The data are exploratory and do not alter the immediate commercial trajectory for LYMPHIR in CTCL. Monitor for a Phase 2 start and any partnership or financing developments. At $18M market cap, positive early signals are supportive but not transformative — the stock's risk profile remains tied to CTCL adoption and cash runway.
Price Chart
Executive Summary
Citius Pharmaceuticals' subsidiary Citius Oncology presented Phase 1 data for LYMPHIR in combination with pembrolizumab at ASCO 2026, showing a 24% ORR and 20.5-month median PFS in a subset of heavily pre-treated gynecologic cancer patients. The data are early-stage and exploratory, with no financial impact disclosed, and do not change the near-term commercial outlook for LYMPHIR in its approved CTCL indication.
Key Facts
- Phase 1 data presented May 30, 2026 at ASCO for LYMPHIR + pembrolizumab in recurrent/refractory gynecologic malignancies.
- 24% overall response rate (5 partial responses) among 21 efficacy-evaluable patients.
- 33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors.
- Median PFS of 20.5 months among 48% of patients achieving clinical benefit; overall mPFS was 5.8 months.
- Only 1 reversible Grade 3 capillary leak syndrome at highest dose; no new safety signals.
- LYMPHIR is not FDA-approved for gynecologic cancers; efficacy in this setting not established.
- Phase 2 expansion study is being planned.
- No financial figures or changes to guidance reported in the filing.
Financial Impact
No financial data provided. The press release is an early clinical data disclosure with no revenue, cost, or guidance implications.
Risk Factors
- Phase 1 data may not predict results from larger or later-stage studies.
- LYMPHIR not approved for gynecologic cancers; significant regulatory and clinical development path ahead.
- Citius faces going-concern risks and needs additional capital to fund operations per forward-looking statements.
- Nasdaq compliance risk noted in risk factors.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-063531 |
| Document: ea0292904-8k_citius.htm | 0001213900-26-063531 |
| Document: 0001213900-26-063531-index-headers.html | 0001213900-26-063531 |
| Document: 0001213900-26-063531-index.html | 0001213900-26-063531 |
| Document: 0001213900-26-063531.txt | 0001213900-26-063531 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 5, 2026 11w ago | 8-K | $0.7809 | awaiting T+60 | — | $0.4512 (−42.22%) |
Jun 3, 2026 20w ago | EFFECT | $0.5800 $0.6290 | ▼ −8.45% | ▼ −5.95% | $0.4512 (+22.21%) |
Jun 1, 2026 20w ago | 8-K | $0.6030 $0.5771 | ▼ −4.30% | ▼ −5.41% | $0.4512 (−25.17%) |
May 22, 2026 22w ago | S-3 | $0.6970 $0.6375 | ▲ +8.54% | ▲ +11.26% | $0.4512 (+35.27%) |
May 15, 2026 23w ago | 8-K | $0.5270 $0.7650 | ▼ −45.16% | ▼ −40.31% | $0.4512 (+14.38%) |
Apr 24, 2026 26w ago | 8-K | $0.6910 $0.5623 | ▲ +18.63% | ▲ +23.40% | $0.4512 (+34.70%) |
Apr 24, 2026 26w ago | 424B5 | $0.7700 $0.5455 | ▲ +29.16% | ▲ +34.24% | $0.4512 (+41.40%) |
US Market Status
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