New Alert: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR)
Last Close: $2.94
Good Morning Member,
Citius Pharmaceuticals, Inc. (CTXR) is our new Nasdaq alert and we believe this company has great potential in the biotech space.
CTXR is a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for large and growing markets.
Citius products offer new and expanded indications for previously approved pharmaceutical products as a means to achieve leading market position or market exclusivity. By using previously approved drugs with substantial safety and efficacy data, Citius seeks to reduce the risks associated with pharmaceutical product development. Citius is currently advancing two proprietary product candidates, their Mino-Lok™ product and a Hydrocortisone-Lidocaine (Hydro-Lido) formulation. The company believes the markets for its products are large and underserved by the current standard of care.
Lets take a look below at CTXR’s proprietary product candidates.
CTXR’s Mino-Lok™ product, developed by clinicians and technologists at the M.D. Anderson Cancer Center, could provide a superior alternative to removing and replacing central venous catheters (CVCs). Of the approximately 7 million CVCs used annually, about 500,000 or 7% become contaminated leading to serious, life threatening infections called catheter-related blood stream infections (CRBSIs).
A 90 patient Phase 2b clinical study using their Mino-Lok™ product demonstrated sufficient safety to proceed to a pivotal Phase 3 trial. Based on Phase 2b results, Citius believes that their Mino-Lok™ product is highly effective in salvaging infected indwelling catheters and is well tolerated, making Mino-Lok™ therapy an attractive alternative to removing and re-inserting a new CVC. CTXR plans to conduct a Phase 3, multi-center, randomized, double blind, placebo- and active- controlled study in 700 patients.
In addition, their Mino-Lok™ product has received a U.S. FDA Qualified Infectious Disease Product (QIDP) designation. Receiving QIDP designation means that Mino-Lok™ is eligible for Fast Track designation, Priority Review for development, and a five-year extension of market exclusivity. Learn More about Mino-Lok™ Here.
Hydro-Lido is a topical formulation of hydrocortisone and lidocaine that is intended to provide anti-inflammatory and anesthetic relief to persons suffering from hemorrhoids. In the United States, hemorrhoids affect nearly 5% of the population, with approximately 10 million patients annually reporting symptoms of hemorrhoidal disease; approximately one-third visit a physician for evaluation and treatment of their hemorrhoids. Citius has recently completed Phase 2a studies for its hydrocortisone-lidocaine topical therapy.
Citius believes their hydrocortisone and lidocaine formulation could become the first FDA-approved product to treat hemorrhoids in the United States. According to IMS, over 25M units of topical combination prescription products for hemorrhoids were sold in the United States during the twelve-month period ended June 2012, comprising an estimated $80M annual market. Learn More about Hydro-Lido Here.
CTXR has a pipeline portfolio of important, high potential, later stage drugs that address unmet medical needs and are in progressive stages. CTXR also has a highly experienced and successful management team with extensive experience building and managing pharmaceutical companies and creating significant shareholder value.
CTXR has also had positive recent developments including a Phase 3 update on their Mino-Lok™ product following an FDA Meeting. Read all of the recent news below.
October 17, 2017– Citius Pharmaceuticals to Present at the Dawson James 2017 Small Cap Growth Stock Conference
October 11, 2017– Citius Pharmaceuticals Issues Shareholder Letter
Highlights of the letter to shareholders include:
- CTXR has recently and successfully uplisted to Nasdaq stock exchange where the company will gain access to broader investor audience.
- The company received a positive response from the U.S. Food and Drug Administration (FDA) for phase 3 trial amendments of Mino-Lok™, their proprietary product that address a potential $750M sector.
- Secured funding of more than $26.8M, including a recent raise of $6.8M, with significant insider participation.
- Finalized the addition of South America to The Company’s worldwide license for Mino-Lok™’s patented technology.
- Completed Phase 2a studies for Hydro-Lido, which could become the first FDA-approved product to address the estimated $500M U.S. hemorrhoid marketplace.
“We are extremely pleased with the significant advancements that we have made and the foundation for long-term growth that we have established,” stated Mr. Myron Holubiak, President and Chief Executive Officer of Citius Pharmaceuticals. “Having transitioned to a more senior exchange and completed key initiatives in advancing our unique technologies, we felt it necessary to provide a thorough update on the overall health and trajectory of the Company. We are confident, now that we now well-funded, to ideally be positioned as potential market leaders in two greatly underserved therapeutic areas. Management is committed to advancing the commercialization efforts of our products, Mino-Lok™ and Hydro-Lido, while remaining focused on our goal of improving shareholder value.“
Source: Yahoo Finance
September 5, 2017– Citius Pharmaceuticals, Inc. Provides Phase 3 Update On Mino-Lok™ Clinical Trial Following FDA Meeting
CTXR announced it has received feedback from the U. S. Food and Drug Administration regarding amendments to the phase 3 study plan for Mino-Lok™, an adjunctive treatment for catheter related blood stream infection. There are currently no approved therapies to salvage infected central venous catheters (“CVCs”). Citius is currently recruiting sites for a phase 3 trial of Mino-Lok in the United States.
The FDA stated that they recognized that there is an unmet medical need in salvaging infected catheters and agreed that an open label, superiority design would address the Company’s concerns and would be acceptable. They also reinforced their commitment to work with the Company to revise the trial design to meet the requirements of a new drug application.
Following the discussion with the FDA, Citius amended the phase 3 study design to remove the saline and heparin placebo control arm and to use an active control arm that conforms with today’s current standard of care. The Company also noted that the dwell times and dosing schedules of the antibiotic lock therapy (“ALT”) active control arm would be changed because there is an extreme level of variability and heterogeneity in how ALTs are dosed and used today.
Mr. Myron Holubiak, Chief Executive Officer of Citius, commented, “We are extremely pleased to work closely with the FDA to design a trial that meets today’s need for better information and evidence as it relates to the treatment of infected CVCs and dosing schedules for ALTs. Experts agree that there is a great deal of variability allowed in the Infectious Disease Society of America (IDSA) guidelines with respect to the antibiotic chosen and the dwell times used for ALT’s. We are confident that we will be able to demonstrate the superiority of our ready-to-use Mino-Lok over hospital compounded antibiotic solutions for which there have not been any largescale controlled studies or data driven evidence.“
Source: Yahoo Finance
Below is the 3 month daily chart on CTXR. CTXR has a support level in the $2.60 area and has significant room to the upside. A break past the 20 SMA of $3.05 and then the 50 SMA of $3.13 could lead to a breakout in the near-term.
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