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18.12.2019 04:53:00

Top Gainers: VIE To Face FDA In June, NLTX Up 65% In Dec., Be AWARE Of ONCY

(RTTNews) - The following are some of today's top gainers in the healthcare sector.

1. Oncolytics Biotech Inc. (ONCY)

Gained 34.33% to close Tuesday's (Dec.17) trading at $1.80.

News: No news

Clinical Trials & Near-term Catalysts:

The Company's lead product candidate is Pelareorep, an intravenously delivered immuno-oncolytic virus in metastatic breast cancer, under a phase I study, in combination with or without Roche's Tecentriq, dubbed AWARE-1.

Interim data from the AWARE-1 trial is due this quarter.

A phase II study of Pelareorep in patients with hormone receptor-positive (HR+) metastatic breast cancer is expected to be initiated in the first quarter of 2020.

2. Venus Concept Inc. (VERO)

Venus Concept, which is the result of the reverse merger between Restoration Robotic Inc. and Venus Concept Ltd., is a global medical aesthetic technology company.

Gained 26.38% to close Tuesday's trading at $5.94.

News: No news

Recent event:

On November 7, 2019, the Company announced that it expects 2019 annual revenue to be in the range of $123 million to $126 million.

3. Viela Bio Inc. (VIE)

Viela Bio is a clinical-stage biotechnology company developing therapeutics for patients with autoimmune and severe inflammatory diseases. Viela Bio was spun out of MedImmune, a division of AstraZeneca (AZN), last February.

Gained 19.92% to close Tuesday's trading at $28.66.

News: No news

Clinical Trials & Near-term Catalysts:

-- The Company's Biologics License Application for Inebilizumab as a first-line monotherapy for neuromyelitis optica spectrum disorder is under FDA review, with a decision expected on June 11, 2020. -- Viela is planning to submit an investigational new drug (IND) application and initiate a pivotal trial of Inebilizumab in myasthenia gravis in first half of 2020. -- In addition, Viela is planning to submit an IND and initiate a phase IIb trial of Inebilizumab in IgG4-related disease in the first half of 2020. -- Furthermore, Viela is planning to initiate a Phase 2 proof-of-concept study to explore the potential of inebilizumab, used alone or in combination with VIB4920, to reduce levels of alloantibodies in kidney transplant candidates thereby improving transplant outcomes before the end of 2019. -- A phase IIb trial of VIB4920 for the treatment of Sjögren's syndrome—a chronic, systemic autoimmune disease involving inflammation and destruction of the salivary and lacrimal glands which leads to severe dryness and chronic pain, was initiated last week. -- A phase 1b multiple ascending dose trial of VIB7734 in patients with cutaneous lupus erythematosus is ongoing.

4. Satsuma Pharmaceuticals Inc. (STSA)

Satsuma Pharma is a clinical-stage biopharmaceutical company focused on developing STS101 (dihydroergotamine mesylate (DHE) nasal powder) for the acute treatment of migraine.

Gained 19.49% to close Tuesday's trading at $15.82.

News: No news

Recent event:

The Company's stock made its debut on the NASDAQ on September 13, 2019, at an opening price of $18.34.

Clinical Trials & Near-term Catalysts:

-- A phase III trial of STS101 in approximately 1,140 migraine patients, dubbed EMERGE, is underway, with top-line data anticipated in the second half of 2020. -- If all goes well as planned, the Company has planned to initiate a 12-month safety trial of STS101, with NDA filing anticipated by the end of 2021.

5. Neoleukin Therapeutics Inc. (NLTX)

Gained 13.27% to close Tuesday's trading at $9.22. The stock touched a 52-week high of $9.54 in intraday trading.

News: No news

Pipeline & Near-term Catalysts:

The lead program is NL-201, the world's first computationally-designed de novo protein therapeutic, which is a potential cancer immunotherapy, under preclinical testing.

--Preclinical and scientific data related to NL-201 are expected to be presented in the first half of 2020. -- An IND for NL-201 is expected to be submitted by the end of 2020.

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