SIGA Technologies Announces FDA Accepts NDA and Grants Priority Review for Oral TPOXX to Treat Smallpox

SIGA Technologies (OTCMKTS:SIGA), a health security company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its oral formulation of TPOXX® (tecovirimat).

As quoted in the press release:

“We are very pleased that the FDA has accepted our NDA for oral TPOXX. This is an important milestone in the regulatory review of our pending application. Based on a comprehensive submission that includes extensive positive efficacy data in animal studies and human clinical safety data without any drug-related Serious Adverse Events, we look forward to a favorable, expedited review of the application,” said Dr. Phil Gomez, Chief Executive Officer of SIGA Technologies, Inc.

Click here to read the full press release.