Analysts Hunt for Undervalued Biotech Stocks - Citius Pharmaceuticals (NASDAQ: $CTXR) Jazz Pharmaceuticals (NASDAQ: $JAZZ) CRISPR (NASDAQ: $CRSP) Krystal Biotech (NASDAQ: $KRYS)

 

Analysts Hunt for Undervalued Biotech Stocks - Citius Pharmaceuticals (NASDAQ: $CTXR) Jazz Pharmaceuticals (NASDAQ: $JAZZ) CRISPR (NASDAQ: $CRSP) Krystal Biotech (NASDAQ: $KRYS)

 

July 17, 2024 - Investorideas.com, a go-to investing platform releases the first of a two-part series looking at biotech/biopharma stocks, featuring Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates.

 

Looking at the sector, Morningstar reported in June, “Biotech had a strong start to 2024, driven by an uptick in M&A and every indication that interest rates would begin to decline,” says Morningstar strategist Karen Andersen. “However, the second quarter has been more mixed for the industry, as rates look to be stabilizing rather than declining, given persistent (but improving) inflation. Higher rates tend to make waiting for uncertain returns on biotech investments less attractive.”

 

“We still see tailwinds for the industry going forward. Smaller-cap names are still targets for acquisitions by bigger biopharma firms, and a wave of acquisitions has continued since late last year, particularly focused on oncology and immunology,” she says. “We think obesity acquisitions are likely going forward, as big biopharma can bring development and commercialization expertise to multiple programs in midstage trials at small biotechs. Second, on a more fundamental level, new technologies and launches in new therapeutic areas are poised to boost productivity and drive biotech performance.”

 

This week, EF Hutton initiated coverage of Citius Pharmaceuticals (Nasdaq:CTXR) with a Buy recommendation with a price target of $6.00. Analyst Jason Kolbert sees the stock as low risk – high reward based on their two late stage therapeutics, Mino-Lok and LYMPHIR. He also notes that a planned IPO for LYMPHIR this summer, in addition to an early August PDUFA should be catalysts to unlock value for Citius.   

 

Paid news dissemination for Citius Pharmaceuticals.

 

Read this article, featuring CTXR in full at: https://www.investorideas.com/news/2024/biotech/07171Undervalued-Biotech-Stocks.asp

 

Mino-Lok (MLT), a novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium, is designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.

 

LYMPHIR is a recombinant fusion protein that combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. In 2011 and 2013, the FDA granted orphan drug designation to LYMPHIR for the treatment of PTCL and CTCL, respectively. In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Subsequently in 2021, Citius acquired an exclusive license with rights to develop and commercialize LYMPHIR in all markets except for Japan and certain parts of Asia.

 

In recent news from the company, 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 opportunities.”

 

In its most recent update, the company also discussed the pending IPO, reporting, “Citius plans to merge a wholly owned subsidiary with TenX Keane Acquisition (Nasdaq:TENK) to form publicly listed company, Citius Oncology, Inc. The transaction is pending review by the U.S. Securities and Exchange Commission (SEC) and TENK shareholder approval as well as contractual and customary closing conditions.”

 

Looking at some of Morningstar’s top biotech picks, they report, “These were the most undervalued biotech stocks that Morningstar’s analysts cover as of June 5, 2024:  Intellia Therapeutics ,Crispr Therapeutics ,Royalty Pharma ,Jazz Pharmaceuticals, Moderna, Ionis Pharmaceuticals, and Incyte.

 

Jazz Pharmaceuticals (NASDAQ: JAZZ), with its diverse portfolio of marketed medicines, including leading therapies for sleep disorders and epilepsy, and a growing portfolio of cancer treatments made their list with them saying, ”Jazz Pharmaceuticals is next on our list of affordable biotech stocks. Strong commercial launches for several products have continued to be Jazz’s primary growth driver. Jazz Pharmaceuticals looks undervalued as it trades 44% below our fair value estimate of $187 per share...”

 

CRISPR Therapeutics AG (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, say it is “Among our best biotech stocks to buy now, Crispr proved most resistant to the recent industry volatility. The company continues to possess a sizable, mostly early-stage pipeline, and it invests heavily in research and development.”

