RAPP · RAP-219
FOS open-label long-term safety trial initial data · Company period: the fourth quarter of 2026 · Period end:
Data from the open-label trial is expected in the fourth quarter of 2026.
SEC 2026-08-05 · 0001193125-26-333862
Published 2026-10-14, two days after the 2026-10-12 window we set for this issue.
ORION Weekly 02
SEC source records · machine_extracted · 2026-10-08–2026-10-14 inclusive (UTC), as of 2026-10-14T02:10:52.988Z. 295 quote-verified schedule records across 132 companies as of 2026-10-14.
Repository source cutoff: 2026-10-14T02:10:52.988Z. Retained SEC issuer-list checks: 2026-10-13–2026-10-13. This issue compares stored repository data; it does not perform a new SEC collection on the issue preparation date.
What was added to the schedule dataset?
295 schedules were added to the repository’s portable SEC dataset during this comparison. That dataset was absent at the inspected baseline. This is a dataset import count; the company filings retain their original dates. 1 schedule records have source filing dates inside the issue period, across 1 distinct issuer/accession filings.
EDIT · EDIT-401
Preclinical LDL-C-reduction durability data at AHA Scientific Sessions · Company period: November 6-9, 2026 · Period end:
The Company also announced that new preclinical data, demonstrating durability of LDL-C reduction with EDIT-401, will be released via an oral presentation at the American Heart Association (AHA) Scientific Sessions 2026, taking place November 6-9, 2026, in Chicago, Illinois.
SEC 2026-10-08 · 0001650664-26-000093
STTK · SL-846
Non-human primate GLP toxicology preclinical safety/PK/receptor-occupancy data at UEG Week · Company period: October 17-20, 2026 · Period end:
Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study are expected to be presented in a poster at UEG Week, to be held October 17-20, 2026.
SEC 2026-08-11 · 0001628280-26-055484
Which company wording changed in this period?
0 changes have both a previous dataset record and a new SEC source filing dated in this period. Earlier wording in newly imported records is retained history; it is not classified as a new company wording change this week. 0 comparisons have no bound previous quotation and are excluded from the verified wording-change count.
Which stated periods ended?
0 held public records have a period end inside 2026-10-08–2026-10-14. The imported dataset also retains 31 periods ending before 2026-10-14; 31 have source-bound resolution evidence. Those earlier period ends are historical records.
Retained periods and resolution sources (31)
ARGX · efgartigimod
ALKIVIA myositis topline results · Company period: third quarter of 2026 · Period end:
Topline results from ALKIVIA study (myositis) expected in third quarter of 2026
SEC 2026-05-07 · 0001628280-26-031739
Resolution filing held: SEC 2026-08-17 · 0001104659-26-097589
topline results from the ALKIVIA Phase 3 study
MIRM · brelovitug
AZURE-1 Phase 3 HDV topline data · Company period: Q3 and Q4 2026 · Period end:
Brelovitug AZURE-1 and AZURE-4 Phase 3 studies in chronic hepatitis delta virus (HDV) topline results expected in Q3 and Q4 2026, respectively.
SEC 2026-08-05 · 0001759425-26-000044
Resolution filing held: SEC 2026-09-28 · 0001759425-26-000049
the Company announced the primary endpoint was met in the Phase 3 portion of the AZURE-1 study evaluating brelovitug
Resolution filing held: SEC 2026-09-28 · 0001759425-26-000049
On September 28, 2026, the Company announced the primary endpoint was met in the Phase 3 portion of the AZURE-1 study evaluating brelovitug, an investigational fully human monoclonal antibody that binds to hepatitis B surface antigen (HBsAg), for the treatment of chronic hepatitis delta virus (“HDV”).
MIRM · volixibat
VISTAS Phase 2b PSC topline data · Company period: Q2 2026 · Period end:
Volixibat VISTAS study in PSC topline data expected Q2 2026
SEC 2026-02-25 · 0001759425-26-000010
Resolution filing held: SEC 2026-08-05 · 0001759425-26-000045
We announced topline results for the VISTAS Phase 2b clinical trial in PSC in May 2026.
