From today's presentation... Mino-Lok (Phase 3): Superior efficacy review in Q2, likely early May… We are still fighting an uphill battle against Covid, we had 31 institutions, sites which were contributing patients. We are now down to 15 but we were as low as six, but we are still muddling through and adding patients. This is what is relevant what is going on with Cormedix… They ran into a manufacturing challenge. We’ve been very sensitized for that and we already have our three registration batches made, they are stable and we are well prepared for the review that may be coming in some of our manufacturing sites. Citius Pharmaceuticals to Feature Product Candidates Including Stem-Cell Therapy for COVID-19-Related Acute Respiratory Conditions at H.C. Wainwright Global Life Sciences Conference March 9-10 Webcast: https://journey.ct.events/view/262c140c-bae9-4791-bee8-7a03b2d8449a
Capital Raises and Clinical Programs Prove the Progress of Citius Pharmaceuticals Mar 22, 2021 https://investorplace.com/2021/03/capital-raises-and-clinical-programs-prove-progress-ctxr-stock/ Citius Pharmaceuticals to Highlight its Phase 3 Clinical Trial Product Mino-Lok® at Benzinga Biotech Small Cap Conference on March 25 March 23, 2021 https://ir.citiuspharma.com/press-r...maceuticals-to-highlight-its-phase-3-clinical
Benzinga Biotech Small Cap Conference | Immunology and Unmet Medical Needs | March 25 05:28:19 Citius Pharmaceuticals Mino-Lok: Review Committee meeting still expected in Q2. Stem-Cell Therapy for COVID-19-Related Acute Respiratory Conditions: "Results of sheep study will be released shortly"
Nice overview... FN Summary: Lead product (Mino-Lok) has QIDP, Fast Track & Priority Review designation with no competition and patent protection until 2036. Phase 2 results had a 100% response rate – Phase 3 now in progress. All-star management has 1) invested side-by-side with the investors, and 2) a long history of biotech product successes. https://frugalnorwegian.com/ctxr/ Table of Contents Next Catalyst Interactive Chart Cash on Hand Pipeline & Timeline Products & Sales Potential Management Clinical Trials Company PDFs Analyst Price Targets Insider Ownership Institutional Holdings Additional Info Relevant CTXR Videos Bearish Video Short Interest Risks
Citius Thrives in 2021 with Critical Care Solutions for ARDS Associated with COVID-19 April 19, 2021 https://www.benzinga.com/general/bi...e-solutions-for-ards-associated-with-covid-19
Only a few more days until the DNC meeting beginning of May. This could be a possible major share price catalyst... "the DNC told us they think they have good news for us at 69 events"
Citius Pharmaceuticals Reports Strong Clinical Community Engagement During Mino-Lok® Phase 3 Trial-Related Webinar April 29, 2021 Citius Pharmaceuticals leads discussion of Mino-Lok's potential to address biofilm and CLABSI challenges Third webinar was the most well-attended in the Mino-Lok Series, drawing strong attendee interest from investigators, clinical trial staff and referring physicians https://ir.citiuspharma.com/press-r...maceuticals-reports-strong-clinical-community
Interesting read. The below is from an email update today from this newsletter. The pump is on, let's hope for good mino-Lok results and we are off to the races... https://tradersnewssource.com/citius-pharma-ctxr-provides-current-information/ Citius Pharma (CTXR) Has a Potential Upcoming Catalyst for Its Mino-Lok Product Good day everyone, We are continuing our coverage of Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products. Current price $2.20 per share Our coverage of CTXR at the end of last week yielded a potential gain for our members of 11% after closing at $2.20 on Friday. We still believe the company’s shares are oversold and the analysts seem to agree with price targets at $6.00 and $8.00/share. You probably know by now that CTXR is advancing four products through clinical studies, Halo Lido for hemorrhoid treatment, Mino-Lok to treat infected Central Venous Catheters, Novecite-iMSCs to treat Acute Respiratory Distress Syndrome, and Mino-Wrap to treat infections associated with Breast Reconstruction. Today we want to talk about Mino-Lok as it will likely be the first commercial product for the company and is nearing the end of a Phase III clinical trial. The data forthcoming from the Interim Efficacy Analysis from the Phase III Mino-Lok may be a significant catalyst for the company shares and we believe the release of that data is coming near-term. Consider: The company announced previously the data would be available in Q2 and here we are in May. The Data Monitoring Committee and the company BOTH agreed to release the efficacy data at 65% enrollment instead of the 75% stated in the protocol. Ponder the implications of that decision. The Mino-Lok Phase 2b clinical trial resulted in 100% efficacy. All indications are that physicians are champing at the bit in anticipation of the Mino-Lok treatment becoming available. Mino-Lok will save lives, the current standard of remove and replace has too high a mortality rate, and it would also save hospitals considerable time and expense. The question we should consider is how high could the value of the company increase given positive efficacy results for Mino-Lok? Estimates place the market at $750M in the USA and $1.8B worldwide. There is no competition for Mino-Lok. No one else has a product at the clinical level to treat infected CVCs. The market belongs to CTXR. Together we're strong, The Traders News Group
Let’s see if we hear something new tomorrow concerning the DMC meeting on Mino-Lok® Phase 3 Trial. There is a chance that the trial will be halted early due to superior efficacy… Citius Pharmaceuticals to Present Mino-Lok® and COVID-related Respiratory Treatment Update at Benzinga Global Small Cap Conference on Thursday, May 13 May 04, 2021 https://ir.citiuspharma.com/press-releases/detail/142/citius-pharmaceuticals-to-present-mino-lok-and Citius Pharmaceuticals to Participate in Fireside Chat at the Gabelli Funds Virtual Microcap Symposium on Tuesday, May 18 May 11, 2021 https://ir.citiuspharma.com/press-r...aceuticals-to-participate-in-fireside-chat-at
Trial Profile Efficacy and Safety of Mino-Lok Therapy (MLT) in Combination With Systemic Antibiotics in the Treatment of Catheter-Related or Central Line-Associated Bloodstream Infection https://adisinsight.springer.com/trials/700276235 Most Recent Events 29 Apr 2021 According to a Citius Pharmaceuticals media release, the company announce that the updated data from this study was presented in a Webinar. 06 Apr 2021 Planned End Date changed from 1 Feb 2021 to 1 Dec 2021. 06 Apr 2021 Planned primary completion date changed from 1 Dec 2020 to 1 Jun 2021.
