News Hub | News Direct

Healthcare

Addiction Biotech Cannabis Genetics Healthcare Medical Devices Pharmaceutical Science Veterinary
Article thumbnail News Release

6 Stocks Positioned to Soar as Investors Focus on MASH

AKRO, MDGL, VKTX, LLY

Investors are making a lot of money on obesity plays. Obesity is at epidemic proportions, so it's easy to see why obesity drugs including GLP-1 agonists have exploded in the marketplace. This class of drugs was originally designed to manage blood sugar levels in diabetics but was expanded to treat obesity, an even bigger market. JP Morgan analyst Richard Vosser estimated the global obesity drug market will reach $71 billion by 2032. The first approval of Byetta® was in 2005 but the market has since grown to include a bunch of diabetes drugs you’ve heard on TV ads like Trulicity®, Victoza®, Adlyxin®, Ozempic®, Rybelsus®, and Mounjaro®. Blockbuster drugs like Ozempic, now called Wegovy®, and Mounjaro, now called Zepbound®, were repurposed as obesity drugs. This repurposing trend is a common theme in the biotech space. The only issue is that obesity has become a common theme, which ultimately makes it a crowded trade and harder to pick the winners and losers. Combination drugs like survodutide, retatrutide, and cagrisema are up-and-coming drugs in phase 3 development for obesity, but investing in these names means you are simply following the herd. Investing requires leading with an edge and some forethought. This article highlights pure-play drug developers in MASH likely to be the focus of investors looking for the next big thing in biotech. Looking Beyond GLP-1 Inhibitors Toward the MASH Epidemic Drug makers like Eli Lilly (NYSE: LLY) with their drug Mounjaro (tirzepatide) have already repurposed their drug once and are looking beyond diabetes and obesity, with their eyes set on and an even more lucrative market of metabolic dysfunction-associated steatohepatitis (MASH). LLY has promising interim clinical data showing 74% of overweight adults who took the higher dose of tirzepatide cleared MASH versus 12.6% in placebo. The first approval of a MASH drug on March 15, 2024 by Madrigal Pharmaceuticals (NASDAQ: MDGL) has ignited the sector with investors looking for the next big pure play. Multiple MASH Targets Metabolic dysfunction-associated steatohepatitis (MASH) is a complicated disease on the regulatory front. Approval criteria are a resolution of MASH symptoms via biopsy without a worsening of fibrosis. The disease formerly known as nonalcoholic steatohepatitis (NASH) is caused by a buildup of fat in the liver that leads to complications which include fibrosis (scarring of the liver), cirrhosis (severe scarring of the liver), and liver cancer. Once MASH progresses this far, liver transplantation is currently the only viable option. After MDGL’s approval of Rezdiffera®, investors have been flocking to other MASH names looking for a follow-on drug that either works in combination with Rezdiffera or one that is superior in safety and efficacy. MASH Drug Targets MASH has several druggable targets. The GLP-1 target is the mainstream approach because it also treats type 2 diabetes. Next in terms of a drug target is the fibroblast growth factor 21 (FGF21) which has a number of players in late-stage development. Galectin-3 is another target for MASH drugs as research has shown it is implicated in fibrotic and inflammatory feedback loops. There are also promising drugs that target the thyroid hormone receptor beta (THRβ). Breaking from the mainstream approaches is the A3 adenosine receptor (A3AR) which is highly expressed in inflammatory and cancer cells whereas low expression is found in normal body cells. FGF21 Agonists 89Bio Inc. (NASDAQ: ETNB) is developing a lead molecule called pegozafermin which is a specifically engineered glycoPEGylated analog of fibroblast growth factor 21 (FGF21). It is similar in mechanism of action to Bristol Myers Squibb’s (NYSE: BMY) drug pegbelfermin which was discontinued despite positive results which showed more than half the patients having NASH resolution at 16 weeks. FGF21 analogues are taken via subcutaneous injection. The targeting of the FGF21 pathway helps regulate metabolism and cellular process, especially in the liver fat tissue. Balancing out this metabolic pathway helps reduce liver fat, which can result in reduction in liver fibrosis (scarring) over time. The company has strong fibrosis data with favorable tolerability and dosing convenience. The long term data suggests there is a cumulative impact on patients taking background GLP-1 therapy. ETNB’s phase 3 program in MASH could achieve accelerated approval using histology in non-cirrhotic (F2-F3) and