The DECLARATION topline safety and immunogenicity data expected in October 2026 is the next major catalyst. If positive, it could support the BLA submission for Accelerated Approval. Monitor for any FDA feedback or changes in the regulatory timeline.
Price Chart
Executive Summary
Invivyd announced positive topline results from the LIBERTY Phase 3 study, showing VYD2311 met all primary and secondary endpoints with clinically and statistically superior safety and tolerability compared to an mRNA-based COVID-19 vaccine. The company plans to submit a Biologics License Application (BLA) for VYD2311 via the FDA's Accelerated Approval Program, with DECLARATION topline safety and immunogenicity data expected in October 2026.
Key Facts
- VYD2311 met all primary and secondary endpoints in the LIBERTY Phase 3 study, demonstrating safety and tolerability superior to an mRNA-based COVID-19 vaccine (p < 0.0001 for co-primary endpoints).
- VYD2311 combined with an mRNA-based COVID-19 vaccine showed no immunologic interference and added approximately 2.5x to vaccine-induced neutralizing titers.
- Invivyd plans to submit a BLA for VYD2311 via the FDA Accelerated Approval Program, based on DECLARATION and LIBERTY data.
- DECLARATION topline safety and immunogenicity data expected in October 2026; clinical efficacy data to remain blinded and serve as confirmatory trial post-approval.
- LIBERTY enrolled 210 healthy adults (18-49 years) randomized 1:1:1 to VYD2311 250mg, mRNA vaccine, or combination.
Financial Impact
No financial figures reported in the filing. The positive Phase 3 data and planned BLA submission represent a significant regulatory catalyst for a pre-revenue biotech.
Risk Factors
- DECLARATION data may not support the BLA submission or Accelerated Approval.
- Viral evolution could reduce VYD2311's neutralizing activity against future SARS-CoV-2 variants.
- Regulatory pathway and FDA acceptance of the BLA remain uncertain.
- Company is pre-revenue and may need additional funding to support commercial launch.
Investment Themes
Documents Analyzed
This report is based on 6 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001193125-26-406007 |
| Document: ivvd-20260929.htm | 0001193125-26-406007 |
| Document: ivvd-ex99_2.htm | 0001193125-26-406007 |
| Document: 0001193125-26-406007-index-headers.html | 0001193125-26-406007 |
| Document: 0001193125-26-406007-index.html | 0001193125-26-406007 |
| Document: 0001193125-26-406007.txt | 0001193125-26-406007 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 29, 2026 27d ago | 8-K | $0.8501 $0.8064 | ▼ −5.14% | ▼ −7.09% | $0.5890 (−30.71%) |
Sep 22, 2026 4w ago | Institutional Cluster | $0.9640 $0.8501 | ▼ −11.82% | ▼ −10.63% | $0.5890 (−38.90%) |
Sep 1, 2026 7w ago | 8-K | $0.8800 $0.7973 | ▼ −9.40% | ▼ −9.48% | $0.5890 (−33.07%) |
Aug 17, 2026 10w ago | 144 | $0.8680 $0.9387 | ▲ +8.15% | ▲ +8.35% | $0.5890 (−32.14%) |
Jul 6, 2026 16w ago | 8-K | $0.8340 $0.7834 | ▲ +6.07% | ▲ +6.56% | $0.5890 (+29.38%) |
Jun 16, 2026 18w ago | Press Release | $0.8918 $0.9346 | ▲ +4.80% | ▲ +7.03% | $0.5890 (−33.95%) |
Jun 11, 2026 19w ago | Institutional Cluster | $0.8125 $0.9312 | ▲ +14.61% | ▲ +14.18% | $0.5890 (−27.51%) |
Jun 9, 2026 19w ago | Press Release | $0.9900 $0.8686 | ▼ −12.26% | ▼ −14.67% | $0.5890 (−40.51%) |
Jun 1, 2026 21w ago | Press Release | $1.22 $1.03 | ▼ −15.57% | ▼ −12.82% | $0.5890 (−51.72%) |
May 14, 2026 23w ago | 8-K | $1.16 $1.11 | ▼ −4.31% | ▼ −3.59% | $0.5890 (−49.22%) |
US Market Status
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