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NRXs (NASDAQ: NRXP) NMDA Modification Therapy And Its Multiple Applications From Mental Health To Chronic Pain

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–News Direct–

By Meg Flippin, Benzinga

The nation may be in a mental health crisis, with many people from the young to the old suffering from depression, anxiety, PTSD and suicidal ideation. The latter is particularly true for patients with bipolar depression. The disease, which afflicts 2.8% of the U.S. population, is marked by high highs and low lows. Thoughts of suicide accompany the depressive lows for nearly half of sufferers. Devastatingly, between 4% to 19% will commit suicide.

There are medicines available to help manage the highs and lows of bipolar disorder, but not a single-dose treatment. Typically, it requires one to manage mania and another for depression. They may not work for everyone and come with their own set of side effects.

Modifying The NMDA Receptor

NRx Pharmaceuticals Inc. (NASDAQ: NRXP), a clinical-stage biopharmaceutical company, believes it has the answer with NRX-101. Its the biopharmaceutical companys FDA-designated investigational Breakthrough Therapy for suicidal treatment-resistant bipolar depression and chronic pain. The company is targeting life-threatening diseases that often go untreated with NRX-101, which is a patented, oral fixed-dose combination of two FDA-approved drugs: D-cycloserine, an NMDA receptor modulator at certain dosage ranges; and Lurasidone, a 5-HT2a receptor antagonist.

Combined, the drugs target the NMDA receptor which is critical for memory function and the formation of new thoughts in the brain. At excessive rates of NMDA activity, ideas including the creation of new ones are slowed down. People with bipolar disorder tend to ruminate on fewer and more negative thoughts in that state. When the NMDA channel is blocked, thoughts can flow rapidly and incoherently, leading to hallucinations and psychosis. The challenge is to strike a healthy balance between the two. By modulating the NMDA, NRx believes it can improve the function of the thought-forming cells in the brain and thus reduce suicidal ideation. If approved by the U.S. Food and Drug Administration (FDA) and other health regulatory agencies, the company says it would be the first medicine regimen targeted to treat severe bipolar depression in patients with both acute and sub-acute suicidal ideation or behavior (ASIB and SSIB).

Trial Over-Enrolled

The company is taking steps to make that a reality, recently completing enrollment of a phase 2b/3 study of NRX-101 for 74 patients suffering from bipolar disorder. Enrollment exceeded the original target of 70 patients, to enhance the statistical power of the study, NRx said. Top-line data is expected later this month.

"To our knowledge, NRX-101 is the first and only oral medication to have demonstrated reduced suicidal ideation in patients with bipolar depression, said Dr. Jonathan Javitt, Founder, Chairman and Chief Scientist of NRx Pharmaceuticals. On the basis of our previous trial, it was awarded Breakthrough Therapy Designation by the FDA and we aim to confirm its effect on depression and suicidal ideation in this trial.

NRX teamed up with Alvogen Pharmaceuticals for the development and marketing of the combined therapy. During its fourth quarter, NRx said Alvogen advanced its first $5.1 million milestone payment. A successful readout from the phase 2b trial and FDA interaction will trigger an additional $4 million milestone payment together with the transfer of future development costs to Alvogen. The partnership provides for potential milestones of $329 million and a royalty reaching 15% on net sales, according to NRx.

Beyond Bipolar Disorder

Its not just bipolar disorder that NRx is aiming to treat with its NMDA therapy platform. The company is making inroads in using its lead compound in chronic pain, betting results of a 200-person efficacy trial conducted by Northwestern University could create a multibillion-dollar opportunity for NRx. Chronic pain is another condition that plagues more than 50 million Americans in which the available treatments have mixed results.

Then theres its new drug application for IV ketamine in acute suicidality. NRx said it is building a specialty pharmaceutical business around ketamine it expects to yield positive cash flow by the end of 2024. Called HOPE Therapeutics, NRx plans to submit a new drug application with the FDA this year. In advance of FDA approval, HOPE partnered with national 503b and 503a pharmacies to address the ketamine shortage reported by the FDA since 2018. The goal is to spin HOPE out into a stand-alone company owned by NRx, current NRx shareholders via a tax-free dividend and new investors. NRx said prospective anchor investors offered $60 million in new investment dollars once HOPE is publicly listed. NRx said HOPE is presenting data from four randomized, prospective trials demonstrating safety and efficacy in 800 patients as the clinical basis for its new drug application (NDA) for HTX-100 (IV Ketamine).

And if thats not enough, NRx recently received Qualified Infectious Disease Product (QIDP) and Fast Track designation from the FDA for NRX-101 in the treatment of complicated urinary tract infections (cUTI) and pyelonephritis. It's a condition the company says affects 3 million people in the U.S. resulting in over 15,000 deaths annually. NRx is currently seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.

