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WALTHAM, Mass. - Invivyd, Inc. (NASDAQ:IVVD), a biotechnology company with impressive gross profit margins of 93%, announced Wednesday that Yale School of Medicine Professor Akiko Iwasaki has joined its SPEAR (Spike Protein Elimination and Recovery) Study Group, which focuses on persistent spike protein from SARS-CoV-2 virus or COVID-19 vaccines. According to InvestingPro data, the company’s stock has shown strong momentum with an 82% return over the past six months.
Dr. Iwasaki, an expert in viral pathogenesis and human immunobiology, co-leads the Yale COVID-19 Recovery Study investigating how vaccination affects immune response in Long COVID patients. She also leads the Yale LISTEN study and the Mount Sinai-Yale Long COVID study. With analysts forecasting sales growth and profitability this year, Invivyd’s research initiatives are drawing increased investor attention.
"Her scientific leadership, particularly in defining immune responses in post-viral syndromes, brings invaluable insight to this urgent effort," said Marc Elia, Chairman of the Board at Invivyd, according to the company’s statement.
The SPEAR Study Group was established following multiple independent case reports suggesting symptom improvement in Long COVID patients after receiving PEMGARDA (pemivibart), Invivyd’s monoclonal antibody currently authorized for COVID-19 prevention in certain immunocompromised individuals.
The group plans to structure clinical trials to assess the safety and exploratory efficacy of monoclonal antibodies in individuals with Long COVID and COVID-19 Post-Vaccination Syndrome using antibodies like Invivyd’s investigational candidate VYD2311.
PEMGARDA is not currently authorized for treating Long COVID. The company notes that early anecdotal evidence aligns with research suggesting persistent spike protein or viral material as a potential therapeutic target.
The emergency use of PEMGARDA is authorized only for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise, according to the press release. While the company maintains a strong balance sheet with more cash than debt, InvestingPro analysis reveals 12 additional key insights about Invivyd’s financial health and market position. Discover comprehensive analysis and detailed metrics in the Pro Research Report, available exclusively to InvestingPro subscribers.
In other recent news, Invivyd, Inc. has announced that its COVID-19 monoclonal antibody candidate, VYD2311, demonstrated a favorable safety profile in a Phase 1/2 clinical trial. The study, which involved 40 participants, revealed that all adverse events were mild to moderate, with the intramuscular route showing the longest half-life at 76 days. Additionally, Invivyd’s investigational monoclonal antibody PEMGARDA® has been included in the National Comprehensive Cancer Network® Clinical Practice Guidelines for B-Cell Lymphomas, providing a new preventive option for immunocompromised patients against COVID-19. Meanwhile, H.C. Wainwright has maintained a Buy rating on Invivyd’s stock, although it has adjusted the price target to $5.00 from $10.00 after reviewing the company’s strategic priorities. This comes after positive data for VYD2311, which H.C. Wainwright noted for its long half-life and flexible administration options. Furthermore, Invivyd has formed the SPEAR Study Group to explore the use of monoclonal antibodies in treating Long COVID and Post-Vaccination Syndrome. This initiative includes collaboration with leading researchers from institutions such as the University of California, San Francisco, and Mount Sinai.
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