Recent 8-K filings for CTXR
Highest-materiality recent filing
Citius Pharma receives FDA approval for LYMPHIR (denileukin diftitox-cxdl) in r/r CTCL
- Phase 3 study showed 36.2% ORR, 8.7% complete response, median time to response 1.41 months.
- First FDA-approved product for Citius; launch expected within next five months.
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Citius Pharma Q2 2026: $5.6M H1 LYMPHIR revenue, 80% gross margins; raises $36.5M at Citius Oncology
Net product revenue $1.7M in Q2 (launch quarter); $5.6M in H1 2026 vs. zero a year ago.
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Citius Oncology ships first international order of LYMPHIR to Europe
First international shipment of LYMPHIR (denileukin diftitox-cxdl) to Europe through a regional distribution partner.
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83% of target accounts have added or are actively progressing LYMPHIR through formulary review.
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Phase 1 trial of LYMPHIR plus KEYTRUDA in 25 evaluable patients with relapsed/refractory gynecologic cancers showed 24% objective response rate and 48% clinical benefit rate.
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Citius subsidiary reports Phase 1 data: LYMPHIR + CAR-T shows 86% ORR, 57% CR in high-risk DLBCL
ORR 86% at 1 month (57% CR, 29% PR) in 14 patients with relapsed/refractory DLBCL.
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Citius Pharma posts first revenue of $3.9M from LYMPHIR launch; Nasdaq warns of bid price deficiency
Q1 FY2026 revenue $3.9M from initial LYMPHIR sales; net loss $8.2M ($0.41 loss per share).
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Citius Pharma reports FY2025 net loss $39.7M; launches LYMPHIR in December 2025
Net loss $39.7M ($3.38/share) vs $40.2M ($5.97/share) prior year; no revenue.
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Citius Oncology launches LYMPHIR for CTCL; first marketed product
LYMPHIR (denileukin diftitox-cxdl) now commercially available in U.S. for relapsed/refractory Stage I–III CTCL after prior systemic therapy.
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Citius Pharmaceuticals raises $6.0M in registered direct offering for LYMPHIR launch
Gross proceeds ~$6.0M; net ~$5.5M after placement agent fees and expenses.
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Citius Pharma Q3 fiscal 2025 net loss narrows to $9.2M; LYMPHIR launch on track for Q4
Net loss of $9.2M ($0.80 per share) vs $10.6M ($1.57 per share) in the prior-year quarter.
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Citius Pharma receives Nasdaq delisting notice for bid price non-compliance
Received Nasdaq letter on May 29, 2025 for failing minimum $1 bid price for 33 consecutive business days.
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Citius Pharma Q2 net loss $11.5M; cash only $26K; needs capital beyond May 2025
Net loss of $11.5M ($1.27 per share) for Q2 fiscal 2025 vs $8.5M a year ago.
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Citius Oncology amends license agreement with Eisai, defers $8.2M in LYMPHIR payments to 2025
Total obligations owed to Eisai: $8,233,209.77 including $5.9M milestone and $2.33M development/inventory costs.
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Citius Pharma Q1 2025 net loss $10.3M; prepares LYMPHIR launch H1 2025
Net loss of $10.3M ($1.30 per share) vs. $9.2M ($1.45) in Q1 2024; cash $1.1M as of Dec 31, 2024.
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Citius Pharma receives permanent J-code J9161 for LYMPHIR, effective April 1, 2025
CMS assigned permanent HCPCS J-code J9161 to LYMPHIR (denileukin diftitox-cxdl) for CTCL.
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Citius Pharma raises ~$3M in registered direct offering of stock and warrants
Offering of 743,496 shares plus warrants for 743,496 shares at combined price of $4.035 per unit.
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Citius Pharma reports LYMPHIR launch prep progress; targeting H1 2025 commercial launch
LYMPHIR approved Aug 2024 for relapsed/refractory CTCL; commercial launch targeted H1 2025.
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Citius Pharma reports FY 2024 net loss of $39.4M; FDA approval of LYMPHIR highlights
Net loss $39.4M ($5.97/share) for FY ended Sep 30, 2024 vs $32.5M ($5.57) prior year.
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Citius Pharmaceuticals regains Nasdaq compliance on bid price rule
Received Nasdaq notice on Dec 18, 2024 confirming compliance with Listing Rule 5550(a)(2).
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Citius Pharmaceuticals Reports Productive FDA Type C Meeting for Mino-Lok Phase 3 Program
Citius Pharma held a constructive in-person Type C meeting with the FDA on November 25, 2024, regarding its Phase 3 Mino-Lok trial for catheter-related bloodstream infections.
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Citius Pharma raises $3M in registered direct offering of 12M shares and 12M warrants
Offering consists of 12M common shares and warrants for 12M shares at combined $0.25; gross proceeds $3.0M.
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Nasdaq panel grants Citius Pharma extension to regain bid price compliance by Dec 3, 2024
Company received bid price deficiency notice on Sep 12, 2023, extended to Sep 9, 2024.
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Citius reports 27% ORR in Phase I trial of pembrolizumab + LYMPHIR for recurrent solid tumors
27% objective response rate (4/15) and 33% clinical benefit rate; median PFS 57 weeks for patients with clinical benefit.
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Citius Pharma receives Nasdaq delisting determination for bid price non-compliance; plans hearing
Received delisting determination on Sept 10, 2024 after failing to regain $1.00 bid price compliance by extended deadline of Sept 9, 2024.
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LYMPHIR added to NCCN Guidelines for CTCL treatment
NCCN Category 2A recommendation supports LYMPHIR as option for relapsed/refractory CTCL after at least one prior systemic therapy.
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Citius Pharma completes SPAC merger, forms Citius Oncology; holds ~90% of new public company
Merger closed Aug 12, 2024; Citius Oncology expected to trade on Nasdaq as CTOR on Aug 13.
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Citius Pharma Q3 net loss $10.6M; FDA approves LYMPHIR, oncology spin-off begins trading
FDA approved LYMPHIR (denileukin diftitox-cxdl) for cutaneous T-cell lymphoma on Aug 12, 2024.
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Citius Pharma receives FDA approval for LYMPHIR (denileukin diftitox-cxdl) in r/r CTCL
Phase 3 study showed 36.2% ORR, 8.7% complete response, median time to response 1.41 months.
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Citius Pharma: Mino-Lok Phase 3 trial meets primary endpoint (p=0.0006) in CLABSI/CRBSI
Primary endpoint: time to catheter failure significantly delayed for Mino-Lok vs control (p=0.0006); hazard ratio 0.53.
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Citius Pharma Q2 net loss $8.5M; LYMPHIR PDUFA Aug 13, Mino-Lok data due Q2
Cash $12.6M at Mar 31; $15M April offering extends runway through Dec 2024.
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Citius Pharma raises ~$15M in registered direct offering of common stock and warrants
Sold 21.43M shares and warrants to buy 21.43M shares at $0.70/combined unit.
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Citius Pharma: FDA accepts BLA resubmission for LYMPHIR (CTCL); PDUFA Aug 13, 2024
FDA accepted BLA resubmission for LYMPHIR (denileukin diftitox) to treat relapsed/refractory cutaneous T-cell lymphoma.
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Nasdaq granted extension until Sept 9, 2024 to regain $1.00 minimum bid price; stock continues trading under CTXR.
Earnings & guidance
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