FDA Denies Invivyd's EUA Expansion Request for COVID-19 Antibody Pemgarda

• The FDA has rejected Invivyd's application to expand Pemgarda's emergency use authorization for treating mild to moderate COVID-19 in immunocompromised patients without alternative treatment options.
• Pemgarda maintains its current EUA status as the market's only pre-exposure prophylactic for COVID-19, following AstraZeneca's Evusheld withdrawal in 2023 due to variant resistance.
• The decision triggered a significant market response, with Invivyd's stock value declining approximately 33%, dropping from $1.77 to $1.21 per share.

The U.S. Food and Drug Administration (FDA) has declined to expand the emergency use authorization (EUA) for Pemgarda, Invivyd's bispecific antibody targeting SARS-CoV-2, dealing a setback to the company's efforts to broaden its COVID-19 treatment portfolio.

The Massachusetts-based biotechnology company had sought to extend Pemgarda's authorization to include the treatment of mild and moderate COVID-19 in immunocompromised individuals who lack alternative treatment options. The antibody therapy currently retains its March 2023 EUA designation for pre-exposure prophylaxis.

Market Impact and Analysis

The announcement prompted a sharp decline in Invivyd's market value, with shares plummeting approximately 33% from $1.77 to $1.21 in a single trading day. HC Wainwright analyst Patrick Trucchio contextualized the decision, noting, "This outcome underscores the FDA's insistence on superior antiviral activity for treatment indications and highlights the challenges of re-purposing monoclonal antibodies amid an evolving viral landscape."

Current Market Position

Pemgarda holds a unique position as the sole pre-exposure prophylactic available for COVID-19 following the 2023 market withdrawal of AstraZeneca's Evusheld. The latter's removal was necessitated by its diminished effectiveness against emerging SARS-CoV-2 variants, highlighting the ongoing challenges in maintaining effective COVID-19 therapeutics.

Strategic Pipeline Development

Despite this regulatory setback, Invivyd continues to advance its COVID-19 therapeutic pipeline, with a particular focus on serving immunocompromised patients who may have limited vaccine options. The company is currently conducting a Phase I clinical trial for VYD2311, a next-generation antibody prophylactic positioned as Pemgarda's potential successor.

The development of VYD2311 represents Invivyd's strategic response to the evolving nature of SARS-CoV-2 variants and the ongoing need for effective prophylactic options, particularly for vulnerable populations who cannot rely on traditional vaccine protection.