VKTX · VK2735
Phase 1 maintenance dosing study data · Company period: 3Q26 · Period end:
Maintenance Dosing Study Data Expected 3Q26
SEC 2026-07-29 · 0001193125-26-323652
Resolution filing held: SEC 2026-09-22 · 0001193125-26-397219
top-line results from the company’s maintenance study of VK2735
VKTX · VK2735
Phase 2 VENTURE-Oral study data · Company period: 2H25 · Period end:
Phase 2 VENTURE-Oral Dosing Trial in Obesity Fully Enrolled; Data Expected in 2H25
SEC 2025-04-23 · 0000950170-25-057337
Resolution filing held: SEC 2025-08-19 · 0001607678-25-000003
top-line results from the company’s Phase 2 clinical trial of the oral tablet formulation of VK2735
ARGX · efgartigimod
PDUFA target action date · Company period: May 10, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date for anti-acetylcholine receptor antibody negative (AChR-Ab-) gMG (MuSK+, LRP4+ and triple seronegative) is May 10, 2026
SEC 2026-05-07 · 0001628280-26-031739
Resolution filing held: SEC 2026-05-11 · 0001104659-26-058143
Food and Drug Administration (FDA) approved a label expansion for VYVGART ® (efgartigimod alfa-fcab) and VYVGART Hytrulo ® (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with generalized myasthenia gravis (gMG)
AXSM · AXS-05
PDUFA target action date · Company period: April 30, 2026 · Period end:
PDUFA target action date of April 30, 2026
SEC 2026-02-23 · 0001193125-26-062421
Resolution filing held: SEC 2026-08-10 · 0001193125-26-342360
In April 2026, the FDA approved AUVELITY for the treatment of agitation associated with dementia due to Alzheimer’s disease (AADDAD)
DNLI · tividenofusp alfa (DNL310)
PDUFA target action date · Company period: April 5, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date of April 5, 2026
SEC 2026-02-26 · 0001714899-26-000020
Resolution filing held: SEC 2026-08-06 · 0001714899-26-000097
AVLAYAH TM (tividenofusp alfa-eknm) received accelerated approval from the U.S. Food and Drug Administration ("FDA") on March 24, 2026
EXEL · cabozantinib
PDUFA target action date · Company period: April 3, 2025 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025
SEC 2025-02-11 · 0000939767-25-000019
Resolution filing held: SEC 2026-02-10 · 0000939767-26-000019
In March 2025, the U.S. FDA approved CABOMETYX for two new NET indications, advanced pancreatic and extra-pancreatic NET (pNET and epNET), based on results from the CABINET study
IONS · olezarsen
PDUFA target action date · Company period: June 30, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026
SEC 2026-04-29 · 0001140361-26-017637
Resolution filing held: SEC 2026-06-24 · 0001140361-26-026232
the U.S. FDA has approved TRYNGOLZA® (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with sHTG
IONS · zilganersen
PDUFA target action date · Company period: September 22, 2026 · Period end:
PDUFA target action date of September 22, 2026
SEC 2026-07-29 · 0001140361-26-029960
Resolution filing held: SEC 2026-09-04 · 0001140361-26-035657
the U.S. FDA has approved ZANVASTRO™ (zilganersen) for the treatment of AxD in pediatric and adult patients
MIRM · zilurgisertib
PDUFA target action date · Company period: September 26, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date for the zilurgisertib NDA is September 26, 2026
SEC 2026-08-05 · 0001759425-26-000044
Resolution filing held: SEC 2026-09-28 · 0001759425-26-000049
Food and Drug Administration (“FDA”) approved Atebrioz™ (zilurgisertib) tablets to reduce the volume of total new heterotopic ossification (“HO”) in adult and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva (“FOP”)
RCKT · marnetegragene autotemcel (KRESLADI)
PDUFA target action date · Company period: March 28, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date for March 28, 2026
SEC 2026-02-26 · 0001140361-26-006981
Resolution filing held: SEC 2026-08-10 · 0001193125-26-342348
