Recent 8-K filings for VNDA
Highest-materiality recent filing
Vanda Pharmaceuticals receives FDA approval for Bysanti (milsaperidone) for bipolar I disorder and schizophrenia
- Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.
- Bysanti is a new chemical entity that interconverts to iloperidone, leveraging 100,000+ patient-years of real-world experience.
-
Vanda shareholders re-elect three Class II directors and approve equity plan amendment
Directors Dugan, Duncan, and Ward re-elected with majority support; broker non-votes of ~10M shares.
-
Vanda Q1 net loss widens to $0.82/share; raises FY2026 revenue guidance on NEREUS launch
Fanapt net product sales $29.6M (+26% YoY); total prescriptions +32%, new-to-brand +76%.
-
Vanda Pharmaceuticals appoints Dr. Charles Duncan to Board of Directors effective April 22, 2026
Board expands from six to seven members; Duncan appointed as Class II director with term ending at 2026 annual meeting.
-
Vanda Pharmaceuticals General Counsel Timothy Williams resigns, effective Apr 10, 2026
Timothy Williams resigns as SVP, General Counsel and Secretary, effective April 10, 2026.
-
Vanda CEO reveals NEREUS launch plan: DTC channel, availability in months
NEREUS approved by FDA for prevention of vomiting induced by motion sickness.
-
Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.
-
Vanda Pharmaceuticals sets 2025 bonuses, 2026 salaries, and grants RSUs/PSUs to executives
CEO Polymeropoulos gets $834,326 2025 bonus; 2026 base $994,625, target bonus 80%.
-
Vanda FY2025: Fanapt sales +24% to $117.3M; net loss $220.5M; guides 2026 rev $230-260M
Fanapt net product sales $117.3M (+24% YoY); total revenues $216.1M (+9%); total prescriptions +28%, NBRx +149%.
-
FDA rejects Vanda's HETLIOZ sNDA for jet lag disorder after expedited re-review
FDA concluded sNDA cannot be approved in current form, citing phase advance protocols not sufficiently analogous to actual jet travel.
-
FDA approved NEREUS (tradipitant) on Dec 30, 2025 for prevention of vomiting induced by motion; first new drug class for motion sickness in >40 years.
-
FDA lifts partial clinical hold on Vanda's tradipitant for motion sickness
FDA lifted partial clinical hold on protocol VP-VLY-686-3403, removing the 90-dose cap on tradipitant studies.
-
FDA extends parcial clinical hold re-review to Dec 5; PDUFA date remains Dec 30 for tradipitant
FDA and Vanda agreed to extend partial clinical hold re-review target to Dec 5, 2025 (from Nov 26) due to CDER personnel transitions.
-
Vanda Q3 revenue up 18% to $56.3M but net loss widens to $22.6M; guidance lowered
Total net product sales $56.3M (+18% YoY): Fanapt $31.2M (+31%), HETLIOZ $18.0M (+1%), PONVORY $7.0M (+20%).
-
Vanda reaches FDA framework to resolve disputes on HETLIOZ and tradipitant
FDA expedited re-review of tradipitant clinical hold by Nov 26, 2025; PDUFA date Dec 30, 2025.
-
Vanda Q2 net loss widens to $27.2M; Fanapt sales up 27% to $29.3M
Fanapt net product sales $29.3M (+27% YoY); HETLIOZ $16.2M (-13%), PONVORY $7.1M (-18%).
-
Vanda shareholders elect directors, ratify auditor, approve say-on-pay and equity plan amendment
Quorum of 46,577,816 shares (79.0%) represented at June 5, 2025 annual meeting.
-
Vanda Q1 net loss widens to $29.5M; Fanapt sales up 14% but PONVORY down 18%
Net product sales $50.0M (+5% YoY); net loss $29.5M vs $4.1M loss a year ago.
-
FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.
-
Vanda Pharma discloses 2024 bonuses, 2025 salaries, and RSU grants for NEOs
CEO Polymeropoulos: 2024 bonus $947,928; 2025 base salary $965,655; target bonus 80%; 450,000 RSUs.
-
Vanda Q4 2024 revenue $53.2M (+17% YoY); guides 2025 rev $210-250M
Q4 2024 net loss $4.9M vs $2.4M loss in Q4 2023; Fanapt sales $26.6M (+18% YoY).
-
Vanda files NDA for tradipitant to treat motion sickness
Vanda disclosed via 8-K that it filed a New Drug Application for tradipitant for motion sickness.