"Walrus" says Citius has a good chance of being included into the Russel Index. If yes, according to the video, this should have a positiv impact on the share price in the month of June. Anyway, the month of June is highly likely going to be the month when the DMC meeting concering Mino-Lok will take place. There is a chance that the phase 3 trial will be halted early because of excellent results so far... 15:43 Russell Index Rebalance: $CTXR Inclusion? Weekly News, $AMC Moon, $CLF, $PLTR, & $CTXR Updates, $BBW ER, $SCWX & $NX Options, Webull, & More! May 30, 2021
CTXR seems to be added to the Russell 3000®Index https://content.ftserussell.com/sites/default/files/russell_3000_index_additions_-_2021.pdf
Citius Pharmaceuticals to be Added to Russell 2000® Index June 07, 2021 https://ir.citiuspharma.com/press-r...maceuticals-to-be-added-to-russell-2000-index
Three weeks to go until the Mino-Lok DMC meeting... Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial June 08, 2021 - Independent Data Monitoring Committee (DMC) to review Mino-Lok® safety, superiority, and futility data at upcoming meeting scheduled for June 29, 2021- https://ir.citiuspharma.com/press-r...harmaceuticals-achieves-next-interim-analysis
CTXR Fact Sheet May 21, 2021 https://ir.citiuspharma.com/presentations Market Opportunity –Critical Care/Infectious Disease: The market potential for an effective antibiotic lock therapy (“ALT”) is estimated at $750 million per year in the U.S. and is projected to reach $1.84 billion globally in 2028... Mino-Lok has the potential to change the standard of care for the management of these serious infections. M-L Phase III Interim Efficacy Q2 ‘21. Market Opportunity – Prescription Hemorrhoid Product: We believe the $2 billion worldwide market... CITI-002 –Halo-Lido: ... We expect to file an IND in Q2 2021 and initiate the phase 2b trial in Q3 2021.
Leonard Mazur, Chairman of Citius Pharmaceuticals (NASDAQ:CTXR) Interviewed on CEORoadshow June 10, 2021
Citius Pharma (CTXR) Prepares for Phase III Data Release at the End of This Month and the Potential Catalysts are Lining Up. June 15, 2021 Highlights Entering the Russell 2000 Index Cash Horde in the Bank Late-stage Phase 3 data release in two weeks https://tradersnewssource.com/citiu...th-and-the-potential-catalysts-are-lining-up/
Citius: Halt For Superiority On The Horizon Jun. 15, 2021 North Shore Research Summary IDMC meets on June 29 for Superiority review. Mino-Lok has no competition. Price target increased to $10. Mino-Lok has Fast Track designation. Enough cash through commercialization. https://seekingalpha.com/article/4434912-citius-halt-for-superiority-on-the-horizon
Investors brace for annual Russell index rebalancing with pandemic imprint June 18, 2021 NEW YORK, June 18 (Reuters) - Market participants are girding for probably the biggest trading event of the year next Friday, as FTSE Russell stages the final reconstitution of its indexes, and trillions of dollars in investments could be influenced by the event that will reflect a wild trading year marked by the pandemic and the “meme” stock craze. https://www.reuters.com/business/in...rebalancing-with-pandemic-imprint-2021-06-18/
https://dawsonjames.com/wp-content/uploads/2021/06/CTXR.6.9.21.pdf Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. The lead product, Mini-Lok, is now in a Phase 3 trial. We conservatively assume just 50% probability of success in our models. On top of this, we also use a 30% risk rate in our free cash flow to the firm (FCFF), our discounted EPS (dEPS) and sum-of-the-parts (SOP) models. We equal weight and average these metrics and then round to the nearest whole number to derive our $8.00 price target. Should go much higher once data is provided and positive. Big short interest, I expect a big squeeze here.