 

CRISPR also made the Insider Monkey top ten biotech stocks list, which noted, “CRISPR Therapeutics AG (NASDAQ: CRSP) is one of the more revolutionary medical companies since it is one of the few and one of the earliest players in the genetic sequencing industry. Estimates suggest that the market for CRISPR gene editing technologies can grow at a compounded annual growth rate of 22.3% between 2022 and 2027 to be worth an estimated $9.2 billion at the end of the forecast period. CRISPR Therapeutics AG's revenue was $370 million in 2023, leaving it with quite a bit of room to grow. Key to CRISPR Therapeutics AG's success though is the broader biotechnology industry's ability to commercialize treatments with its technology. These led to royalty payments, and one such payment came in Q1 from pharma giant Vertex Pharmaceuticals. Vertex's Casgevy is one of the few sickle cell disease treatments in the world, and its maker paid CRISPR Therapeutics AG $170 million in 2023 as a milestone payment. CRISPR Therapeutics AG, is eligible for another $130 million, and will also receive royalties from future treatments developed with its technology.”

 

For investors getting a sense of the rankings, According to IBD, “The industry group has a Relative Strength Rating of 83, which has improved from 74 just a week ago, according to IBD Digital. This means the industry group now ranks in the top 17% of all industry groups in terms of 12-month performance.”

 

On June 11^th, IBD reported, “Krystal Biotech (NASDAQ:KRYS) stock cleared an important technical benchmark, seeing its Relative Strength (RS) Rating jump into the 90-plus percentile with an improvement to 91, up from 88 the day before.”

 

On June 20^th, TimesSquare Capital Management, an equity investment management company, released its ‘US Small Cap Growth Strategy’ first-quarter 2024 investor letter. TimesSquare Capital US Small Cap Growth Strategy highlighted stocks like Krystal Biotech, Inc. (NASDAQ: KRYS), in the first quarter 2024 investor letter. Krystal Biotech, Inc. is a commercial-stage biotechnology company that develops genetic medicines for patients with rare diseases. The one-month return of Krystal Biotech was 5.15%, and its shares gained 43.27% of their value over the last 52 weeks. On June 20, 2024, the stock closed at $171.21 per share with a market capitalization of $4.889 billion.

 

Krystal Biotech joined the S&P 600 Index on June 24^th.

 

Biotech stocks took center stage during Covid and as the sector continues to reinvent the future of health, they are still on the must watch list for analysts searching for an undervalued opportunity,

 

Research and find more biotech stocks at Investorideas.com

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Breaking Uranium Stock News - Pegasus Resources (TSXV: $PEGA.V) (OTC PINK: $SLTFF) Investor Update; @pegasusresinc

Breaking Uranium Stock News - Pegasus Resources (TSXV: $PEGA.V) (OTC PINK: $SLTFF) Investor Update; @pegasusresinc

 

Key Highlights:

Strategic Acquisition and Exploration Progress: The acquisition of the Jupiter Project, located just 3 km north of Energy Sands, completed on July 10, 2024, features over 100 historical drill holes. This positions Pegasus to rapidly advance toward developing a uranium resource estimate and to deepen our understanding of the area's potential.

 

Advancing Geological Understanding: Our 2024 exploration efforts began with a successful ground sampling program at Energy Sands in January, which demonstrated a favourable environment for uranium mineralization. Subsequent acquisition of historical drilling data and analysis by Dahrouge Geological Consulting USA Ltd. revealed trends indicative of paleochannel-hosted mineralization, refining our target areas for potential resource development.

 

Permitting and Preparations for Drilling: We have initiated the permitting process and submitted all necessary documents to commence a comprehensive summer drilling program at both projects, aiming to explore and expand known mineralization zones.

 

VANCOUVER, BC / July 12, 2024 / (Investorideas.com Newswire) Pegasus Resources Inc. (TSX-V:PEGA) (OTCPK:SLTFF) (Frankfurt:0QS0) (the "Company" or "Pegasus") is excited to enter the third quarter of 2024 with significant developments in our exploration initiatives, particularly with the recent acquisition of the Jupiter Project and ongoing activities at our established Energy Sands project. As we advance these projects, we are positioned to significantly enhance shareholder value through strategic exploration and development.

