Tonix Pharmaceuticals stock halted ahead of FDA approval news
CRANFORD, N.J. - Citius Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CTXR), a biotechnology company with a market capitalization of $110 million, and its subsidiary Citius Oncology announced today that they are making significant strides in preparing for the commercial launch of LYMPHIR™, a novel immunotherapy for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL). The stock has shown remarkable momentum, gaining nearly 34% in the past week according to InvestingPro data. The company aims to have LYMPHIR available for patients in the first half of 2025, following its FDA approval in August 2024.
LYMPHIR is designed to target and deplete immunosuppressive regulatory T lymphocytes (Tregs) and exhibit antitumor activity through direct action on IL-2R-expressing tumors. It has been indicated for use in Stage I-III disease after at least one prior systemic therapy.
To ensure a successful launch, Citius has secured commercial supply agreements with contract manufacturing organizations and completed the production of the first-year launch supply. The company has also initiated targeted education programs for healthcare providers and launched an information platform providing clinical data, dosing guidelines, and safety information.
Efforts to facilitate patient access include working closely with payers and healthcare providers to secure reimbursement pathways, submitting an application for a unique J-code under the HCPCS, and securing the inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines.
Additionally, Citius has designed a patient assistance program and is developing a patient services center to support administrative and prescribing needs. A core marketing campaign to raise awareness among healthcare providers has been launched, and the company is building a specialized field sales team.
The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies. While InvestingPro analysis indicates the company currently operates with moderate debt levels and faces some liquidity challenges with a current ratio of 0.34, Citius Oncology's management is exploring growth opportunities, including licensing partnerships in key international markets, expanded indications for LYMPHIR, and its potential as a combination immunotherapy. InvestingPro subscribers have access to over 10 additional key insights about Citius's financial health and market position.
Citius Pharmaceuticals' pipeline also includes other late-stage products, such as Mino-Lok®, for catheter-related bloodstream infections, and CITI-002 (Halo-Lido), for hemorrhoid relief. Both have completed clinical trials in 2023, with Mino-Lok meeting primary and secondary endpoints. According to InvestingPro metrics, while the company is not yet profitable, analysts have set a consensus price target suggesting potential upside, with detailed financial projections available to Pro subscribers.
The information in this article is based on a press release statement from Citius Pharmaceuticals, Inc.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.