| Citius Pharmaceuticals has made substantial progress in advancing its late-stage product candidates and achieving key operational milestones.
Here are some notable developments:
Mino-Lok®: In May 2024, Citius announced positive topline results from the Phase 3 study of Mino-Lok®, an antibiotic lock solution designed to salvage catheters in patients with bloodstream infections. The study met both primary and secondary endpoints with statistical significance.
Next steps include preparing a submission to the U.S. FDAand scheduling a Type B meeting.
LYMPHIR™: The Biologics License Application (BLA) for LYMPHIR™, a novel IL-2R immunotherapy for treating cutaneous T-cell lymphoma (CTCL), is currently under FDA review, with August 13, 2024, set as the PDUFA target action date. If approved, LYMPHIR™ could potentially receive 12 years of exclusivity as a new biologic.
Citius is preparing for the near-term commercialization of LYMPHIR™. LYMPHIR™ has received orphan designation for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Ongoing Phase 1 studies are exploring additional indications for LYMPHIR™.
Halo-Lido: Citius completed enrollment in its Phase 2b trial of Halo-Lido (CITI-002), a topical formulation for relieving hemorrhoid symptoms. Positive data from the trial showed a meaningful reduction in symptom severity.
The company held an end-of-Phase 2b meeting with the FDA to discuss the next phase of development for Halo-Lido.
Operational Achievements
Citius Pharmaceuticals has also strengthened its fiscal position and operational capabilities:
Capital Structure: In April 2024, Citius completed a $15M registered direct offering, extending the company's ca-sh runway and supporting future growth initiatives.
Oncology Spin-Off: Citius plans to form Citius Oncology, Inc., a standalone publicly traded company with LYMPHIR™ as its primary asset. This transaction is pending review by the U.S. Securities and Exchange Commission (SEC) and approval by TenX Keane Acquisition (Nasdaq: TENK) shareholders.
National Sales Director: Citius has on-boarded a National Sales Director to recruit and lead the sales organization in preparation for the anticipated launch of LYMPHIR™.
Leadership Perspective
Leonard Mazur, Chairman and CEO of Citius, emphasized the company's strategic vision and operational achievements:
"Our solid execution since the beginning of the year sets us up for potentially transformative catalysts in the coming months. Mino-Lok's strong Phase 3 topline results support its potential to become part of the standard of care for treating catheter-related bloodstream infections. For LYMPHIR™, the FDA is currently reviewing our Biologics License Application, with an expected decision on August 13th. We are preparing for near-term commercialization of LYMPHIR if approved. These near-term catalysts should enable the company to optimize its current ca-sh runway, future ca-sh needs, as well as create potential non-dilutive ca-sh opps."
Mazur added, "Our primary purpose and mission for these late-stage assets is to provide best-in-class, highly effective treatment options for patients and caregivers. Ultimately, we believe our achievements and milestones offer powerful levers for value creation."
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is at a pivotal point in its journey, with significant near-term milestones and transformative catalysts on the horizon.
The company's innovative late-stage product candidates, Mino-Lok and LYMPHIR, are poised to address critical unmet medical needs and offer substantial market potential.
With a strong fiscal foundation and strategic operational initiatives, Citius is well-positioned for sustained growth and value creation. Industry stakeholders should keep a close eye on Citius Pharmaceuticals as it continues to advance its pipeline and achieve key milestones in 2024.
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