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AGEN Soars On GILD Deal, FENC Rolling Ahead, AIMT Gaining Steam

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

1. Vaxart Inc. (VXRT)

Vaxart is a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection.

Gained 24.43% to close Thursday's (Dec.20) trading at $2.75.

News: No news

Clinical Trials & Near-term Catalysts:

-- In October, the Company announced data from its phase II Challenge Study of its H1 influenza oral tablet vaccine. According to the trial results, the oral tablet vaccine provided 39% reduction in flu illness compared to 27% for Sanofi's Fluzone.
-- A phase I bivalent and phase II challenge norovirus studies are expected to begin in the first half of 2019.
-- An IND for the Company's first therapeutic vaccine for the treatment of human papillomavirus is expected to be filed in 2019.

2. Agenus Inc. (AGEN)

Gained 23.38% to close Thursday's trading at $2.48.

News: Gilead Sciences Inc. (GILD) and Agenus have entered into a partnership to develop and commercialize up to five novel immuno-oncology therapies.

Gilead will receive worldwide exclusive rights to Agenus' AGEN1423, and also receive the exclusive option to license two additional programs - AGEN1223 and AGEN2373.

The IND for AGEN1423 is expected to be filed by year-end 2018, and that for AGEN2373 in the first half of 2019. The IND for AGEN1223 has been filed by Agenus.

As part of the deal, Agenus will receive $150 million upon closing, which includes a $120 million upfront cash payment and a $30 million equity investment. The agreement also includes approximately $1.7 billion in potential future fees and milestones.

3. Fennec Pharmaceuticals Inc. (FENC)

Gained 19.74% to close Thursday's trading at $6.43.

News: The Company has initiated a rolling New Drug Application for PEDMARK.

PEDMARK, a unique formulation of sodium thiosulfate (STS) to be administered by infusion, is proposed for the prevention of ototoxicity induced by cisplatin chemotherapy in patients 1 month to less than 18 years of age with localized, non-metastatic, solid tumors.

The Company is targeting U.S. approval of PEDMARK in the second half of 2019. PEDMARK has been granted Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA.

4. Aimmune Therapeutics Inc. (AIMT)

Gained 15.48% to close Thursday's trading at $25.07.

News: Aimmune has initiated an international, phase III clinical trial of AR101 in peanut-allergic children ages 1-3 years, dubbed POSEIDON. AR101 is the Company's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy.

The positive results from a pivotal phase III efficacy trial of AR101 in patients with peanut allergy, dubbed PALISADE, were reported in February of this year.

5. PolarityTE Inc. (PTE)

PolarityTE is a commercial-stage biotechnology and regenerative biomaterials company.

Gained 10.66% to close Thursday's trading at $16.20.

News: No news

Recent event:

On December 19, the Company announced that SkinTE is available for use throughout the University Hospitals Cleveland Medical Center network of healthcare facilities.

SkinTE is the first commercially-available autologous, homologous product that regenerates full-thickness skin that is fully-functional, and is an alternative to skin grafts and skin substitutes. University Hospitals is the first healthcare provider in the state of Ohio to offer SkinTE to its patients.

6. Tilray Inc. (TLRY)

Gained 10.28% to close Thursday's trading at $78.30.

News: The Company has entered into a partnership with AB InBev, the world's leading brewer.

The partnership with AB InBev, which is limited to Canada, will focus on non-alcohol beverages containing tetrahydrocannabinol (THC) and cannabidiol (CBD), combining AB InBev's deep experience in beverages with Tilray's expertise in cannabis products.

The two companies intend to invest up to US$50 million each, for a total of up to US$100 million.

7. Kezar Life Sciences Inc. (KZR)

Kezar is a clinical-stage biotechnology company developing novel small molecule therapeutics for patients with autoimmune diseases and cancer.

Gained 10.25% to close Thursday's trading at $22.38.

News: No news

The Company went public on the Nasdaq Global Select Market on June 21, pricing its shares at $15 each. The stock, which opened at $20 in its market debut, touched an intraday high of $36.33 on Dec 13, a gain of nearly 82%.

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is KZR-616.

-- 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 study 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.

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