An Upcoming FDA Decision And The Nasdaq Biopharma (CTXR) Ready For Commercialization

Friday we saw a breakout runner make a major move. An Upcoming FDA Decision And The Nasdaq Biopharma (CTXR) Ready For Commercialization August 4th Dear Reader, Friday we saw a breakout runner make a major move. Brought to your attention after landing at $1.45 at Thursday's closing bell, it put the pedal to the metal just ahead of the weekend to shoot to a day high of $2.05. That $.60 move resulted in a surge of approximately 41%. And that's just the start. How about these other profiles that have popped off recently: July 29th - This Nasdaq alert flew approx. 37% short term. July 25th - This profile caught fire as it erupted for move approx. 205% overall! July 21st - This profile exploded for a run of approx. 66% in a blink. July 11th - This low float idea popped-off for approx. 66% intraday. We're talking an incredible 425% combined (approx.) over just a handful of recent profiles. That said, let's keep moving forward... 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. In May 2024, Citius announced positive topline results of Mino-Lok®, its antibiotic lock solution to salvage catheters in patients with bloodstream infections. The Biologics License Application for LYMPHIR™, a novel IL-2R immunotherapy for an initial indication in the treatment of cutaneous T-cell lymphoma, is currently under review by the FDA with August 13, 2024 assigned as the PDUFA target action date. Citius previously announced plans to form Citius Oncology, a standalone publicly traded company with LYMPHIR as its primary asset. LYMPHIR received orphan drug designation by the FDA for the treatment of CTCL and PTCL. In addition, Citius completed enrollment in its Phase 2b trial of CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. ----- 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](