MLNT stock more than tripled following Melinta Therapeutics Inc (NASDAQ:MLNT) announcing that its supplemental New Drug Application (sNDA) for Baxdela was approved by the FDA.
Big Day for MLNT Stock
Connecticut-based Melinta Therapeutics, which is involved in the development and marketing of antibiotics meant for the treatment of bacterial infections, received a major boost today from the United States Food and Drug Administration.
In a new development, the company’s supplemental New Drug Application (sNDA) for the product named Baxdela has been permitted a priority review, and as everyone knows, this is a significant milestone for Melinta. The sNDA is aimed at making the product applicable to adult patients, and needless to say, if that happens, then it will be able to cater to a much larger market.
Considering the fact that Baxdela was already granted the status of a Qualified Infectious Disease Product by the FDA earlier, it made it easier for the agency to grant this particular product review. While a standard review takes a minimum of 10 months to arrive at a conclusion, a priority review takes only six months.
More importantly, a Prescription Drug User Fee Act (PDUFA) action date has also been assigned by the FDA. The PDUFA action date is October 24, 2019, and on that day, many investors will be keeping an eye on any news from Melinta closely.
The market also reacted with great positivity to the news, and MLNT stock rose by as much as 185% to $5.66. It is a clear indication of the positivity surrounding Melinta Therapeutics at this time.
The chief medical officer at Melinta, Sue Cammarata, also spoke about the scope of Baxdela. She said, “BAXDELA’s potency and activity against the most common bacterial pathogens seen in CABP indicate it could play a significant role in the treatment of this life-threatening illness if approved. We look forward to working with the FDA to help evaluate bringing this potential option to people with CABP as soon as possible.”
However, MLNT stock is down 85% from its 52-week high of $42.68.
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