Today CTXR released a business update including highlights and upcoming milestones. The company has clarified the status of its lead product Mino-Lok.

Today CTXR released a business update including highlights and upcoming milestones. The company has clarified the status of its lead product Mino-Lok.

News out this morning. The company has clarified the status of its lead product Mino-Lok.

Is the Market Value of Citius Pharma (CTXR) About to Make a Big Move?

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 $2.24 per share

After closing at $2.16/share in last Friday’s session CTXR shares climbed to a high of $2.32 in early trading. Trading volume has been brisk with nearly 4M shares traded in the first 30 minutes of today’s session.

Today CTXR released a business update including highlights and upcoming milestones. The company has clarified the status of its lead product Mino-Lok:

On July 1, 2021, Citius reported that the independent DMC recommended continuation of the Phase 3 Mino-Lok® pivotal superiority trial as planned with no modifications or safety concerns,

Citius expects to complete the Mino-Lok® trial by the end of 2021 or early 2022, subject to continued easing of COVID-19 restrictions in the U.S.,

Citius plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022 following completion of its Phase 3 Mino-Lok® trial.

We urge you to read the CTXR article linked above as part of your due diligence as it clarifies the exact status of Mino-Lok in detail and dispels any recent misinformation.

We want to reiterate that the recent interim analysis by independent Data Monitoring Committee (DMC) for the Mino-Lok® Phase 3 Pivotal Superiority Trial was a positive event and we are excited about it and the associated implications.

2 Wall Street analysts have issued ratings and price targets for Citius Pharmaceuticals in the last 12 months. Their average twelve-month price target is $5.00, predicting that the stock has a possible upside of 131.48%. The high price target for CTXR is $6.00 and the low-price target for CTXR is $4.00. There are currently 2 buy ratings for the stock, resulting in a consensus rating of “Buy.”

The Traders News Group

This mornings report below


Citius Pharma (CTXR) Shares Fell After Releasing Positive News in Phase III Trial

The company shares have retreated 52%. How will YOU play the dip?

Good day everyone,

WE are updating 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 $2.15 per share

CTXR shares retreated from their June 22nd high of $4.56/share last week after a report by the independent Data Monitoring Committee (DMC) for the Mino-Lok® Phase 3 Pivotal Superiority Trial recommended proceeding with the trial as planned. News of the interim DMC report at 65% enrollment left some investors wanting. The company shares are down 52.85% and may represent a rare buying opportunity.

Here is what we heard from CTXR last week:

Citius Pharmaceuticals, Inc. Announces Positive Recommendation by Independent Data Monitoring Committee to Continue the Mino-Lok® Phase 3 Trial as Planned

The independent Data Monitoring Committee (DMC) for the Mino-Lok Phase 3 Pivotal Superiority Trial has recommended to proceed with the trial as planned, following a unblinded data review of safety and efficacy. The DMC did not identify any safety concerns and no modifications were recommended.

CTXR and Mino-Lok have NOT experienced a negative event. The interim review by the DMC was positive news.

“With Covid-19 restrictions easing, we believe we are now better positioned to accelerate our efforts to complete the trial. To that end, we will continue to engage with the U.S. Food and Drug Administration (FDA) and look forward to their guidance as we advance this program,” said Mr. Myron Holubiak, President and CEO of CTXR.

We read a couple articles posted about the recent phase III interim report, downplaying the DMC interim review results and here’s the gist of them:

“Another interim analysis has come and gone with an unsatisfying result. Mino-Lok hasn’t achieved superiority over standard care yet. The Mino-Lok phase III trial is taking too long.”

Frankly, we had hoped there would be safety and efficacy data included in the DMC report. That data has been collected by the DMC, just not reported to the company. We are reminded that the phase 2b clinical trial resulted in 100% efficacy with virtually no side effects.

We are curious about the failure to establish superiority over the standard of care comment. The current standard of care is to remove and replace an infected catheter. It works. Regrettably too many people die from the procedure, and it can cost up to $50,000 verses, an estimated $1,500 for treatment with Mino-Lok.

Yes, the phase III clinical trial for Mino-Lok is taking a long time. We are now 15 months into the coronavirus pandemic, an event that has shut down many clinical trials being conducted in hospitals. There are still 3,798 Americans in critical condition with covid. While most of us can now go to our favorite restaurant or shopping venue, be assured that hospitals are still operating with restrictions.

As defined in the DMC charter, the primary role of the independent DMC is to safeguard the interests of study participants, assess the safety of the treatment, and monitor the overall conduct of the study. To ensure the protection of patients enrolled in the trial and to assure the timely and efficient completion of the study, each DMC recommendation is bound by strict parameters outlined in the DMC charter.

The interim analysis last week at 65% enrollment, is the third one in the phase III trial and as in the prior two reports, the DMC did not identify any safety concerns and no modifications were recommended. That’s a big leap for any company with a drug in a late-stage phase III clinical trial.

Let’s review some of the positive aspects of CTXR we’ve liked all along:

The company has 4 viable pipeline products.
Their share structure is small.
CTXR is entering the Russell 2000.
They have a hoard of cash close to $100M.
Mino-Lok is a late-stage phase 3 product.
A strong experienced management team.
Two analysts issued a “buy” rating this year.
One analyst has a target of $6.00/share.

We posed the question above, how will you play this dip? The future of Mino-Lok does not seem uncertain, it’s likely it will be approved by the FDA this year. The company has previously stated that on their website. There will be catalysts in H2 for the company shares provided by Mino-Lok news and potentially one or more of the other CTXR pipeline products.

It seems like CTXR shares have been oversold based upon a reaction to some questionable press and we believe the current price is a rare buying opportunity.

Stay tuned and stay informed.
The Traders News Group


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