8-K
filed February 23, 2026, 6:59 PM ET
ticker ALUR
CIK 0001964979
regulatory
confidence high
sentiment positive
materiality 0.85
FDA grants PMA approval for Allurion gastric balloon system for obesity
ALLURION TECHNOLOGIES, INC.
- Allurion Smart Capsule approved for adults 22-65 with BMI 30-40 kg/m² after unsuccessful weight loss attempt.
- Balloon swallowed in 15-min office visit, no surgery/endoscopy/anesthesia; stays ~4 months, then passes naturally.
- AUDACITY pivotal trial data supported approval; over 200,000 patients treated outside US with 14% total body weight loss.
- Opens access to ~80 million US adults with obesity; alternative to GLP-1s and bariatric surgery.
- Company cited 65% GLP-1 discontinuation rate within first year and rapid weight regain as unmet need.
Machine-readable event card
- schema_version
- secwatch.filing_event.v1
- accession
- 0001193125-26-062599
- form_type
- 8-K
- ticker
- ALUR
- cik
- 0001964979
- company_name
- ALLURION TECHNOLOGIES, INC.
- filed_at
- 2026-02-23T23:59:59+00:00
- discovered_at
- 2026-05-14T18:02:36.893694+00:00
- generated_at
- 2026-05-16T01:16:25.907588+00:00
- sec_items
- ["7.01", "9.01"]
- event_type
- regulatory
- sentiment
- positive
- materiality_score
- 0.85
- calibrated_materiality_score
- 0.85
- confidence
- high
- secwatch_canonical_url
- https://secwatch.observer/filing/0001193125-26-062599
- json_url
- https://secwatch.observer/filing/0001193125-26-062599.json
- markdown_url
- https://secwatch.observer/filing/0001193125-26-062599.md
- text_url
- https://secwatch.observer/filing/0001193125-26-062599.txt
- edgar_index_url
- https://www.sec.gov/Archives/edgar/data/1964979/000119312526062599/0001193125-26-062599-index.htm
- edgar_primary_document_url
- https://www.sec.gov/Archives/edgar/data/1964979/000119312526062599/alur-20260223.htm
- generated_by_model
- deepseek-v4-flash:cloud@v2
- review_status
- machine_generated
- human_reviewed
- false
- corrected
- false
- correction_note
- null
- correction_timestamp
- null
- superseded_by
- null
Comparable filings
ATNM
Actinium receives NYSE American non-compliance notice for low stockholders' equity; must submit plan by June 26
Actinium Pharmaceuticals, Inc.
May 29, 2026, 5:10 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
REPL
Replimune to resubmit RP1 BLA for advanced melanoma; FDA agrees to prioritize review
Replimune Group, Inc.
May 29, 2026, 9:56 AM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
VSTD
Vestand receives Nasdaq delisting notice for late quarterly and annual filings
Vestand Inc.
May 26, 2026, 5:18 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
MDAI
Spectral AI receives FDA De Novo clearance for DeepView System for burn indication
Spectral AI, Inc.
May 26, 2026, 4:00 PM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
NVVE
Nuvve receives Nasdaq delisting notice for late Q1 10-Q filing; already under $1.00 bid price review
Nuvve Holding Corp.
May 22, 2026, 6:35 PM ET
regulatory
Items 3.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
RGTI
Rigetti signs LOI for up to $100M CHIPS Act award for quantum R&D; government to receive equity
Rigetti Computing, Inc.
May 21, 2026, 7:30 AM ET
regulatory
Items 3.02, 8.01, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
GYRE
Gyre Therapeutics' NDA for F351 accepted by China's NMPA for CHB-induced liver fibrosis
GYRE THERAPEUTICS, INC.
May 12, 2026, 5:03 PM ET
regulatory
Items 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
MLTX
MoonLake aligns with FDA on BLA for sonelokimab in HS; Q1 cash $357.9M
MoonLake Immunotherapeutics
May 11, 2026, 7:59 PM ET
regulatory
Items 2.02, 7.01, 9.01
same SEC item: 7.01, 9.01
same event type: regulatory
similar materiality
Filing page
SEC filing
This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice.
See methodology for how this pipeline works.