(Nasdaq: CTXR) Receives Backing From 4 Key Potential Catalysts (FDA Decision Fast Approaches)

Friday we saw a breakout runner make a major move. (Nasdaq: CTXR) Receives Backing From 4 Key Potential Catalysts (FDA Decision Fast Approaches)  August 5th Dear Reader, Right now, I've got a Nasdaq Biopharma profile to get on radar ASAP. As of close Friday, this profile [closed above]( 3 key technical chart lines in its 50-Day Simple Moving Average (SMA), its 200-Day SMA, and its 13-Day Exponential Moving Average (EMA). On top of that, at least 3 analyst targets are suggesting over 400% potential upside from current levels over at [TipRanks](. Pair all of that with the game-changing potential of an [upcoming FDA decision]( which could spur commercialization efforts in a $300+Mn estimated addressable U.S. market. With an August 13th decision date ahead, timing could be critical to get this Biopharma on your radar right now: *Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)* Citius Pharma is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. And based on several potential catalysts, CTXR could earn some serious breakout buzz near term. Check them out: No. 1 - August 13th FDA Decision Could Lead To Product Commercialization! No. 2 - Positive Topline Results In Phase 3 Clinical Trial Makes CTXR A Biopharma To Take Seriously. No. 3 - Analysts Combined Targets Suggest Must-See Upside Potential From Current Levels! No. 4 - Closing Above 3 Key Technical Lines Means Chart Support Could Be Strengthening. But more on those in a second... CTXR Pipeline Breakdown - Key Product Candidates To Track The Company's diversified pipeline includes two late-stage product candidates: MINO-LOK® A novel first and only antibiotic lock solution to salvage central venous catheters (CVCs) in patients with catheter-related bloodstream infections. - Status: Positive Topline results with full data analysis underway; engaging with FDA next steps in Mino-Lok program; eligible for FDA priority review of NDA once submitted. - Positive Phase 3 Topline results: Achieved primary and secondary endpoints; Mino-Lok outperforms hospital-specific antiinfective lock solutions. - Market: Catheter-related bloodstream infection (CRBSI) and central line-associated bloodstream infection (CLABSI) market total estimated at >$1.8B worldwide. - First and only advantage: No current FDA-approved or investigational products for salvaging infected CVCs; potential to change standard of care. LYMPHIR™ The only systemic therapy to work on the IL-2 receptor in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL), both as a targeted therapy that eliminates malignant T cells in the skin and as an immunotherapy that depletes Tregs. - Status: Prescription Drug User Fee Act (PDUFA) target action date August 13, 2024; 2H 2024 commercialization planned, if approved. - Positive Phase 3 results: 36% objective response rate in heavily pretreated (median of 4 prior therapies; significant reduction in skin tumors for 84% of patients. - Market: Estimated $300-$400+Mn addressable U.S. market with additional growth opp's; historically, new market entrants have expanded the size of the market. - Market advantage: No curative therapeutics on the market. Only IL-2R targeted therapy. HALO-LIDO A proprietary topical cream formulation intended to provide anti-inflammatory and anesthetic relief to individuals suffering from hemorrhoids. - Status: Dose for Phase 3 trial selected; ongoing engagement with FDA. - Positive Phase 2b results: Meaningful reduction in symptom severity when compared to individual components alone. - Market: +10Mn patients report symptoms of hemorrhoidal disease; 1/3 seek physician treatment.(1) - First and only advantage: No FDA-approved prescription hemorrhoid products available. Grab More Company Details Here: [CTXR Website.]( [Fact Sheet.]( ----- As mentioned above, CTXR has several potential catalysts to watch for this moment. Check them out: No. 1 CTXR Potential Catalyst - August 13th FDA Decision Could Lead To Product Commercialization! Citius Pharmaceuticals Details Near-Term Milestones for Late-Stage Candidates CRANFORD, N.J., July 10, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), ..., today announced expected milestones in the second half of calendar 2024 and recapped key achievements year-to-date. Leonard Mazur, Chairman and CEO of Citius stated, "Our solid execution since the beginning of the year sets us up for potentially transformative catalysts in the coming months. Mino-Lok's strong Phase 3 topline results support its potential to become part of the standard of care for treating catheter-related bloodstream infections. Mino-Lok would also have a first and only advantage in a market with no approved or investigational products for salvaging infected central venous catheters. For LYMPHIR™, the FDA is currently reviewing our Biologics License Application, with an expected decision on August 13th. We are preparing for near-term commercialization of LYMPHIR if approved. These near-term catalysts should enable the company to optimize its current cash runway, future cash needs, as well as create potential non-dilutive cash opp's." ... [Read the full article here.]( ----- No. 2 CTXR Potential Catalyst - Positive Topline Results In Phase 3 Clinical Trial Makes CTXR A Biotech To Take Seriously. Citius Pharmaceuticals Achieves Primary and Secondary Endpoints in Phase 3 Trial of Mino-Lok Antibiotic Lock Solution CRANFORD, N.J., May 21, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), ..., today announced positive topline results of its pivotal Phase 3 clinical trial of Mino-Lok®, a novel antibiotic lock solution designed to salvage catheters in patients with central line-associated infections (CLABSI) or catheter-related bloodstream infections (CRBSI). The study met its primary endpoint with a statistically significant improvement in the time to failure event in patients receiving Mino-Lok compared to Control arm patients receiving clinician-directed anti-infective lock solution. The data demonstrate that Mino-Lok is well-tolerated. ... [Read the full article here.]( ----- No. 3 CTXR Potential Catalyst - Analysts Combined Targets Suggest Must-See Upside Potential From Current Levels! Take a look at what's being reported over at [TipRanks]( The graphic above shows that 3 different Wall Street analysts believe CTXR could be undervalued from current levels. In fact, with their combined targets, there may be over 400% potential upside for CTXR from current levels. Just imagine how important this August 13th FDA decision could be... ----- No. 4 CTXR Potential Catalyst - Closing Above 3 Key Technical Lines Means Chart Support Could Be Strengthening. Take a peek at CTXR's 3-month chart: On Friday, CTXR closed above 3 important technical chart lines in its: - 50-Day Simple Moving Average (SMA), its - 200-Day SMA, and its - 13-Day Exponential Moving Average (EMA). If support at those levels strengthens and CTXR is able to take on and break down $1.00 psychological resistance, big things could lie ahead for this Nasdaq Biopharma. ----- CTXR Recap - Key Catalyst Potential Could Create A Breakout Spark Near Term No. 1 - August 13th FDA Decision Could Lead To Product Commercialization! No. 2 - Positive Topline Results In Phase 3 Clinical Trial Makes CTXR A Biopharma To Take Seriously. No. 3 - Analysts Combined Targets Suggest Must-See Upside Potential From Current Levels! No. 4 - Closing Above 3 Key Technical Lines Means Chart Support Could Be Strengthening. ----- Coverage is officially initiated on (Nasdaq: CTXR). Get this Biotech profile front and center this week. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer Source 1: MAYO CLINIC Hemorrhoidal disease: Diagnosis and management (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) Fierce | 4834 NW 2nd Ave Unit #388 | Boca Raton, FL 33431 US [Unsubscribe]( | [Update Profile]( | [Constant Contact Data Notice](