Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, recently issued a shareholder letter providing a corporate update on the Company's recent achievements and anticipated milestones for 2021.
23 Feb 2021, 1:30 Extensive Demand for T-Cell Adoptive -2-
"Our important achievements against the COVID headwinds last year give us great confidence that 2021 will be a banner year for advancing our three product platforms in the clinic, and our corporate decision to commence the development of NoveCite next-generation cellular therapies further expands our goal as a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for significant unmet medical needs" said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "Our advanced clinical program for Mino-Lok is moving forward with expected full enrollment for the Phase 3 pivotal trial this year. For Halo-Lido, we expect to file an Investigational New Drug Application (IND) for the combination by the second quarter and initiate our Phase 2b trial by year-end. We also plan to start pre-clinical pharmacology and toxicology studies for Mino-Wrap within the next few months along with chemistry, manufacturing and controls (CMC) development, and we target filing an IND by the end of 2021. In addition to the plans described above for our NoveCite i-MSCs Program, we plan to submit an IND to the FDA and initiate our Phase 1 first-in-human clinical trial in COVID-19 ARDS by the end of the second quarter of 2022. Our recent $20 million private round of financing and investors' exercise of warrants for net proceeds of approximately $4.5 millionprovides significant financial runway to move forward with our three programs in the clinic, as well as manufacturing development for our unique induced-mesenchymal stem cell therapy for ARDS associated with COVID-19. We are excited about the road ahead and thankful as always for the ongoing support of our shareholders."
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Recent CTXR News
- Form 8-K - Current report • Edgar (US Regulatory) • 09/13/2024 12:30:09 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/11/2024 09:26:01 PM
- Citius Pharmaceuticals to Participate in the H.C. Wainwright 26th Annual Global Investment Conference • PR Newswire (US) • 09/05/2024 08:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/05/2024 08:15:10 PM
- Citius Pharmaceuticals, Inc. and Citius Oncology, Inc. Announce LYMPHIR™ (Denileukin Diftitox-cxdl) Added to National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology • PR Newswire (US) • 09/05/2024 12:30:00 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/30/2024 08:01:05 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/30/2024 08:01:03 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/16/2024 08:35:55 PM
- Form SC 13D - General Statement of Acquisition of Beneficial Ownership • Edgar (US Regulatory) • 08/16/2024 08:34:29 PM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 10:25:24 PM
- Form 3 - Initial statement of beneficial ownership of securities • Edgar (US Regulatory) • 08/14/2024 10:19:43 PM
- Citius Pharmaceuticals, Inc. Reports Fiscal Third Quarter 2024 Financial Results and Provides Business Update • PR Newswire (US) • 08/12/2024 09:28:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/12/2024 09:25:09 PM
- Form 424B5 - Prospectus [Rule 424(b)(5)] • Edgar (US Regulatory) • 08/12/2024 09:10:24 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/12/2024 08:51:13 PM
- Citius Pharmaceuticals Completes Merger of Subsidiary with TenX Keane to form Citius Oncology, Inc. • PR Newswire (US) • 08/12/2024 08:22:00 PM
- Citius Pharmaceuticals to Host Investor Call to Discuss Recent and Upcoming Developments • PR Newswire (US) • 08/12/2024 12:00:00 PM
- TenX Keane Acquisition Addresses Trading Halt, Continues Towards Closing of Business Combination, and Provides Market Update • GlobeNewswire Inc. • 08/09/2024 11:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/08/2024 01:20:18 PM
- Citius Pharmaceuticals Receives FDA Approval for LYMPHIR™ (denileukin diftitox-cxdl) Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma • PR Newswire (US) • 08/08/2024 10:59:00 AM
- Citius Pharmaceuticals Announces TenX Keane Shareholder Approval of Merger with Citius Oncology, Inc. • PR Newswire (US) • 08/05/2024 12:00:00 PM
- TenX Keane Acquisition Shareholders Approve Previously Announced Merger to Form Citius Oncology, Inc., a Publicly Listed Subsidiary of Citius Pharmaceuticals • GlobeNewswire Inc. • 08/05/2024 12:00:00 PM
- Citius Pharmaceuticals Details Near-Term Milestones for Late-Stage Candidates • PR Newswire (US) • 07/10/2024 01:10:00 PM
- Citius Pharmaceuticals to Host Investor Call to Discuss Topline Results of Phase 3 Trial of Mino-Lok Antibiotic Lock Solution • PR Newswire (US) • 05/29/2024 12:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 05/21/2024 08:05:34 PM
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