FDA Denies Expansion of Invivyd's COVID-19 Antibody EUA, Impacting Stock and Future Strategy

The U.S. Food and Drug Administration (FDA) has rejected Invivyd's application to expand the emergency use authorization (EUA) for its COVID-19 antibody treatment, Pemgarda. This decision has significant implications for the company's market position and future development plans in the evolving landscape of COVID-19 therapeutics.

Pemgarda EUA Expansion Denied

Invivyd, a Waltham, Massachusetts-based biopharmaceutical company, announced on Monday that the FDA declined to broaden the EUA for Pemgarda. The company had sought to include the treatment of mild to moderate COVID-19 in immunocompromised individuals who lack alternative treatment options. Currently, Pemgarda maintains its EUA status as a pre-exposure prophylactic, which was granted by the FDA in March of the previous year.

The FDA's decision underscores the regulatory body's stringent requirements for antibody activity, particularly in the context of treatment indications. Patrick Trucchio, an analyst at HC Wainwright, commented on the outcome, stating, "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."

Market Impact and Strategic Implications

The news of the FDA's decision had an immediate and substantial impact on Invivyd's stock performance. By Monday afternoon, the company's shares had plummeted by approximately one-third, dropping from $1.77 at market open to around $1.21 per share.

Despite this setback, Pemgarda remains the sole pre-exposure prophylactic for COVID-19 available on the market. This unique position was established following the withdrawal of AstraZeneca's Evusheld in 2023, which lost its efficacy against emerging SARS-CoV-2 variants after its initial approval in 2021.

Future Developments and Pipeline Focus

In light of the FDA's decision, Invivyd's strategic focus on developing antibody treatments and prophylaxis for COVID-19 takes on renewed importance. The company is particularly targeting immunocompromised patients who may not respond adequately to vaccines.

Invivyd is currently conducting a Phase I clinical trial for VYD2311, a next-generation antibody COVID-19 prophylactic. Earlier this month, the company released promising initial data for this potential successor to Pemgarda. Tim Lee, Invivyd's Chief Commercial Officer, emphasized the potential impact of VYD2311, stating, "Deploying a new protective mAb in the future that has the convenience and scalability of current vaccine boosts but with substantially more attractive protection, safety, and durability [than Pemgarda] would be a massive step change in medical value for millions of Americans in need."