 

"We are entering an exciting phase of exploration with the recent acquisition of the Jupiter Project and the work completed on the Energy Sands projects," stated Christian Timmins, CEO, "The strategic integration of these projects allows us to leverage extensive historical data and modern geological techniques to maximize our exploration potential. Our dedicated team is focused on advancing these projects rapidly, aiming to enhance our understanding of the mineral resources and expand our operational scope. With our upcoming drill program set to commence this summer, we are confident in our ability to deliver substantial value to our shareholders and reinforce Pegasus Resources' position as a leader in the uranium sector."

 

This news is paid advertisement/ news disseminated on behalf of/issued on behalf of Pegasus Resources Inc.

 

Read this in full at https://www.investorideas.com/news/2024/07121PEGA-Investor-Update.asp

 

Figure 1: Utah Area Map

 

2024 Overview:

The year commenced with a successful ground sampling program at Energy Sands in Utah in January 2024. The significant results, announced on March 25, 2024, indicated a favourable environment for uranium mineralization. Following this, we added to our geological understanding by acquiring historical drilling data of the area, which further defined the area's potential. As detailed in our June 04, 2024 news release, analysis conducted by Dahrouge Geological Consulting USA Ltd. identified a trend indicative of paleochannel-hosted mineralization. This significant discovery, aligning with structural measurements and the identified mineralization trends, aids in targeting potential mineral-hosting paleochannels across the property. We have initiated the permitting process and have submitted all necessary documents to launch a summer drilling program.

 

Adding to our portfolio, the recent acquisition of the Jupiter Project (July 10, 2024), located 3 km north of Energy Sands, marks a pivotal expansion. Jupiter, boasting over 100 historical drill holes, is an exciting project that uniquely positions Pegasus to expedite the development of a uranium resource estimate. This strategic proximity to Energy Sands and Jupiter provides a significant opportunity for us to use the available historical drill logs and future company drilling programs to better understand the uranium mineralization in the area while looking to find the next discovery. The strategic significance of this acquisition is immense, and we are poised to begin work at Jupiter once we have secured the required permits and funding, and completed the tendering process to acquire the necessary equipment and crews for a summer drilling program, with expectations set on rapidly advancing our exploration and resource development objectives at Jupiter.

 

Exploration Update:

As we progress through 2024, Pegasus Resources is actively advancing our exploration initiatives at both the Jupiter Project and Energy Sands, leveraging historical data and recent geological studies to guide resource development.

 

Jupiter Project: Our exploration approach at the Jupiter Project is comprehensive, involving the twinning of historical drill holes, detailed logging of old drill holes, and the identification of new drill targets. These efforts are crucial not only for expanding the known resource base but also for discovering new mineralization zones. We are developing a robust geological model for the Jupiter Project that will substantially enhance our resource development plans. Utilizing extensive historical drilling data, our goal is to refine our exploration strategies and produce a resource estimate that meets the current CIM Definition Standards on Mineral Resources and Mineral Reserves. The wealth of historical data available underscores the considerable potential for uranium mineralization, laying a strong foundation for our ongoing exploration efforts.

 

Energy Sands: Following a successful ground program in January 2024, which involved a detailed review of historical drill logs, we have moved forward with securing the necessary drilling permits for the Energy Sands project. Once permits are in place, our next steps include initiating the tendering process to source the essential equipment and skilled crews required for a comprehensive summer drilling program. This upcoming program is designed to build upon the insights gained from recent mapping conducted by Dahrouge Geological Consulting USA Ltd. Our focus will be on targeting and further investigating potential mineral-hosting paleochannels that have been identified across the property, aiming to delineate and expand these mineralized zones.

 

Integrated Exploration Strategy: By synchronizing our exploration strategies at both Jupiter and Energy Sands, Pegasus Resources is effectively harnessing synergies between the two projects. This integrated approach not only streamlines our operational efforts but also enhances our ability to quickly adapt and respond to geological findings as they emerge. The proximity of Jupiter to Energy Sands offers unique opportunities for operational efficiencies and resource sharing, ensuring that our exploration programs are both cost-effective and strategically aligned.

 

These combined efforts at Jupiter and Energy Sands underscore our commitment to advancing these projects toward their full potential, with the aim of significantly enhancing shareholder value through the discovery and development of valuable uranium resources. As we continue to progress with our drilling and exploration programs, Pegasus Resources remains dedicated to upholding the highest standards of resource estimation and sustainable mining practices.

 

Pine Channel: Located on the north side of the Athabasca Basin, Pine Channel is slated for a gravity survey this summer. This survey will enhance our understanding of the property and refine targets for future drilling operations. The gravity survey will play a crucial role in our strategic exploration efforts.

