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."
Don't trust me, I don't know any more than you do!
Recent CTXR News
- Citius Pharmaceuticals to Participate in Upcoming EF Hutton and H.C. Wainwright Investor Conferences • PR Newswire (US) • 05/10/2024 12:30:00 PM
- Citius Pharmaceuticals Announces Closing of $15 Million Registered Direct Offering • PR Newswire (US) • 04/30/2024 08:05:00 PM
- Citius Pharmaceuticals Announces $15 Million Registered Direct Offering • PR Newswire (US) • 04/26/2024 12:00:00 PM
- Citius Pharmaceuticals Announces Addition of City of Hope to UMN's Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma • PR Newswire (US) • 04/11/2024 12:30:00 PM
- Citius Pharmaceuticals to Present at the LD Micro Invitational XIV Investor Conference • PR Newswire (US) • 04/04/2024 12:30:00 PM
- Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma • PR Newswire (US) • 03/18/2024 12:30:00 PM
- Citius Pharmaceuticals, Inc. Secures $2.4 million through New Jersey Economic Development Program • PR Newswire (US) • 03/07/2024 01:30:00 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 03/04/2024 05:15:18 AM
- Citius Pharmaceuticals Announces Filing of Form S-3 Shelf Registration Statement to Replace Expiring Prior Shelf Registration • PR Newswire (US) • 02/26/2024 12:30:00 PM
- Form S-3 - Registration statement under Securities Act of 1933 • Edgar (US Regulatory) • 02/23/2024 09:23:46 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 02/23/2024 09:18:59 PM
- Citius Pharmaceuticals to Participate in Upcoming BIO CEO and Sidoti Investor Conferences • PR Newswire (US) • 02/23/2024 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/15/2024 01:45:11 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 02/14/2024 09:40:26 PM
- Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2024 Financial Results and Provides Business Update • PR Newswire (US) • 02/14/2024 09:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 02/14/2024 02:18:38 PM
- Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma • PR Newswire (US) • 02/14/2024 01:01:00 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 01/26/2024 09:08:28 PM
- Form DEF 14A - Other definitive proxy statements • Edgar (US Regulatory) • 01/26/2024 09:05:57 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/23/2024 09:05:27 PM
- Citius Pharmaceuticals Announces Nomination of Pharmaceutical Executive Robert J. Smith to its Board of Directors • PR Newswire (US) • 01/23/2024 01:30:00 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/05/2024 09:05:12 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 01/02/2024 09:04:14 PM
- Citius Pharmaceuticals Completes Enrollment in Pivotal Phase 3 Trial of its Mino-Lok® Therapeutic to Salvage Catheters • PR Newswire (US) • 01/02/2024 01:31:00 PM
Avant Technologies Equipping AI-Managed Data Center with High Performance Computing Systems • AVAI • May 10, 2024 8:00 AM
VAYK Discloses Strategic Conversation on Potential Acquisition of $4 Million Home Service Business • VAYK • May 9, 2024 9:00 AM
Bantec's Howco Awarded $4.19 Million Dollar U.S. Department of Defense Contract • BANT • May 8, 2024 10:00 AM
Element79 Gold Corp Successfully Closes Maverick Springs Option Agreement • ELEM • May 8, 2024 9:05 AM
Kona Gold Beverages, Inc. Achieves April Revenues Exceeding $586,000 • KGKG • May 8, 2024 8:30 AM
Epazz plans to spin off Galaxy Batteries Inc. • EPAZ • May 8, 2024 7:05 AM