| Today's Stock Alert Is (NASDAQ:CTXR) Good morning traders, If you haven't done so pull up (NASDAQ:CTXR) and start doing your research. You know that we are a fan of a good looking chart and CTXR chart's is looking pretty sweet! Not to mention this stock is carrying a $4.00 Price target from 2 different analysts and calling it a strong buy.  Keep (NASDAQ:CTXR) IS at the the top of our list for the open. The stock is already up 13% from yesterday and has traded over 200k shares.. The market isn;t even open yet! Can we see another massive rally like over previous alert this week? (NASDAQ:CTXR) To the moon! Full Company Profile below: Is this Emerging NASDAQ Company Poised to be the Next Big Breakout Play in the Biotech Arena? Momentum looks HOT right now! Greetings All, After a slew of takeover deals in 2023, the interest in biotech and biopharma began in 2024 with some great promise. Innovation is thriving in this growing space and big winners have continuously emerged. One company going underfollowed on the NASDAQ may be the crème of the top and should be high on your radar! Add Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) to your watch list!  Trading in mere pennies, CTXR is a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products. Immediate reasons why you should have your eyes on CTXR right now include a "BUY" rating at BarChart.com, and a "STRONG BUY" rating at NASDAQ.com with two notable analysts rating the stock: - H C WAINWRIGHT
- MAXIM GROUP,LLC
AND… NASDAQ.com has a $4 price target listed! In the last few weeks, CTXR has seen some big gains before slightly pulling back. Shares moved from around 60 cents to over $1! It looks like the stock may be on an upward move again. So, what is CTXR doing and why does it matter? Citius Pharma's diversified pipeline includes two late-stage product candidates. At the end of 2023, Citius completed enrollment in a Phase 3 pivotal superiority trial of Mino-Lok® , an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. The company resubmitted the Biologics License Application for LYMPHIR, a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), in early 2024, and announced plans to form Citius Oncology , a standalone publicly traded company with LYMPHIR as its primary asset. What is LYMPHIR? LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and Periphel T-cell Lymphoma (PTCL). In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. The company believes LYMPHIRTM is a novel targeted oncology asset with an attractive near-term revenue opportunity and a substantially de-risked path to support commercial success. What is Mino-Lok? Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line-associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions , especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge. Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected! Program Highlights ►Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs ► In a Phase 2b trial, Mino-Lok® demonstrated a 100% efficacy rate in salvaging colonized CVCs; Mino-Lok® had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced. Learn more… ► A multicenter Phase 3 pivotal superiority trial is currently underway. Learn more… ►Mino-Lok® was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036! ►Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center  CTXR had some pretty big news last week…. CTXR announced that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas. Citius is collaborating with the University of Minnesota (UMN) in this investigator-initiated study. This Phase 1 dose-finding study to evaluate LYMPHIR prior to CAR-T therapies tisagenlecleucel (KYMRIAH®), axicabtagene ciloleucel (YESCARTA®), or lisocabtagene maraleucel/BREYANZI®), in patients with B-cell lymphomas (BCL) (NCT0485525) was initiated in May 2021 and has been expanded to include City of Hope. Enrollment is underway for patients diagnosed with relapsed or refractory BCL, for which treatment with CAR-Ts is planned, and who are considered at high risk for progression after CAR-T therapy. The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of ONLY 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S. "We are encouraged by the scientific community's interest in exploring the potential benefits of LYMPHIR beyond cutaneous T-cell lymphoma, for which a Biologics License Application is currently under review by the FDA. We are very excited to support UMN's expansion of its study to City of Hope as distinguished oncologists Dr. Bachanova and Dr. Mei conduct innovative research to evaluate LYMPHIR in combination with CAR-T treatment," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. Other big news… CTXR Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma T he U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has assigned a PDUFA goal date of August 13, 2024. Leonard Mazur, Chairman and CEO of Citius has said, "We believe there remains a critical unmet need for an additional viable treatment option for patients with relapsed or refractory CTCL as current therapies are non-curative. We are grateful for the FDA's vital support for rare disease drug development as we work to expand treatment options for patients with cutaneous T-cell lymphoma. We look forward to the FDA's decision and the potential benefit LYMPHIR may provide patients with relapsed or refractory CTCL." In summary… Biotech… it's one of the most thrilling arenas where a simple news announcement about a study or trial can send shares exploding. And then there's the potential of a holy grail FDA announcement…. This is usually what keeps investors watching biotech companies closely. Finding remarkable companies in this space that are relatively anonymous compared to bigger players in the industry is what savvy investors hunt for. One emerging biotech company not to ignore right now is Citius Pharmaceuticals, Inc. (NASDAQ: CTXR). CTXR has BULLish ratings, a $4 price target, and two LATE-STAGE product candidates. Keep an eye out for developments! You never know what could be a catalyst to drive a rally! OH… and to reiterate… a whopping $26.5M has been invested by the company's founders!! With a diversified pipeline and products addressing some of the world's most addressable markets, Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) is a biotech company that may be trading at a supreme premium right now…. |