On March 26, 2026, the FDA granted accelerated approval
REGN · aflibercept 8 mg
PDUFA target action date · Company period: April 20, 2025 · Period end:
target action date of April 20, 2025
SEC 2025-02-05 · 0001804220-25-000011
Resolution filing held: SEC 2025-04-29 · 0001804220-25-000020
In April 2025, the FDA issued a CRL regarding the sBLA for the addition of extended dosing intervals
REGN · cemiplimab
sBLA target action date · Company period: October 2025 · Period end:
target action date in October 2025
SEC 2025-08-01 · 0000872589-25-000017
Resolution filing held: SEC 2025-10-28 · 0000872589-25-000026
In October 2025, the FDA approved an sBLA for Libtayo as an adjuvant treatment for adults with CSCC at high risk of recurrence after surgery and radiation
REGN · dupilumab
sBLA target action date · Company period: February 2026 · Period end:
target action date in February 2026
SEC 2026-01-30 · 0000872589-26-000004
Resolution filing held: SEC 2026-04-29 · 0000872589-26-000014
the FDA approved Dupixent
REGN · dupilumab
PDUFA target action date · Company period: April 18, 2025 · Period end:
target action date of April 18, 2025
SEC 2025-02-05 · 0001804220-25-000011
Resolution filing held: SEC 2025-08-01 · 0000872589-25-000017
In April 2025, the FDA approved Dupixent for the treatment of adults and adolescents aged 12 years and older with CSU who remain symptomatic despite antihistamine treatment
REGN · dupilumab
PDUFA target action date · Company period: June 20, 2025 · Period end:
target action date of June 20, 2025
SEC 2025-04-29 · 0001804220-25-000022
Resolution filing held: SEC 2025-08-01 · 0000872589-25-000017
In June 2025, the FDA approved Dupixent for the treatment of adults with bullous pemphigoid
REGN · linvoseltamab
PDUFA target action date · Company period: July 10, 2025 · Period end:
target action date of July 10, 2025
SEC 2025-04-29 · 0001804220-25-000022
Resolution filing held: SEC 2025-08-01 · 0000872589-25-000017
In July 2025, the FDA granted accelerated approval for Lynozyfic (linvoseltamab) to treat adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy
REGN · odronextamab
PDUFA target action date · Company period: July 30, 2025 · Period end:
target action date of July 30, 2025
SEC 2025-04-29 · 0001804220-25-000022
Resolution filing held: SEC 2025-08-01 · 0000872589-25-000017
On July 30, 2025, the FDA issued a Complete Response Letter (CRL) for the BLA for odronextamab, a bispecific antibody targeting CD20 and CD3, in relapsed/refractory follicular lymphoma after two or more lines of systemic therapy
VERA · atacicept
PDUFA target action date · Company period: July 7, 2026 · Period end:
Prescription Drug User Fee Act (PDUFA) target action date of July 7, 2026
SEC 2026-05-07 · 0001193125-26-212143
Resolution filing held: SEC 2026-08-10 · 0001193125-26-342380
On July 7, 2026, the U.S. Food and Drug Administration (FDA) granted accelerated approval to TRUTAKNA TM (atacicept-vymj) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk for disease progression
EXEL · cabozantinib
ODAC meeting to discuss NET sNDA · Company period: March 2025 · Period end:
In November 2024, we announced that our sNDA would be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025
SEC 2025-02-11 · 0000939767-25-000019
Resolution filing held: SEC 2025-02-11 · 0000939767-25-000019
in January 2025, we announced that the FDA had notified us that our sNDA would no longer be the subject of discussion at an ODAC
AXSM · AXS-05
sNDA submission · Company period: 3Q 2025 · Period end:
sNDA submission for AXS-05 in Alzheimer’s disease agitation on track for 3Q 2025
SEC 2025-08-04 · 0000950170-25-101624
Resolution filing held: SEC 2025-11-03 · 0001193125-25-261651
Axsome has submitted a supplemental NDA (sNDA) to the FDA for AXS-05 in Alzheimer’s disease agitation.
