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Investing.com - H.C. Wainwright has reiterated its Buy rating and $5.00 price target on Invivyd Inc. (NASDAQ:IVVD) following the company’s second quarter 2025 corporate update. The stock, currently trading at $0.58, has seen significant volatility, with analyst targets ranging from $3 to $5. According to InvestingPro data, the stock maintains a strong Buy consensus among analysts.
The firm highlighted a clear regulatory path for VYD2311, Invivyd’s next-generation monoclonal antibody designed for both prevention and treatment of COVID-19. The FDA has agreed that a single randomized Phase 2/3 prevention trial supported by a streamlined safety database could form the basis for a Biologics License Application.
The upcoming trial will employ low-dose intramuscular delivery, with parallel pediatric planning underway. This development could potentially shift the company from an Emergency Use Authorization-based business to a broadly accessible, BLA-approved franchise.
H.C. Wainwright also noted seasonal reacceleration potential for PEMGARDA in COVID-19 prevention and pipeline progress in RSV and measles as additional positive factors for the company.
The firm believes Invivyd is well-positioned with its commercial PEMGARDA uptake, limited manufacturing expenses for VYD2311, and disciplined operating expenses to develop a durable, multi-asset respiratory and outbreak prevention portfolio. The company maintains impressive gross profit margins of 93.4% and holds more cash than debt on its balance sheet, though it’s currently burning through cash reserves. InvestingPro subscribers can access 8 additional key insights and a comprehensive analysis of IVVD’s financial health.
In other recent news, Invivyd, Inc. announced that its COVID-19 monoclonal antibody, PEMGARDA, continues to show neutralizing activity against the XFG variant, which is a significant concern in the current wave of COVID-19 infections in the United States. Additionally, Invivyd has received guidance from the FDA on a potential Biologics License Application (BLA) pathway for its antibody candidate VYD2311. The FDA suggested that a single Phase 2/3 trial could support a BLA submission, with a focus on reducing symptomatic COVID-19 cases.
In a strategic move to enhance its research capabilities, Invivyd has established the SPEAR Study Group to explore the use of monoclonal antibodies in treating Long COVID and Post-Vaccination Syndrome. The group includes notable experts such as Dr. Michael Peluso and Dr. Amy Proal. Furthermore, Yale Professor Akiko Iwasaki has joined Invivyd’s research group, bringing her expertise in viral pathogenesis to the team.
On the financial front, H.C. Wainwright maintained its buy rating for Invivyd, citing positive Phase 1/2 data for VYD2311, which demonstrated a long half-life and a favorable safety profile. These developments reflect Invivyd’s ongoing efforts in COVID-19 prevention and treatment.
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