 

The company also announces an agreement with Fairfax Partners Inc. dated July 9th, which will provide social media marketing communication support for a two-month period for a fee of C$75,000 plus goods and services tax, then C$10,000 plus goods and service tax for the following 6 months. The services include content development, social media campaign and analytics. The total term of the Fairfax agreement is for a period of 8 months ending March 9th, 2025. Fairfax and its principals are arm's length to the company.

 

As we continue to advance our strategic projects, Pegasus Resources is uniquely positioned in the uranium sector to capitalize on both established and emerging opportunities. Our recent agreements and exploration advancements underscore our commitment to leading the industry in discovery and resource development. For more information and regular updates, investors are encouraged to visit our website or contact our investor relations team.

 

NI 43-101 Disclosure

The technical content of this news release has been reviewed and approved by Jacob Anderson, CPG, MAusIMM, who is a Resource Geologist for Dahrouge Geological Consulting USA Ltd., and a Qualified Person under National Instrument 43-101, who has prepared and/or reviewed the content of this press release.

 

About Pegasus Resources Inc.

Pegasus Resources Inc. is a diversified Junior Canadian Mineral Exploration Company with a focus on uranium, gold, and base metal properties in North America. The Company is also actively pursuing the right opportunity in other resources to enhance shareholder value. For additional information, please visit the Company at www.pegasusresourcesinc.com.

 

On Behalf of the Board of Directors:

 

Christian Timmins

President, CEO and Director

Pegasus Resources Inc.

700 - 838 West Hastings Street

Vancouver, BC V6C 0A6

PH: 1-403-597-3410

 

X: https://twitter.com/MrChris_Timmins

X: https://twitter.com/pegasusresinc

E: info@pegasusresourcesinc.com

 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accept responsibility for the adequacy or accuracy of this release.

 

Forward Looking Statements

Statements included in this announcement, including statements concerning the Company's plans, intentions, and expectations, which are not historical in nature are intended to be, and are hereby identified as, "forward-looking statements." Forward-looking statements may be identified by words including "anticipates," "believes," "intends," "estimates," "expects" and similar expressions. The Company cautions readers that forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are subject to certain risks and uncertainties that could cause actual results to differ materially from those indicated in the forward-looking statements.

 

SOURCE: Pegasus Resources, Inc.

 

Pegasus Resources Inc. (TSX-V:PEGA) (OTCPK:SLTFF) (Frankfurt:0QS0) is a featured mining stock on Investorideas.com

 

More info on PEGA at Investorideas.com Visit: https://www.investorideas.com/CO/PEGA/

 

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June IPOs to Watch in Tech, Biotech, Automotive and Mining (Nasdaq: $LIF) (Nasdaq: $WAY) (Nasdaq: $GAUZ) (Nasdaq: $FLYE) (Nasdaq: $RAPP) (Nasdaq: $TEM) (TSXV: $ONAU.V)

June IPOs to Watch in Tech, Biotech, Automotive and Mining (Nasdaq: $LIF) (Nasdaq: $WAY) (Nasdaq: $GAUZ) (Nasdaq: $FLYE) (Nasdaq: $RAPP) (Nasdaq: $TEM) (TSXV: $ONAU.V)

 

 

 

 

July 12, 2024 – (Investorideas.com Newswire) Investorideas.com, a global news source and expert investing resource, announces today’s roundup of stocks – all recent IPO’s.

 

This month’s IPOs cover the tech, biotech, transportation and mining industry sectors.

 

Read this in full at https://www.investorideas.com/news/2024/main/07121Stocks.asp

 

Investor Ideas is always researching and searching for new stocks to add to our growing list of free stock directories. The directories are not meant as recommendations but as a research tool to discover opportunities and trading ideas in a particular sector.”

 

New Stocks Added to the Tech Directories:

Life360, Inc. (Nasdaq:LIF) a family connection and safety company, keeps people close to the ones they love. The category-leading mobile app and Tile tracking devices empower members to stay connected to the people, pets, and things they care about most, with a range of services, including location sharing, safe driver reports, and crash detection with emergency dispatch. Life360 delivers peace of mind and enhances everyday family life in all the moments that matter, big and small.

