$CTXR “Ultimate Stock Alerts” Citius Pharmaceuticals Inc. Newsletter 7:35:57 AM October 7, 2020

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CTXR Promotional Newsletter

The following is a newsletter released by "Ultimate Stock Alerts" promoting Citius Pharmaceuticals Inc.

Caution

The following newsletter has not been verified for accuracy or completeness.

UltimateStockAlerts

Don't Want Anymore Emails

Hello

New Trade Alert Citius Pharmaceuticals, Inc. NASDAQ CTXR

We are continuing our coverage of CTXR, our most recent trade opportunity.

Since our last update in September, the company has announced several developments that could be additional growth catalysts.

CTXR has presented you with several incredible opportunities this year that we have highlighted to you.

As a reminder, CTXR is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products.

The company focuses on anti-infectives and cancer care.

The companys strategy is unique whereby it uses innovative, patented, or proprietary formulations of previously-approved active pharmaceutical ingredients.

Furthermore, CTXR develops products that have intellectual property protection and competitive advantages to existing therapeutic approaches.

CTXR is leveraging the FDAs 505b2 pathway for new drug approvals to bring products to market faster and with lower cost than other FDA new drug approval pathways.

Specifically, this method helps avoid unnecessary duplication of studies already performed on previously approved drugs.

CTXR is currently advancing three proprietary product candidates into large markets that are underserved by the current standards of care.

Mino-Lok, which is in FDA Phase III trials, is the companys lead product and is an antibiotic lock solution for use to treat cancer patients or hemodialysis patients with catheter-related bloodstream infections CRBSIs.
Mino-Wrap or CITI-101, which is pre-clinical, is a bio-absorbable film impregnated with minocycline and rifampin used to prevent post-surgical infections and reduce microbial colonization of breast tissue expanders used in breast reconstruction following mastectomies.
Halo-Lido or CITI-002, which is in FDA Phase II trials, is being developed for symptomatic relief of hemorrhoids and combines the high-potency steroid halobetasol with lidocaine.

In addition, earlier this year the company announced

Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome ARDS Associated with COVID-19

Since our last update, CTXR has released several developments that could present the company with continued growth potential.

Citius Pharmaceuticals Achieves Chemical Manufacturing and Control Milestones for Mino-Lok

Here are the companys comments from this press release

A typical drug approval contains one drug substance, so for all practical purposes our team has developed three products. Mino-Lok is unique in many ways, this being one of them, said Myron Holubiak, Chief Executive Officer of Citius. It's important to know that we expect to be prepared to immediately move to validationcommercial manufacturing upon the completion of our Phase 3 clinical trial and receiving the required FDA clearance.

Last week the company announced

Citius Pharmaceuticals Reports Positive Results from Recent Data Monitoring Committee Meeting for Mino-Lok Phase 3 Trial

Here are the companys comments from this press release

We are very pleased with the outcome of the DMC's independent review of the Mino-Lok data. This information is very encouraging and supports the confidence that we have long held in the safety and efficacy of Mino-Lok, said Myron Holubiak, Chief Executive Officer of Citius. Despite challenges in recruiting patients recently due to the COVID-19 pandemic, we have continued to recruit patients and are now approaching the late stage of our pivotal study. Holubiak continued, I want to thank the DMC committee members for their thoughtful review, and also all of the study investigators and their staff that continue to support our trial in these challenging times.

In addition, last week, the company announced

Citius's Mino-Lok trial sites resupplied with registration batch product

CRANFORD, N.J., Sept. 30, 2020 PRNewswire -- Citius Pharmaceuticals, Inc. Citius or the Company Nasdaq CTXR, a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that the Mino-Lok Clinical Trial Material CTM at each of the clinical sites has been replaced with registration batch product. This means that going forward subjects enrolled in the trial will be treated with Mino-Lok that was manufactured with same process that will be used commercially should FDA approval be obtained.

Here are the companys comments from this announcement

We are extremely pleased to be able provide common packaging for the 2 Mino-Lok components and to resupply our clinical sites with registration product, said Myron Holubiak, Chief Executive Officer of Citius. Holubiak continues, It's also important to note that we are prepared to immediately move to validation commercial manufacturing upon completing our phase 3 clinical trial and receiving FDA clearance.

But thats not all

Just this morning, the company announced potentially big news

Citius Pharmaceuticals Signs an Exclusive Worldwide Licensing Agreement with Novellus Therapeutics for Unique iMSC-Therapy for Acute Inflammatory Respiratory Conditions including COVID-19 Related Acute Respiratory Distress Syndrome ARDS

Here is a summary from this press release

NoveCite, a newly formed subsidiary of Citius Pharmaceuticals, Inc., plans to develop, manufacture and commercialize a unique induced mesenchymal stem cells NC-iMSCs
Novellus, a Cambridge, Mass-based cell engineering company, has developed patented, non-immunogenic mRNA-based induced mesenchymal stem cell iMSC platform
NC-iMSCs demonstrate higher potency, uniformity and consistency - significant advantages over donor derived MSCs

CTXR continues to present increased growth potential.

Make sure to do your own due diligence.

Sources , , , , , , , , , , , , , , , , ,

Happy Trading

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