Invivyd forms research group to study monoclonal antibodies for Long COVID

WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biotechnology company with a market capitalization of $86.5 million and impressive year-to-date returns of 62.8%, has established the SPEAR Study Group to investigate the potential benefits of monoclonal antibodies in treating Long COVID and Post-Vaccination Syndrome, according to a company statement released Wednesday. According to InvestingPro data, the company’s stock is currently trading near its Fair Value, suggesting balanced market expectations for this research initiative.

The research initiative brings together prominent investigators including Dr. Michael Peluso from the University of California, San Francisco, Dr. Amy Proal from the Polybio Research Foundation, and Dr. David Putrino from Mount Sinai’s Cohen Center for Recovery from Complex Chronic Diseases. The company’s strong gross profit margin of 93.3% and debt-free balance sheet position it well to support this extensive research program.

The formation of this clinical and translational study group follows multiple independent reports suggesting that PEMGARDA (pemivibart), Invivyd’s monoclonal antibody currently authorized for COVID-19 prevention in immunocompromised individuals, may provide relief for Long COVID symptoms.

"It is now clear from a growing body of high-quality, peer-reviewed research that persistent spike protein or viral reservoirs can be identified in a meaningful portion of people with Long COVID," said Dr. Peluso in the press release.

The SPEAR Study Group plans to conduct rigorous clinical trials evaluating anti-SARS-CoV-2 spike protein monoclonal antibody therapy in populations affected by persistent virus or circulating spike protein. Initial research will focus on safety, translational biology, and exploratory efficacy assessments.

According to the company, as many as 5% of Americans have reported recent Long COVID symptoms. PEMGARDA is not currently authorized for treating Long COVID or Post-Vaccination Syndrome.

The research group also intends to study VYD2311, Invivyd’s next-generation monoclonal antibody candidate, as part of its collaborative, multi-center clinical research efforts.

Invivyd Chairman Marc Elia stated that the company will meet with the FDA early in the third quarter to discuss approval pathways for COVID-19 monoclonal antibodies. With analysts forecasting sales growth and profitability this year, the company appears positioned for potential advancement. For detailed analysis and additional insights, including 12 more exclusive ProTips, visit InvestingPro, where you can access comprehensive research reports covering 1,400+ top stocks.

In other recent news, Invivyd Inc. reported its Q1 2025 earnings, revealing net product revenue of $11.3 million from its COVID-19 prevention product, PEMGARDA. Despite a 15% reduction in operating expenses, the earnings and revenue fell short of forecasts, prompting a strategic focus on achieving profitability by mid-2025. H.C. Wainwright adjusted its price target for Invivyd to $5.00, down from $10.00, while maintaining a Buy rating, citing potential catalysts for near-term value creation. The company’s monoclonal antibody candidate, VYD2311, demonstrated a promising safety profile in a Phase 1/2 clinical trial, with no serious adverse events reported. Invivyd’s PEMGARDA has also been included in the National Comprehensive Cancer Network Clinical Practice Guidelines for B-Cell Lymphomas, providing a new preventive option for patients with B-cell malignancies. Additionally, Invivyd announced new discovery programs targeting measles and respiratory syncytial virus (RSV), indicating a shift towards a broader focus on infectious diseases. A Type C meeting with the FDA is scheduled for early third quarter to discuss approval pathways for VYD2311, which could expand its use for both prevention and treatment of COVID-19.

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