Invivyd (NASDAQ:IVVD) Surges 7.21% on FDA Fast-Track Alignment and SPEAR Study Endorsement

Invivyd (NASDAQ:IVVD) surged 7.2072% in pre-market trading on December 17, 2025, as investors reacted to developments in its pipeline of monoclonal antibodies targeting respiratory diseases.

The rally followed recent regulatory alignment with the U.S. FDA on a fast-tracked approval pathway for its lead candidate, VYD2311, a potential alternative to vaccines for preventing COVID-19 in adults and adolescents. This update reinforced optimism about the drug’s commercial viability amid ongoing public health challenges.

Additional momentum stemmed from the SPEAR Study Group’s endorsement of a long-COVID antibody study design incorporating VYD2311, scheduled for presentation at an industry workshop in late September 2025. Analysts noted that the drug’s demonstrated neutralizing activity against dominant SARS-CoV-2 variants, including the XFG strain, further strengthens its therapeutic positioning.

Despite insider selling activity and a recent price target reduction to $1.00 by D. Boral Capital, the stock’s performance underscored investor focus on Invivyd’s role in addressing unmet needs in respiratory disease prevention, particularly as seasonal demand for antibody therapies remains elevated.