-
Vanda Q3 2024 revenue up 23% to $47.7M; guidance raised; net loss $5.3M
Q3 total net product sales $47.7M (+23% YoY); Fanapt $23.9M (+12%), HETLIOZ $17.9M (+2%), PONVORY $5.9M (-32% QoQ).
-
Vanda rejects Cycle Group's $8.00/share acquisition proposal as undervaluing company
Board unanimously determined second unsolicited proposal from Cycle Group not in best interests; terms identical to earlier May bid.
-
Board approved amended bylaws effective October 2, 2024; changes include clarifying special meeting scope to agenda topics only.
-
FDA issues Complete Response Letter declining Vanda's tradipitant NDA for gastroparesis
FDA declined to approve tradipitant for gastroparesis on Sept 18, 2024; issued CRL citing need for additional studies.
-
Vanda amends Rights Agreement to clarify definitions of Acting in Concert and Beneficial Owner
Entered Amendment No. 2 to Rights Agreement on August 7, 2024 with Equiniti Trust Company as rights agent.
-
Vanda Q2 2024 revenue $50.5M (+10% YoY); net loss $4.5M; Fanapt bipolar launch underway
Q2 2024 total revenues $50.5M (up 10% YoY); net loss $4.5M vs net income $1.5M in Q2 2023.
-
Vanda Board rejects two unsolicited takeover proposals, citing undervaluation
Cycle Group bid $8.00/share cash; Future Pak offered $8.50-$9.00/share plus CVRs.
-
Future Pak LLC proposes $8.50-$9.00 per share cash plus Contingent Value Rights for Vanda Pharmaceuticals.
-
Vanda receives unsolicited acquisition proposal from Cycle Group at $8.00/share
Cycle Group Holdings Ltd. made an unsolicited, non-binding proposal to acquire Vanda for $8.00 per share in cash.
-
Vanda board rejects conditional resignation of director Chrousos after less-than-majority vote
Director Phaedra S. Chrousos received less than majority votes at 2024 annual meeting, tendered conditional resignation.
-
Vanda Pharmaceuticals Board Rejects Revised Unsolicited Takeover Bid from Future Pak
Future Pak offered $7.25-$7.75 per share in cash plus Contingent Value Rights to acquire Vanda.
-
Vanda director Chrousos fails re-election, tenders resignation after majority withhold vote
Phaedra S. Chrousos received 20,071,828 for vs 22,780,322 against; less than majority of votes cast.
-
Vanda Q1 revenue $47.5M, net loss $4.1M; Fanapt bipolar approval, PONVORY launch in Q3
Net loss $4.1M (diluted EPS -$0.07) vs net income $3.3M ($0.06) in Q1 2023; revenue $47.5M, -24% YoY.
-
Vanda receives revised unsolicited takeover proposal from Future Pak at $7.25-$7.75/share plus CVRs
Revised proposal of $7.25-$7.75 per share in cash plus Contingent Value Rights (CVRs).
-
Vanda amends Rights Agreement to exempt BlackRock from poison pill up to 20% ownership
Amendment adds BlackRock and its managed funds as 'Exempt Person' under the Rights Agreement.
-
Vanda adopts limited-duration rights plan; rejects Future Pak's $7.25-$7.75/share bid
Board adopted a one-year stockholder rights plan effective April 17, 2024, triggered at 10% beneficial ownership.
-
Vanda's Fanapt receives FDA approval for bipolar I disorder indication
FDA approved Fanapt (iloperidone) on April 2, 2024 for acute treatment of manic or mixed episodes in bipolar I disorder in adults.
-
FDA issues Complete Response Letter for Vanda's HETLIOZ insomnia sNDA
Received CRL on March 4, 2024 for HETLIOZ (tasimelteon) to treat insomnia with sleep initiation difficulties.
-
Vanda approves 2023 bonuses, 2024 salaries, and RSU grants for NEOs
CEO Polymeropoulos receives $983K bonus for 2023, 450,000 RSUs vesting over 4 years.
-
Purchase price $100M for U.S./Canadian rights of PONVORY (ponesimod) from Johnson & Johnson.
-
Vanda reports FY2023 revenue $192.6M (-24% YoY); Q4 net loss $2.4M; PDUFA dates in 2024
Full year 2023 net product sales $192.6M, down 24% from $254.4M; Q4 net loss $2.4M vs income $6.9M in Q4 2022.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.65 · Most common event regulatory