AXSM · AXS-12
NDA submission · Company period: 1Q 2026 · Period end:
AXS-12 for narcolepsy, NDA submission (1Q 2026)
SEC 2026-02-23 · 0001193125-26-062421
Resolution filing held: SEC 2026-08-10 · 0001193125-26-342360
an NDA for AXS-12 for the treatment of cataplexy in narcolepsy (which was accepted for filing by the FDA in July 2026)
Resolution filing held: SEC 2026-08-10 · 0001193125-26-341206
Axsome’s NDA submission for AXS-12 for the treatment of cataplexy in narcolepsy was accepted by the FDA and assigned a PDUFA target action date of May 1, 2027.
Resolution filing held: SEC 2026-05-04 · 0001193125-26-202506
NDA for AXS-12 for the treatment of cataplexy in narcolepsy submitted to the FDA
AXSM · AXS-14
NDA submission · Company period: 1Q 2025 · Period end:
NDA submission for AXS-14 in fibromyalgia (1Q 2025)
SEC 2025-02-18 · 0000950170-25-021801
Resolution filing held: SEC 2025-05-05 · 0000950170-25-063158
We have submitted our NDA for AXS-14 for the management of fibromyalgia
EXEL · cabozantinib + atezolizumab
sNDA submission · Company period: during the fourth quarter of 2024 · Period end:
We intend to submit an sNDA to the FDA during the fourth quarter of 2024.
SEC 2024-10-29 · 0000939767-24-000150
Resolution filing held: SEC 2026-02-10 · 0000939767-26-000021
in July 2025, we announced our intention not to file a supplemental New Drug Application (sNDA) for CONTACT-02.
Resolution filing held: SEC 2025-07-28 · 0000939767-25-000113
Exelixis does not intend to file a supplemental New Drug Application for CONTACT-02.
IONS · olezarsen
sNDA submission · Company period: by the end of the year · Period end:
Ionis is on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the FDA by the end of the year.
SEC 2025-11-10 · 0001140361-25-041225
Resolution filing held: SEC 2026-02-25 · 0001140361-26-006718
Olezarsen sHTG launch preparations on track, sNDA submitted
Resolution filing held: SEC 2026-01-12 · 0001140361-26-000893
sNDA for sHTG submitted for review
IONS · zilganersen
NDA submission · Company period: in Q1 2026 · Period end:
Planned NDA submission in Q1 2026
SEC 2026-01-12 · 0001140361-26-000893
Resolution filing held: SEC 2026-02-26 · 0000874015-26-000115
We also submitted the NDA for zilganersen in January 2026 and plan to launch zilganersen in the second half of 2026 for the treatment of Alexander disease, or AxD.
Resolution filing held: SEC 2026-02-25 · 0001140361-26-006718
NDA submitted with approval decision anticipated in H2:2026
PTCT · vatiquinone
NDA submission · Company period: in December 2024 · Period end:
The Company plans to submit an NDA for vatiquinone for the treatment of FA in the United States in December 2024.
SEC 2024-11-07 · 0001070081-24-000023
Resolution filing held: SEC 2026-07-30 · 0001070081-26-000017
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2026-05-07 · 0001070081-26-000012
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2026-02-19 · 0001104659-26-017575
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2025-11-04 · 0001070081-25-000028
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2025-08-07 · 0001558370-25-010796
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2025-05-06 · 0001070081-25-000019
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
Resolution filing held: SEC 2025-02-27 · 0001070081-25-000012
In December 2024, we submitted an NDA to the FDA for vatiquinone for the treatment of children and adults living with FA.
