SIGA - SIGA hits new 52-week high as U.S. declares an emergency over monkeypox

• SIGA Technologies ( NASDAQ: SIGA ) reached a new 52-week on Friday as the monkeypox drug developer drew renewed investor interest a day after the U.S. declared the viral outbreak a public health emergency.
• The commercial-stage pharma company witnessed a ~23% decline in its shares last Friday after the FDA highlighted the need for clinical trials to prove the safety and efficacy of its TPOXX treatment for monkeypox.
• The FDA approved TPOXX for the related smallpox virus in 2018 based on the regulator’s so-called Animal Rule.
• The CDC made an exception to recommend TPOXX for monkeypox on a case-by-case basis under a program called non-research expanded access Investigational New Drug (EA-IND) protocol, a regulatory hurdle preventing ready access to the therapy.
• The emergency declaration issued for monkeypox under section 319 of the Public Health Service (PHS) Act does not grant the FDA authority to issue emergency authorizations for vaccines, tests, and treatments to contain the viral disease.
• However, an emergency provision under Section 564 of the Federal Food, Drug, and Cosmetic Act will permit SIGA ( SIGA ) to win a potential EUA nod for TPOXX.

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