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Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company dedicated to protecting individuals from serious viral infectious diseases, with an initial focus on SARS-CoV-2. The company leverages its proprietary INVYMAB™ platform to develop monoclonal antibodies (mAbs) that address evolving viral threats. Invivyd's primary product is PEMGARDA™, a monoclonal antibody authorized for emergency use in the prevention of COVID-19 in immunocompromised individuals.
- PEMGARDA™ - A monoclonal antibody authorized for emergency use by the FDA for pre-exposure prophylaxis (PrEP) of COVID-19 in adults and adolescents with moderate-to-severe immune compromise.
- VYD2311 - A monoclonal antibody candidate currently in early-stage clinical trials, aimed at addressing additional viral threats.
- Given the recent FDA warning and the confusion it caused among healthcare providers and patients regarding PEMGARDA's efficacy, what specific steps are you taking to rebuild trust and mitigate similar risks in the future?
- You withdrew your revenue guidance of $150 million to $200 million due to recent headwinds; with modest net product revenue growth, what gives you confidence in achieving profitability by the end of June 2025?
- With anticipated significant reductions in R&D expenses and manufacturing costs, how will this impact the development and regulatory timelines of your next-generation antibody, VYD2311?
- Can you elaborate on how seasonality affects PEMGARDA's sales, and what adjustments are you making in your commercial strategy to account for the non-seasonal nature of COVID-19 among immunocompromised patients?
- Considering the challenges posed by SARS-CoV-2 variants and potential reduction in antibody efficacy, how are you leveraging your technology to develop antibodies with enhanced potency and durability to address future virus variations?