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The Medicines Company ($MDCO) reported that the  FDA has agreed to a Phase 3 program for cholesterol med inclisiran that will support a New Drug Application (NDA). The news sent the stock price over 5 percent up. The company said that the late-stage program will include clinical trials in patients with atherosclerotic cardiovascular disease (ASCVD) and familial hypercholesterolemia (FH) and will collectively enroll approximately 3,000 subjects. The Medicines Company expects to submit its NDA for ASCVD and FH at the end of 2019.
The company stock has gained over 37 percent in the past 12 months while its Year to Date gain stands at over 44 percent.

Akebia Therapeutics ($AKBA) stock jumped as the company announced expanding its vadadustat collaboration with Otsuka Pharmaceutical ($OTSKY). The augmented collaboration provides Otsuka the commercialization rights in  Europe, China, Russia, Canada, Australia and the Middle East. The deal also provides for the payment of at least $208 million in committed capital from Otsuka to Akebia. This will include upfront payment of $73 million and minimum $135 million in development funding.
The original collaboration was inked in December last year and entailed co-development of the HIF stabilizer in the US. Akebia stock jumped over 33 percent in pre-market trading session, trimming its Year to Date losses to 10 percent.

 

Laboratory Corporation of America Holdings ($LH) announced its plans to expand its launchPad business process improvement initiative to its Covance Drug Development unit.  The company plans to implement this two-phase plan over the course of three years. The first phase involves better alignment of  Covance's resources with its near-term outlook. The second phase involves long-term structural changes designed to create a more efficient business model.

Shire Plc ($SHPG) announced receiving conditional approval from the European Commission for its Natpar product. The product is designed for the adjunctive treatment of adults with chronic hypoparathyroidism that cannot be adequately controlled with standard therapy alone. Natpar is marketed in the U.S. as Natpara.

Paratek Pharmaceuticals ($PRTK) reported data from a Phase 1 study of its road spectrum antibiotic omadacycline showed intravenous administration produced steady-state concentrations in the plasma and key structures that were 3x higher than tigecycline in healthy subjects. There were no serious adverse events following IV dosing and there was a lower incidence of gastrointestinal adverse events compared to tigecycline.
Catabasis Pharmaceuticals ($CATB) reported data from Part B of its Phase 2 clinical trial, MoveDMD, assessing edasalonexent in boys with Duchenne muscular dystrophy. The functional data showed a numerical improvement, but none are statistically significant since the study was not powered to demonstrate it for these parameters.

 

Alere ($ALR) announced the commercial launch of the Alere Malaria Ag P.f., a rapid blood screening test for malaria infection in asymptomatic people. The company claimed that the test  has more than 10x better sensitivity than other rapid tests with a shorter turnaround time.

Valeant Pharmaceuticals ($VRX) filed a marketing application in Canada seeking approval to sell Contrave, an obesity treatment. If approved, Contrave will be marketed by Valeant Canada under its August 2016 distribution agreement with Orexigen.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Rodman & Renshaw
Initiates
Apricus Biosciences (APRI)
Buy

High
Raymond James Financial
Downgrades
C R Bard (BCR)
Strong-Buy -> Mkt Perform

Low
Jefferies Group LLC
Reiterates
CytomX Therapeutics (CTMX)
Buy
$25.00
Low
Mizuho
Raises Target
Quest Diagnostics (DGX)
Buy
$110.00 -> $115.00
Low
Edward Jones
Downgrades
Express Scripts Holding Company (ESRX)
Buy -> Hold

Low
Jefferies Group LLC
Reiterates
Lantheus Holdings (LNTH)
Buy
$15.00
Low
Jefferies Group LLC
Reiterates
MEDNAX (MD)
Hold
$58.00
Low
Needham & Company LLC
Reiterates
MiMedx Group (MDXG)
Buy
$15.00
Low
Needham & Company LLC
Reiterates
Stryker (SYK)
Sell

Low

Gainers (% price change) Last Trade Change Mkt Cap
HealthStream, Inc. HSTM 27.81 +4.19 (17.74%) 882.48M
Sangamo Therapeutics Inc SGMO 4.75 +0.45 (10.47%) 357.44M
Albany Molecular Research AMRI 17.54 +1.63 (10.25%) 753.03M
Antares Pharma Inc ATRS 3.06 +0.25 (8.90%) 473.36M
Achillion Pharmaceuticals ACHN 3.48 +0.27 (8.41%) 419.59M
Losers (% price change)
The Medicines Company MDCO 49.11 -2.34 (-4.55%) 3.48B
Laboratory Corp. of LH 138.89 -5.72 (-3.96%) 14.36B
Eli Lilly and Co LLY 81.20 -2.22 (-2.66%) 91.27B
Teva Pharmaceutical TEVA 30.76 -0.84 (-2.66%) 31.66B
AcelRx Pharmaceuticals ACRX 2.55 -0.05 (-1.92%) 117.87M
Most Actives (dollar volume)
Akorn, Inc. AKRX 33.09 +0.37 (1.13%) 4.09B
C R Bard Inc BCR 303.51 +1.10 (0.36%) 26.23B
Biogen Inc BIIB 286.89 +10.03 (3.62%) 62.84B
Eli Lilly and Co LLY 81.20 -2.22 (-2.66%) 91.27B
Becton Dickinson and Co BDX 179.07 +2.00 (1.13%) 36.42B