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GlycoMimetics ($GLYC) reported receiving the FDA Breakthrough Therapy Designation for its GMI-1271 drug candidate. The drug is designed to be used for treating adult relapsed/refractory acute myeloid leukemia. It is currently being evaluated in the Phase 2 portion of a Phase 1/2 clinical trial in patients with AML. GlycoMimetics stock jumped over 33 percent in the pre-market session, trimming its 12 months losses down to 14 percent.
The company also announced new data from the ongoing Phase 2 clinical trial showing higher-than-expected remission rates and lower-than-expected induction-related mortality rates. The researchers also observed that baseline expression of the E-selectin ligand biomarker on leukemia cells was predictive of clinical response.

Syndax Pharmaceuticals ($SNDX) announced its non-small cell lung cancer cohort for ENCORE 601 study meeting its pre-specified objective response threshold. This will allow the progression to the second stage of the trial. The company also said that the enrollment has been opened with with the immediate effect. The cohort consisted of NSCLC patients who failed to respond to anti-PD-1 or PD-L1 therapy. 
The company stock gained over 44 percent in its previous trading session, pushing its Year to Date gain to 89 percent. The stock is up 6 percent in the past 12 months.

 

Endologix ($ELGX) reported that it will conduct a new confirmatory study on its Nellix Endovascular Aneurysm Sealing System. The new study will incorporate previously updated instructions for the use of the system. It will also employ  the Gen2 device design, which is currently marketed in Europe and other international markets. The company expects to start the enrollment process in Q4.
AB Sciences ($ABSCF) has been handed a negative opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use for its  marketing application seeking approval of masitinib for the treatment of adult patients with smoldering or indolent systemic severe mastocytosis who have not responded to other treatments. The committee expressed concerns about the reliability of clinical trial results after on-site inspections.

Vertex Pharmaceuticals ($VRTX) announced receiving the FDA approval for its Kalydeco for the e treatment of cystic fibrosis patients with 33 genetic mutations, up from 10 mutations. The approval is partially based on laboratory test results. It also used the results from earlier clinical trials.
Dr. Reddy’s Laboratories ($RDY) announced receiving approval from the FDA for the launch of its Doxorubicin Hydrochloride Liposome Injection. The injection is a therapeutic equivalent generic version of Doxil. The company expects the commercial launch in near future.

 

Express Scripts ($ESRX) acquires myMatrixx for an undisclosed sum. The Tampa based firm provides pharmacy benefit solutions for the workers compensation industry. MyMatrixx CEO Artemis Emslie will lead the workers comp team.
Aduro Biotech ($ADRO) announced its collaboration with Merck for a  Phase 2 clinical trial assessing CRS-207, with Keytruda (pembrolizumab) in patients with treatment-resistant malignant pleural mesothelioma. The companies have already collaborated on assessing the combination in a Phase 2 study in gastric cancer.

 

Immune Design Corp ($IMDZ) reported its net loss and net loss per share for the first quarter of 2017 were $12.6 million and $0.50, respectively, compared to $12.3 million and $0.61, respectively, for the first quarter of 2016. Its revenue for the first quarter of 2017 was $5.5 million, up from $1.9 million for the previous corresponding quarter.
ObsEva ($OBSV) announced that its net loss for the first quarter of 2017 was $15.5 million, or $0.58 per basic and diluted share.  As of March 31, 2017, ObsEva had cash and cash equivalents of $104.2 million. The company’s research and development expenses for the quarter were $13.1 million and general and administrative expenses were $2.7 million.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Leerink Swann
Upgrades
Achillion Pharmaceuticals (ACHN)
Market Perform -> Outperform

High
HC Wainwright
Lowers Target
Aurinia Pharmaceuticals (AUPH)
Buy -> Buy
$12.00 -> $10.00
Medium
Maxim Group
Upgrades
Bioline RX Ltd (BLRX)
Hold -> Buy
$1.00 -> $3.00
High
Stifel Nicolaus
Downgrades
Endologix (ELGX)
Buy -> Hold
$10.00 -> $5.50
Low
BTIG Research
Downgrades
Endologix (ELGX)
Buy -> Neutral
$7.00
Low
Stifel Nicolaus
Raises Target
Johnson & Johnson (JNJ)
Hold -> Hold
$124.00 -> $128.00
Low
Ladenburg Thalmann Financial Services
Upgrades
Tenax Therapeutics (TENX)
Neutral -> Buy

High

Gainers (% price change) Last Trade Change Mkt Cap
Omeros Corporation OMER 16.25 +1.30 (8.70%) 711.16M
CARDIOME PHARMA CORP CRME 3.63 +0.21 (6.14%) 115.38M
BioDelivery Sciences Intl BDSI 2.05 +0.10 (5.13%) 110.58M
Davita Inc DVA 63.95 +1.86 (3.00%) 11.70B
Fonar Corporation FONR 23.40 +0.60 (2.63%) 149.50M
Losers (% price change)
Oclaro, Inc. OCLR 8.35 -0.88 (-9.53%) 1.41B
Meridian Bioscience, Inc. VIVO 13.45 -1.30 (-8.81%) 563.81M
Fluidigm Corporation FLDM 5.47 -0.48 (-8.07%) 161.06M
Exelixis, Inc. EXEL 19.86 -1.70 (-7.88%) 5.77B
Accelerate Diagnostics AXDX 26.90 -2.30 (-7.88%) 1.53B
Most Actives (dollar volume)
Pfizer Inc. PFE 32.23 -0.37 (-1.13%) 188.92B
Johnson & Johnson JNJ 126.67 -1.10 (-0.86%) 343.32B
UnitedHealth Group Inc UNH 168.86 +0.74 (0.44%) 159.49B
Gilead Sciences, Inc. GILD 64.51 -1.21 (-1.84%) 84.00B
Humana Inc HUM 224.92 -1.28 (-0.57%) 31.77B