™ being placed in Schedule II of the Controlled Substances Act.  The drug was approved by the FDA on July 1, 2016. It is indicated in adults for the treatment of Anorexia associated with weight loss in patients with AIDS, and Nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.

The company stock is up over 14 percent this year so far, erasing some of the losses it incurred in the past 12 months. The stock is expected to retain its positive trend in the near future.

 

Amgen Inc. ($AMGN) reported receiving the European Commission approval for its biosimilar drug Amgevita (adalimumab) for the treatment of certain inflammatory diseases in adults. The approval includes treatment for various indications like moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe active ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS and several other conditions.

Merck (MKGAF) receives the US FDA approval for Bavencio for treating patients with metastatic Merkel cell carcinoma, a rare and aggressive form of skin cancer. The drug was developed with Pfizer as part of an agreement from 2014 that paid Merck $850 million at the time. There are other milestone payments involved as well.

HTG Molecular Diagnostics ($HTGM) announced that its HTG EdgeSeq ALKPlus Assay EU has obtained CE marking in the European Union. The drug candidate is an in vitro diagnostic assay intended to measure and analyze mRNA ALK gene rearrangements in formalin-fixed, paraffin-embedded lung tumor specimens from patients previously diagnosed with non-small cell lung cancer.

Alexion Pharmaceuticals ($ALXN) has filed a marketing application with the Japanese Ministry of Health, Labour and Welfare seeking approval of Soliris (eculizumab) for the treatment of patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody-positive. Currently, there are no approved therapies for the condition.

 

BioLineRx ($BLRX) has acquired Agalimmune Ltd., a private UK-based company. The company will pay $6 million upfront payment, of which $3 million is in cash and the remainder in BioLineRx shares. The consideration also includes milestone payments. Agalimmune's lead compound is AGI-134, a synthetic alpha-Gal immunotherapy in development for solid tumors. 

GlobeImmune ($GBIM) reported inking a new deal with NantCell. The collaboration involves GlobeImmune selling 12.83 million shares  of common stock to NantCell in exchange for $100K in cash and 200K shares of NantCell stock.

 

Neuralstem Inc. ($CUR) reported its full year results. The company’s net loss stood at $21.1 million or $2.53 per share on a split-adjusted basis, compared to a loss of approximately $20.9 million or $2.99 per share in the year ended December 31, 2015.  Its research and development expenditures, at $13.2 million, increased by approximately $0.5 million in 2016 as compared to expenditures of $12.6 million in 2015. 

Cellect Biotechnology ($APOP) announced that its net loss for the fourth quarter and for the full year of 2016 was $0.75 million and $3.98 million respectively, or $0.007 per share for the fourth quarter and $0.044 per share for the year of 2016 respectively. Tne company’s cash and  cash equivalents (including marketable securities and short terms deposits) totaled $8.0 million as of December 31, 2016, compared to $9.4 million on September 30, 2016, and $3.1 million on December 31, 2015. 

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Wedbush
Raises Target
Ascendis Pharma A/S (ASND)

$34.00
Low
Cowen and Company
Initiates
Five Prime Therapeutics (FPRX)
Outperform

Low
Sanford C. Bernstein
Set Price Target
Pfizer (PFE)
Buy
$35.00
Low
Cowen and Company
Initiates
Syndax Pharmaceuticals (SNDX)
Outperform

Low
B. Riley
Downgrades
Tandem Diabetes Care (TNDM)
Buy -> Neutral
$1.50
Medium
Argus
Initiates
TESARO (TSRO)
Buy

Low
Piper Jaffray Companies
Initiates
Zosano Pharma Corp (ZSAN)
Overweight

High

Gainers (% price change)Last TradeChangeMkt CapRigel PharmaceuticalsRIGL3.05+0.28 (10.11%)379.83MPacific Biosciences ofPACB5.00+0.27 (5.71%)470.59MFluidigm CorporationFLDM5.52+0.27 (5.14%)161.23MSangamo Therapeutics IncSGMO4.20+0.20 (5.00%)294.00MInfinity PharmaceuticalsINFI3.20+0.14 (4.58%)156.26MLosers (% price change)Merit Medical SystemsMMSI28.25-1.35 (-4.56%)1.25BEmergent Biosolutions IncEBS28.36-1.01 (-3.44%)1.17BNxStage Medical, Inc.NXTM26.20-0.88 (-3.25%)1.68BLandauer IncLDR46.15-1.45 (-3.05%)440.36MIdera Pharmaceuticals IncIDRA2.42-0.07 (-2.81%)429.86MMost Actives (dollar volume)Johnson & JohnsonJNJ125.90-0.36 (-0.29%)338.65BPfizer Inc.PFE34.29-0.18 (-0.52%)204.20BUnitedHealth Group IncUNH165.29-1.74 (-1.04%)156.59BAmgen, Inc.AMGN166.04-1.41 (-0.84%)122.72BMerck & Co., Inc.MRK63.28-0.22 (-0.35%)172.63B