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Bayer ($BAYRY) has been intimated by the FDA regarding its copanlisib treatment. The FDA has agreed to accept its New Drug Application seeking the approval as the third-line treatment of relapsed/refractory follicular lymphoma under Priority Review. The treatment already has Orphan Drug and Fast Track designations attached to it. The priority review shortens  the review period to six months from the normal 10 months. 
The company stock created its new 52 weeks high at $130.35. It is currently trading 20 percent up on 12 months basis while its Year to Date gain stands at over 24 percent. Copanlisib is a pan-Class I phosphatidylinositol-3-kinase (PI3K) inhibitor.

Adaptimmune Therapeutics ($ADAP) announced the start of its  first site for its MAGE‑A4 SPEAR T-cell study in patients with multiple malignant solid tumors. The company has started enrollment for the study. This Phase I, open label, dose escalation study is designed to evaluate the safety and anti-tumor activity of Adaptimmune’s MAGE-A4 therapeutic candidate in patients who are HLA-A*02 positive and have inoperable locally advanced or metastatic melanoma, urothelial, head and neck, ovarian, non-small cell lung, esophageal, and gastric cancers expressing MAGE-A4. 
The company stock gained close to 8 percent in its previous trading session, trimming its 12 months losses to 34 percent. The stock price has gained over 36 percent on Year to Date basis.

 

UnitedHealth ($UNH) is being sued by the DOJ for obtaining over $1 billion from Medicare to which it was not entitled. The complaint has been filed in federal court in Los Angeles. The company has not commented on the situation.
Sinovac Biotech ($SVA) announced that it will be unable to file its 20-F for 2016 by end of the extension period allowed under Nasdaq's late filing rules. The company said that the delay is due to additional time required by its Board's Audit Committee for completing its internal investigation into allegations raised in a report published by Geoinvesting.

Edward Lifesciences ($EW) reported one year data from a European post-approval study of its SAPIEN 3 transcatheter heart valve. The study showed a  high survival rate at 88.2%, low stroke rate at 1.1% and low rate of 2.7% for moderate paravalvular leak. There were no instances of severe leak.
 
Johnson & Johnson ($JNJ) has been asked by the FDA to add a boxed warning to the package inserts of diabetes meds Invokana, Invokamet and Invokamet XR. The warning labels pertain to the risks of leg and foot amputations from taking canagliflozin, the active ingredient.

 

Quidel ($QDEL) announced closing its acquisition of the InflammaDry and AdenoPlus businesses from RPS Diagnostics. The company has paid nearly $14 million in cash. The product portfolio acquired by the company includes  rapid point-of-care tests for the detection of infectious and inflammatory diseases and conditions of the eye. The company will show the revenue under its Immunoassay category.

Neptune Technologies & Bioressources ($NEPT) formed collaboration with Groupe DJB and  Université de Sherbrooke. The consortium will work towards researching, developing and producing medical cannabis. The company did not disclose the financial terms of the collaboration.

 

Evogene Ltd. ($EVGN) announced its revenue for the first quarter of 2017 at $0.7 million, down from $2.0 million for the first quarter of 2016. The company incurred $4 million on its R&D expenses, compared to $3.7 million for the first quarter of 2016. As on March 31, 2017, the Company had $83.4 million in cash, short-term bank deposits and marketable securities.

Pressure BioSciences Inc. ($PBIO) announced 16 percent increase in its products and services revenue to $525,998 for Q1 2017 as compared to $454,350 for Q1 2016. its operating losses decreased 4 percent to $999,103 in Q1 2017 from $1.04 million for the same period in 2016.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Jefferies Group LLC
Initiates
AmerisourceBergen Corp. (ABC)
Hold

Low
Jefferies Group LLC
Initiates
Cardinal Health (CAH)
Hold

Low
JPMorgan Chase & Co.
Upgrades
Clovis Oncology (CLVS)
Neutral -> Overweight

Low
Jefferies Group LLC
Initiates
McKesson (MCK)
Hold

Low
Goldman Sachs Group
Initiates
Acceleron Pharma (XLRN)
Sell

Low

Gainers (% price change) Last Trade Change Mkt Cap
Alnylam Pharmaceuticals ALNY 72.01 +6.01 (9.11%) 7.22B
ImmunoGen, Inc. IMGN 4.86 +0.30 (6.58%) 482.95M
Catalyst Pharmaceuticals CPRX 2.11 +0.09 (4.46%) 183.14M
Cumberland CPIX 6.64 +0.28 (4.40%) 105.50M
Accelerate Diagnostics AXDX 29.20 +1.10 (3.91%) 1.64B
Losers (% price change)
Davita Inc DVA 62.09 -3.94 (-5.97%) 11.97B
Rexahn Pharmaceuticals RNN 4.07 -0.23 (-5.35%) 104.44M
Depomed Inc DEPO 11.19 -0.57 (-4.85%) 695.23M
Sangamo Therapeutics Inc SGMO 8.00 -0.40 (-4.76%) 589.55M
AcelRx Pharmaceuticals ACRX 2.50 -0.10 (-3.85%) 117.99M
Most Actives (dollar volume)
Pfizer Inc. PFE 32.60 -0.52 (-1.57%) 194.78B
Johnson & Johnson JNJ 127.77 +0.78 (0.61%) 353.52B
UnitedHealth Group Inc UNH 168.12 -3.41 (-1.99%) 161.75B
Eli Lilly and Co LLY 78.99 -1.31 (-1.63%) 87.27B
Bristol-Myers Squibb Co BMY 54.39 -0.71 (-1.29%) 89.72B