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Iovance updates corporate presentation; guides FY26 revenue $350M-$370M, Q2 $86M-$88M
Q2 2026 revenue guidance of $86M-$88M; FY26 revenue guidance $350M-$370M; ~45% YoY quarterly growth.
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Iovance's Amtagvi granted TGA approval in Australia for advanced melanoma
Therapeutic Goods Administration of Australia approved Amtagvi for previously treated advanced melanoma.
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Iovance Q1 revenue $71M (+45% YoY); guides FY26 $350-370M; endometrial cancer 40% cORR
Total product revenue ~$71M in Q1 2026, up 45% YoY; U.S. Amtagvi revenue ~$60M, Proleukin ~$11M.
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Iovance Q4 product revenue $87M (30% QoQ), FY2025 $264M; FDA Fast Track for NSCLC
Q4 product revenue ~$87M, up ~30% QoQ; FY2025 total $264M, within $250-300M guidance.
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Iovance reaffirms FY2025 revenue guidance of $250-300M; cash $307M as of Q3
Expects to achieve previously disclosed FY2025 revenue guidance of $250-300M in first full year of Amtagvi sales.
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Iovance Q3 revenue $68M (+13% QoQ), margin 43%; lifileucel NSCLC data durable
Q3 2025 product revenue ~$68M, up 13% sequentially; gross margin 43% on ~$39M cost of sales.
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Iovance Biotherapeutics enters $350M ATM equity offering agreement with Jefferies
Agreement with Jefferies LLC to sell up to $350M of common stock in at-the-market offerings.
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Iovance's Amtagvi receives Health Canada approval for advanced melanoma
Health Canada issued NOC/c for Amtagvi (lifileucel) for unresectable/metastatic melanoma after anti-PD-1 and targeted therapy.
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Iovance reports Q2 2025 earnings: $60M revenue, appoints new CFO, extends cash runway into Q4 2026
Q2 2025 total product revenue $60.0M (Amtagvi $54.1M, Proleukin $5.9M), net loss $111.7M.
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Iovance CFO Bellemin departs effective June 30; SVP Finance Rosinack named interim CFO
CFO Jean-Marc Bellemin's resignation accelerated from July 10 to June 30, 2025 by mutual agreement.
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Iovance CFO Jean-Marc Bellemin resigns effective July 10, 2025
Jean-Marc Bellemin, CFO and principal financial & accounting officer, resigns effective July 10, 2025.
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Iovance Q1 2025 revenue $49.3M; FY2025 guidance revised to $250-300M
Q1 2025 product revenue $49.3M from Amtagvi ($43.6M) and Proleukin ($5.7M); net loss $116.2M ($0.36 diluted).
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Iovance Q4 2024 product revenue $73.7M; FY24 total $164.1M, achieving upper end of guidance
Full year 2024 product revenue of $164.1M, within $160-165M guidance; Amtagvi $103.6M, Proleukin $60.5M.
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Iovance Q3 product revenue $58.6M; net loss narrows to $0.28/shr; FY24 guidance reaffirmed
Q3 2024 product revenue $58.6M ($42.1M Amtagvi, $16.5M Proleukin); net loss $83.5M ($0.28/shr) vs $113.8M ($0.46/shr) YoY.
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Iovance posts Q2 product revenue $31.1M; guides FY24 $160-165M, FY25 $450-475M
Q2 net loss $97.1M ($0.34/shr) vs. $106.5M ($0.47) a year ago; revenue $31.1M from Amtagvi ($12.8M) and Proleukin ($18.3M).
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Iovance submits MAA to EMA for lifileucel in advanced melanoma; first of multiple global filings
MAA seeks approval for lifileucel after prior PD-1 and BRAF/MEK therapy; would be first approved TIL therapy in EU.
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Iovance reports $363M cash, 50+ ATCs onboard for Amtagvi; frontline melanoma data shows 65.2% ORR
Cash position of ~$363M as of 3/31/2024; 600+ employees and 50+ payers covering 200M+ lives have approved Amtagvi for at least one patient.
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Iovance reports 65% ORR, 30% complete response rate for lifileucel + pembro in frontline melanoma
Confirmed ORR of 65.2% (30.4% CR, 34.8% PR) in 23 evaluable frontline advanced melanoma patients.
