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0.000262444230601007 0.00122473974280466 -0.000437407051001637 0.000349925640801384 0.000962295512203652 -0.00411162627941561 -0.00516140320181964 -0.00594873589362254
Stock impact report

Mesoblast (MESO) to File Pediatric GVHD Drug BLA, Stock Up [Yahoo! Finance]

Incyte Corporation (INCY) 
Last incyte corporation earnings: 2/13 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: incyte.com/ir/investor-overview.aspx
Company Research Source: Yahoo! Finance
is being developed for the treatment of pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD). Post additional scrutinization, the FDA informed the company that the available clinical data from the phase III MSB-GVHD001 study of remestemcel-L is adequate to support the resubmission of the biologics license application (BLA) for remestemcel-L to treat pediatric patients with SR-aGVHD. Mesoblast is currently gearing up to file the BLA resubmission during the second quarter of 2024, seeking to address all remaining product characterization issues. Presently, there are also no approved therapies in the United States for patients under 12 years of age suffering from aGvHD, which provides MESO with a significant market opportunity, subject to the FDA approval of the regulatory filing for remestemcel-L in this indication. In the past year, shares of MESO have plunged 37% compared with the industry's 8.5% decline. Image Source: Zacks Investment Resear Show less Read more
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