08:21 AM EDT, 05/31/2024 (MT Newswires) -- Invivyd ( IVVD ) said Friday it was in general alignment with the Food and Drug Administration on a future potential emergency use authorization pathway for its monoclonal antibodies for the prevention and treatment of symptomatic COVID-19.

The pathway gives the company the chance to accelerate COVID-19 medicines by establishing a clinical trial protocol that could do away with new protocols for every new monoclonal antibody. The company said it estimates the clinical cost for generating safety and pharmacokinetic data at $25 millioin to $40 million.

Invivyd ( IVVD ) said it used a similar approach for its investigational monoclonal antibody Pemgarda, which is authorized for emergency use by the FDA.

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