Pfenex (NYSEAMERICAN:PFNX) stock is on the rise Monday following an update for its osteoporosis treatment.
The Pfenex news today includes the pharmaceutical company getting approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application for PF708. This is the company’s new treatment for osteoporosis that works similar to Forteo.
This Pfenex news is a major deal for PFNX stock due to it being the first time that the company has been awarded approval for a commercial product. The company is also seeking to have the FDA recognize PF708 as therapeutically equivalent to Forteo. Doing so would allow it to be substituted for Forteo in many states.
Eef Schimmelpennink. CEO of PFNX, has this to say about the future of the drug in a Pfenex news release.
“Looking ahead, we are confident in the planning that Alvogen has done thus far in preparation for the commercial launch of PF708 and their established sales and marketing teams are excited to bring PF708 to market. To optimize patient and payer impact, we currently expect our commercial partner Alvogen to launch PF708 upon an FDA decision on the therapeutic equivalence rating.”
Pfenex notes that it is expecting to submit final results to the FDA as early as the second half of October. This should be all the company needs to get the therapeutic equivalence designation from the organization.
PFNX stock was up 15.55% when the markets closed on Monday.
As of this writing, William White did not hold a position in any of the aforementioned securities.