Eli Lilly and Co (NYSE: LLY) is having an relatively strong start to the trading session this morning after announcing plans to resubmit a New Drug Application with the United States Food and Drug Administration. Of course, this led to excitement among investors who sent the stock toward the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:20), LLY is trading at $79.80 per share after a gain of $1.25 per share or 1.59% thus far today.
LLY Announces Resubmission Plans
As mentioned above, Eli Lilly and Co announced today, along with Incyte Corporation (NASDAQ: INCY), that after discussions with the United States Food and Drug Administration, the company will resubmit a key New Drug Application. The application surrounds baricitinib and will be resubmitted before the end of January of 2018. Baricitinib is a once-daily oral investigational medication for the treatment of patients with moderate-to-severe rheumatoid arthritis, also known as RA.
Along with the resubmission, LLY intends on including new safety and efficacy data. It is expected that the FDA will classify the application as a Class II resubmission. If this is indeed the case, a new six-month review cycle will begin. In a statement, Christi Shaw, President at LLY Bio-Medicines, had the following to offer…
“We are committed to making life better for people living with RA. There is a significant unmet need for Americans suffering from this debilitating disease in spite of available therapies… We are pleased with the opportunity to provide our resubmission package for baricitinib sooner than anticipated and look forward to continuing to work with the FDA as we seek to bring baricitinib to people with RA in the U.S.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on LLY. In particular, we’ll be following the story surrounding the New Drug Application resubmission and are excited about the potential here. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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