Legal & controls
Item 3 and Item 9A as filed · every verdict is the registrant’s own sentence, printed below it · a filing that fails an extraction gate reads “not extracted”
| Fiscal year | Filed | Item 3 | ICFR | disclosure controls | material weakness | Filing |
|---|---|---|---|---|---|---|
| 2025-12-31 | 2026-02-26 | none stated | effective | effective | none in Item 9A | EDGAR |
Item 3 · None. Item 9A · ICFR · Based on the COSO criteria, our management has concluded that our internal control over financial reporting as of December 31, 2025 was effective at the reasonable assurance level. Item 9A · disclosure controls · Based on the evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2025. | ||||||
| 2024-12-31 | 2025-02-24 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · On January 19, 2023 and May 30, 2023, certain of our officers and directors were named as defendants in two shareholder derivative actions filed in the Delaware Court of Chancery. The complaints assert, inter alia, breach of fiduciary duty claims arising from the facts underlying a securities class action related to ROCTAVIAN that was previously settled in the United States District Court for the Northern District of California. The derivative complaints seek unspecified monetary damages, internal governance reforms by the Company, attorneys’ fees and costs, and any other relief the court may deem just and proper. The parties in the derivative lawsuits have entered into a stipulation of settlement, that, subject to final approval by the Court of Chancery, will resolve the derivative lawsuits. The Court of Chancery held a final approval hearing on July 23, 2024 and did not approve the settlement. Instead, it instructed the plaintiffs to voluntarily dismiss the case or brief a motion to dismiss. On February 13, 2025 and February 14, 2025 the plaintiffs filed stipulations to voluntarily dismiss their cases without prejudice, which the Court granted. Item 9A · ICFR · Based on the COSO criteria, our management has concluded that our internal control over financial reporting as of December 31, 2024 was effective at the reasonable assurance level. Item 9A · disclosure controls · Based on the evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2024. | ||||||
| 2023-12-31 | 2024-02-26 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · On September 25, 2020, a purported shareholder class action lawsuit was filed against us, our Chief Executive Officer, our President of Worldwide Research and Development and our Chief Financial Officer in the United States District Court in the Northern District of California, alleging violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as amended (the Exchange Act). The complaint alleges that we made materially false or misleading statements regarding the clinical trials and Biologics License Application (BLA) for ROCTAVIAN (formerly known as valoctocogene roxaparvovec) by purportedly failing to disclose that differences between the Company’s Phase 1/2 and Phase 3 clinical studies limited the ability of the Phase 1/2 study to support ROCTAVIAN’s durability of effect and, as a result, that it was foreseeable that the Food and Drug Administration (FDA) would not approve the BLA without additional data. The complaint seeks an unspecified amount of damages, prejudgment and post-judgment interest, attorneys’ fees, expert fees, and other costs. The lead plaintiff filed an amended complaint in February 2021, dropping our Chief Financial Officer as a defendan… Item 9A · ICFR · Based on the COSO criteria, our management has concluded that our internal control over financial reporting as of December 31, 2023 was effective at the reasonable assurance level. Item 9A · disclosure controls · Based on the evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2023. | ||||||
| 2022-12-31 | 2023-02-27 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · On September 25, 2020, a purported shareholder class action lawsuit was filed against us, our Chief Executive Officer, our President of Worldwide Research and Development and our Chief Financial Officer in the United States District Court in the Northern District of California, alleging violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as amended (the Exchange Act). The complaint alleges that we made materially false or misleading statements regarding the clinical trials and Biologics License Application (BLA) for ROCTAVIAN (formerly known as valoctocogene roxaparvovec) by purportedly failing to disclose that differences between the Company’s Phase 1/2 and Phase 3 clinical studies limited the ability of the Phase 1/2 study to support ROCTAVIAN’s durability of effect and, as a result, that it was foreseeable that the Food and Drug Administration (FDA) would not approve the BLA without additional data. The complaint seeks an unspecified amount of damages, prejudgment and post-judgment interest, attorneys’ fees, expert fees, and other costs. The lead plaintiff filed an amended complaint in February 2021, dropping our Chief Financial Officer as a defendan… Item 9A · ICFR · Based on the COSO criteria, our management has concluded that our internal control over financial reporting as of December 31, 2022 was effective at the reasonable assurance level. Item 9A · disclosure controls · Based on the evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2022. | ||||||
| 2021-12-31 | 2022-02-25 | described here | effective | effective | none in Item 9A | EDGAR |
Item 3 · On September 25, 2020, a purported shareholder class action lawsuit was filed against us, our Chief Executive Officer, our President of Worldwide Research and Development and our Chief Financial Officer in the United States District Court in the Northern District of California, alleging violations under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as amended (the Exchange Act). The complaint alleges that we made materially false or misleading statements regarding the clinical trials and Biologics License Application (BLA) for valoctocogene roxaparvovec by purportedly failing to disclose that differences between the Company’s Phase 1/2 and Phase 3 clinical studies limited the ability of the Phase 1/2 study to support valoctocogene roxaparvovec’s durability of effect and, as a result, that it was foreseeable that the FDA would not approve the BLA without additional data. The complaint seeks an unspecified amount of damages, prejudgment and post-judgment interest, attorneys’ fees, expert fees, and other costs. The lead plaintiff filed an amended complaint in February 2021, dropping our Chief Financial Officer as a defendant, and asserting that the Company misled inv… Item 9A · ICFR · Based on the COSO criteria, our management has concluded that our internal control over financial reporting as of December 31, 2021 was effective at the reasonable assurance level. Item 9A · disclosure controls · Based on the evaluation, our Chief Executive Officer and our Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of December 31, 2021. | ||||||
5 of 5 annual reports on record have their filing text cached on this host; the rest are listed with their EDGAR link and no extraction, because this surface never fetches from SEC on a page load.
- Item 3 and Item 9A are located in the filing HTML already cached on this host and read with the same line-anchored item matcher and largest-gap body disambiguation the filing-narrative pass uses for Item 1A and Item 7 — no fetch, no model, no summarization.
- A heading is accepted as a section only when it is not a table-of-contents row (a trailing page number), not a quoted reference in prose, and names its own section; the span must then clear a per-item length band and carry readable text after the heading. Anything that fails a gate is served as 'not extracted' with the reason — never as a default value.
- An effectiveness conclusion is read only from a sentence that names its own control set (disclosure controls and procedures, or internal control over financial reporting) and states an outcome. Conditional sentences — the standard limitations paragraph and forward-looking remediation language — are excluded, because they are hypotheses rather than conclusions.
- When a filing's own sentences disagree — an effective conclusion beside an unremediated material-weakness disclosure, or two conclusions of opposite sign — no verdict is asserted. A wrong 'controls were effective' reading is worse than no reading.
- Every verdict is shown beside the verbatim sentence it was read from. The excerpt is the filing's own words, capped at 1,200 characters; the filing itself is one link away.