cirrhotic (F4) patients although the FDA has acknowledged greater importance in clinical outcomes and not histology. They have clinical trials in both fibrosis and cirrhosis and expect to initiate their cirrhosis trial in Q2 2024. The company has almost $600 million in cash with a market cap of $875 million. The slight premium over cash, solid and consistent trial results, along with short and long-term catalysts make this an attractive setup for investors. This is the first on the top 6 list. Akero Therapeutics (NASDAQ: AKRO) is also targeting MASH and MASH cirrhosis with an FGF21 agonist. Their drug is called efruxifermin and is commonly referred to as EFX. In their phase 2b MASH trial they showed a 65% reduction in liver fat content vs 11% in placebo which places them close to the front of the pack because it was done in only 12 weeks. Unfortunately, their phase 2b trial in MASH missed the endpoint for improvement in liver fibrosis at the 12-week time frame but showed 60% had MASH resolution after 36 weeks versus 26% in placebo. The company lost a lot of value on that readout but the statistics show a cleanly designed trial is likely to hit the regulatory endpoints. Guidance from an end-of-trial FDA meeting is forthcoming, but the timing is still uncertain and weighing on the stock price. While there is a lot of potential in this name, the uncertain timing of the regulatory pathway makes this ideal for the patient investor looking more for a NASH cirrhosis play. The company is well funded with over $550 million in cash and a $1.5 billion market cap. Galectin-3 Antagonists Galectin Therapeutics (NASDAQ: GALT) has an adaptive design phase 2/3 study in NASH cirrhosis with an interim readout before year end 2024. Their intravenously administered galectin antagonist called belapectin showed complete prevention of esophageal varices in a phase 2 trial despite failing to meet their (now defunct) primary endpoints. Their pivotal trial used lessons learned from the phase 2 trial, utilizing a primary endpoint of prevention of esophageal varices. If the interim results confirm a complete or near complete prevention of varices like they did in their phase 2 trial, they would have a compelling argument for conditional approval, likely with another post-market confirmatory phase 3 trial. Almost 50% of patients that develop esophageal varices die within a year, and the varices are extremely costly to treat. So eliminating the significant and imminent threat of death is the compelling benefit. The company is in solid financial shape with enough cash runway to complete their pivotal trial by 2025. They also have the backing of a billionaire investor who is also their Chairman of the Board. Additionally, their drug demonstrated promising results in cancer, psoriasis, and atopic dermatitis which could lead to a label expansion once they are approved. The market cap of the company is sitting around $225 million despite the near certainty of a positive interim trial readout within the next 8 months, which could translate into billions within that time frame. The company is not alone in the space and has 2 other competitors with oral galectin-3 antagonists. Galecto Bioscience (NASDAQ: GLTO) announced they were scrapping their cancer drug, which had a 60% response rate after three months, to focus on NASH. GLTO had a failed trial in idiopathic pulmonary fibrosis because of their drug’s poor tolerability, which has forced them to seek strategic alternatives with a focus on liver disease. As a result, their development timelines for MASH are in flux. Galecto’s small molecule approach to inhibiting intracellular galectin-3 is the likely culprit for their drug’s poor tolerability and its more likely large molecules which target extracellular galectin-3 will succeed. Bioxytran Inc. (OTCMKTS: BIXT) has the most technologically advanced oral galectin antagonist that completed phase 2 trials in standard risk COVID-19, but the company is underfunded and therefore moving forward cautiously. Both Bioxytran and Galectin Therapeutics are developing larger molecules compared with Galecto and both their drugs have been found to be safe as opposed to Galecto. Bioxytran’s additional benefit is that their drug doesn’t require intravenous administration. Their clinical trials in NASH or cancer are dependent upon them finding a partner or a couple million dollars to get a shot at a number of multibillion dollar opportunities. Management indicated that the quickest way to approval was a COVID-19 regulatory approval and then proceeding with the label expansion. While the company boasts impressive technology and experienced management, they don’t have the resources to prove