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Citius Pharmaceuticals reports developments across its critical care and targeted oncology business, including activity at majority-owned subsidiary Citius Oncology. The company’s recurring updates center on LYMPHIR (denileukin diftitox-cxdl), an engineered IL-2 diphtheria toxin fusion protein approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy.
Company news also covers LYMPHIR commercialization, U.S. launch progress, international access through Named Patient Programs, and investigator-initiated oncology studies involving gynecologic cancers and diffuse large B-cell lymphoma. Capital updates include registered direct offerings, warrant issuances, non-dilutive funding and other financing actions that support product commercialization and development programs.
Citius Oncology (Nasdaq: CTOR) reported Phase 1 data from an investigator-initiated study of LYMPHIR (denileukin diftitox-cxdl) plus pembrolizumab in recurrent or refractory gynecologic malignancies presented at ASCO 2026.
Among 21 efficacy-evaluable patients, the combination achieved a 24% overall response rate, 48% clinical benefit rate, and median progression-free survival of 20.5 months in those with clinical benefit, with manageable tolerability and no new safety signals. A Phase 2 expansion is planned.
Citius Oncology (Nasdaq: CTOR) will present Phase 1 data on LYMPHIR (denileukin diftitox‑cxdl) plus pembrolizumab in relapsed/refractory gynecologic malignancies at the ASCO 2026 Annual Meeting in Chicago.
The investigator‑initiated trial reported a 24% objective response rate, average 21.1‑month duration of response in responders, and a favorable safety profile, which is described as signaling potential to augment immune checkpoint inhibitor efficacy and expand LYMPHIR’s role beyond CTCL.
The abstract (No. 2564) will be presented as a poster in the Developmental Therapeutics—Immunotherapy session on May 30, 2026, from 1:30 PM to 4:30 PM CDT.
Citius Oncology (Nasdaq: CTOR) reported fiscal Q2 2026 results and a business update. LYMPHIR® generated $1.7 million in quarterly and $5.6 million in first-half 2026 net revenue at ~80% gross margins. About 83% of target accounts have LYMPHIR on formulary or in review, with near 100% commercial payer coverage and no reimbursement denials.
The company held $2.6 million in cash at March 31, 2026, then secured up to $36.5 million in combined debt and equity in May. A one-time $19.7 million CMO contract cancellation drove G&A higher and contributed to a $26.6 million quarterly net loss.
Citius Pharmaceuticals (Nasdaq: CTXR) reported fiscal Q2 2026 results and a business update for majority-owned Citius Oncology (Nasdaq: CTOR). LYMPHIR generated $1.7M Q2 and $5.6M H1 2026 net revenue at ~80% gross margin, with payer coverage near 100% and 83% of target accounts on or in formulary review.
Citius Pharma held $4.6M cash on March 31, 2026, then raised $5M via a registered direct offering. Citius Oncology arranged up to $36.5M in combined warrant and debt financing. Management expects combined funds to support operations through November 2026. Net loss to common stockholders was $21.2M in Q2 2026, including a $19.7M one-time CMO contract cancellation charge.
The company highlighted initial LYMPHIR shipments to Europe via Uniphar, near-term completion of the U.S. commercial field force, and positive preliminary topline Phase 1 data from two investigator-initiated LYMPHIR combination studies. Engagement with the FDA continues for Mino-Lok and Halo-Lido.
Citius Oncology (Nasdaq: CTOR) announced its first shipment of LYMPHIR (denileukin diftitox-cxdl) to Europe via a regional distribution partner on April 29, 2026, expanding patient access outside the United States.
LYMPHIR will be available through Named Patient Programs in specific countries under local regulations; it lacks EMA marketing authorization. The company continues U.S. commercial rollout after FDA approval in August 2024 and a December 2025 U.S. launch.
Citius Pharmaceuticals (Nasdaq: CTXR) closed a registered direct offering priced at-the-market, selling 5,076,143 shares (or pre-funded warrants) at $0.985 per share and issuing unregistered warrants to purchase up to 5,076,143 shares at a $0.86 exercise price.
The aggregate gross proceeds were approximately $5.0 million before placement agent fees and expenses. The company intends to use net proceeds to support the commercial launch of LYMPHIR™, product development and general corporate purposes. H.C. Wainwright acted as exclusive placement agent.
Citius Pharmaceuticals (Nasdaq: CTXR) announced a registered direct offering of 5,076,143 shares (or pre-funded warrants) at $0.985 per share and a concurrent private placement of unregistered warrants to purchase up to 5,076,143 shares at an $0.86 exercise price. Gross proceeds are expected to be approximately $5 million, with closing on or about April 24, 2026. The company intends to use net proceeds to support the commercial launch of LYMPHIR™, development programs, and general corporate purposes.
Citius Oncology (Nasdaq: CTOR) provided a commercial update on the U.S. launch of LYMPHIR for cutaneous T‑cell lymphoma on March 31, 2026. Early metrics show sequential order growth, 83% of target accounts progressing formulary review, ~135 health plans covering ~80% of lives, and no reported reimbursement denials. Clinical collaborations reported positive topline data at ASTCT 2026 and completed Phase I results at UPMC, with ongoing analyses and next‑stage discussions.
Commercial supply, international distribution agreements, and upcoming field team onboarding support continued launch expansion.
Citius Oncology (Nasdaq: CTOR) will attend the USCLC Annual Workshop on March 26, 2026 in Denver to discuss cutaneous T‑cell lymphoma (CTCL) care and clinical experience with LYMPHIR™ (denileukin diftitox‑cxdl), which the company recently launched in the U.S. The team will hold one‑on‑one meetings with CTCL specialists.
Citius Oncology (Nasdaq: CTOR) reported positive topline Phase 1 results for LYMPHIR (denileukin diftitox-cxdl) combined with pembrolizumab in relapsed or refractory gynecologic cancers on March 10, 2026. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed.
The trial showed a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR) among 21 evaluable patients, and full results will be presented at an international cancer conference later this year.