CRANFORD, N.J., Feb. 14, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter ended December 31, 2024.

Fiscal First Quarter 2025 Business Highlights and Subsequent Developments

Substantially advanced operational readiness for commercial launch of LYMPHIR in the first half of 2025;Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR™, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025;Announced promising preliminary results from an ongoing investigator-initiated Phase I clinical trial of a combined regimen of checkpoint inhibitor pembrolizumab and LYMPHIR (denileukin diftitox-cxdl) in patients with recurrent solid tumors. Presented data at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting;Supported expansion of the University of Minnesota's investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center;Engaged with the U.S. Food and Drug Administration (FDA) to clarify development paths for pipeline assets Mino-Lok® and Halo-Lido;Advanced strategic and financing initiatives to help secure the capital needed to drive the full potential of our clinical and commercial programs.Citius Oncology (Nasdaq: CTOR), our majority-owned subsidiary, engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value;Completed registered direct offerings of common stock and warrants in November 2024 and January 2025, and sold shares of common stock through the Company's "at-the-market" facility in January 2025 for combined gross proceeds of $6.5 million;Effective November 25, 2024, the Company executed a reverse stock split of its common stock, at a ratio of 1-for-25; and,On December 18, 2024, the Company received notification that it had regained compliance with the $1.00 per share requirement for continued inclusion on the Nasdaq Stock Market.

Permanent J-Code (J9161) expected to be effective April 1, 2025

LYMPHIR is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

CRANFORD, N.J., Feb. 6, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary, Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), today announced that LYMPHIR™ (denileukin diftitox-cxdl) has been assigned a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) by the Centers for Medicare & Medicaid Services (CMS).

CRANFORD, N.J., Jan. 8, 2025 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has entered into definitive agreements for the purchase of an aggregate of 743,496 shares of its common stock and accompanying warrants to purchase up to an aggregate of 743,496 shares of its common stock, at a purchase price of $4.035 per share and accompanying warrant in a registered direct offering priced at-the-market under Nasdaq rules. The warrants will have an exercise price of $3.91 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date.  The closing of the offering is expected to occur on or about January 8, 2025, subject to the satisfaction of customary closing conditions.

CRANFORD, N.J., Jan. 7, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) and its oncology-focused subsidiary, Citius Oncology (Nasdaq: CTOR), today announced significant progress in preparations for the commercial launch of LYMPHIR™, an innovative immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Management is focused on making LYMPHIR available to patients as quickly as possible, with preparations underway for launch in the first half of 2025.

CRANFORD, N.J., Jan. 6, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or "the Company") (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has retained Jefferies LLC as its exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value.

Clinical and regulatory success in 2024 expected to drive value in 2025

CRANFORD, N.J., Dec. 27, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal full year ended September 30, 2024.

Fiscal Full Year 2024 Business Highlights and Subsequent Developments

Achieved U.S. Food and Drug Administration (FDA) approval of LYMPHIR™ (denileukin diftitox-cxdl), an immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL);Advanced manufacturing, marketing and sales activities in preparation for commercial launch of LYMPHIR in the first half of 2025;Completed the merger of Citius Pharma's oncology subsidiary with TenX Keane to form Citius Oncology, Inc., a standalone publicly traded company which began trading on the Nasdaq exchange under the ticker symbol CTOR on August 13, 2024;Supported two investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of Minnesota;Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab; and,Met primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok®, demonstrating a statistically significant improvement in time to catheter failure of infected catheters compared to other physician-selected anti-infective lock solutions.

CRANFORD, N.J., Nov. 25, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company held a constructive in-person Type C meeting with the U.S. Food and Drug Administration (FDA). The meeting followed successful completion of the Company's pivotal Phase 3 clinical trial of Mino-Lok®, a novel catheter lock solution designed to salvage central venous catheters in patients suffering from central line-associated bloodstream infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The primary discussion centered on responses to the FDA's questions related to Mino-Lok's clinical trial data and a pathway to a future submission.

CRANFORD, N.J., Nov. 22, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR) announced today that it will be executing a reverse stock split of its common stock, par value $0.001 per share, at a ratio of 1-for-25 ("Reverse Stock Split"). Pursuant to the laws of the State of Nevada and subject to prior approval by the Company's Board of Directors, Citius Pharma was not required to obtain shareholder approval to effectuate the Reverse Stock Split. The Reverse Stock Split will become effective at 5:00 pm Eastern Time on November 25, 2024. The Company's common stock will begin trading on the Nasdaq Capital Market on a split-adjusted basis beginning upon market open on November 26, 2024, under the Company's existing trading symbol "CTXR" with the new CUSIP number 17322U306.

CRANFORD, N.J., Nov. 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today closed its previously announced registered direct offering for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 per share and accompanying warrant. The warrants have an exercise price of $0.25 per share, are exercisable immediately upon issuance, and expire five years from the initial exercise date. 

CRANFORD, N.J., Nov. 15, 2024 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has entered into definitive agreements for the purchase of an aggregate of 12,000,000 shares of its common stock and accompanying warrants to purchase up to an aggregate of 12,000,000 shares of its common stock, at a purchase price of $0.25 per share and accompanying warrant in a registered direct offering. The warrants will have an exercise price of $0.25 per share, will be exercisable immediately upon issuance, and will expire five years from the initial exercise date.  The closing of the offering is expected to occur on or about November 18, 2024, subject to the satisfaction of customary closing conditions.