Биотех Invivyd планирует получить полное одобрение FDA для терапии PEMGARDA

Invivyd plans to seek full FDA approval for its COVID prevention treatment. New Haven-based biotechnology company Invivyd said Monday it has received notice from the U.S. Food and Drug Administration that the emergency use authorization for its COVID-19 prevention therapy, PEMGARDA, will expire on June 29, 2027, as the federal government winds down its pandemic-era emergency authorization framework. The notice follows the U.S. Department of Health and Human Services' decision to terminate the COVID emergency use authorization declaration effective June 29, 2027. Invivyd said it is working with the FDA on a path toward traditional approval and plans to submit a biologics license application for PEMGARDA, which is an antibody treatment designed to help prevent COVID-19 infections in certain people with weakened immune systems who may not receive adequate protection from vaccination. The regulatory change could be significant for the company. In its most recent annual report, Invivyd said PEMGARDA is its only authorized commercial product and warned investors that losing its emergency authorization before obtaining full FDA approval could materially harm its business. Invivyd has also been advancing its next-generation COVID prevention therapy, VYD2311, which entered late-stage clinical testing after receiving FDA clearance last year. In November, the Nasdaq-listed company raised about $117 million in a public stock offering to help fund VYD2311 and other pipeline programs. Invivyd employed 122 full-time workers as of Feb. 1, according to its most recent annual report. About 9% of its workforce is based in Connecticut. The company reported first-quarter revenue of $13.7 million, up from $11.3 million a year earlier, but posted a net loss of $41.4 million. It ended the quarter with $184.2 million in cash and cash equivalents.