Market reactionShares fell 10% on Nov 5.
Invivyd sells PEMGARDA, a COVID-19 prevention antibody for people with weakened immune systems, under an emergency use authorization ending June 2027, and is developing VYD2311, an unapproved COVID-19 prevention antibody.
Invivyd's case rests on VYD2311, a COVID-19 prevention antibody. In LIBERTY, it caused fewer side effects than an mRNA vaccine (56.5% versus 91.4% with any reaction over six days). After a September Type C meeting, Invivyd plans an accelerated-approval BLA if DECLARATION safety and antibody-level data, due in October, are supportive. PEMGARDA's emergency authorization ends June 29, 2027. Cash was $160.1 million at June 30, and the 10-Q reports going-concern doubt.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: DECLARATION supports an accelerated filing
Do DECLARATION safety and neutralizing-titer results support an accelerated-approval BLA for VYD2311?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
VYD2311 awaits DECLARATION data for an accelerated filing as PEMGARDA's authorization nears its end
DECLARATION data in hand by end of Q3 2026, with cash covering only through the readout — approval hinges on a single Phase 3 trial result
PEMGARDA's EUA clock is ticking; everything pivots on whether DECLARATION Phase 3 data earns VYD2311 a BLA before the approved product loses its authorization
About this history: every entry shows when the Thesis moved and what it said. The reasoning behind each move (the evidence, the analysis and the source filing) and the earnings write-ups are part of a subscription.
Dates, trials and completed outcomes are open to everyone. What each upcoming milestone hinges on is part of a subscription.
Disease areas: Infectious diseases
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Competitive landscape
3 peers tracked
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.