RCKT · KRESLADI / RP-L201
BLA resubmission · Company period: in 2025 · Period end:
Submission of a complete BLA to resolve CRL is anticipated in 2025.
SEC 2025-08-07 · 0000950170-25-104996
Resolution filing held: SEC 2026-02-26 · 0001140361-26-006981
FDA accepted the resubmission of the BLA for KRESLADI TM (marnetegragene autotemcel; marne-cel) for the treatment of severe leukocyte adhesion deficiency-I (LAD-I).
Resolution filing held: SEC 2025-11-06 · 0001140361-25-040774
FDA accepted the resubmission of the BLA for KRESLADI TM (marnetegragene autotemcel; marne-cel) for the treatment of severe leukocyte adhesion deficiency-I (LAD-I).
REGN · Dupixent
sBLA submission · Company period: fourth quarter 2024 · Period end:
BP sBLA submission planned for fourth quarter 2024
SEC 2024-10-31 · 0001804220-24-000038
Resolution filing held: SEC 2025-01-13 · 0001104659-25-002826
a supplemental Biologics License Application (sBLA) was submitted in the fourth quarter of 2024.
What correction records were added?
14 dated correction entries are retained for this issue period.
- · AMLX · SEC acceptance time corrected from 2026-08-06T15:04:23.000Z to 2026-08-06T11:04:23.000Z. · SEC source · Correction record
- · MRNA · SEC acceptance time corrected from 2026-08-01T00:17:41.000Z to 2026-07-31T20:17:41.000Z. · SEC source · Correction record
- · MRNA · SEC acceptance time corrected from 2026-08-01T00:17:41.000Z to 2026-07-31T20:17:41.000Z. · SEC source · Correction record
- · ALNY · SEC acceptance time corrected from 2026-07-30T16:11:02.000Z to 2026-07-30T12:11:02.000Z. · SEC source · Correction record
- · KPTI · SEC acceptance time corrected from 2026-08-13T15:40:35.000Z to 2026-08-13T11:40:35.000Z. · SEC source · Correction record
- · BMY · SEC acceptance time corrected from 2026-07-30T15:05:39.000Z to 2026-07-30T11:05:39.000Z. · SEC source · Correction record
- · BHVN · Display rule corrected — equivalent timing phrases (e.g., 'H2 2026' / 'second half of 2026') are now shown as Statement retained. Source quotes and status unchanged. · SEC source · Correction record
- · BHVN · Added source-context excerpts from 2026-09-10 SEC Form 8-K. · SEC source · Correction record
- · BHVN · Added previously omitted 2026-09-10 SEC Form 8-K timing source. · SEC source · Correction record
- · SRRK · Display rule corrected — equivalent timing phrases (e.g., 'H2 2026' / 'second half of 2026') are now shown as Statement retained. Source quotes and status unchanged. · SEC source · Correction record
- · SRRK · Added previously omitted 2026-08-06 SEC Form 10-Q timing source. · SEC source · Correction record
- · SEPN · Corrected the April 13 event label to Statement retained; removed that equivalent expression from Wording changes. · SEC source · Correction record
- · SEPN · Added the August 10 10-Q sentence about extending MAD cohort dosing to 14 days as a Context disclosed row. · SEC source · Correction record
- · SEPN · Updated the Changes explanation to: Status is set by founder review of the original filings. · SEC source · Correction record
Which periods end in the next seven days?
1 unresolved held schedule periods end during 2026-10-15–2026-10-21 inclusive (UTC). These dates are company-stated periods, not predictions.
STTK · SL-846
Non-human primate GLP toxicology preclinical safety/PK/receptor-occupancy data at UEG Week · Company period: October 17-20, 2026 · Period end:
Preclinical data for SL-846, including safety, pharmacokinetics, and receptor occupancy from the ongoing GLP toxicology study are expected to be presented in a poster at UEG Week, to be held October 17-20, 2026.
SEC 2026-08-11 · 0001628280-26-055484