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Iovance reports Q1 net loss $113M; Amtagvi launch strong with 100+ patients enrolled across 40+ ATCs
Net loss $113.0M ($0.42 per share) vs $107.4M ($0.50) YoY; revenue $0.7M from Proleukin sales.
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Iovance settles derivative suit over director compensation; $600k fee, option cancellations
Iovance cancels 12,796 (2019), 11,731 (2020), 8,603 (2021) options to non-employee directors; awards reduced below 75th peer percentile.
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FDA lifts clinical hold on Iovance's IOV-LUN-202 NSCLC trial; enrollment to resume
FDA cleared Iovance to resume patient enrollment in registrational IOV-LUN-202 trial for LN-145 TIL therapy in NSCLC.
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Iovance reports $485M cash, AMTAGVI launch ongoing; partial clinical hold on lung TIL trial
Cash position ~$485M as of 2/22/24, including $197.1M from Feb 2024 equity offering.
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Iovance reports $444M net loss for 2023; Amtagvi approved and launched Feb 2024
FDA approved Amtagvi (lifileucel) on Feb 16, 2024 — first T cell therapy for a solid tumor (advanced melanoma).
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Iovance closes $197.1M public offering of 23M shares at $9.15/share
Closed sale of 23,014,000 shares at $9.15 per share in underwritten offering.
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Iovance receives FDA accelerated approval for AMTAGVI (lifileucel) in advanced melanoma
AMTAGVI is first FDA-approved T cell therapy for a solid tumor cancer, indicated for advanced melanoma after anti-PD-1 and BRAF/MEK therapy.
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Iovance prices $211M common stock offering at $9.15/share
Issues 23,014,000 shares at $9.15; gross proceeds ~$211M, net ~$197.1M.
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Iovance discloses FDA clinical hold on NSCLC TIL trial; BLA for lifileucel in melanoma under review
FDA placed clinical hold on IOV-LUN-202 trial (NSCLC) on Dec 22, 2023; new enrollment paused.
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Iovance updates pipeline: BLA under review, NSCLC trial on hold
BLA for lifileucel in advanced melanoma under FDA review; pre-license inspection of iCTC facility completed in 2023.
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FDA places clinical hold on Iovance's LN-145 NSCLC trial after fatal adverse event
FDA placed clinical hold on IOV-LUN-202 on Dec 22, 2023, after a Grade 5 fatal SAE potentially linked to preconditioning.
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Iovance reports Q3 net loss of $113.8M; BLA for lifileucel on track with PDUFA Feb 24, 2024
Net loss of $113.8M ($0.46/share) vs $99.6M ($0.63/share) in Q3 2022; revenue of $0.5M from Proleukin acquisition.
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FDA extends PDUFA date for Iovance's lifileucel BLA to Feb 24, 2024 due to resource constraints
FDA extended PDUFA target action date for lifileucel BLA from prior to February 24, 2024, citing resource constraints.
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Iovance reports LN-145 + pembrolizumab 42.1% ORR in ICI-naïve mNSCLC trial
ORR of 42.1% in ICI-naïve mNSCLC; 80% in treatment-naïve, 42.9% post-chemo, 14.3% EGFR-mutated post-TKI.
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Iovance reports Q2 2023 net loss $106.5M, cash $317.3M; lifileucel PDUFA Nov 25
FDA set PDUFA date Nov 25, 2023 for lifileucel BLA in advanced melanoma under priority review.
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Iovance Biotherapeutics closes $172.5M public offering of 23M shares at $7.50/share
Closed underwritten public offering of 23,000,000 shares at $7.50 per share.
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Iovance prices $150M public offering of 20M shares at $7.50; underwriter option for 3M more
Priced 20M shares at $7.50/share for gross proceeds of $150M; net proceeds ~$140.2M.
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Iovance gets FDA positive feedback for TIL therapy in NSCLC; 26.1% ORR in 23 patients
FDA Type B meeting supports IOV-LUN-202 trial design for accelerated approval of LN-145 in post-anti-PD-1 advanced NSCLC.
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Iovance enters $450M ATM equity offering with Jefferies, replaces prior program
Company entered new Open Market Sale Agreement with Jefferies for up to $450M in at-the-market common stock sales.