SIGA - SIGA shares rebound despite regulatory hurdles on monkeypox drug

SIGA Technologies ( NASDAQ: SIGA ) has added ~11% in the pre-market after the shares of the U.S. pharma focused on infectious diseases crashed ~23% last Friday in reaction to an FDA announcement on the limitations of the company’s monkeypox therapy tecovirimat, also known as TPOXX.

The FDA approval of TPOXX in 2018 for the related smallpox virus under the regulator’s so-called Animal Rule was not based on human data as it was unethical to infect humans with the now-eradicated smallpox virus.

However, the CDC has made an exception for the use of TPOXX in monkeypox, allowing its use on a case-by-case basis under a program called non-research expanded access Investigational New Drug (EA-IND) protocol .

While the FDA highlighted the need for clinical trials to prove the safety and efficacy of TPOXX against monkeypox, critics point to the regulatory hurdles that prevent ready access to the drug at a time when monkeypox cases surge in the U.S.

“The TPOXX issues, from a scientific perspective, make zero sense,” Scientific American reported quoting gay rights activist James Krellenstein, co-founder and managing director for strategy and policy at PrEP4All, an organization with a mission to raise access to HIV and COVID-19 drugs.

In a letter to the heads of the U.S. Department of Health and Human Services, CDC and FDA in June, Krellenstein and a group of infectious disease experts requested one of two solutions to improve avaialbility of TPOXX.

In one, the CDC would withdraw the IND requirement to permit access to TPOXX from the national stockpile and in the other, the FDA would issue an emergency use authorization (EUA) for the drug.

However, the latter requires the secretary of HHS to declare the current monkeypox outbreak an emergency under Section 564 of the Federal Food, Drug, and Cosmetic Act.

Regardless, SIGA ( SIGA ) remains a favorite among Seeking Alpha authors, with contributor Damon Verial arguing that the company “stands to profit greatly” with “an extremely promising treatment for this global health emergency."

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