We are investigating Pfenex Inc. (PFNX) (“Pfenex” or the “Company”) for potential violations of the federal securities laws.
On April 15, 2020, Pfenex issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) had “informed Alvogen Malta Operations Ltd., the Company’s commercialization partner for PF708, via a General Advice letter that additional comparative use human factors (CUHF) data, specifically from Forteo® (teriparatide injection) experienced users, would be required before PF708 Therapeutic Equivalence (TE) could be determined.” Specifically, Pfenex’s Chief Executive Officer stated that “[w]hile the previously submitted CUHF study included Forteo-experienced patients and caregivers, the FDA requested that a larger number of experienced subjects be studied[.]” On this news, Pfenex’s stock price fell sharply during intraday trading on April 15, 2020, damaging investors.