 

Waystar Holding Corp. (Nasdaq:WAY) mission-critical software is purpose-built to simplify healthcare payments so providers can prioritize patient care and optimize their financial performance. Waystar serves approximately 30,000 clients, representing over 1 million distinct providers, including 18 of 22 institutions on the U.S. News Best Hospitals list. Waystar's enterprise-grade platform annually processes over 5 billion healthcare payment transactions, including over $1.2 trillion in annual gross claims and spanning approximately 50% of U.S. patients. Waystar strives to transform healthcare payments so providers can focus on what matters most: their patients and communities.

 

New Stocks Added to the Automotive/Transportation Directories:

Gauzy Ltd. (Nasdaq:GAUZ) is a fully-integrated light and vision control company, focused on the research, development, manufacturing, and marketing of vision and light control technologies that are developed to support safe, sustainable, comfortable, and agile user experiences across various industries. Headquartered in Tel Aviv, Israel, the Company has additional subsidiaries and entities based in Germany, France, the United States, Canada, China, Singapore, and Dubai. Gauzy serves leading brands in over 30 countries through direct fulfillment and a certified and trained distribution channel. Automotive grade LCG® smart glass technologies support glare mitigation, thermal comfort, interior protection, and transparent displays for an array of applications in passenger and commercial vehicles. Fully customized turn-key shading solutions provided as a Tier 1 with LCG® smart glass, or traditional shades supporting on demand cabin shading, ambiance, and cockpit shading for commercial and private jets.

 

Fly-E Group, Inc. (Nasdaq:FLYE) is an electric vehicle company that is principally engaged in designing, installing and selling smart electric motorcycles, electric bikes, electric scooters and related accessories under the brand “Fly E-Bike.” Our commitment is to encourage people to incorporate eco-friendly transportation into their active lifestyles, ultimately contributing towards building a more environmentally friendly future.

 

New Stocks Added to the Biotech Directories:

Rapport Therapeutics, Inc. (Nasdaq:RAPP)         is a clinical-stage biotechnology company dedicated to discovering and developing transformational precision neuromedicines for patients suffering from central nervous system (CNS) disorders. The Company’s founders have made pioneering discoveries related to the function of receptor associated proteins (RAPs) in the brain. Their findings form the basis of Rapport’s RAP technology platform, which enables a differentiated approach to generate precision small molecule product candidates with the potential to overcome many limitations of conventional neurology drug discovery. Rapport’s precision neuroscience pipeline includes the Company’s lead clinical program, RAP-219, designed to achieve neuroanatomical specificity through its selective targeting of a RAP expressed in only discrete regions of the brain. The Company is currently advancing RAP-219 in clinical trials in focal epilepsy, peripheral neuropathic pain, and bipolar disorder. Additional preclinical and late-stage discovery stage programs are also underway, targeting CNS disorders including chronic pain and hearing disorders.

 

Tempus AI, Inc. (Nasdaq:TEM) is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of multimodal data, and an operating system to make that data accessible and useful, Tempus provides AI-enabled precision medicine solutions to physicians to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data.

 

New Stocks Added to the Mining Directories:

OnGold Resources Ltd. (TSXV:ONAU) (formerly 1348515 B.C. Ltd.) is a reporting issuer in the provinces of British Columbia and Alberta with no current activities or operations. ONGold owns significant exploration assets in Northern Ontario, highlighted by the district-scale TPK Project and October Gold Project. These projects represent a strategic footprint in one of Canada's most prolific gold-producing regions.

 

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Bloodstream Infections – From Threats to Solutions; Stocks to Watch: Citius Pharmaceuticals, Inc. (Nasdaq: $CTXR), BD (Becton, Dickinson and Company) (NYSE: $BDX), CorMedix Inc. (Nasdaq: $CRMD), Vir Biotechnology, Inc. (Nasdaq: $VIR), Abbott Laboratories (NYSE: $ABT)

 

Bloodstream Infections – From Threats to Solutions; Stocks to Watch: Citius Pharmaceuticals, Inc. (Nasdaq: $CTXR), BD (Becton, Dickinson and Company) (NYSE: $BDX), CorMedix Inc. (Nasdaq: $CRMD), Vir Biotechnology, Inc. (Nasdaq: $VIR), Abbott Laboratories (NYSE: $ABT)

 

July 11, 2024 - Investorideas.com, a go-to investing platform releases the second of a two-part series looking at recent news and developments in the blood infections treatment market, featuring Citius Pharmaceuticals, Inc. (Nasdaq:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The Company's diversified pipeline includes two late-stage product candidates.

