FLGT Abuzz, INSY Breathes Easy, NITE Sparkles

pharma daily 061218

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

1. Fulgent Genetics Inc. (FLGT)

Gained 30.38% to close Thursday's (June 14) trading at $4.85.

News: No news

Recent event:

On May 7, the Company reported financial results for its first quarter ended March 31, 2018.

On a non GAAP basis, the Company incurred a loss of $1.16 million or $0.11 per share compared to net income of $560 thousand or $0.01 per share in the year-ago quarter.
First quarter revenue was $4.7 million, a decrease of 12% year over year from $5.3 million in the first quarter of 2017.

2. Flex Pharma Inc. (FLKS)

Gained 29.81% to close Thursday's trading at $1.35. The stock is recovering some of what it lost yesterday.

Recent events:

On June 13, 2018, the Company announced that it is ending its ongoing phase II clinical trial investigations of FLX-787 in amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT) due to oral tolerability concerns observed in both studies.

Based on the recent developments, the Company is restructuring its organization to reduce costs, including reducing its workforce by approximately 60%. The news sent the stock down 75% that day.

3. INSYS Therapeutics Inc. (INSY)

Gained 15.38% to close Thursday's trading at $8.10.

News: The Company announced that its investigational epinephrine nasal spray showed promise in an early clinical trial as a potential needle-free, non-invasive and easy-to-use alternative to intramuscular injection for the treatment of anaphylaxis.

The trial, which involved 60 people with seasonal allergies, showed that the bioavailability of the Company's novel, proprietary formulation of epinephrine delivered intranasally was similar to that of intramuscular injection with EpiPen (0.3 mg).

4. Viveve Medical Inc. (VIVE)

Gained 13.84% to close Thursday's trading at $3.29.

News: No news

Recent event:

On June 4, the Company announced that it has resolved its patent infringement litigation with ThermiGen LLC, ThermiAesthetics LLC, and Dr. Red Alinsod in the U.S. District Court for the Eastern District of Texas.

As part of the settlement, Viveve will receive a monetary payment and on-going royalty, as well as other mutual agreements relating to certain intellectual property owned by the companies.

5. Nightstar Therapeutics plc (NITE)

Gained 14.14% to close Thursday's trading at $15.98.

News: The FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to NSR-REP1, the Company's lead product candidate currently in Phase 3 development for the treatment of choroideremia, a rare, degenerative, genetic retinal disorder that leads to blindness.

The RMAT designation grants all of the benefits of Breakthrough Therapy Designation, including eligibility for priority review, rolling review and accelerated approval.


-- On September 28, 2017, the Company made its debut on The NASDAQ Global Select Market, offering its American Depositary Shares at a price of $14.00 per ADS.

Nightstar is a clinical-stage gene therapy company developing treatments for rare inherited retinal diseases.

Clinical Trials & Near-term Catalysts:

-- NSR-RPGR for the treatment of patients with X-linked retinitis pigmentosa, is under phase I/II clinical trial, dubbed XIRIUS. The initial data on safety and tolerability from the dose escalation cohorts of the trial is expected to be presented in Q3 2018, ahead of schedule.

-- The expansion study in the XIRIUS trial will begin in Q4, 2018. The study is intended to enroll approximately 30 patients at a therapeutic dose informed by the dose escalation study. Preliminary Data from expansion study in the XIRIUS trial is expected in mid-2019.

-- One-year follow-up data from dose escalation study is anticipated in 2H, 2019.

-- A phase III trial of iNSR-REP1 for the treatment of choroideremia, dubbed STAR, is ongoing, with enrollment expected to be completed in the first half of 2019.
One-year follow-up data from the STAR trial is expected in 2020.

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