their technology for all these indications yet. It's for these reasons that the stock should remain high on peoples watch lists—in case they get funding. Thyroid Hormone Agonists Viking Therapeutics (NASDAQ: VKTX) is the largest pure play MASH company measured by market capitalization with a number of molecules in phase 2 or 3 development. Their leading drug candidate, VK2809, is a THRβ agonist. They also have a dual agonist for both the GLP-1 hormone and glucose-dependent insulinotropic polypeptide (GIP), VK2735. Clinical trials for VK2735 have been highly successful making it a darling with a market cap of $7.56 which exceeds the market cap of MDGL that has an approved MASH drug that also targets THRβ. Viking’s VK2809 targets non-alcoholic steatohepatitis (NASH) and fatty liver. It aims to reduce liver fat, preventing inflammation, damage, and potential progression to cirrhosis. Clinical trial results for VK2809 include significant weight loss (up to 14.7% of baseline body weight) and improvements in liver fat content. Notably, 85% of VK2809 patients experienced a >30% decrease in liver fat by week 12, correlating with improved histology. At least 88% of participants lost at least 10% weight loss versus 4% for placebo. The company is also innovating for their next generation, orally administered NASH drug, which had positive phase 1 trial results. Other Approaches CanFite Biopharma’s (NYSE: CANF) lead drug candidate, namodenoson, is an A3 adenosine receptor (A3AR) antagonist, but what makes them stand out from the crowd is their platform technology that has the ability to screen targets in both the inflammatory and tumor micro-environment. It is also the only drug in the MASH space that is taken orally once a day. Both inflammatory and cancerous cells are overexpressed with A3AR which makes them an ideal target in MASH and liver cancer. The company completed both phase 2 and 3 studies for other indications such as liver cancer, so the favorable safety profile is well established in hundreds of patients. MASH study results showed a linear reduction in weight over time, a reduction in liver fat measured by proton density fat fraction (PDFF) on magnetic resonance imaging, validation of blocking the A3AR receptor, and the liver protective effect of the drug manifested by a reduction in hepatic inflammation. The company has a favorable status with both the EMA and FDA which could lead to a conditional approval. Their platform technology includes other large-market disease indications including psoriasis, pancreatic cancer, liver cancer, and erectile dysfunction. The company also has 6 major drug partners and the potential to earn $130 million on regulatory and sales milestones for their 2 pivotal phase 3 assets. With a compressed market cap of $10 million which is trading barely over their cash and the potential of regulatory approval within the next 1.5 years, it's easy to see how this biotech could translate into an extraordinary investment if it achieves regulatory approval. The company has a solid management team with a low burn rate which means they are less likely to dilute because their interests are aligned with shareholders. This rounds out the top 6 MASH companies with the best risk to reward ratio. Disclaimers: The Private Securities Litigation Reform Act of 1995 provides investors a safe harbor in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, assumptions, objectives, goals, assumptions of future events or performance are not statements of historical fact may be forward looking statements. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as projects, foresee, expects, will, anticipates, estimates, believes, understands, or that by statements, indicating certain actions & quotes; may, could or might occur Understand there is no guarantee past performance is indicative of future results. Investing in micro-cap or growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor's investment may be lost or due to the speculative nature of the companies profiled. RazorPitch Inc is responsible for the production and distribution of this content. RazorPitch is not operated by a licensed broker, a dealer, or a registered investment advisor. It should be expressly understood that under no circumstances does any information published herein represent a recommendation to buy or sell a security. RazorPitch Inc authors, contributors, or its agents, may be compensated for preparing research, video graphics, and editorial content. RazorPitch Inc has not been compensated to produce and syndicate this content. Contact Details RazorPitch Inc Mark McKelvie +1 585-301-7700 markrmckelvie@gmail.com Company Website http://RazorPitch.com

