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AstraZeneca ($AZN) reported results from its CVD-REAL studies for patients with type 2 diabetes (T2D) who were treated with SGLT-2 inhibitors.  The trial studied data  from more than 300K T2D patients across six countries and showed that treatment with SGLT-2 inhibitors [AstraZeneca's Farxiga (dapagliflozin); Janssen's Invokana (canagliflozin); Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin)] reduced the risk of hospitalization for heart failure by 39% and death from any cause by 51%. For the composite endpoint of hospitalization for heart failure and all-cause mortality, the reduction in risk was 46%
The company said that the “real-world data from this study provide striking evidence that the newer SGLT-2i class of medicines cuts the rate of hospitalizations for heart failure and death by approximately half.” AstraZeneca stock has grown by over 12 percent this year so far and is likely to maintain the momentum.

AveXis ($AVXS) stock popped as the company announced positive results from a Phase 1 trial of AVXS-101 in spinal muscular atrophy Type 1. The company said that no new treatment-related safety or tolerability findings resulted from the trial. The early-stage, dose-escalating study assessed the safety and tolerability of the gene therapy in spinal muscular atrophy (SMA) patients.

AveXis also reported its fourth quarter and full year financial results. As of December 31, 2016, the company had $240.4 million in cash and cash equivalents. Its research and development expenses were $18.3 million for the fourth quarter of 2016, including $1.6 million of non-cash stock-based compensation expense. The company’s general and administrative expenses stood at $7.2 million for the time period. It incurred net loss of $25.4 million, or $0.92 per share, for the fourth quarter, compared to a net loss of $13.2 million, or $1.82 per share, for the corresponding quarter of 2015.

 

BioDelivery Sciences International Inc. ($BDSI) reported a fourth-quarter loss of $15.9 million or $0.29 per share. It lagged behind consensus estimate of $0.28 per share in loss. The specialty pharmaceutical company posted revenue of $3.9 million in the period, beating expectations of $3.7 million in revenue. For the full year, the company’s loss stood at $67.1 million, or $1.25 per share. Its revenue was reported as $15.5 million.

Eli Lilly ($LLY) reported that a Phase 3 clinical trial, MONARCH 2, assessing abemaciclib in patients with relapsed/refractory HR+/HER2- breast cancer met its primary endpoint.  The participants treated with abemaciclib and fulvestrant  showed a statistically significant improvement in progression-free survival (PFS) compared to those receiving placebo and fulvestrant.

AveXis ($AVXS) announced positive results from a Phase 1 trial of AVXS-101 in spinal muscular atrophy Type 1. No new treatment-related safety or tolerability findings resulted from the trial. The key measures of efficacy were the time from birth to an “event,” which was defined as either death or at least 16 hours per day of required ventilation support for breathing for 14 consecutive days in the absence of acute reversible illness or perioperatively, and video confirmed achievement of ability to sit unassisted. 

Array BioPharma ($ARRY) announced that it has withdrawn its New Drug Application (NDA) in the U.S. seeking approval of binimetinib for the treatment of NRAS mutation-positive melanoma, a rare subtype of skin cancer. The company took the decision upon receiving feedback from the FDA that concluded that data from the Phase 3 NEMO study was not sufficient to demonstrate a clinical benefit. However, it plans to continue the development.

 

Arbutus Biopharma ($ABUS) announced that it has inked a new deal with Alexion Pharmaceuticals ($ALXN). The collaboration pertains to licensning of lipid nanoparticle technology. Under the terms of the deal, Alexion will pay Arbutus $7.5 million upfront, and payments of up to $75 million for achievement of development, regulatory, and commercial milestones, as well as single digit royalties. Arbutus will also carry out technology development and provide manufacturing and regulatory support for the rapid advancement of Alexion's mRNA product candidate.

CytomX Therapeutics ($CTMX) announced that it has augmented its strategic collaboration with Bristol-Myers Squib. The newly fortified deal now includes  eight additional targets using CytomX's Probody platform. Under the terms of the new agreement, CytomX will receive an upfront payment of $200M, research funding, up to $448M in milestones and tiered mid-single-to-low-double-digit royalties on net sales of commercialized products.

 

CorMedix Inc. ($CRMD) announced its fourth quarter and full year results. The company said that for the full year, it recorded a net loss of $24.6 million, or $0.65 per share, compared with a net loss of $18.2 million, or $0.58 per share, during 2015. its cash on hand as of December 31, 2016, was $20.2 million, including short term investments, compared with $35.4 million as of December 31, 2015.  CorMedix also reported that it expects to complete enrollment in LOCK-IT 100 study by year-end 2017. It is likely to report top-line data in the second half of 2018.

Caladrius Biosciences Inc. ($CLBS) reported that its total revenue for the fourth quarter of 2016 increased 35% to $10.2 million compared with $7.6 million in the fourth quarter of 2015. The net loss attributable to Caladrius common stockholders for the fourth quarter was $6.0 million or $0.73 per share, compared to $33.2 million or $5.92 per share for same period in 2015. For the full year, the company’s full revenue stood at $35.3 million while net loss was reported at $32.7 million.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Goldman Sachs Group
Lowers Target
Amgen (AMGN)

$202.00
Low
Cowen and Company
Lowers Target
Array Biopharma (ARRY)

$14.00
Low
Janney Montgomery Scott
Reiterates
BioDelivery Sciences International (BDSI)
Buy

Low
Wedbush
Reiterates
Catabasis Pharmaceuticals (CATB)
Outperform
$4.00
Low
HC Wainwright
Lowers Target
Fate Therapeutics (FATE)

$6.00
N/A
Wedbush
Initiates
Global Blood Therapeutics (GBT)
Outperform -> Reduce

Low
Leerink Swann
Upgrades
Illumina (ILMN)
Market Perform -> Outperform

Low
SunTrust Banks
Downgrades
INC Research Holdings (INCR)
Buy -> Hold
$48.00
Low
HC Wainwright
Reiterates
The Medicines Company (MDCO)
Positive

N/A
BTIG Research
Reiterates
Medtronic plc. (MDT)
Neutral

Low
Cowen and Company
Reiterates
Omeros (OMER)
Outperform

Low

Gainers (% price change) Last Trade Change Mkt Cap
BioTime, Inc. BTX 3.59 +0.49 (15.81%) 394.77M
Infinity Pharmaceuticals INFI 3.55 +0.30 (9.23%) 179.01M
MannKind Corporation MNKD 2.22 +0.15 (7.25%) 217.78M
Enzo Biochem, Inc. ENZ 7.51 +0.48 (6.83%) 346.67M
Vermillion, Inc. VRML 2.33 +0.13 (5.91%) 121.79M
Losers (% price change)
Omeros Corporation OMER 10.54 -1.06 (-9.14%) 452.33M
The Medicines Company MDCO 48.38 -4.20 (-7.99%) 3.34B
Cytokinetics, Inc. CYTK 12.40 -0.95 (-7.12%) 506.07M
Amgen, Inc. AMGN 168.61 -11.50 (-6.38%) 122.48B
CTI BioPharma Corp CTIC 4.20 -0.18 (-4.11%) 120.19M
Most Actives (dollar volume)
Amgen, Inc. AMGN 168.61 -11.50 (-6.38%) 122.48B
Johnson & Johnson JNJ 128.06 -0.40 (-0.31%) 347.47B
Pfizer Inc. PFE 34.32 -0.11 (-0.32%) 203.09B
Gilead Sciences, Inc. GILD 69.06 +0.52 (0.76%) 90.36B
Regeneron Pharmaceuticals REGN 380.29 -12.30 (-3.13%) 39.81B