Thinly traded micro cap Pfenex (NYSEMKT:PFNX) is up 2% premarket on light volume in response to results from a human factors study that showed the non-inferiority (no worse than) of the user interface of PF708 to Eli Lilly’s (NYSE:LLY) Forteo [teriparatide (rDNA origin) injection].
The company says the data complete the information
package required by the FDA to assess the therapeutic equivalence of
PF708. Alvogen will manufacture and commercialize in the U.S.
The FDA approved the Forteo biosimilar last week under its 505(b)(2) pathway but requested the human factors study to complete the data package.
https://seekingalpha.com/news/3505486-pfenex-2-percent-premarket-positive-human-factor-data-pf708
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