April 22, 2024 06:00 AM Eastern Daylight Time

Image
Article thumbnail News Release

Capturing Consumer Spending on Health Care with XLV

Select Sector SPDR

With consumer spending on health care continuing to increase, the Health Care Select Sector SPDR Fund ( XLV ) provides an opportunity for investors to leverage this trend. XLV tracks health care stocks within the S&P 500 Index, offering broad exposure to core companies in the U.S. healthcare sector. The fund's top holdings* are comprised of market leaders across several sub-sectors of healthcare including companies such as Eli LIlly & Co (11.34%), Unitedhealth Group (8.36%), Johnson & Johnson (6.96%), Merck & Co (6.11%), AbbVie Inc. (5.87%), Thermo Fisher Scientific (4.10%), Abbott Laboratories (3.61%), Danaher Corp (3.00%), Pfizer (2.86%), and Amgen (2.78%). Growth Drivers in the Healthcare Sector As the health care sector continues to grow, these companies are well-positioned to benefit from increased consumer spending. The growth history in this sector has been driven by several factors, including a rise in chronic diseases, an aging population, and advancing medical technology. Total spending on health care rose from 16% of GDP in 2007 to an estimated 18% in 2023. Simultaneously, the total GDP has risen nearly 70% in that time, from 14.47 trillion in 2007 to 25.5 trillion in 2022. Investing in XLV offers a diversified way to capture steady consumer spending on health care. By investing in the health care market in a broad way, the ups and downs of a particular big name in the sector are mitigated by the exposure to other healthcare companies. DISCLAIMER: This is a work of research and should not be taken as investment or financial advice. Therefore, Select Sector SPDRs or the publisher is not liable for any decision made based on the publication. About the Company: Select Sector SPDR ETFs offer flexibility and customization opportunities. Many investors have similar outlooks, but no two are exactly alike. Select Sector SPDR ETFs let investors select the sectors that best meet their investment goals. *Holdings, Weightings & Assets as of 3/31/24 subject to change DISCLOSURES The S&P 500 Index is an unmanaged index of 500 common stocks that is generally considered representative of the U.S. stock market. The index is heavily weighted toward stocks with large market capitalizations and represents approximately two-thirds of the total market value of all domestic common stocks. The S&P 500 Index figures do not reflect any fees, expenses or taxes. An investor should consider investment objectives, risks, fees and expenses before investing. One may not invest directly in an index. Transparent ETFs provide daily disclosure of portfolio holdings and weightings All ETFs are subject to risk, including loss of principal. Sector ETF products are also subject to sector risk and nondiversification risk, which generally will result in greater price fluctuations than the overall market. Diversification does not eliminate risk. An investor should consider investment objectives, risks, charges and expenses carefully before investing. To obtain a prospectus, which contains this and other information, call 1-866-SECTOR-ETF (732-8673) or visit www.sectorspdrs.com. Read the prospectus carefully before investing. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is distributor for the Select Sector SPDR Trust. Media Contact: Company: Select Sector SPDRs Contact: Dan Dolan* Address: 1290 Broadway, Suite 1000, Denver, CO 80203 Country: United States Email: dan.dolan@sectorspdrs.com Website: https://www.sectorspdrs.com/ *Dan Dolan is a Registered Representative of ALPS Portfolio Solutions Distributor, Inc. ALPS Portfolio Solutions Distributor, Inc., a registered broker-dealer, is the distributor for the Select Sector SPDR Trust. SEL007449 EXP 5/31/24 Contact Details Dan Dolan +1 203-935-8103 dan.dolan@sectorspdrs.com Company Website https://www.sectorspdrs.com/

April 22, 2024 05:00 AM Eastern Daylight Time

Article thumbnail News Release

Elsevier Appoints Dr Kieran West MBE as Executive Vice President of Strategy

Elsevier

Elsevier, a global leader in scientific information and analytics, announced today the appointment of Dr Kieran West MBE as Executive Vice President of Strategy, effective immediately. As an established senior executive with a track record of driving transformation and growth, Kieran joins Elsevier with extensive experience in healthcare, retail, consumer goods, and pharmaceuticals across international markets. Most recently, he served as Strategy Director at Bupa Global and UK, a leading healthcare provider and insurer, where he was instrumental in shaping the company's strategic direction. Prior to his time at Bupa, he served as an Associate Partner at McKinsey, where he advised both domestic and global companies on achieving commercial success. He previously taught mathematics at King’s College School, UK. His academic achievements include a PhD in History from the University of Cambridge, an MA in War Studies from King’s College London, and a PGCE degree in Mathematics. Kieran is also a world champion rower and Olympic gold-medallist, having won in the Men’s Eights in the 2000 Sydney Olympics. Kumsal Bayazit, CEO of Elsevier, said: “I am thrilled to welcome Kieran to Elsevier and look forward to the contribution that he will make with his strong strategic and operational experience, and his understanding of the healthcare, life sciences and academic communities. He is also passionate about developing individuals and delivering as a team, which is very much aligned with our values as an organization.” Kieran joins Elsevier’s Executive Leadership Team and will work across all areas of the company to develop and drive global strategic plans, including business development initiatives. He will be based in London. About Elsevier As a global leader in scientific information and analytics, Elsevier helps researchers and healthcare professionals advance science and improve health outcomes for the benefit of society. We do this by facilitating insights and critical decision-making with innovative solutions based on trusted, evidence-based content and advanced AI-enabled digital technologies. We have supported the work of our research and healthcare communities for more than 140 years. Our 9,500 employees around the world, including 2,500 technologists, are dedicated to supporting researchers, librarians, academic leaders, funders, governments, R&D-intensive companies, doctors, nurses, future healthcare professionals and educators in their critical work. Our 2,900 scientific journals and iconic reference books include the foremost titles in their fields, including Cell Press, The Lancet and Gray’s Anatomy. Together with the Elsevier Foundation, we work in partnership with the communities we serve to advance inclusion and diversity in science, research and healthcare in developing countries and around the world. Elsevier is part of RELX, a global provider of information-based analytics and decision tools for professional and business customers. For more information on our work, digital solutions and content, visit www.elsevier.com. Contact Details Dan DiPietro-James +1 323-252-0645 Dan.james@elsevier.com

