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QURE Exudes Hope, ZFGN Catches Eyes, NDRA On Watch, XENE Hits New High

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The following are some of today's top gainers in the pharma/biotech sector.

1. uniQure N.V. (QURE)

Gained 13.58% to close Thursday's (June 28) trading at $38.55.

News: This gene therapy company has enrolled its first patient in a phase III pivotal study of AMT-061, for the treatment of patients with severe and moderately severe hemophilia B, dubbed HOPE-B.

Dosing of patients in the HOPE-B pivotal trial is expected to start early in the first quarter of 2019.

In addition to the HOPE-B trial, the Company has initiated patient recruitment for its Phase IIb dose-confirmation study, and expects to commence enrollment in July. Top-line data from this trial is expected before the end of the year.

Yesterday, B. Riley FBR analyst Madhu Kumar initiated coverage of uniQure with a Buy rating and a 12-month price target of $50 per share.

2. Zafgen Inc. (ZFGN)

Gained 12.94% to close Thursday's trading at $9.60.

News: The Company has offered to sell 8 million shares of its common stock to the public at a price of $7.50 each for total gross proceeds of $60 million. The underwriters have a 30-day option to purchase up to an additional 1.2 million shares of common stock.

The offering is expected to close on July 2, 2018, subject to customary closing conditions.

As of March 31, 2018, the Company had cash of $89.1 million.

Recent events:

-- On June 25, 2018, the Company joined the Russell 3000 Index.
-- On June 23, 2018, the Company announced positive full results from its phase II clinical trial of ZGN-1061 in patients with type 2 diabetes. Additionally, supportive nonclinical data for ZGN-1061, including data on combination treatment with ZGN-1061 and liraglutide, and data on treatment with ZGN-1061 in nonalcoholic steatohepatitis (NASH) were reported.

It is estimated that up to 70 percent of people with type 2 diabetes have concomitant NASH.

3. ENDRA Life Sciences Inc. (NDRA)

Gained 13.10% to close Thursday's trading at $2.85.

News: No news

ENDRA is developing a next generation Thermo-Acoustic Enhanced UltraSound (TAEUS) system that will help clinicians to visualize tissue function, composition, and monitor a variety of therapeutic interventions at the point of care.

The first TAEUS application will focus on the quantification of fat in the liver, for early detection and monitoring of Non-Alcoholic Fatty Liver Disease.

Near-term Catalyst:

Human studies for TAEUS clinical product targeting NAFLD is underway, and at the time of reporting Q1, 2018 financial results last month, the Company had stated that its expects the first human study to be completed by mid-2018.

4. Amarin Corp. plc (AMRN)

Gained 10.18% to close Thursday's trading at $3.03.

News: The Company announced that the last patient study visit has occurred in its potential landmark cardiovascular outcomes study, REDUCE-IT.

REDUCE-IT is a phase III cardiovascular outcomes study to determine whether the Company's approved drug Vascepa will reduce cardiovascular risk in statin treated patients that still have elevated or high triglyceride levels.

Approved in July 2012, Vascepa is indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Near-term Catalyst:

-- Top-line results from the REDUCE-IT trial are expected to be reported before the end of Q3, 2018.

5. Xenon Pharmaceuticals Inc. (XENE)

Gained 9.49% to close Thursday's trading at $8.65.

News: No news


The clinical stage drug candidates include XEN1101 and XEN901, both of which are being developed for the treatment of epilepsy, and XEN007 for the treatment of hemiplegic migraine (HM), a rare and debilitating neurological disorder. There is also a partnered clinical program with Genentech - GDC-0310 to treat pain.

Near-term Catalysts:

-- Present complete results from a phase I trial evaluating XEN901's safety, tolerability and pharmacokinetics in both single ascending dose (SAD) and multiple ascending dose (MAD) cohorts of approximately 64 healthy subjects in the second half of this year, and initiate a Phase 2 clinical trial thereafter.
-- Positive interim data from the ongoing phase I trial of XEN1101 were released last month. A phase II trial of XEN1101 in adult patients with focal seizures is expected to start by year-end.
-- XEN007 for the treatment of hemiplegic migraine is a phase II-ready compound.
-- Phase II trial of GDC-0310 for the oral treatment of pain might start in the second half of this year.

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