Pfenex Receives U.S. FDA Approval for PF708 to Treat Osteoporosis
PFENEX INC (PFNX)
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pfenex.com
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Source: GlobeNewswire
Pfenex earns a $2.5M milestone payment from Alvogen for U.S. approval Comparative human factors study report expected to be submitted to FDA as early as the second half of October 2019 SAN DIEGO, Oct. 07, 2019 (GLOBE NEWSWIRE) -- Pfenex Inc. (NYSE American: PFNX) announced today that the U.S. Food and Drug Administration (FDA) has approved the new drug application (“NDA”) for PF708 submitted under the 505(b)(2) regulatory pathway, with Forteo® (teriparatide injection) as the reference drug. Like Forteo, the FDA-approved PF708 product is indicated for the treatment of osteoporosis in certain patients at high risk for fracture. “The FDA’s approval of PF708 marks a major milestone in Pfenex’s history as our first approved commercial product and further validates our Pfenex Expression Technology platform. We look forward to continuing to work with our commercialization partner Alvogen to launch PF708 in the U.S. We believe PF708 has the potential to significantly enhance patient acc
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