IVVD — what changed in the latest 10-Q
A section-by-section comparison of IVVD's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-08-13 vs the prior 10-Q · 2026-05-14
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +45 | −23 | ~40 | 107 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | 0 | 0 | ~3 | 0 |
| Legal proceedings | Text added/removed | 0 | 0 | ~1 | 0 |
| Risk factors | Some risk factors updated | +19 | 0 | ~1 | 0 |
| Other information | Text added/removed | 0 | 0 | ~1 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
Text added vs the prior filing · source: 10-Q · 2026-08-13
our expectations related to the future termination of the PEMGARDA EUA, to be effective on June 29, 2027, following the U.S. Department of Health and Human Services (“HHS”) announcement on June 30, 2026, providing advance notice of termination of the COVID-19 emergency use declaration for drugs and …
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), …
In July 2025, we announced that we had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein mAb therapy in people suffering from…
Study Group intends to launch multi-center translational clinical research on Long COVID and PVS using next-generation antibodies like our investigational mAb candidate VYD2311. In January 2026, we and the SPEAR Study Group announced plans to initiate a Phase 2 clinical trial evaluating VYD2311 in i…
In addition to our COVID-19 programs, in November 2025, we announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children. We expect to advance VBY329 toward IND readiness in the second half of 2026. A…
Text removed vs the prior filing · source: 10-Q · 2026-05-14
The emergency use of PEMGARDA is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (“FDCA”), …
pharmacokinetics. Like pemivibart, VYD2311 was engineered from adintrevimab, our investigational mAb that has a robust safety data package and demonstrated clinically meaningful results in global Phase 2/3 clinical trials for both the prevention and treatment of COVID-19.
In July 2025, we announced that we had formed the SPEAR (Spike Protein Elimination and Recovery) Study Group with leading investigators to structure and guide anticipated clinical trials evaluating the effects of broadly neutralizing anti-SARS-CoV-2 spike protein mAb therapy in people suffering from…
In addition to our COVID-19 programs, in November 2025, we announced the selection of VBY329, a potential best-in-class mAb candidate being developed for the prevention of RSV infections in neonates, infants and children. We expect to advance VBY329 toward IND readiness in the second half of 2026. A…
advancement of VMS063, a novel, highly potent, half-life-extended, high resistance barrier measles mAb candidate. We have begun IND-enablement and regulatory outreach to support rapid VMS063 development, with the goal of expedited development with target IND readiness in late 2026. Through our propr…
Risk factors
Text added vs the prior filing · source: 10-Q · 2026-08-13
The HHS declaration under Section 564 of the FDCA authorizing emergency use of COVID-19 drugs and biologics will be terminated, effective June 29, 2027, and, consequently, the EUA for PEMGARDA is set to terminate on such date. When the EUA for PEMGARDA is terminated, we will be unable to sell PEMGAR…
PEMGARDA is our first and only product candidate that has received regulatory authorization. PEMGARDA is not approved, but has been authorized for emergency use in the United States by the FDA under an EUA for pre-exposure prophylaxis of COVID-19 in certain immunocompromised patients. The emergency …
We may not market any drug product candidates in the United States unless we have regulatory authorization with an EUA or approval of a BLA from the FDA. Other than the EUA for PEMGARDA in the United States, we have not obtained regulatory authorization or approval for any other product candidate in…
Our potential to obtain a BLA for PEMGARDA before the EUA for PEMGARDA terminates will require aligning with the FDA on the data required to support such regulatory approval, including whether the existing body of evidence supporting the emergency use of PEMGARDA is sufficient to satisfy BLA approva…
Other risks and uncertainties associated with the future PEMGARDA EUA termination and the twelve-month transition period before the PEMGARDA EUA is set to terminate include:
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice