Recent 8-K filings for DBVT
Highest-materiality recent filing
DBV Technologies reports positive Phase 3 VITESSE results; BLA submission on track for H1 2026
- VITESSE met primary endpoint: response rate 46.6% vs 14.8% placebo (p<0.001); lower bound CI 24.5% >15% threshold.
- Safety consistent with prior studies: low discontinuations (3.2% active vs 0.5% placebo), no treatment-related SAEs.
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DBV Technologies grants CEO 1.74M PSUs tied to FDA acceptance of Viaskin Peanut BLAs
1,740,000 PSUs granted to CEO Daniel Tassé with grant date May 5, 2026.
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DBV Technologies reports Q1 net loss of $47.6M; cash of $229M into Q2 2027
Net loss of $47.6M ($0.11 per share) vs $27.1M ($0.26) in Q1 2025; loss per share improved due to equity base from PIPE.
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DBV Technologies FY2025 net loss $147M; cash runway into Q2 2027; BLA on track H1 2026
Net loss of $147M for FY2025, compared to $113.9M in FY2024; diluted EPS -$1.05.
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82.8% of treated children increased eliciting dose at month 12 vs ~48% placebo; 60.1% increased by ≥2 doses vs 23.4% placebo.
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DBV Technologies secures €166.7M from full exercise of warrants after positive VITESSE trial
€166.7M gross proceeds from full exercise of ABSA Warrants (34.1M) and BS Warrants (71.0M) issued March 2025.
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DBV Technologies reports positive Phase 3 VITESSE results; BLA submission on track for H1 2026
VITESSE met primary endpoint: response rate 46.6% vs 14.8% placebo (p<0.001); lower bound CI 24.5% >15% threshold.
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DBV Technologies appoints Philina Lee to Board of Directors effective October 30, 2025
Lee replaces Daniel Soland; appointment subject to shareholder ratification at next annual meeting.
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Net loss $33.2M in Q3 2025 ($0.24/share); nine-month loss $102.1M ($0.82/share), wider than prior year.
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Board member Daniel Soland resigns from DBV Technologies effective immediately
Daniel Soland resigned from DBV's Board and Compensation Committee effective immediately on September 18, 2025.
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DBV Technologies establishes $150M ATM equity program via Citizens JMP; up to 50% dilution
ATM program allows sale of up to $150M in ADSs (each representing 5 ordinary shares) on Nasdaq through Citizens JMP.
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DBV Tech Q2 2025 net loss $41.9M; cash $103.2M; going concern doubt persists
Q2 2025 net loss of $41.9M vs $33.1M in Q2 2024, driven by R&D spend on COMFORT Toddlers study.
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DBV Technologies screens first subject in Phase 3 COMFORT Toddlers study for Viaskin Peanut
First subject screened at Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein as PI.
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Shareholders approved 2024 ex-post compensation for CEO Daniel Tassé: $348,000 variable comp and $150,000 exceptional bonus.
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DBV Tech Q1 cash $13M, net loss $0.26/share; new $306.9M financing to fund into June 2026
Cash used in operations $19.7M; cash balance fell to $13.0M as of March 31, 2025 from $32.5M.
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DBV Technologies raises up to $306.9M via private placement for Viaskin Peanut BLA
Gross proceeds up to $306.9M: $125.5M upfront plus up to $181.4M if all warrants exercised.
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DBVT: FDA agrees on safety data for Viaskin BLA in 4-7 yr olds; cash only into Apr 2025
FDA aligns: safety data from VITESSE Phase 3 and OLE sufficient for BLA; no COMFORT Children study needed; BLA filing 1H 2026, potential launch acceleration ~1 year.
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DBV Technologies reports positive 3-year EPITOPE OLE data; 68.2% passed food challenge at month 36
68.2% of toddlers completed oral food challenge (~12-14 peanut kernels) without meeting stopping criteria at month 36, vs 30.7% at month 12.
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DBV Tech amends CMO and CFO employment agreements to add change-in-control severance
CMO Pharis Mohideen eligible for 24 months base salary + 1x target annual bonus lump sum upon CIC termination.
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DBV Technologies regains Nasdaq minimum bid price compliance on Dec 13, 2024
Received Nasdaq Staff letter on Dec 13, 2024 confirming compliance with Rule 5550(a)(2).
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FDA confirmed Phase 3 EPITOPE efficacy data serves as intermediate endpoint for Accelerated Approval.
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DBV Technologies plans 1-for-5 ADS reverse split effective Nov 29 to regain Nasdaq compliance
ADS ratio changes from 1 ADS = 1 ordinary share to 1 ADS = 5 ordinary shares.
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DBV Technologies reports Q3 cash $46.4M; going concern doubt, cash runway into Q1 2025
Net loss of $90.9M for 9M ended Sep 30 2024 vs $61.5M prior year; Q3 net loss $30.4M.
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FDA confirmed Accelerated Approval pathway for Viaskin Peanut patch in 1-3 year-olds; COMFORT safety study (n=300-350) to start Q2 2025.
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DBV completes VITESSE Phase 3 screening early; topline data expected Q4 2025
Screening closed in August 2024, ahead of schedule; enrollment exceeded original goal.
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DBV reports Q2 net loss $33.1M, cash $66.2M, going concern doubt; VITESSE on track
Q2 net loss of $33.1M (US GAAP), basic EPS -$0.34 vs -$0.26 in Q2 2023.
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DBVT granted second 180-day compliance period for Nasdaq bid-price rule; transfer to Capital Market
Nasdaq transferred DBVT ADS listing from Global Select to Capital Market tier effective June 20, 2024.
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DBV Technologies delays ADS ratio change to June 7, 2024; 1-for-2 reverse split
ADS ratio change expected effective June 7, 2024, previously planned June 3.
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DBV Technologies plans 1-for-2 reverse ADS split effective June 3 to meet Nasdaq bid price
ADS ratio changes from 1 ADS = 1/2 ordinary share to 1 ADS = 1 ordinary share.
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DBV Technologies shareholders approve reverse split and ATM program at AGM
Shareholders approved a 10:1 reverse split (par value to €1); 46.6M for, 2.3M against.
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DBV Technologies reports Q1 net loss $27.3M; cash runway only through Dec 2024, substantial doubt
Cash & equivalents $101.5M as of March 31, down from $141.4M at Dec 31, 2023.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.95 · Median 0.72 · Most common event other_material