April 22, 2024 04:00 AM Eastern Daylight Time

Article thumbnail News Release

UNOS unveils new artwork honoring organ donors and recipients

United Network for Organ Sharing

Today, the United Network for Organ Sharing (UNOS) installed a mural by acclaimed artist Hamilton Glass to recognize the far-reaching impact of organ donation and to pay tribute to organ donors. The artwork is a Glass original, designed specifically for UNOS, and lives above the main entrance of UNOS’ headquarters in Richmond, Va. The mural portrays the interconnectedness of the organ donation and transplant community, with hands symbolizing the gesture of giving and receiving the gift of life. The blue ripples illustrate the ripple effect of donation on families and communities. “The artwork serves as a poignant reminder that every donation is a gift that touches us all, creating a network of support that UNOS tirelessly collaborates with daily to save lives,” said Glass. UNOS invited Richmond-based architect and artist Glass and his wife and business partner Taekia to design and create a piece of art that visually connects to and builds on the meaning of the National Donor Memorial. The memorial honors organ, eye and tissue donors and is open 24/7 to allow visitors to reflect on the journey of donation and transplant. “The lifesaving and lifechanging impact an organ donor has on both a recipient and their loved ones is incredibly profound, which is why we wanted to work with Hamilton Glass to create a piece of art that honors the selfless gifts organ donors provide,” said Maureen McBride, Ph.D., CEO of UNOS. “We want people to visit this mural and take in and learn how significant and impactful organ donation is.” Glass uses art to engage the public through big, bold designs and messages of hope, and has more than 300 murals on display throughout Richmond. The mural is approximately 16 feet tall and 40 feet wide and is comprised of 18 PVC panels. It is located on the exterior of UNOS’ building on North 4th Street in Richmond, Va. About UNOS United Network for Organ Sharing (UNOS) is the mission-driven non-profit serving as the nation’s transplant system under contract with the federal government. We lead the network of transplant hospitals, organ procurement organizations, and thousands of volunteers who are dedicated to honoring the gifts of life entrusted to us and to making lifesaving transplants possible for patients in need. Working together, we leverage data and advances in science and technology to continuously strengthen the system, increase the number of organs recovered and the number of transplants performed, and ensure patients across the nation have equitable access to transplant. Contact Details United Network for Organ Sharing Anne Paschke +1 804-782-4730 anne.paschke@unos.org Company Website https://unos.org

April 19, 2024 03:54 PM Eastern Daylight Time

Image
Article thumbnail News Release

BioHarvest Sciences secures new state of the art 80,0000 square foot manufacturing facility

BioHarvest Sciences Inc

BioHarvest Sciences CEO Ilan Sobel joined Steve Darling from Proactive to to unveil two significant agreements that mark a transformative milestone for the company: an equipment purchase agreement for 12 state-of-the-art GMP clean rooms and a long-term lease agreement for a new 80,000 square foot facility in Yavne, Israel. Sobel elaborated on the exciting developments, highlighting that the new facility represents a major expansion for BioHarvest Sciences. Equipped with industry-leading clean rooms, as well as fully built-out laboratory space and offices, the facility is poised to support the company's ambitious growth plans. Notably, it also provides the necessary infrastructure to accommodate the anticipated expansion of the Contract Development and Manufacturing Organization (CDMO) Business Unit. The strategic significance of this transaction lies in its immediate access to cutting-edge clean rooms and laboratories, essential for meeting the evolving needs of both the Products Business Unit and CDMO customers. Furthermore, the facility boasts ample additional space, enabling the construction of a new 50-ton manufacturing facility slated for operation in the second half of 2025. This facility will incorporate upgraded equipment and technologies, representing the second generation of the Botanical Synthesis manufacturing process. These enhancements are designed to optimize production yields and efficiencies, further solidifying BioHarvest Sciences' position as a leader in botanical synthesis technology. Sobel emphasized that the relocation of Research & Development and corporate administrative offices to the new BioHarvest Campus is imminent, expected to be completed within the next 6-9 months. This consolidation of operations underscores BioHarvest Sciences' commitment to streamlining its operations and fostering collaboration across its various business units. As BioHarvest Sciences embarks on this exciting new chapter of growth and expansion, Sobel expressed confidence in the company's ability to capitalize on the vast opportunities that lie ahead. With its state-of-the-art facilities and cutting-edge technologies, BioHarvest Sciences is poised to drive innovation and deliver value to its customers and stakeholders alike. Stay tuned for further updates as the company continues to forge ahead on its journey of growth and success. Contact Details Proactive North America +1 604-688-8158 NA-editorial@proactiveinvestors.com

April 18, 2024 09:43 AM Eastern Daylight Time

Video
Article thumbnail News Release

Citius Pharmaceuticals (NASDAQ: CTXR) Advances Oncology Asset, Paving Way For Spin Out Of Advanced T-cell Lymphoma Treatment

