ORION Biotech Catalyst Calendar
Menu
Skip to company history
COMPANY HISTORY / RETAINED ORIGINAL SOURCES

What did the company say,
and what came next?

In the reviewed release recorded , ORION retains 24 historical announcement records as of for 10 companies. Read the original sources and their publication dates below or inspect the dated catalog.

Last updated: · page presentation. Reviewed catalog release: · reviewed catalog release, not a fresh source check

  1. 1 Choose one ticker
  2. 2 Read the evidence
  3. 3 Keep a starting point

10 companies · 24 retained records · Reviewed 2026-09-26T07:20:44Z.

What did ALNY disclose about Vutrisiran?

Alnylam Pharmaceuticals · HELIOS-B Phase 3 topline results · 3 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: Early 2024

Source published · Original announcementSource-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 ↗. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcementSource-link check: this original issuer URL opened the press-release list in Chrome on . The original recorded URL is retained.
Exact SEC copy: UNAVAILABLE — no matching copy established in this source check.. ORION first recorded .

Follow-up research question

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

What did BMRN disclose about Valoctocogene roxaparvovec (ROCTAVIAN)?

BioMarin Pharmaceutical · ROCTAVIAN US FDA review · 3 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: March 31, 2023; potential three-month extension disclosed

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

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

What did BIIB disclose about Tofersen (QALSODY)?

Biogen · Tofersen US FDA review · 3 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: 2023-01-25

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

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

What did ALT disclose about Pemvidutide?

Altimmune · MOMENTUM Phase 2 48-week results · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: Q4 2023

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

What do the complete 48-week results show about weight change, discontinuations and safety?

What did BEAM disclose about BEAM-101?

Beam Therapeutics · BEACON Phase 1/2 initial clinical data · 3 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: Second half of 2024

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

How do the abstract and later presentation differ in patient count, follow-up and safety findings?

What did CRSP disclose about Exagamglogene autotemcel (exa-cel / CASGEVY)?

CRISPR Therapeutics · Exa-cel US review for sickle cell disease · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: 2023-12-08

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

Which indication and age group were approved, and how does that differ from the separate thalassemia application?

What did EXEL disclose about Cabozantinib (CABOMETYX)?

Exelixis · CABOMETYX US review for advanced NET · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: 2025-04-03

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

Which previously treated neuroendocrine tumor populations were included in the final label?

What did GILD disclose about Lenacapavir?

Gilead Sciences · PURPOSE 1 Phase 3 update · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: Second half of 2024

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

Was this an interim analysis or final readout, and which population and comparator were studied?

What did IONS disclose about Olezarsen (TRYNGOLZA)?

Ionis Pharmaceuticals · Olezarsen US review for FCS · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: 2024-12-19

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

Which patients were included in the FCS approval, and how does this differ from the separate severe-hypertriglyceridemia program?

What did LLY disclose about Donanemab?

Eli Lilly and Company · TRAILBLAZER-ALZ 2 Phase 3 topline results · 2 retained source records as of .

Earlier selected statement

Read the source context →

Stated timing: Q2 2023

Source published · Original announcement. ORION first recorded .

Later selected disclosure

Read the source context →

Source published · Original announcement. ORION first recorded .

Follow-up research question

What did the prespecified analysis show, and how do the full safety results affect interpretation?

YOUR PRIVATE STARTING POINT

Compare with what you saved.

Save a milestone to your account’s Notebook. Reopen its original snapshot here and compare with this reviewed catalog. Email subscriptions use a separate opt-in.

Sign inManage Notebook allowance
Source index · readable without the interactive view

Alnylam Pharmaceuticals (ALNY)

HELIOS-B Phase 3 topline results

  1. Q3 2023 results: HELIOS-B timing

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

    Stated timing: Early 2024

    Original announcementSource-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 published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. 2023 year-end results: revised HELIOS-B plan

    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.

    Stated timing: Late June or early July 2024

    Original announcementSource-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 published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  3. HELIOS-B topline results announcement

    Alnylam published HELIOS-B topline results and reported that the study met its primary and secondary endpoints. This is evidence that a readout was announced; it is not an independent review of every efficacy or safety claim.

    Original announcementSource-link check: this original issuer URL opened the press-release list in Chrome on . The original recorded URL is retained.
    Exact SEC copy: UNAVAILABLE — no matching copy established in this source check.    .

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

BioMarin Pharmaceutical (BMRN)

ROCTAVIAN US FDA review

  1. 2022 year-end results: ROCTAVIAN review date

    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.

    Stated timing: March 31, 2023; potential three-month extension disclosed

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. Q1 2023 results: FDA extended the review

    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.

    Stated timing: 2023-06-30

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  3. ROCTAVIAN US approval announcement

    BioMarin announced FDA approval of ROCTAVIAN for eligible adults with severe hemophilia A on June 29, 2023. The announcement contains eligibility and safety information; approval should not be read as suitable treatment for every patient.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Biogen (BIIB)

Tofersen US FDA review

  1. Tofersen application accepted for FDA review

    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.

