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WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company with a market capitalization of $91.23 million, announced today that its investigational monoclonal antibody PEMGARDA® (pemivibart) has been incorporated into the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for B-Cell Lymphomas. According to InvestingPro data, the company maintains impressive gross profit margins of 93.32%, though it’s currently in a cash-intensive development phase. This follows the previous recommendation by the Infectious Disease Society of America (IDSA) to use PEMGARDA for pre-exposure prophylaxis (PrEP) in certain immunocompromised individuals.
PEMGARDA is designed for individuals with moderate to severe immune compromise due to medical conditions or treatments, who may not respond adequately to COVID-19 vaccination. The NCCN’s inclusion of PEMGARDA offers a new preventive option for patients with B-cell malignancies, who are at increased risk of severe outcomes from COVID-19.
The antibody has been authorized for emergency use by the U.S. Food and Drug Administration (FDA) for PrEP of COVID-19 in the specified patient group. It targets the SARS-CoV-2 spike protein to prevent virus attachment to host cells and has shown in vitro activity against various SARS-CoV-2 variants. While the stock has seen significant volatility, with a 71.63% year-to-date return, InvestingPro analysts project positive sales growth and profitability for the current year.
Dr. George Yaghmour and Tim Lee of Invivyd expressed the importance of this development, noting that PEMGARDA could help protect vulnerable patients, allowing them to continue cancer care and focus on recovery. The updated NCCN Guidelines, now available on their website, aim to assist oncology providers in making evidence-based treatment decisions.
PEMGARDA’s EUA is based on an immunobridging approach and its parent monoclonal antibody, adintrevimab, which demonstrated efficacy in global clinical trials. However, the company acknowledges limitations in the data supporting PEMGARDA’s benefits and the potential emergence of SARS-CoV-2 variants with reduced susceptibility to the treatment.
The inclusion of PEMGARDA in the NCCN Guidelines represents a significant step for Invivyd in its mission to protect against viral infectious diseases, starting with SARS-CoV-2. The company continues its efforts to monitor and adapt its antibody candidates to address evolving threats.
This news is based on a press release statement from Invivyd, Inc. and has not been independently verified. Investors seeking deeper insights can access comprehensive analysis and 12 additional ProTips through InvestingPro, including detailed financial health metrics and growth projections, with analyst price targets ranging from $0.80 to $10.00 per share.
In other recent news, Invivyd Inc. announced its Q1 2025 financial results, reporting a net product revenue of $11.3 million from its COVID-19 prevention product, PEMGARDA. The company’s earnings per share and revenue did not meet analysts’ expectations, leading to a strategic focus on achieving profitability by mid-2025. Invivyd has reduced its operating expenses by 15% quarter-over-quarter, from $32.3 million to $27.4 million, and holds approximately $48 million in cash and cash equivalents. The company is also advancing its clinical development of a new molecule, VYD2311, and expanding its pipeline in viral prevention. Invivyd internalized its sales force and increased the availability of PEMGARDA from 120 to 880 sites, although this transition caused disruptions impacting sales figures. The company aims to leverage its strategic and operational choices to create medical value and translate it into shareholder value. Invivyd remains optimistic about its financial outlook, projecting a potential earnings per share of $0.01 for Q2 2025 and $0.04 for Q3 2025. Additionally, the firm secured access to up to $30 million in non-dilutive funding through a term loan facility with SVB.
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