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ADIL Leaps, HIIQ Settles With Insurance Regulators, KZR Hits New High

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

1. Adial Pharmaceuticals Inc. (ADIL)

Gained 104.93% to close Thursday's (Dec.13) trading at $4.16.

News: The Company announced that it is planning to explore the potential of its lead asset AD04, beyond alcohol use disorder, to now include its potential use in patients with opioid use disorder.

Clinical Trial & Near-term Catalyst:

The lead investigational product is AD04 for the treatment of alcohol use disorder "AUD".

A Phase 2b clinical trial of AD04 for the treatment of AUD showed promising results in reducing frequency of drinking, quantity of drinking and heavy drinking (all with statistical significance), and no overt safety concerns, according to the Company.
A phase III clinical trial of AD04 is expected to begin in the first half of 2019.

2. Health Insurance Innovations Inc. (HIIQ)

Gained 19.08% to close Thursday's trading at $35.82.

News: Health insurance has entered into a settlement agreement with insurance regulators in 43 states related to the Company's 2016 multi-state market conduct examination that reviewed its sales, marketing, and administration practices.

As part of the agreement, among other things, the Company will pay to the Settling Jurisdictions a "Multistate Payment" in the aggregate amount of $3.4 million for the examination, administrative costs, and compliance in connection with the market conduct examination.

The Company also announced that its Board of Directors authorized an increase in its previously disclosed share repurchase program from $50 million to $100 million of the Company's outstanding Class A Common Stock.

3. Zai Lab Limited (ZLAB)

Gained 16.71% to close Thursday's trading at $24.72.

News: The China National Medical Products Administration has accepted the Company's New Drug Application for ZEJULA, as a Category 1 drug for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal ovarian cancer who are in a complete or partial response to platinum-based chemotherapy.

Zejula was approved in the U.S. in March 2017, and in Hong Kong as recently as October of this year.

4. Neurotrope Inc. (NTRP)

Gained 16.23% to close Thursday's trading at $4.44.

News: No news

Clinical Trial & Near-term Catalyst:

A confirmatory phase II trial evaluating 20 µg dose of Bryostatin-1 in moderate-to-severe Alzheimer's disease patients not on *memantine is underway. Data from this study are expected during the second half of 2019.

*Memantine is a prescription medicine used to treat moderate to severe Alzheimer's disease.

5. Forty Seven Inc. (FTSV)

Gained 14.95% to close Thursday's trading at $22.45.

News: No news

Pipeline:

The most advanced ongoing clinical trial is a phase 1b/2 combination trial using 5F9 and rituximab in patients with relapsed and refractory NHL. A phase 1b/2 combination clinical trial of 5F9 and cetuximab in patients with advanced relapsed or refractory solid tumors, including colorectal cancer is also underway.

FSI-189, an anti-SIRPa antibody, for the treatment of cancer is under preclinical testing.

Recent event:

The Company went public on the Nasdaq Global Select Market on June 28, 2018, offering its shares at a price of $16 each.

6. Kezar Life Sciences Inc. (KZR)

Gained 12.29% to close Thursday's trading at $32.90.

News: No news

Clinical Trials & Near-term Catalysts:

Enrollment continues in phase Ib/II trial of KZR-616 in lupus and lupus nephritis, with top-line results from the initial two cohorts of the Phase 1b expected in the first half of 2019.

The phase II portion of the trial in lupus nephritis patients is expected to be initiated during the first half of 2019.

Recent event:

The Company went public on the Nasdaq Global Select Market on June 21, 2018, offering its shares at a price of $15 per share.

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