Invivyd Reports Strong Q4 & Full-Year 2025 Results, Doubling PEMGARDA Revenue and Advancing Key Clinical Trials

summarizeSummary

Invivyd, Inc. announced strong Q4 and full-year 2025 financial results, including a doubling of PEMGARDA revenue and a robust cash position, alongside significant progress in its VYD2311 clinical trials and pipeline expansion.

check_boxKey Events

• Strong Financial Performance

  Reported full-year 2025 net product revenue of PEMGARDA at $53.4 million, more than doubling the $25.4 million from 2024. Q4 2025 PEMGARDA revenue reached $17.2 million, representing 25% year-over-year and 31% quarter-over-quarter growth.

• Robust Cash Position

  Ended 2025 with $226.7 million in cash and cash equivalents, after successfully raising over $200 million from financing transactions in the second half of 2025, providing sufficient capital for ongoing clinical trials and commercial preparedness.

• VYD2311 Clinical Trial Progress

  The DECLARATION Phase 3 pivotal clinical trial for VYD2311 (COVID prevention) is fully enrolled, with top-line data expected mid-2026. The Independent Data Monitoring Committee (IDMC) recommended allowing pregnant and breastfeeding women to enroll based on early safety data.

• Regulatory Milestones Achieved

  VYD2311 received Fast Track designation from the FDA in December 2025. The company also announced alignment with the FDA on the LIBERTY Phase 3 clinical trial protocol, which will assess VYD2311's safety and immunologic profile against mRNA COVID vaccines.

auto_awesomeAnalysis

This 8-K filing, which follows a GlobeNewswire announcement on the same day, provides comprehensive positive updates for Invivyd. The company reported robust financial performance for Q4 and full-year 2025, with PEMGARDA revenue more than doubling year-over-year and a strong cash position of $226.7 million, secured by over $200 million in financing during 2H 2025. This significantly extends their operational runway. Furthermore, the DECLARATION Phase 3 clinical trial for VYD2311 is fully enrolled and on track for top-line data mid-2026, with positive safety recommendations from the IDMC. The FDA's Fast Track designation for VYD2311 and alignment on the LIBERTY Phase 3 trial further de-risk the development pathway. The expansion into RSV and measles antibody candidates also signals future growth potential. These combined factors indicate strong operational execution and a solid financial foundation, which are critical for a life sciences company.