Citius Pharmaceuticals, Inc. CTXR
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is an oncology drug developer. Its lead program, LYMPHIR (denileukin diftitox-cdxl), is in Phase 3 for Persistent or recurrent cutaneous T-cell lymphoma (CTCL). Its next catalyst on record is Citius Oncology expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with Form 10-K filing. (December 2026).
Upcoming catalysts
- December 2026Citius Oncology expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with Form 10-K filing.
Citius Oncology expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with the filing of its Annual Report on Form 10-K.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| LYMPHIR (denileukin diftitox-cdxl) | CTCL (FDA approved Aug 2024; US launch Dec 2025); investigator-initiated Phase 1 combination studies (CAR-T in DLBCL; pembrolizumab in gynecologic cancers) | protein/peptide | Approved |
| Mino-Lok | Catheter-related bloodstream infections (antibiotic lock solution) | small molecule | Phase 3 |
| Halo-Lido | Hemorrhoids (corticosteroid-lidocaine topical) | small molecule | Phase 2 |
| NoveCite | Acute respiratory distress syndrome / acute pneumonitis (mesenchymal stem cell therapy) | cell therapy | Phase 1 |
Recent results and decisions
- Oct 10, 2026positive Citius Oncology presented positive quality of life data from pivotal Study 302 of LYMPHIR showing sustained improvement in skin-related quality of life measures among responders.
Patients who responded to LYMPHIR reported sustained improvement in skin-related quality of life measures
Filing - Mar 10, 2026positive Completed Phase 1 dose-escalation showed 24% ORR and 48% clinical benefit rate among 21 evaluable patients, with no unexpected safety signals in 25 evaluable patients.
In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level.
Filing - Mar 4, 2026positive Investigator-initiated Phase 1 (n=14) of LYMPHIR before CAR-T showed 86% ORR (57% CR, 29% PR), 1-year PFS 77%, and no dose-limiting toxicities.
Overall response rate (ORR) was 86% at one month, including 57% complete responses (CR) and 29% partial responses (PR)
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.