Each brokerage/analyst has given CTXR a target over 100% higher than this Nasdaq past champ's closing valuation as of Wednesday.
What's even better is HC Wainwright has boosted their target from $4.00 to $6.00.
Could CTXR really be as undervalued as these brokerages/analysts suppose?
No. 2 CTXR Potential Catalyst - Business Highlights And Possible 2022 Catalyst Milestones
Citius Pharmaceuticals, Inc. Provides Business Update, Highlights Upcoming Milestones
CRANFORD, N.J., May 3, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today provided a business update for the first quarter ended March 31, 2022 and reported on recent corporate developments and upcoming milestones.
Recent Highlights and Upcoming Milestones
- Citius anticipates filing a biologics license application (BLA) for I/ONTAK® with the U.S. Food and Drug Administration (FDA) in the second half of 2022;
- Topline data from the Phase 3 study of cancer immunotherapy I/ONTAK are consistent with the previously-approved formulation of denileukin diftitox (ONTAK), and there are no new safety signals;
- Halo-Lido Phase 2b trial initiated in April 2022 with last patient enrollment anticipated by the end of 2022;
- Phase 3 Mino-Lok® trial proceeding without modification as recommended by the independent data monitoring committee (DMC) following all three DMC reviews;
- Mino-Lok Phase 3 trial completion anticipated by end of 2022; and,
- Pre-clinical development ongoing for Citius' Mino-Wrap and induced mesenchymal stem cell programs.
"2022 is a year of important catalysts for Citius as we continue to make progress on multiple fronts. We recently released topline results for I/ONTAK which were consistent with the prior FDA-approved and marketed formulation of denileukin diftitox (ONTAK). In preparation for a planned BLA submission in the second half of 2022, we are marshalling the necessary manufacturing and commercial resources to support the application, and ultimately a successful launch," stated Leonard Mazur, Chairman and CEO of Citius.
"Our Mino-Lok program continues to advance in accordance with the recommendations of the independent data monitoring committee, which advised us to continue with the trial as planned, following each of its three data reviews. We remain encouraged by the positive signal conveyed by the DMC guidance to proceed. Coupled with the recent ramp up in patient recruitment following an easing of CV19-related hospital restrictions, we believe our efforts to increase engagement with existing trial sites and to onboard additional sites will continue to drive trial enrollment and enable us to achieve the necessary trial events to support statistically significant results," added Mazur.
"In April, we initiated our Phase 2b Halo-Lido trial for the treatment of hemorrhoids. By the end of 2022, we expect to complete trial enrollment. A data readout will follow upon validation and analysis of the information provided in the electronic patient reported outcome tool (ePRO) designed with guidance from the FDA. The results will be used to design the Phase 3 trial. As this product would ultimately be marketed directly to consumers, rather than to targeted physician and hospital groups like our other pipeline candidates, we will evaluate alternatives to optimize the value of this asset as we advance the program. Citius considers all strategic alternatives to maximize the value of our portfolio, individually and collectively, on an ongoing basis. We believe we remain well capitalized to advance our programs through multiple catalysts this year, and we plan to continue building long-term value in the business by focusing on execution," concluded Mr. Mazur.
2022 Achieved and Anticipated Catalysts
- Report Topline results of I/ONTAK Phase 3 trial (April 2022)
- Initiate Halo-Lido Phase 2b trial (April 2022)
- Submit I/ONTAK BLA application (2H 2022)
- Complete enrollment in Mino-Lok Phase 3 trial (end of 2022)
- Complete enrollment in Halo-Lido Phase 2b trial (end of 2022)
Read the full article here.
No. 3 CTXR Potential Catalyst - Topline Results Help Citius Get Closer To Product Commercialization
Citius Pharmaceuticals Reports Topline Data from the Pivotal Phase 3 Study of Cancer Immunotherapy I/ONTAK (E7777) for the Treatment of Persistent or Recurrent Cutaneous T-Cell Lymphoma (CTCL) in Support of BLA Submission
CRANFORD, N.J., April 6, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products in oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies, today reported topline results from the pivotal Phase 3 trial of I/ONTAK (E7777), an engineered IL-2-diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). The topline results for I/ONTAK (denileukin diftitox), a purified and more bioactive formulation of previously marketed ONTAK®, were consistent with the prior formulation. Moreover, no new safety signals were identified. Based on this data, Citius anticipates filing a biologics license application (BLA) with the U.S. Food and Drug Administration (FDA) in the second half of 2022.
"We are encouraged by the results of the study, which we believe are clinically meaningful, and are hopeful that I/ONTAK will be an important treatment option for patients with persistent or recurrent CTCL. There is no single standard of care for this orphan disease. We believe the full body of data from this and prior studies will support a successful reintroduction of denileukin diftitox to the market. We are eager to move forward with a BLA submission for the treatment of CTCL later this year. This important milestone brings Citius one step closer to launching its first commercial product next year, if approved by the FDA," stated Myron Holubiak, Chief Executive Officer of Citius.
"The topline results demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control without cumulative toxicity. I/ONTAK has a unique dual mechanism of action that exerts both direct tumor cell killing and transient elimination of immunosuppressive Tregs within the tumor microenvironment. The topline data further demonstrate that I/ONTAK has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies. If approved, we believe this biologic with its observed efficacy and safety data, and which is already approved for CTCL and peripheral T-cell lymphoma (PTCL) patients in Japan, would arm oncologists in the U.S. with an important additional treatment option for this devastating orphan disease," added Dr. Myron Czuczman, Chief Medical Officer of Citius.
Read the full article here.
No. 4 CTXR Potential Catalyst - Key Technical Indicators Are Leaning Oversold
As of close on Thursday, Barchart was reporting this profile to have several oversold leaning technicals.
These technicals could be signaling a healthy reversal in the near term.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Now, here are some key technicals (as of close Thursday) that could signal CTXR to be leaning oversold and on the verge of a potential reversal.
- 9-Day Relative Strength Index:
- 14-Day Relative Strength Index:
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 14-Day Raw Stochastic:
- 14-Day Williams %R:
As the Raw Stochastic nears the 10% range and lower and the Williams %R nears the 90% range or higher, these technical indicators may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely.
No. 5 CTXR Potential Catalyst - Major Institutional Positions
Over at WhaleWisdom, you can see which asset management companies and hedge funds think CTXR could be in for a bright future.
Here's a quick breakdown:
(1.) Allspring Global Investments Holdings is an assets management fund who recently jumped on the CTXR train when they added over 500k shares (reported 1/28/22).
(2.) American in-vestment ad-visor, Vanguard Group has a total position of approximately 6.17Mn overall shares after adding roughly 398k more (reported on 2/14/22).
(3.) In-vestment management company, BlackRock Inc., currently owns 5%+ of CTXR and a total of approx. 8.12Mn shares (reported on 2/23/22).
Don't think twice about this. This is huge news and only the tip of the iceberg.
Just take a look at WhaleWisdom's site and you'll see how many different institutions are taking positions in CTXR.
Could it be that these institutions see a big future for this Nasdaq profile?
CTXR Recap - 5 Potential Catalysts For This Nasdaq Past Champ
No. 1 - Strong Analyst Coverage Including A Pair Of $6.00 Targets
No. 2 - Business Highlights And Possible 2022 Catalyst Milestones
No. 3 - Topline Results Help Citius Get Closer To Product Commercialization
No. 4 - Key Technical Indicators Are Leaning Oversold
No. 5 - Major Institutional Positions
Coverage is officially reinitiated on CTXR. When you have time later, do this: