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.
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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%.
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Bysanti (milsaperidone) approved for acute manic/mixed episodes of bipolar I disorder and schizophrenia in adults.
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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%.
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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.
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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.
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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.
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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%).
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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.
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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%).
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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.
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FDA accepted for filing Vanda's NDA for tradipitant to treat motion sickness; PDUFA target date set for December 30, 2025.
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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).
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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.
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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).
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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.
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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.
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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.
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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.
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Future Pak LLC proposes $8.50-$9.00 per share cash plus Contingent Value Rights for Vanda Pharmaceuticals.
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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Purchase price $100M for U.S./Canadian rights of PONVORY (ponesimod) from Johnson & Johnson.
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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.
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FDA identifies deficiencies in Vanda's sNDA for HETLIOZ insomnia; Vanda alleges FDCA violation
FDA notified Vanda on Feb 4, 2024 of deficiencies in sNDA for HETLIOZ (tasimelteon) for insomnia; no details disclosed.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.85 · Median 0.65 · Most common event regulatory