NERV — what changed in the latest 10-Q
A section-by-section comparison of NERV'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 · 2026-08-07 vs the prior 10-Q · 2026-05-05
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +23 | −12 | ~19 | 19 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | 0 | 0 | ~1 | 2 |
| Legal proceedings | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Risk factors | Text added/removed | 0 | 0 | ~3 | 15 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Not shown (absent or not faithfully extractable): Other information
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 · 2026-08-07
In connection with our interactions with the FDA subsequent to the CRL, the FDA stated that it would consider a resubmission of the NDA that included a double-blind, placebo- or active-controlled trial of roluperidone with a duration of at least 52 weeks with the efficacy primary endpoint at week 12…
We submitted the protocol for the new Phase 3 confirmatory trial, which we refer to as the C19 trial, to the FDA on December 3, 2025. Consistent with the previous Phase 2b (C03) and Phase 3 (C07) clinical trials of roluperidone, the C19 trial will include patients diagnosed with schizophrenia who pr…
The primary efficacy endpoint of the C19 trial is expected to be the change from baseline in the PANSS Marder negative symptoms factor score (“NSFS”) at 12 weeks of treatment with roluperidone compared to placebo. Following the initial 12-week treatment period, patients are expected to enter a 52-we…
In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV (“Janssen”), a subsidiary of Johnson & Johnson, for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). As a result of our collaboration with Janssen, we were entitled to c…
We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have i…
Text removed vs the prior filing · source: 10-Q · 2026-05-05
Consistent with the previous Phase 2b (C03) and Phase 3 (C07) clinical trials of roluperidone, the new Phase 3 confirmatory trial, which we refer to as the C19 trial, will include patients diagnosed with schizophrenia who present with stable impairing negative symptoms and stable positive symptoms f…
On March 31, 2026, we announced that the first patient had been screened in the C19 trial. The trial is designed to enroll 380 patients, randomized on a 1:1 basis to receive either placebo or a double-blinded single daily 64 mg dose of roluperidone. The primary efficacy endpoint is expected to be th…
In addition, we previously co-developed seltorexant with Janssen Pharmaceutica NV (“Janssen”), a subsidiary of Johnson & Johnson, for the treatment of insomnia disorder and adjunctive treatment of Major Depressive Disorder (“MDD”). As a result of our collaboration with Janssen, we were entitled to c…
We have not received any regulatory approvals to commercialize any of our product candidates, and we have not generated any revenue from the sales or license of our product candidates. We routinely evaluate the status of our drug development programs as well as potential strategic options. We have i…
Non-GAAP adjusted net loss is defined as GAAP net loss, adjusted to exclude non-cash items related to: (i) stock-based compensation expense and (ii) changes in fair value of the warrant liability. Non-GAAP adjusted net loss per share, basic and diluted, is defined as GAAP net loss per share, basic a…
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