Portalix BioTherapeutics Rg (NYSEMKT: PLX) is having an incredibly strong morning in the pre-market trading hours, and for good reason. The company announced that the FDA has accepted a Supplemental New Drug Application. Of course, this led to excitement among investors who pushed the stock toward the sky. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (8:37), PLX is trading at $0.96 per share after a gain of $0.06 per share or 6.70% thus far today.
PLX Gains On FDA News
As mentioned above, Protalix BioTherapeutics is having an incredibly strong start in the pre-market hours this morning after announcing news that it has received from the United States Food and Drug Administration. According to a press release that was released early this morning the FDA has approved a Supplemental New Drug Application, or sNDA. This approval will allow the company to convert its manufacturing facility in Carmiel, Israel, into a multi-product facility. Before the approval, the facility was dedicated to a single product.
The company said that capacity at the manufacturing facility is strong enough to serve the current and expected commercial needs of PLX. The company said that this approval, allowing the facility to be converted into a multi-product facility, is the key that will allow the company to build the production it needs for the anticipated commercialization of pegunigalsidase alfa for the treatment of Fabry disease. This is also a big help with the current and expected significant increase in the manufacturing of taliglucerase alfa, a treatment that is expected to fly off of the shelves in Brazil. In a statement, Moshe Manor, President and CEO at PLX, had the following to offer…
“We have been producing drug substance for our clinical trials of pegunigalsidase alfa in our facility and have already upgraded our manufacturing facility to become a multi-product facility to support the potential manufacturing of both pegunigalsidase alfa and taliglucerase alfa in a commercial scale… Given the unique aspects of our ProCellEx® protein expression system, the conversion of he facilities did not entail substantial additional capital expenditures of pegunigalsidase alfa, if approved. We are excited to have reached this milestone in our progression towards the commercialization of pegunigalsidase alfa alongside the expected increase in activities in Brazil.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on PLX. In particular, we’re interested in watching as the sNDA approval turns into profits for the company down the road. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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