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Viela Bio (VIE) Hits Record High, Faces FDA In June

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Shares of Viela Bio Inc. (VIE), which have been hitting new highs, are up a whopping 100% since the Company's market debut on October 3, 2019.

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), in February 2018.

The Company's lead drug candidate Inebilizumab, proposed as a first-line monotherapy for neuromyelitis optica spectrum disorder, is under FDA review, with a decision expected on June 11, 2020.

Neuromyelitis optica spectrum disorder, previously known as Devic's disease, is a severe and rare autoimmune disease characterized by debilitating relapse/attacks, which often leads to blindness and paralysis. About 10,000 people in the U.S., 8,000 in Europe and 5,000 in Japan are said to suffer from this disease.

Inebilizumab's potential is also being explored in the indications of Myasthenia Gravis, IgG4-Related Disease and Kidney Transplant Desensitization.

-- A phase II trial of Inebilizumab, used alone or in combination with VIB4920, in highly sensitized patients on the deceased donor waiting list for kidney transplantation was initiated last month.
-- In the first half of this year, Viela is planning to submit an investigational new drug (IND) application and initiate a pivotal trial of Inebilizumab in myasthenia gravis, and submit an IND and initiate a phase IIb trial of Inebilizumab in IgG4-Related Disease.

Viela has a strategic collaboration with Mitsubishi Tanabe Pharma Corp. to develop and commercialize Inebilizumab in nine Asia regions for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential future indications. The nine Asian countries are Japan, Thailand, South Korea, Indonesia, Vietnam, Malaysia, Philippines, Singapore, and Taiwan.

Next up in the pipeline is VIB4920, a fusion protein designed to inhibit the stimulation of dendritic cells and monocytes by T cells, which reduces the production of proinflammatory mediators and with the potential to address multiple indications involving co-stimulatory pathway.

-- 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 month.
-- A phase II trial of VIB4920 and Belatacept for prophylaxis of allograft rejection in adults receiving a kidney transplant was initiated last October.

The third clinical asset of the Company is VIB7734, which is under phase Ib multiple ascending dose trial in patients with cutaneous lupus erythematosus. The trial has 3 cohorts - 8 patients in cohort 1 and 12 each in cohorts 2 and 3.

The interim efficacy analysis in cohorts 2 and 3 of the phase Ib multiple ascending dose trial of VIB7734 is planned for the first half of 2020.

Viela Bio went public on the Nasdaq Global Select Market on October 3, 2019, offering its shares at a price of $19 each. The stock opened the first day of trading at $21.50 and closed at $23.41. The IPO lock-up period expires on March 31, 2020.

VIE touched a record high of $47.79 in intraday trading on Thursday (Jan.16, 2020) before closing at $47.00, up 10.67%.

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