ORION Biotech Catalyst Calendar
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QUIET CHANGES / ORIGINAL RECORDS

What changed.
The evidence beside it.

Compare 3 historical company-statement comparisons, with earlier and later values and original sources. The latest 50-record registry check completed 19 Oct 2026, 00:17 UTC. Collection details

Public registry feed paused since (database quota). The gap will be marked, not backfilled.

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HISTORICAL COMPANY ANNOUNCEMENTS

Earlier wording. Later disclosure.

These are retained historical comparisons, collected retrospectively. They are separate from newly detected registry changes below and do not trigger watchlist alerts.

3 historical timing comparisons shown.

ALNY / HISTORICAL TIMING UPDATE

HELIOS-B Phase 3 topline results

Later source published · First recorded by ORION

EARLIER WORDING · 2023-11-02

Early 2024

Alnylam expected the HELIOS-B Phase 3 topline results in early 2024. The company did not give an exact calendar deadline in this statement.

Original announcement ↗Source-link check: this original issuer URL opened the press-release list in Chrome on . The original recorded URL is retained.
SEC filing copy of this announcement ↗ · Parent 8-K ↗

LATER WORDING · 2024-02-15

Late June or early July 2024

Alnylam described changes to the statistical analysis plan, endpoint structure and study exposure, and expected topline results in late June or early July 2024. This records a changed timing statement, without assigning an invented day to either phrase.

Original announcement ↗Source-link check: this original issuer URL opened the press-release list in Chrome on . The original recorded URL is retained.
SEC filing copy of this announcement ↗ · Parent 8-K ↗
Source dates and ORION record times

Earlier statement

Source published
Event effective
Not recorded
ORION first seen
ORION ingested

Later statement

Source published
Event effective
Not recorded
ORION first seen
ORION ingested

How did the revised analysis plan differ from the earlier plan, and what did the full results establish?

Read the full source trail →

BMRN / HISTORICAL TIMING UPDATE

ROCTAVIAN US FDA review

Later source published · First recorded by ORION

EARLIER WORDING · 2023-02-27

March 31, 2023; potential three-month extension disclosed

BioMarin reported a March 31, 2023 FDA target action date and explicitly said a three-month extension was possible if FDA considered it necessary. The date was a review target, not a promise of approval.

Original announcement ↗

LATER WORDING · 2023-04-26

2023-06-30

BioMarin reported that FDA had extended the review in March and set June 30, 2023 as the new target. The company said the requested three-year study analysis constituted a major amendment. This source does not identify the exact day in March when the change occurred.

Original announcement ↗
Source dates and ORION record times

Earlier statement

Source published
Event effective
Not recorded
ORION first seen
ORION ingested

Later statement

Source published
Event effective
Not recorded
ORION first seen
ORION ingested

What did the FDA review extension cover, and which patients are included in the resulting approval?

Read the full source trail →

BIIB / HISTORICAL TIMING UPDATE

Tofersen US FDA review

Later source published · First recorded by ORION

EARLIER WORDING · 2022-07-26

2023-01-25

Biogen reported FDA acceptance and priority review of the tofersen application, with a target action date of January 25, 2023. Acceptance for review was not approval.

Original announcement ↗

LATER WORDING · 2022-10-17

2023-04-25

Biogen announced a new FDA target of April 25, 2023. It said responses to FDA information requests were considered a major amendment requiring additional review time.

Original announcement ↗
Source dates and ORION record times

Earlier statement

Source published
Event effective
Not recorded
ORION first seen
ORION ingested

Later statement

Source published
Event effective
ORION first seen
ORION ingested

What was the basis of accelerated approval, and what clinical benefit still required confirmation?

Read the full source trail →

DAILY COLLECTION / REVIEWED REGISTRY CHANGES

Which registry comparisons are published?

Public registry feed checked . Historical company announcements remain a separate evidence set.

Daily registry checks

Read the collection log and explore the original historical comparisons below.

Published comparisons in this selection

0 published registry comparisons as of . Source matching and human review precede publication; company announcements have their own records.

Daily observation started
Earlier verified window: 4 scheduled daily checks verified through

19 Oct check: verification pending. The latest source completion is available; the verified count remains 4.

What this dated count means

The unit is one completed scheduled run across selected study records. Manual, acceptance, QA, failed and partial runs are excluded; the count is calculated from retained results within the stated window.

Verified against retained collection results and scheduler records. This history snapshot and the current collection status above have different last-run dates.

Archived verification: 27–29 September

These 3 completed scheduled runs cover the retained 27–29 September window. They are not 3 new changes or 150 unique studies. No continuity outside this window is claimed.

Verified scheduled collection receipts
Started (UTC)Completed (UTC)Status
COMPLETED
COMPLETED
COMPLETED

Download these check receipts (CSV) · Read the dated public feed (JSON)

How are registry records and company statements different?

Registry dates describe study records. Company announcements describe what a company said. ORION keeps them separate and connects them only when the study identity is verified.

How registry changes are classified

ORION compares five fields: primary completion, enrollment, primary outcomes, status and study arms. An estimate replaced by an actual value is shown separately from a change on the same value basis. Formatting and list order alone do not establish a new finding.

Renamed or ambiguous outcome and arm items are shown as complete before/after lists with item correspondence unconfirmed. Missing information is never filled with zero or the previous value. Categories are computed using policy registry-fields-v1; original observations and human review remain separate. No scores or clinical or price effects are inferred.

Coverage & method · Corrections