Shares of Pfenex (NYSE: PFNX) jumped over 15% in today’s pre-market trading session as the clinical-stage biotech company received approval from the FDA for its osteoporosis treatment drug PF708. PFNX stock, which dropped 6.05% to $7.46 on Friday, reached a 52-week high ($10.20) on September 17. Pfenex stock has surged 134% so far this year and 60% from this time last year.
Pfenex had asked FDA to announce PF708 as an equivalent drug to Eli Lilly’s (NYSE: LLY) osteoporosis treatment drug Forteo, which had a worldwide sales of $1.6 billion in 2018. FDA had asked Pfenex to conduct a comparative study between PF708 and Forteo. The San Diego, California-based company targets to submit the final study report to the FDA in the latter half of October 2019.
The opportunity for PF708 reaches beyond the US from the fact that Forteo accounted for $289 million of sales in the EU in 2018. In May, the European Medicines Agency (EMA) accepted the Marketing Authorization Application for PF708, which was submitted by Pfenex’s partner Alvogen. If EMA approval is received, PF708 will be authorized for marketing in all 28 member states of the EU.
“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,” said Pfenex CEO Eef Schimmelpennink.