WALTHAM, Mass. – Invivyd Inc. (NASDAQ: IVVD), a biopharmaceutical company, has announced an agreement with the U.S. Food and Drug Administration (FDA) on a new clinical trial pathway for the expedited development of monoclonal antibodies (mAbs) for COVID-19.
This immunobridging approach is designed to streamline the process for potential emergency use authorizations (EUAs) of novel mAbs aimed at treating and preventing symptomatic COVID-19, particularly in vulnerable populations.
The pathway allows for a master, registrational clinical trial protocol that could replace the need for separate protocols for each new mAb, with the goal of evaluating new candidates in smaller clinical programs. These programs are expected to involve hundreds of participants and to provide the necessary safety and pharmacokinetics data to support future EUA requests, estimated to cost between $25-40 million.
Invivyd's proprietary mAb technology platform and engineering capabilities are central to this initiative, which aims to match the rapid evolution of the SARS-CoV-2 virus. The company's efforts over the past two years have focused on novel development pathways to keep pace with this evolution.
Mark Wingertzahn, SVP of Clinical Development and Medical Affairs at Invivyd, highlighted the importance of the pathway for advancing the field of COVID-19 mAb treatments. Invivyd is also exploring different routes of administration, such as intramuscular injections, to improve patient and system accessibility.
PEMGARDA™ (pemivibart), Invivyd’s investigational mAb, has been authorized for emergency use by the FDA for pre-exposure prophylaxis (PrEP) in certain immunocompromised individuals. It targets the SARS-CoV-2 spike protein receptor binding domain and has shown neutralizing activity against major variants. However, PEMGARDA is not approved for the treatment of COVID-19 or post-exposure prophylaxis.
The company anticipates discussing the new pathway with global regulators, aiming to provide a repeatable and efficient process to bring new medicines to patients. Invivyd's INVYMAB™ platform is designed to facilitate the rapid generation of new mAbs to address evolving viral threats.
This announcement is based on a press release statement and reflects the company's alignment with the FDA on a potential future EUA pathway. It does not constitute an endorsement of Invivyd's products or claims. The effectiveness and safety of Invivyd's products have not been established, and the forward-looking statements involve risks and uncertainties.
InvestingPro Insights
As Invivyd Inc. (NASDAQ: IVVD) forges ahead with its innovative approach to developing monoclonal antibodies for COVID-19, its financial health and market performance provide additional context for investors considering the company's prospects. With a market capitalization of $215.79 million, Invivyd's size speaks to its position within the biopharmaceutical sector.
An InvestingPro Tip that stands out for Invivyd is its balance sheet strength, holding more cash than debt, which is a positive sign for the company's financial stability. This could be particularly important for Invivyd as it continues to invest in clinical trials and research for COVID-19 treatments. Moreover, the firm's liquid assets exceed its short-term obligations, suggesting a comfortable liquidity position to support ongoing operations.
However, challenges are evident in the company's financial metrics. Invivyd has not been profitable over the last twelve months, and analysts do not anticipate it will be profitable this year. Moreover, the company's valuation implies a poor free cash flow yield, and it has been quickly burning through cash, which may raise concerns about long-term financial sustainability.
The stock itself has fared poorly over the last month, with a 1-month price total return of -18.47% and a significant 3-month price total return drop of -53.94%. These figures indicate recent market skepticism about the company's short-term growth prospects.
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