VYGR Sails Ahead, SGYP Awaits FDA Decision, AMRN Readies For Landmark Trial Data

Dec20 up 122017

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

1. Voyager Therapeutics Inc. (VYGR)

Gained 11.16% to close Wednesday's (Dec.20) trading at $15.74.

News: No news

Near-term catalysts:

-- Dose the first patient in its pivotal phase 2/3 program of VY-AADC01 in advanced Parkinson's disease patients during Q2, 2018.
-- Identify a lead clinical candidate for the treatment of Friedreich's ataxia during 2018.
-- Advance VY-SOD101 for monogenic form of ALS, VY-HTT01 for Huntington's disease and VY-FXN01 for Friedreich's ataxia towards IND filing in 2019.

2. Synergy Pharmaceuticals Inc. (SGYP)

Gained 9.76% to close Wednesday's trading at $2.25.

News: Troy Hamilton, previously Executive Vice President, Chief Commercial Officer, has taken over as CEO of the Company, effective immediately. Gary S. Jacob, previously President, CEO and Chairman, has assumed the position of Executive Chairman of the Board of Directors.

Recent event:

-- On November 9, 2017, the Company reported Q3, 2017 financial results.

The net loss for the third quarter ended September 30, 2017 was $48.87 million or $0.22 per share on total net sales of $5.0 million. This compared with a net loss of $40.24 million or $0.22 per share and nil sales in the year-ago period.

The Company's marketed drug is Trulance, which was approved by the FDA in January of this year, for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients. The drug was launched in the market in mid-March.

Near-term catalyst:

-- The Company's supplemental New Drug Application for TRULANCE for the treatment of adults with irritable bowel syndrome with constipation is under FDA review - with a decision date set for January 24, 2018.

3. Fulgent Genetics Inc. (FLGT)

Gained 9.70% to close Wednesday's trading at $4.41.

News: No news

Recent event:

-- On November 6, 2017, the Company reported Q3, 2017 financial results and provided guidance for the fourth quarter.

GAAP loss for the third quarter of 2017 was $1.1 million or $0.06 per share, and non-GAAP loss, which excludes equity-based compensation expenses and equity loss in investee, and uses a corporate tax rate of 36% for the quarter, was $442,000, or $0.02 per share.

Revenue for the recent third quarter was $4.5 million, a decrease of 10% year over year from $5.0 million in the third quarter of 2016.

Looking ahead to the fourth quarter, the Company expects revenue to increase to $5 million.

4. Deciphera Pharmaceuticals Inc. (DCPH)

Gained 9.19% to close Wednesday's trading at $18.66.

News: No news

Recent events:

-- On October 3, 2017, the Company closed its initial public offering of 7.5 million shares of its common stock at a public offering price of $17.00 each.
-- The Company was added to the Russell 2000 Index, as part of Russell's quarterly IPO additions, effective December 15, 2017, after market close.


The Company's lead candidate is DCC-2618, currently in a first-in-human Phase 1 clinical trial. DCC-2618 is in clinical development for the treatment of KIT and/or PDGFRa-driven cancers, including gastrointestinal stromal tumors, glioblastoma multiforme and systemic mastocytosis. DCC-2618 is designated an Orphan Drug by the EMA.

Near-term catalysts:

-- Plans to initiate two pivotal phase III clinical trials of DCC-2618 in gastrointestinal stromal tumors in 2018 - a placebo-controlled randomized, pivotal Phase 3 clinical trial in patients with fourth-line GIST in the first half of 2018 and a second pivotal Phase 3 clinical trial comparing DCC-2618 to Pfizer's Sutent in second-line GIST patients in the second half of 2018.

5. Amarin Corporation plc (AMRN)

Gained 8.91% to close Wednesday's trading at $3.91.

News: The Company announced that it is on track to report clinical results from its REDUCE-IT trial before the end of Q3, 2018.

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.

The REDUCE-IT study has enrolled 8,175 patients who have been randomized, in accordance with the study protocol, on a 1:1 basis between Vascepa and placebo.

The final patient visits of the study are expected to commence on March 1, 2018. The onset of the targeted 1,612th primary major adverse cardiovascular event (MACE) in this study is projected to occur before the end of Q1 2018, noted the Company.

6. Dicerna Pharmaceuticals Inc. (DRNA)

Gained 8.57% to close Wednesday's trading at $7.98.

News: No news

The Company is involved in developing subcutaneously delivered ribonucleic acid interference (RNAi)-based pharmaceuticals to treat chronic liver diseases, cardiovascular diseases and viral infectious diseases.

Near-term catalysts:

-- Upon approval by the MHRA in the United Kingdom, a phase I study of DCR-PHXC for primary hyperoxaluria is expected to be conducted in the first quarter of 2018.
-- File an IND application in the U.S. and/or CTA in Europe for a second candidate for an undisclosed rare disease involving the liver in the second quarter of 2018.
-- File an IND application in the U.S. or CTA in Europe for DCR-HBVS program, which targets HBV directly, at approximately the end of 2018.

7. Apollo Endosurgery Inc. (APEN)

Gained 8.24% to close Wednesday's trading at $4.60.

News: No news

The Company deals with less invasive medical devices for bariatric and gastrointestinal procedures.

Recent event:

-- On November 27, 2017, the Company received FDA Clearance for OverStitch Sx endoscopic suturing system. It will be introduced in the US and Europe in the first half of 2018.
-- On October 26, 2017, the Company reported third quarter financial results.

In the third quarter ended September 30, 2017, the Company's total sales were $16.5 million compared to $15.8 million in the year-ago quarter. The Company generates sales from Endo-bariatric products and surgical products.

Net loss for the recent third quarter narrowed to $4.9 million or $0.32 per share from $5.93 million or $24.85 per share in the year-ago quarter.

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