 

“Bloodstream infections (BSI) are a growing threat to public health worldwide. The 2 million cases of BSIs that occur annually in North America and Europe are associated with 250,000 deaths, making BSIs the leading cause of mortality from infection”, says a recent report in the Journal of Clinical  Microbiology.

 

Citius Pharmaceuticals, Inc. (Nasdaq:CTXR) just announced expected milestones in the second half of calendar 2024 and recapped key achievements year-to-date.

 

Citius reported it has significantly advanced its two late-stage product candidates in the first six months of 2024, and expects several key milestones in the near term.

 

Paid news dissemination for Citius Pharmaceuticals.

 

Read this article, featuring CTXR in full at: https://www.investorideas.com/news/2024/biotech/07114Bloodstream-Infections-Stocks.asp

 

Citius recently announced positive topline data from the Phase 3 study of Mino-Lok® in catheter-related bloodstream infections (CRBSIs). Primary and secondary endpoints were met with statistical significance.

 

Next steps for the Mino-Lok program are to prepare a submission to the U.S. Food and Drug Administration (FDA) and schedule a Type B meeting.  

 

Mino-Lok (MLT), a novel antibiotic lock solution that combines minocycline, ethanol and edetate disodium, is designed to treat patients with catheter-related blood stream infections. Citius licensed Mino-Lok from an affiliate of The University of Texas MD Anderson Cancer Center. Mino-Lok is designed to offer an alternative to removing and replacing a central venous catheter (CVC), which may lead to a reduction in serious adverse events and cost savings to the healthcare system. If approved, Mino-Lok would be the first and only FDA-approved treatment that salvages central venous catheters that cause central line-related blood stream infections.

 

In late May, Citius 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.

 

"We are extremely pleased by the strong results of the trial, which demonstrate the safety and efficacy of Mino-Lok in preserving indwelling catheters in patients with bloodstream infections. The data indicate, with a high degree of statistical significance, that Mino-Lok outperforms anti-infective lock solutions utilized in patients with CLABSI or CRBSI in the study's control arm. We believe Mino-Lok could potentially set a new standard of care (SOC) as an adjunct therapy in the treatment of patients with bloodstream infections. This therapy offers a non-invasive treatment option compared to catheter removal and replacement," stated Leonard Mazur, Chairman and Chief Executive Officer of Citius.

 

"We look forward to engaging with the US Food and Drug Administration (FDA) to determine the optimal path forward for Mino-Lok. Our focus remains on improving outcomes for patients and offering a much-needed alternative to the current practice of catheter removal and replacement," added Mazur.

 

Mino-Lok Phase 3 Trial Design

 

MDA 2013-0039 (NCT02901717) is a completed Phase 3 multicenter, randomized, open-label, active-controlled assessor-blinded trial conducted to evaluate the safety and efficacy of Mino-Lok as an adjunctive therapy to systemic anti-infectives for the treatment of catheter-related bloodstream infections (CRBSI) and central line-associated infections (CLABSI).

 

More from the news: A total of 241 patients in the U.S. and India, with an indwelling central venous catheter before the onset of a bloodstream infection, were randomized in a 1:1 ratio to receive either Mino-Lok or SOC site-specific anti-infective lock solution plus SOC systemic antibiotics. Enrollment was not limited to patients with specific types of catheters. Patients in the Mino-Lok arm received one Mino-Lok dose daily with a dwell time of two to four hours for a total of seven doses over a period of up to 15 days.

 

The primary endpoint for this study is the time to a catheter failure event between randomization and test of cure (TOC) at six weeks, measured in days following randomization. Additional secondary outcome measures include overall success, microbiological eradication, and clinical cure, among others.

 

For subjects in the Control arm, the investigator determined the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.

 

TOPLINE RESULTS

 

Efficacy:

The primary endpoint in the study was time to catheter failure between randomization and six-weeks following the first dose of Mino-Lok or SOC lock solution. Catheter failure was defined as the inability to administer study lock solution, catheter removal for any infection-related reason (including worsening clinical signs and symptoms or persistence or recurrence of baseline pathogen, or new infection), and all-cause mortality.

