Biotech Stocks Facing FDA Decision In May

SIGA Technologies
SIGA Technologies

An FDA advisory committee is scheduled to review SIGA Technologies Inc.’s (SIGA) New Drug Application for oral formulation of smallpox medication, TPOXX, on May 1, 2018.

TPOXX was developed under the FDA "Animal Rule," in which efficacy endpoints are determined in animal studies, and human clinical studies are conducted to determine safety and confirm dosing.

There is one FDA-approved vaccine by the name ACAM2000 to prevent smallpox, which is now under the aegis of Emergent BioSolutions Inc. (EBS). But this vaccine is associated with significant adverse events - some of which are life-threatening.

The FDA’s final decision on TPOXX is expected on August 8, 2018.

SIGA closed Friday’s (Apr.27) trading at $5.97, down 1.32%.