    Stated timing: 2023-01-25

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. Tofersen FDA review extended by three months

    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.

    Stated timing: 2023-04-25

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  3. Partner Ionis: QALSODY approval announcement

    Ionis announced that its partner Biogen received accelerated FDA approval for QALSODY in adults with SOD1-associated ALS. The approval used a biomarker endpoint; continued approval could depend on confirmation of clinical benefit.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Altimmune (ALT)

MOMENTUM Phase 2 48-week results

  1. Q1 2023 update: MOMENTUM timing

    Altimmune expected the 48-week topline results of the MOMENTUM Phase 2 obesity trial in the fourth quarter of 2023.

    Stated timing: Q4 2023

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. MOMENTUM 48-week topline announcement

    Altimmune announced the 48-week MOMENTUM topline results on November 30, 2023. This records publication of the readout, not an ORION efficacy comparison or investment recommendation.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Beam Therapeutics (BEAM)

BEACON Phase 1/2 initial clinical data

  1. 2024 milestones: BEAM-101 first clinical data

    Beam expected initial data from multiple BEACON participants in the second half of 2024.

    Stated timing: Second half of 2024

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. ASH abstracts: first BEAM-101 clinical data

    Beam released initial BEACON findings with accepted ASH abstracts. The preliminary data used a July 2 cutoff. The release also described a patient death judged likely related to conditioning and unrelated to BEAM-101; readers should review the full safety context.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  3. ASH announcement: updated BEACON data

    Beam announced updated BEACON data using an October 28 cutoff, including seven treated participants in the analysis. This was an additional disclosure after the November abstract, not a second initial-data promise.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

CRISPR Therapeutics (CRSP)

Exa-cel US review for sickle cell disease

  1. Exa-cel FDA application acceptance

    CRISPR and Vertex reported a December 8, 2023 FDA target date for the sickle cell disease application. The separate thalassemia application had a different target and is not combined into this milestone.

    Stated timing: 2023-12-08

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. Vertex and CRISPR: CASGEVY US SCD approval

    Vertex and CRISPR announced FDA approval of CASGEVY for sickle cell disease in patients aged 12 years and older with recurrent vaso-occlusive crises.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Exelixis (EXEL)

CABOMETYX US review for advanced NET

  1. 2025 milestones: CABOMETYX NET review date

    Exelixis reported FDA review of the supplemental application for previously treated advanced neuroendocrine tumors, with an April 3, 2025 target action date.

    Stated timing: 2025-04-03

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. CABOMETYX advanced NET approval announcement

    Exelixis announced FDA approval of CABOMETYX for specified previously treated advanced pancreatic and extra-pancreatic neuroendocrine tumors. The approval announcement preceded the published target date.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Gilead Sciences (GILD)

PURPOSE 1 Phase 3 update

  1. Q4 2023 prepared remarks: PURPOSE 1 timing

    Gilead expected a Phase 3 PURPOSE 1 update in the second half of 2024. The presentation described timing estimates, not a guaranteed efficacy outcome.

    Stated timing: Second half of 2024

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. PURPOSE 1 interim topline announcement

    Gilead published results from a PURPOSE 1 interim analysis and reported a committee recommendation to stop the blinded phase. This interim announcement was earlier than the previously indicated update window; it was not final regulatory approval.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Ionis Pharmaceuticals (IONS)

Olezarsen US review for FCS

  1. Q3 2024 results: olezarsen FCS review date

    Ionis reported a December 19, 2024 FDA target action date for olezarsen in familial chylomicronemia syndrome. Other olezarsen indications and their trials are separate milestones.

    Stated timing: 2024-12-19

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. TRYNGOLZA US FCS approval announcement

    Ionis announced FDA approval of TRYNGOLZA as an adjunct to diet for adults with familial chylomicronemia syndrome.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Eli Lilly and Company (LLY)

TRAILBLAZER-ALZ 2 Phase 3 topline results

  1. Donanemab regulatory update and Phase 3 timing

    Lilly expected the confirmatory TRAILBLAZER-ALZ 2 topline readout in Q2 2023. The announcement separately described a complete response letter for the earlier accelerated-approval application; those are different events.

    Stated timing: Q2 2023

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    UNAVAILABLE
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)
  2. TRAILBLAZER-ALZ 2 topline announcement

    Lilly announced Phase 3 topline results and reported meeting the primary endpoint. The release also described serious amyloid-related imaging abnormalities, including deaths; the readout is not a blanket safety claim.

    Original announcement.

    Source published (published_at)
    Event effective (effective_at)
    ORION first seen (first_seen_at)
    ORION ingested (ingested_at)

Scope

These selected company announcements preserve publication dates separately from ORION’s later recording times. Registry completion dates and follow-up research questions are separate from company announcements; this historical release does not establish current guidance or continuous monitoring.

Coverage & method → · Corrections · Catalog manifest

THE WEEKLY RESEARCH NOTE

Keep the original sources close.

Sign up for ORION’s free English research email. Company-specific monitoring is separate.

Checking email signup availability…