 

Results of blinded-assessor clinical outcome analyses in all randomized patients demonstrated that Mino-Lok achieved its primary endpoint:

 

Time to catheter failure events in patients receiving Mino-Lok therapy occurred substantially later than in patients in the Control arm (p value = 0.0006)

 

Median time-to-failure (MTF) of Control arm: 33 days; 95% confidence interval (CI) (14 days – 44 days; n = 122)

 

Median time-to-failure (MTF) of Mino-Lok arm: MTF exceeded the time the patients were on trial and therefore not estimable (NE); 95% CI (50 days - NE; n = 119)

 

The hazard ratio of this study was 0.53

 

The critical secondary endpoints included the proportion of patients at six weeks with overall treatment success including no catheter failure, clinical cure (absence of baseline clinical signs and symptoms of infection or improvement of clinical signs and symptoms such that no additional therapy was necessary), or microbiological eradication (absence of the baseline pathogen).

 

Results in all randomized patients who received at least one dose of study lock solution demonstrate overall treatment success in 57.1% of patients in the Mino-Lok arm and 37.7% of patients in the Control arm (p=0.0025).

 

Safety:

Mino-Lok is designed for intracatheter instillation and is not for intravenous injection or systemic circulation.

 

No serious adverse events were drug-related

 

Serious adverse events occurred in 45.1% of patients in the Mino-Lok arm and 46.1% of patients in the Control arm

 

BD (Becton, Dickinson and Company) (NYSE:BDX), a leading global medical technology company, today issued the following statement related to a US FDA letter to health care providers regarding the supply of blood culture vials:

 

Nikos Pavlidis, worldwide president of BD Diagnostic Solutions said, "BD is experiencing reduced availability of blood culture vials from our supplier. We understand the critical role that blood culture testing plays in diagnosing and treating infections and are taking all available measures to address this important issue, including providing the supplier our manufacturing expertise, using air shipments, modifying BD manufacturing schedules for rapid production, and collaborating with the U.S. Food and Drug Administration to review all potential options to mitigate delays in supply. As an additional stopgap measure, our former supplier of glass vials will restart production to help fill the intermittent gap in supply.

 

"We take our responsibility to support health care providers and patients very seriously and, while we are able to meet the majority of global demand, we are taking all available measures to address this important issue. BD BACTEC™ blood culture vials are being allocated manually so we can best mitigate any impact to patient care. Customers have been advised to prioritize the use of blood culture vials based on clinical needs and following guidelines, such as the most recent update from the Infectious Disease and Society of America and/or the World Health Organization.

 

"While this supplier issue is not expected to have a material financial impact on BD, we are fully focused on returning the supply of blood culture vials to normal levels."

 

CorMedix Inc. (Nasdaq:CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, recently announced that it has commenced commercialization of DefenCath® (taurolidine and heparin) to outpatient dialysis centers and vascular access clinics where patients receive outpatient dialysis and catheter placement services. The outpatient launch coincides with the effective date of July 1st for outpatient reimbursement of DefenCath® as directed by the Center for Medicare & Medicaid Services (CMS).

 

Late last year, CorMedix announced that the US Food and Drug Administration (FDA) had approved DefenCath® (taurolidine and heparin) catheter lock solution (CLS) to reduce the incidence of catheter-related bloodstream infections (CRBSIs) for the limited population of adult patients with kidney failure receiving chronic hemodialysis through a central venous catheter (CVC). DefenCath® is the first and only FDA-approved antimicrobial CLS in the U.S. and was shown to reduce the risk of CRBSIs by up to 71% in a Phase 3 clinical study.

 

Vir Biotechnology, Inc. (Nasdaq:VIR), an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases, recently announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.

 

"The IND clearance and Fast Track designation from the FDA, along with the encouraging preliminary data from our Phase 2 hepatitis delta trial, underscore the potential of tobevibart and elebsiran to transform the treatment landscape for people living with this severe and life-threatening disease," said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. "We are committed to working closely with health authorities to bring this potential groundbreaking treatment to patients as quickly as possible, addressing a critical unmet medical need."

 

Some of the biggest pharma companies including Abbott Laboratories (NYSE:ABT) are grabbing market share in the blood infections testing market, estimated at over 875 Million in 2023.

 

From testing to treatments, the life threatening bloodstream infection market is seeing breakthroughs in technology to answer the call.

 

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