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Gilead Sciences Inc. ($GILD) announced that it has received approval in Canada for its ODEFSEY for treating HIV-1 infection. ODEFSEY is indicated in Canada as a complete regimen for the treatment of adults infected with HIV-1 with no known mutations associated with resistance to the non-nucleoside reverse transcriptase inhibitor (NNRTI) class, tenofovir or emtricitabine, and who have HIV-1 RNA levels less than or equal to 100,000 copies per mL.
Gilead also reported that it has inked a deal with Amygdala Neurosciences Inc. for S-6637, a highly selective ALDH2 inhibitor with the potential to treat behavior and substance addictions. Amygdala plans to initiate clinical trials for the treatment of both cocaine and alcohol use disorders."

Valeant Pharmaceuticals International Inc. ($VRX) saw a slump in its price despite receiving FDA approval for its Biologics License Application (BLA) for SILIQ™ (brodalumab) injection. The injection is designed for subcutaneous use and is a monoclonal antibody that targets the IL-17 receptor for patients with moderate-to-severe plaque psoriasis.
The drug comes with a Black Box Warning for the risks in patients with a history of suicidal thoughts or behavior. The company has clocked over 11 percent gain this year so far. However, it lost 81 percent of its value in the past 12 months. The new approval is likely to boost the stock price in the coming time period.

 

• XBiotech Inc. ($XBIT) announced that it has met the primary endpoints for investigator sponsored randomized Phase 2 study evaluating XBiotech`s True Human antibody, MABp1, as a treatment for Hidradenitis Suppurativa. The trial demonstrated significant improvement of HS patients compared to control after 12 weeks of therapy. Efficacy measures include assessment of HiSCR scores, a validated method for evaluating efficacy in HS patients, as well as quality of life assessment and ultrasonographic evaluation.
• Roche ($RHHBY) announced that its Genentech unit plans to sue Amgen ($AMGN) in the US for determining whether Amgen's biosimilar to Avastin (bevacizumab) infringes on its patents. The company wants the court’s intervention before Amgen's product is approved by the FDA so it has "sufficient time" to assert its patents. Roche has accused Amgen of obstructing its ability to conduct its analysis.

• Mylan NV ($MYL) reported that the U.S. Food and Drug Administration (FDA) has accepted Mylan's Biologics License Application (BLA) for MYL-1401H, a proposed biosimilar to Neulasta® (pegfilgrastim), for filing through the 351(k) pathway. The FDA goal date set under the Biosimilar User Fee Act (BsUFA) is Oct. 9, 2017. Mylan developed the product in collaboration with India-based Biocon Ltd.
• AstraZeneca PLC ($AZN) reported that the FDA approval of Valeant Pharmaceuticals' ($VRX) Siliq, triggers a $130 million milestone payment. LEO Pharma owns the European rights under an agreement with AstraZeneca.Kyowa Hakko Kirin Co. Ltd. owns the rights in Japan and certain other Asian countries under an agreement with Amgen.

 
• TRACON Pharmaceuticals ($TCON) announced that it has initiated patient dosing in its Phase 3 TAPPAS trial of TRC105. The company also noted that TRC105 has orphan drug designation for soft tissue sarcoma in the U.S. and the EU, and the first patient dosed represents the culmination of TRACON’s extensive work with regulators in both regions to design a robust Phase 3 trial. The trial has an initial enrollment target of 124 patients and, based on an interim analysis, allows for sample size re-estimation up to a maximum of 200 patients.
• Neuralstem ($CUR) announced that it has completed the target of enrolling 220 subjects ahead of schedule in its Phase 2 clinical trial evaluating NSI-189 for the treatment of major depressive disorder (MDD). Top-line data should be available in the third quarter.

 
• Molina Healthcare Inc. ($MOH) reported its fourth quarter net income per diluted share at $0.14, down from $2.58 in 2015. Adjusted net income per diluted share decreased to $0.50 in 2016 compared with $2.78 in 2015. The decrease is mainly due to the result of the declining profitability of the company’s Marketplace program. The company reported that robust enrollment growth generated approximately $16.3 billion of premium revenue. Its General and administrative expenses ratio decreased to 7.9% in 2016. The company provided its 2017 guidance at $1.72 net income per diluted share and $2.09 adjusted net income per diluted share.