Benzinga

By Meg Flippin, Benzinga Chemotherapy and radiation are proven ways to treat cancer, but for the patients, they usually mean untold suffering. Finding effective alternatives, especially for people with rare cancers, can seem impossible. For rare cancers, there often isn’t a lot of information to help develop treatments, enough animal or cell models to test, or tumor samples to research. As a result, rare cancers account for 25 % of all cancer deaths in the U.S. Immunotherapy To Kill Cancer Cells One alternative treatment that seems to be getting attention is immunotherapy. It’s a treatment that uses the patient’s immune system to seek and kill cancer cells. Immunotherapy treatments are designed to boost a patient’s immune system so the body can work harder to destroy cancer cells. It is proving effective with companies including Citius Pharmaceuticals Inc. (NASDAQ: CTXR) advancing oncology treatments through an innovative immuno-oncology approach. Citius’ lead asset aims to leverage the body's own defense mechanisms to destroy malignant tumors. The therapy targets the interleukin-2 receptors found on malignant T-cells regulatory T-cells (Tregs), opening the potential for new therapeutic approaches to the treatment of cutaneous T-cell lymphoma (CTCL). This innovation could be transformative for individuals with rare cancers like CTCL, potentially enhancing their quality of life significantly. Additionally, Citius highlights compelling market opportunities that the company says are poised for growth. Broadly, the global cancer therapy market is forecast to grow at a CAGR of 9.12% from now until 2027, while the immuno-oncology market is projected to grow at a CAGR of 22.94%, hitting $396.07 billion by 2034. LYMPHIR Poised to Make Inroads The company’s lead immunotherapy, LYMPHIR, is under review by the U.S. Food and Drug Administration (FDA) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. In Japan, the formulation is approved and marketed for the treatment of CTCL and peripheral T-cell lymphoma (PTCL). Just last month, the U.S. FDA accepted the resubmission of a Biologics License Application (BLA) for LYMPHIR for the treatment of patients with relapsed or refractory CTCL after at least one prior systemic therapy. According to the company, the FDA has assigned a PDUFA goal date of August 13, 2024, the company 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,” said Leonard Mazur, Chairman and CEO of Citius. “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,” continued Mazur. Citius believes the market for LYMPHIR for CTCL will exceed $400 million and is particularly attractive because it is underserved by existing treatments. The Proof Is In The Results LYMPHIR is a recombinant engineered fusion protein that combines interleukin-2 and diphtheria toxin. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. Notably, malignant T-cells and immunosuppressive regulatory T-cells share a common marker, the IL-2 receptor. Consequently, LYMPHIR targets both malignant T-cells and transiently eliminates Tregs, supporting the potential to unleash potent immune responses by the patient’s immune system against their tumors. In recent preclinical studies, denileukin diftitox has demonstrated the ability to deplete murine Tregs in-vivo and human Tregs ex vivo. In addition, the combination of denileukin diftitox with anti-PD1 showed improved tumor response and very significant improvement in survival in the combination groups relative to either therapy alone in a syngeneic mouse solid tumor model. Based on this data, two investigator-initiated trials are underway to evaluate the potential safety and efficacy of LYMPHIR in combination with Pembrolizumab (anti-PD1) in patients with recurrent or metastatic solid tumors and LYMPHIR given prior to lymphodepletion (LD) chemotherapy and CAR-T therapies for the treatment of relapsed/refractory B-cell lymphomas. The results of these preclinical trials will determine if the company will develop these treatments further. The Path To Commercialization In addition to inroads on the regularity front, the company is making strides to commercialize LYMPHIR. A spinout to form Citius Oncology is in the works. The company announced plans to form a standalone public oncology company a few months ago. In a recent press release, Citius mentioned the transaction will improve the company’s access to the public equity markets and help facilitate the commercialization of LYMPHIR. "We believe this transaction will allow us to unlock the value of LYMPHIR, and solidly position Citius Pharma to advance our diversified pipeline,” said Mazur at the time. “This transaction will enable Citius Oncology, with access to the broader capital markets, to better support the successful commercialization of LYMPHIR, if approved, and explore additional potential targeted oncology therapies. Our majority ownership position and shared services agreement ensures that the Citius Pharma management team will remain fully engaged with the development and commercialization efforts at Citius Oncology.” Featured photo by the National Cancer Institute on Unsplash. Benzinga is a leading financial media and data provider, known for delivering accurate, timely, and actionable financial information to empower investors and traders. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Contact Details Benzinga +1 877-440-9464 info@benzinga.com Company Website http://www.benzinga.com

April 18, 2024 08:45 AM Eastern Daylight Time

Image
Article thumbnail News Release

Hydrogen Utopia CEO discusses advances in cannabis operation and future hydrogen projects

