Pharma stock under pressure: Viela Bio Inc (NASDAQ: VIE)

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Viela Bio Inc (NASDAQ: VIE) stock continued its bearish momentum on Jan 21st, 2020 (as of  11:57 am GMT-5; Source: Google finance) after falling 14.57% on Jan 20th , 2020.

On the other hand, the U.S. Food and Drug Administration (FDA) had already accepted for review the Company’s Biologics License Application (BLA) for inebilizumab, which is a clinically studied as a first-line monotherapy for neuromyelitis optica spectrum disorder (NMOSD). The FDA set a Prescription Drug User Fee Act, or PDUFA, date of June 11, 2020, which means FDA will give its decision on this date. Inebilizumab’s potential commercialization is underway currently. Therefore, if approved, in the United States, Viela will be focusing on the development of a dedicated commercial team to target medical centers of excellence. Further, Viela intends to submit an investigational new drug (IND) application and start a pivotal trial in myasthenia gravis in first half of 2020. Viela is also planning to submit an IND and start a Phase 2b trial 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, for the reduction of levels of alloantibodies in kidney transplant candidates.

Moreover, VIE has already dosed its first patient  in a Phase 2b trial of VIB4920 for the treatment of Sjögren’s syndrome, which is a chronic, systemic autoimmune disease that involves inflammation and destruction of the salivary and lacrimal glands which results in severe dryness and chronic pain.  The patients with this disease suffer from debilitating fatigue and extensive mouth and eye dryness, and in some cases, lung and kidney disease along with an increased risk of lymphoma.

VIE has partnered with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of inebilizumab in nine Asia regions, including Japan, for NMOSD and other potential future indications. The Company will receive an upfront licensing fee of $30 million along with the development and commercialization milestones and payments based, in part, on sales revenue. Viela has also currently partnered with Hansoh Pharmaceuticals Group Company Limited for the development and commercialization of inebilizumab for autoimmune diseases and hematologic cancers in China, Hong Kong and Macau. Viela received a $20 million upfront collaboration fee and is eligible to receive milestone payments of more than $203 million plus royalties on product sales.

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