• Anika Therapeutics ($ANIK) reported its fourth quarter and full year results. The company’s net income for the fourth quarter of 2016 was $8.1 million, or $0.54 per diluted share, compared to $11.0 million, or $0.72 per diluted share, for the fourth quarter of 2015. Net income for the full year of 2016 increased $1.8 million to $32.5 million, or $2.15 per diluted share, compared to $30.8 million, or $2.01 per diluted share, for the full year of 2015. Anika reported that its product revenue increased 11% for the fourth quarter of 2016, and 17% for the full year of 2016, as compared to the same periods in 2015. revenue increased 11% for the fourth quarter of 2016, and 17% for the full year of 2016, as compared to the same periods in 2015.

Brokerage Action Company Rating Price Target
J P Morgan Chase & Co Downgrades The Advisory Board Company (ABCO)
Overweight -> Neutral
Jefferies Group LLC Reiterates Abbott Laboratories (ABT)
Buy $51.00
Credit Suisse Group Reiterates Alexion Pharmaceuticals (ALXN)
Buy
Royal Bank Of Canada Lowers Target Alexion Pharmaceuticals (ALXN)
Outperform $187.00 -> $177.00
Needham & Company LLC Reiterates Cytokinetics, Incorporated (CYTK)
Strong-Buy
Piper Jaffray Companies Reiterates Cytokinetics, Incorporated (CYTK)
Overweight $15.00
FBR & Co Reiterates Cytokinetics, Incorporated (CYTK)
Outperform
Noble Financial Initiates ESSA Pharma (EPIX)
Buy $9.00
Needham & Company LLC Downgrades Genocea Biosciences (GNCA)
Buy -> Hold
Jefferies Group LLC Reiterates Eli Lilly and Company (LLY)
Buy
Cantor Fitzgerald Raises Target Allscripts Healthcare Solutions (MDRX)
In-Line $13.00
Cantor Fitzgerald Reiterates Nabriva Therapeutics AG (NBRV)
Overweight
Jefferies Group LLC Reiterates Pfizer (PFE)
Hold $34.00
Berenberg Bank Set Price Target Pfizer (PFE)
Neutral $39.00
Wells Fargo & Company Upgrades Quintiles Transitional Holdings (Q)
Market Perform -> Outperform
CL King Initiates Quidel Corporation (QDEL)
Neutral
Guggenheim Reiterates Shire PLC (SHPG)
Neutral $3.37 -> $0.11
Needham & Company LLC Reiterates Zimmer Biomet Holdings (ZBH)
Strong-Buy $151.00

Gainers (% price change) Last Trade Change Mkt Cap
Progenics Pharmaceuticals
PGNX (NASDAQ)
10.54 +0.92 (9.56%) 734.52M
BioCryst Pharmaceuticals
BCRX (NASDAQ)
6.58 +0.42 (6.82%) 517.24M
Pacific Biosciences of
PACB (NASDAQ)
5.56 +0.29 (5.50%) 521.05M
AMAG Pharmaceuticals, Inc
AMAG (NASDAQ)
24.20 +0.85 (3.64%) 853.46M
ABIOMED, Inc.
ABMD (NASDAQ)
114.25 +3.63 (3.28%) 5.05B
Losers (% price change)
Molina Healthcare, Inc.
MOH (NYSE)
49.18 -10.71 (-17.88%) 2.82B
Cryolife Inc
CRY (NYSE)
16.10 -3.45 (-17.65%) 541.32M
Achillion Pharmaceuticals
ACHN (NASDAQ)
4.27 -0.44 (-9.34%) 616.34M
Genomic Health, Inc.
GHDX (NASDAQ)
28.50 -2.62 (-8.42%) 1.05B
Keryx Biopharmaceuticals
KERX (NASDAQ)
5.08 -0.44 (-7.97%) 537.31M
Most Actives (dollar volume)
Pfizer Inc.
PFE (NYSE)
33.62 +0.11 (0.33%) 208.75B
Johnson & Johnson
JNJ (NYSE)
118.08 +0.88 (0.75%) 323.56B
Merck & Co., Inc.
MRK (NYSE)
65.26 +0.10 (0.15%) 178.56B
Gilead Sciences, Inc.
GILD (NASDAQ)
70.31 +0.51 (0.73%) 95.72B
Alexion Pharmaceuticals
ALXN (NASDAQ)
130.39 -1.61 (-1.22%) 29.76B