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• Portola Pharmaceuticals’ ($PTLA) new drug application has been accepted by the FDA for priority review. The application pertains to its oral, once-daily Factor Xa inhibitor anticoagulant, betrixaban. The company is looking to get the drug approved forextended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
The priority review will have considerably shorter review time of nearly six months. The regular review period is at 10 months. It is likely that the company will receive the results by June 24, 2017. The company also informed that the drug has been accepted for review in the EU as well.

• Anthera Pharmaceuticals ($ANTH) announced that its drug Sollpura failed to meet a primary endpoint in its Phase 3 SOLUTION study. However, the company claimed that the results are encouraging and required an additional study. Sollpura missed its target for change of the coefficient of fat absorption non-inferiority margin.
The study related to examine the drug in cystic fibrosis patients with exocrine pancreatic insufficiency. The company stock showed steep decline in its pre-market session. Anthera claimed that the structure of the study may have hindered the results by not allowing some patients to increase their dosage during the testing. The company plans to initiate a new experiment in the first quarter of 2017.

 

• Endologix ($ELGX) has reportedly put hold on its shipping of its AFX Endovascular AAA System to probe a manufacturing issue related to the size of the product.
• MiMedx Group ($MDXG) announced that a preliminary probe into allegations of channel stuffing has shown no credible evidence that the practice took place.

• Seattle Genetics ($SGEN) has been notified by the FDA for several clinical or partial holds on the company's trials involving vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia, with evaluation of possible hepatotoxicity risks to patients treated with SGN-CD33A who received allogeneic stem cell transplants either prior to or after treatment cited as reasoning.

 
• Capnia ($CAPN) announced its plan to merge with privately held Essentialis. The new entity will be a rare disease therapeutics company and will focus on a late-stage clinical asset addressing Prader-Willi Syndrome.
• Ensign Group ($ENSG) announced acquiring the real estate of 15 assisted living operations in Wisconsin. The company had been operating each facility since last year under a lease-purchase option through a subsidiary.

• Angiodynamics ($ANGO) received a Buy rating from Cantor Fitzgerald. The price target for the stock has been set at $19.
• Cerus Corp. ($CERS) received Buy rating from FBR Capital. The stock price target has been set at $10 per share.

Gainers (% price change) Last Trade Change Mkt Cap
Psychemedics Corp.
PMD (NASDAQ)
24.84 +1.40 (5.97%) 139.44M
Sucampo Pharmaceuticals
SCMP (NASDAQ)
13.95 +0.65 (4.89%) 646.72M
Ariad Pharmaceuticals
ARIA (NASDAQ)
12.65 +0.43 (3.52%) 2.53B
Air Methods Corp
AIRM (NASDAQ)
32.20 +0.90 (2.88%) 1.18B
Synergy Pharmaceuticals
SGYP (NASDAQ)
5.93 +0.16 (2.77%) 1.30B
Losers (% price change)
Endologix, Inc.
ELGX (NASDAQ)
5.27 -1.92 (-26.70%) 442.87M
Seattle Genetics, Inc.
SGEN (NASDAQ)
52.36 -9.50 (-15.36%) 7.56B
China Cord Blood Corp
CO (NYSE)
5.37 -0.97 (-15.30%) 464.52M
Cerus Corporation
CERS (NASDAQ)
4.38 -0.28 (-6.01%) 479.96M
CARDIOME PHARMA CORP
CRME (NASDAQ)
2.83 -0.16 (-5.35%) 102.78M
Most Actives (dollar volume)
Gilead Sciences, Inc.
GILD (NASDAQ)
73.73 +0.09 (0.12%) 97.59B
Biogen Inc
BIIB (NASDAQ)
291.12 +3.59 (1.25%) 64.34B
Johnson & Johnson
JNJ (NYSE)
115.91 -0.05 (-0.04%) 316.76B
Pfizer Inc.
PFE (NYSE)
32.53 +0.05 (0.15%) 198.26B
Merck & Co., Inc.
MRK (NYSE
59.79 +0.23 (0.39%) 164.79B