Hydrogen Utopia International PLC

Hydrogen Utopia International PLC (LSE:HUI, OTCQB:HUIPF) CEO Aleksandra Binkowska joined Proactive's Stephen Gunnion to discuss progress at the company’s cannabis operation in Macedonia, highlighting two successful harvests and ongoing developments. Binkowska noted the company has a 49% option in Ohrid Organics, highlighting its impressive facilities and high-tech enhancements, including an advanced drying system that significantly improves product quality. Binkowska emphasized the importance of the location’s natural benefits and technological enhancements for achieving high-quality outputs. Currently, Hydrogen Utopia is awaiting laboratory results to officially confirm the product quality, which is necessary for obtaining the requisite governmental paperwork for product sales. She mentioned preparations for EU GMP certification audits, which will facilitate entry into the European market at higher certification levels, potentially allowing for a higher product price point. Furthermore, Binkowska outlined the financial success of Ohrid Organics, projecting earnings that would fund Hydrogen Utopia’s first waste plastics hydrogen facility. The profits from Ohrid could potentially finance this without additional capital raising, underscoring the strategic advantage of the investment. She also highlighted the supportive role of the Macedonian government in facilitating the company's initiatives in both the cannabis and hydrogen sectors. Contact Details Proactive UK Ltd +44 20 7989 0813 uk@proactiveinvestors.com

April 18, 2024 08:40 AM Eastern Daylight Time

Video
Article thumbnail News Release

CURE ALZHEIMER’S FUND REACHES $200 MILLION IN RESEARCH GRANTS

Alzheimer’s Disease Research Foundation

April 18, 2024 — Cure Alzheimer’s Fund, a nonprofit dedicated to funding the most promising research to prevent, slow or reverse Alzheimer’s disease, announced today that it has reached an important milestone—awarding more than $200 million in research grants to leading scientists throughout the world investigating the disease. Since its establishment in 2004, Cure Alzheimer’s Fund (CureAlz) has supported more than 840 innovative grants led by more than 300 scientists resulting in 1,182 published peer-reviewed papers in prominent scientific journals. Many of these projects have yielded significant breakthroughs, resulting in findings contributing to new and critical avenues for development of novel treatments. “CureAlz was founded with one mission: to fund research that will accelerate prevention, treatment and a cure for this disease,” said Henry McCance, Chair of Cure Alzheimer’s Fund. “Since the beginning, our approach has attracted others to join us in this fight, all who have been vital to what we have achieved. It has been an honor to deploy more than $200 million dollars in funding that is enabling and accelerating extraordinary research pursued by brilliant and determined scientists around the world.” Funded projects have included: · The Alzheimer’s Genome Project, the first large-scale, family-based study of the human genome specific to Alzheimer’s disease. · Projects that explore how the body’s complex immune responses may contribute to Alzheimer’s disease. · A consortium of experts to expand our understanding of the role the APOE gene may have in Alzheimer’s disease. “For 19 years, our Founders and Board of Directors have been steadfast in their commitment to our mission to end the terrible burden of Alzheimer’s. The field’s top scientists contribute their expertise and guidance to CureAlz, meaning science and data are always our lodestars to a cure,” said Meg Smith, CEO of Cure Alzheimer’s Fund. “Our leadership’s vision, drive and generosity are matched by that of our dedicated donor and researcher communities. We celebrate this milestone as the shared achievement it is, and at the same time rededicate ourselves to accelerating an end to Alzheimer’s.” Cure Alzheimer’s Fund is a non-profit dedicated to funding the most promising research to prevent, slow, or reverse Alzheimer’s disease. Since its founding in 2004, Cure Alzheimer’s Fund has provided more than 840 grants to more than 300 of the world’s leading researchers and contributed more than $200 million to research. Its funded initiatives have been responsible for many key breakthroughs in understanding the causes and pathology of Alzheimer’s disease. Cure Alzheimer’s Fund has received a 4-star rating for more than 12 consecutive years from Charity Navigator. Our Board of Directors, Trustees, and a core group of other donors direct their donations to our overhead expenses so that 100% of general donations go to our research program. For more information, visit CureAlz.org. To learn about the impact of Alzheimer’s on women and women working towards a cure, WomenandAlzheimers.org. Contact Details Barbara Chambers +1 978-417-9890 BChambers@CureAlz.org Company Website https://curealz.org

April 18, 2024 08:00 AM Eastern Daylight Time

Article thumbnail News Release

MJ ATTACHÉ LAUNCHES BUSINESS WITH DEBUT OF FIRST-OF-ITS-KIND LUXURY CACHE-AND-CARRY BAG FOR CANNABIS CONNOISSEURS, IN TIME FOR APRIL 20, CANNABIS CELEBRATION DAY

