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GlycoMimetics ($GLYC) stock received a positive fillip as the company announced receiving Orphan Drug designation from the European Commission for its GMI-1271 drug candidate for treating acute myeloid leukemia. The drug was also awarded Breakthrough Therapy status for the same indication by the FDA last week. The Orphan Drug status in Europe offers a 10-year period of market exclusivity for the indication, if approved.
The stock has created a new 52 week high at $16.94 and is up 127 percent on Year to Date basis. Its 12 months gain stands at 88 percent. GlycoMimetics has also commenced a public offering of 7 million shares of common stock. The stock is priced at $11.50 per share.

Trovagene ($TROV) announced results from a Phase 1 safety study of blood cancer candidate PCM-075. The study showed that the most common dose-limiting toxicities were thrombocytopenia (low blood platelets) and neutropenia (low level of white blood cells called neutrophils), which was expected due to PCM-075's inhibition of polo-like kinase 1. The toxicities were reversible. The company intends to start a Phase 1/2 study in acute myeloid leukemia.
The company stock has lost over 67 percent of its value this year while its 12 months loss stands at 86 percent. It is currently trading close to its 52 weeks low of $0.65. Trovagene had licensed the drug Nerviano Medical Sciences.

 

Anika Therapeutics ($ANIK) announced enrolling the first patient for its supplemental Phase 3 clinical trial evaluating CINGAL for the treatment of osteoarthritis of the knee. The company expects to complete the study next year and anticipates approval in the U.S. in 2019. The study involves recruiting participants at 30 European sites who will receive either CINGAL or triamcinolone hexacetonide over 26 weeks.

Abeona Therapeutics ($ABEO) reported that its  lead gene therapy candidate, Phase 2-stage EB-101 has been granted an Orphan Drug status by the FDA for the treatment of dystrophic epidermolysis bullosa, a genetic skin disorder characterized by skin blisters and erosions over the body. Orphan Drug status provides a seven-year period of market exclusivity for the indication, if approved.

Intercept Pharmaceuticals ($ICPT) announced receiving conditional approval from Health Canada for its Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC) when used in combination with ursodeoxycholic acid (UDCA) in adults who fail to respond adequately to UDCA or as monotherapy in adult patients unable to tolerate UDCA. The approval is subject to the results of clinical trials to confirm its treatment benefit.

Pfizer ($PFE) received the approval from the FDA’s Oncologic Drugs Advisory Committee for its biosimilar to Amgen’s Epogen (epoetin alfa) across all indications. The company is collaborating with Vifor Pharma to commercialize the product in certain channels.

 

Transgenomic ($TBIO) announced that it plans to hold a special meeting of shareholders on June 5 to vote on its proposed merger with Precipio Diagnostics. The company board has authorized a 1:30 reverse split of its common shares in order to be in compliance wiht Nasdaq listing requirements for minimum bid price.

Merck ($MRK) inked a deal with Teijin Pharmaceuticals with regard to exclusive global rights to an anti-tau antibody for the potential treatment of various nervous system disorders  including Alzheimer’s disease. Under the terms of the deal, Teijin will retain the right to co-promote the product in Japan and Merck will pay an upfront fee, milestones and royalties on net sales.

 

Patterson Companies Inc. ($PDCO) reported revenue for its fourth quarter at $1.4 billion while its reported net income  from continuing operations stood at $61.4 million, or $0.65 per diluted share, compared to $65.6 million, or $0.68 per diluted share, in last year’s fiscal fourth quarter. 

Medtronic ($MDT) reprorted 5.3 percent incarese in its profit for the fourth quarter of the year to touch $1.16 billion. On per share basis, its net income stood at $0.84 per share. Earnings, adjusted for amortization costs and non-recurring costs, stood at $1.33 per share. The company’s revenue rose 4.6 percent to $7.92 billion in the period.

Brokerage
Action
Company
Rating
Price Target
Impact on Share Price
Aegis
Reiterates
Axsome Therapeutics (AXSM)
Buy
$20.00
Medium
Aegis
Reiterates
Mediwound Ltd (MDWD)
Buy
$11.00
Low
Bank of America Corp
Reiterates
Amicus Therapeutics (FOLD)
Buy
$9.00 -> $10.00
Medium
Bank of America Corp
Reiterates
Puma Biotechnology (PBYI)
Buy
$72.00 -> $86.00
Low
BMO Capital Markets
Reiterates
Neurocrine Biosciences (NBIX)
Outperform
$75.00
Low
Cantor Fitzgerald
Reiterates
Biogen (BIIB)
Hold
$277.00
Low
Cowen and Company
Upgrades
Puma Biotechnology (PBYI)
Neutral -> Outperform
$91.00
N/A
Credit Suisse Group AG
Reiterates
Puma Biotechnology (PBYI)
Outperform
$58.00 -> $90.00
N/A
Deutsche Bank AG
Reiterates
Alexion Pharmaceuticals (ALXN)
Buy
$160.00 -> $153.00
High

Gainers (% price change) Last Trade Change Mkt Cap
BioCryst Pharmaceuticals BCRX 6.73 +1.60 (31.19%) 539.13M
Insys Therapeutics Inc INSY 14.21 +0.79 (5.89%) 1.04B
Cutera, Inc. CUTR 23.50 +1.20 (5.38%) 325.68M
Rockwell Medical Inc RMTI 7.48 +0.38 (5.35%) 412.02M
Patterson Companies, Inc. PDCO 44.75 +1.68 (3.90%) 4.30B
Losers (% price change)
Cerus Corporation CERS 2.02 -0.24 (-10.62%) 210.89M
AMAG Pharmaceuticals, Inc AMAG 18.20 -1.05 (-5.45%) 678.35M
ZIOPHARM Oncology Inc. ZIOP 6.57 -0.35 (-5.06%) 922.87M
Sarepta Therapeutics Inc SRPT 30.85 -1.64 (-5.05%) 1.71B
Compugen Ltd. (USA) CGEN 5.10 -0.25 (-4.67%) 261.76M
Most Actives (dollar volume)
Alexion Pharmaceuticals ALXN 98.50 -2.58 (-2.55%) 21.37B
Johnson & Johnson JNJ 127.53 +0.05 (0.04%) 343.52B
UnitedHealth Group Inc UNH 178.05 +2.49 (1.42%) 171.94B
Pfizer Inc. PFE 32.16 +0.11 (0.34%) 190.98B
Bristol-Myers Squibb Co BMY 54.39 +0.57 (1.06%) 88.96B