When biotech or pharmaceutical companies win approvals from the United States Food and Drug Administration, the stock prices almost always go up, and that is what happened with VVUS stock this morning. VVUS is normally a thinly traded nano-cap stock, but this morning, the stock soared after it emerged that the FDA has granted the approval of VIVUS, Inc’s (NASDAQ:VVUS) new product.
The product in question is a new formulation of Pancreaze (pancrelipase), and there is a 36-month shelf life for it across the range of different dosages.
The approval granted by the FDA is actually a supplemental New Drug Application (sNDA), which is granted to products that are an improvement on an existing formulation. VIVUS got the sNDA approval for its improved formulation of Pancreaze (pancrelipase). The company collaborated with its manufacturing partner Nordmark Arzneimittel GmbH & Co. KG on this project.
This is a hugely significant development for the company, and the reaction from the market is not a surprise at all. VVUS stock soared by as much as 70% to $3.89 in morning trade as investors piled onto the stock, and it is likely that VVUS is going to be in sharp focus for the rest of the trading session.
The medicine in question is meant for treating exocrine pancreatic insufficiency (EPI) that is brought about by cystic fibrosis or other conditions. The Chief Executive Officer of the company, John Amos, stated that approval is an important milestone for the company and also for patients who suffer from EPI. He went on to state, “It highlights our ability to derive additional value from our marketed products and allows patients to store PANCREAZE for longer periods of time, which may help to reduce their out-of-pocket expenses.”
The developments today have been a landmark for VIVUS, and market watchers will, no doubt, be following VVUS stock closely over the coming weeks.
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