MJ Attaché

MJ Attaché, a designer and developer of luxury Italian-made leather bags and accessories for the cannabis connoisseur, announced today the official launch of the business. The commencement of MJ Attaché is marked by the introduction of the first-of-its-kind, premium, 100% Italian leather bag, The Anthony, carefully curated for cannabis cache and carry. The Anthony’s debut comes just in time for April 20 th, a day when cannabis is celebrated. MJ Attaché’s bags are market-disrupting; they boast patent-pending modular elements -- not found in any other bag -- that encourage a personalized cannabis experience specific to each one’s individual consumption needs. Catering to both male and female cannabis users, The Anthony’s novel magnetic, re-attachable accessories are fully customizable. Elements inside the bag can be easily added or deleted, depending on what each user prefers for their cannabis self-care ritual. Cleverly crafted by hand in Florence, Italy of the finest Italian leather, The Anthony’s features distinguish it from any other cannabis carry-all bag currently available in the market. Available in five colors, The Anthony bag includes a secure lock closure, removable smooth leather rolling tray, modular elements for customization, such as a pipe case, lighter sleeve, jar sleeve a smell-proof glass jar and a removable, adjustable crossbody strap. The combination of the leather and smell-proof jar aids in disguising odors and keep contents discreet. The MJ Attaché brand challenges outdated, inaccurate stereotypes of cannabis consumers by offering mainstream users a way to elevate their cache-and-carry preferences and experiences. Cannabis has come a long way from its prior perceptions, and MJ Attaché recognizes its broader adoption by users spanning the spectrum. Like many entrepreneurs, ideas are often spurred by personal experience. MJ Attaché is no exception. Founder Christy Fuicelli created the brand and designed its premium bag when she was personally searching for a sophisticated, safe and discreet carry-all solution for her cannabis and accessories. She came up emptyhanded when shopping for options of the same high-quality, sophistication and style to which she was accustomed. Fuicelli believed this void in the marketplace stemmed from stigmas associated with overall cannabis use and she set out to change the market landscape with the design, development and introduction of The Anthony. “I went on a crusade to create a stylish, luxury, handcrafted bag many would be proud to carry. With its impeccable style, quality Italian leather components and customizable modular system, The Anthony bag transcends the outdated “stoner” stereotypes cannabis users are often perceived as and creates the ultimate luxury cannabis experience. I travelled on this journey witnessing nearly a dozen iterations of The Anthony until I was pleased because I could not find a functional, sophisticated, stylish and well-made cannabis transport option, which sparked my interest in developing one myself,” entrepreneur Fuicelli said. “Additionally, I was determined to challenge preconceived notions relating to cannabis use stereotypes. Many people use cannabis medicinally as well as to reduce stress and anxiety and promote relaxation. For me, my cannabis use not only helped alleviate certain medical conditions but also can be directly attributed to the deep creativity it ignited in me, sparking my idea for The Anthony and other bags and accessories in the MJ Attaché product line. I am hoping adoption of The Anthony and other MJ Attaché offerings will simplify the lives of cannabis users around the world. The Anthony truly marks an entry into a market where no other bag like it exists,” Fuicelli concluded. The Anthony, with a price point of $2,150.00, can be purchased here. Looking ahead, MJ Attaché is currently developing other cannabis bag styles and accessories, which are slated for introduction into the marketplace in the latter part of 2024. About MJ Attaché Denver-based MJ Attaché is a designer and developer of high-quality, handmade Italian leather bags and accessories for the cannabis connoisseur. The luxury brand, with its moniker MJ (short for Mary Jane an alias for marijuana), was founded by entrepreneur Christy Fuicelli, a stylish cannabis user. She realized a void in the marketplace to cache and carry her cannabis in a discreet manor reflective of the luxury she enjoyed in other personal products she owned and believed this stemmed from stigmas associated with cannabis use. Determined to bridge this gap, MJ Attaché was born. Fuicelli set out to create a premium bag that would appeal to both male and female cannabis users. She spent years designing and creating beautifully crafted bags that embody elevated style, sophistication, high quality and fine craftmanship. By bringing ease and style to the cannabis industry with her bags, MJ Attaché brings the first accessory of its kind, The Anthony bag, to the marketplace. For more information, visit www.mjattache.com and connect with the Company and its products on Facebook and Instagram. Contact Details PAIRELATIONS, LLC for MJ Attaché Susan J. Turkell +1 303-766-4343 sturkell@pairelations.com

April 17, 2024 10:00 AM Eastern Daylight Time

Image
1 ... 3132333435 ... 251