IDYA — what changed in the latest 10-Q
A section-by-section comparison of IDYA'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 · 2026-11-03 vs the prior 10-Q · 2026-08-04
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +20 | −19 | ~27 | 38 |
| Market risk (Item 3) | Text added/removed | 0 | 0 | ~1 | 2 |
| Controls & procedures | Text added/removed | 0 | 0 | ~2 | 1 |
| Legal proceedings | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Risk factors | No material changes reported (points to the 10-K) | — | — | — | — |
| Other information | Text added/removed | +3 | −1 | 0 | 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 · 2026-11-03
Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor (the darovasertib combination), in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) in patients with first line, human leukocyte antigen-A*02:01 negative (HLA*A2(-)) mUM…
During the third quarter, we successfully submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program to support a potential U.S. approval of the darovasertib combination in mUM. The RTOR progr…
Neoadjuvant UM. We are evaluating single-agent darovasertib in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic diseas…
Due to ongoing site activation and enrollment challenges, we have decided to stop enrollment and close the Phase 3 OptimUM-010 trial. We remain committed to enabling patient access to neoadjuvant darovasertib, and
plan to submit published data from OptimUM-09 to support potential inclusion in clinical practice guidelines. If successful, guideline inclusion is intended to provide evidence to support the potential clinical benefit of neoadjuvant darovasertib and may allow payor coverage for eligible patients in…
Text removed vs the prior filing · source: 10-Q · 2026-08-04
Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor, in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) for human leukocyte antigen-A*02:01 negative (HLA*A2(-)), patients with first line mUM. In April 2026, we reported p…
We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. approval. Pursuant to Food and Drug Administration's (FDA) authorization, we have begun pre-submitting components of the NDA under the Oncology Center of Excellence Real-Time Oncology R…
We are also evaluating the combination of darovasertib and crizotinib in HLA*A2:01 positive (HLA*A2(+)), mUM patients in our ongoing, single-arm Phase 2 OptimUM-01 trial. We plan to present updated clinical data from this trial at the 2026 European Society for Medical Oncology (ESMO) Congress being …
Neoadjuvant UM. We are evaluating single-agent darovasertib in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic diseas…
Adjuvant UM. In collaboration with our partner, Servier, we have initiated a global Phase 3 registrational trial (OptimUM-11) of darovasertib and crizotinib in the adjuvant setting of primary UM. The trial is expected to enroll approximately 450 primary UM patients with increased risk of metastasis,…
Other information
Text added vs the prior filing · source: 10-Q · 2026-11-03
During the three months ended September 30, 2026, our Section 16 officers and directors adopted or terminated contracts, instructions or written plans for the purchase or sale of our securities as noted below:
* Intended to satisfy the affirmative defense of Rule 10b5-1(c)
** Not intended to satisfy the affirmative defense of Rule 10b5-1(c)
Text removed vs the prior filing · source: 10-Q · 2026-08-04
During the quarter ended June 30, 2026, no director or “officer” of the Company (as defined in Rule 16a-1(f) of the Exchange Act) adopted or terminated a “Rule 10b5-1 trading arrangement” or a “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408 of Regulation S-K.
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