"2023 was a pivotal year for NRx in which we advanced from a single clinical trial in a single indication to a dramatically streamlining operation with a 50% reduction in overhead costs, a 25% reduction in overall costs and a $0.20 per share improvement in negative earnings, while completing our clinical trial objectives, says Stephen Willard, J.D., Chief Executive Officer and Director of NRx Pharmaceuticals. We expect data from two key trials this month and predict our first commercial revenue by the end of 2024.

Featured photo by Fernando @cferdophotography 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.

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View source version on newsdirect.com: https://newsdirect.com/news/nrxs-nasdaq-nrxp-nmda-modification-therapy-and-its-multiple-applications-from-mental-health-to-chronic-pain-179610199

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Monique Nikkole Releases Empowering New Single “Queen Of The Hustle”

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Monique Nikkole, the rising R&B artist known for her powerful vocals and empowering lyrics, has just dropped her latest single “Queen Of The Hustle”. The song, which is now available on all major streaming platforms, is a celebration of hard work, determination, and resilience.

“Queen Of The Hustle” is a timely release, as it comes at a time when many people are facing challenges and uncertainties due to the ongoing pandemic. The song serves as a reminder that no matter the circumstances, we all have the strength and resilience to overcome any obstacle and achieve our goals.

Monique Nikkole’s soulful voice and heartfelt lyrics make “Queen Of The Hustle” a must-listen for anyone in need of a motivational boost. The song’s catchy beat and uplifting message will have listeners feeling empowered and ready to take on the world.

In addition to her powerful vocals, Monique Nikkole is also known for her philanthropic efforts. She has used her platform to raise awareness and funds for various causes, including mental health and women’s empowerment. With “Queen Of The Hustle”, she continues to inspire and uplift her audience, spreading a message of strength and resilience.

“Queen Of The Hustle” is just the beginning for Monique Nikkole, as she has more music and projects in the works. Fans can stay updated on her latest releases and performances by following her on social media and streaming her music on all major platforms. With her talent, passion, and dedication, Monique Nikkole is undoubtedly on her way to becoming a household name in the music industry.

For media inquiries or to schedule an interview with Monique Nikkole, please contact www.moniquenikkole.com. Don’t forget to check out “Queen Of The Hustle” and let Monique Nikkole’s powerful voice and inspiring lyrics be the soundtrack to your hustle.

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MEYA MINING’S 391-CARAT DIAMOND RECOVERY MARKS MEGA CLIPPIR DISCOVERY

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Trustco Group Holdings Ltd (“Trustco”) has announced the findings of a recent examination of the 391.47-carat diamond recovered by Meya Mining (“Meya”) in Sierra Leone. Trustco holds a 19.5% interest in Meya, which operates under a 25-year exclusive diamond mining license in the Kono District.

The 391.47-carat diamond was part of a 515-carat rough diamond recovered in the Meya River kimberlite domain on Tuesday, 20 August 2024, in the first of 16 domains targeted by Meya. Along with two smaller fragments weighing 105.43 carats and 18.11 carats, this marks the second significant find from the region, confirming its potential as a source of high-value diamonds.

A detailed examination, conducted by Dr. Evan M. Smith of the Gemological Institute of America (GIA), confirmed the diamond as Type IIa, a classification that indicates high purity due to the absence of nitrogen. Further analysis showed the diamond is part of the CLIPPIR variety (Cullinan-like, large, inclusion poor, pure, irregular, resorbed), similar to some of the world’s most valuable diamonds.

According to the examination report, the diamond contains metallic inclusions, mainly iron-rich metals, which suggest it formed deep in the Earth, between 360 and 750 kilometers below the surface. Despite these inclusions, large parts of the stone remain clear, making it an important geological find. The discovery of this CLIPPIR diamond at the Meya mine confirms that the area contains large Type IIa diamonds.

Quinton Z van Rooyen, Deputy CEO of Trustco

Quinton Z van Rooyen, Deputy CEO of Trustco, added: “The recovery of this CLIPPIR diamond sheds light on Meya’s extraordinary geological landscape. As the diamond world contemplates the eventuality of a 5000-carat stone, our recent find indicates that Meya’s unique geology positions us well for potentially historic discoveries in the future.”

On June 5, 2024, shareholders were informed that Z Star Mineral Consultants, an independent consulting firm, estimated the in situ resource of Meya River Domain at USD 763 million. This Meya River domain accounts for less than 3% of the overall Meya Mining project potential resources. (Available here: https://tinyurl.com/2twpv78v).

Additionally, on September 2, 2024, shareholders were advised that the NI 43-101 Technical Report for the Meya Diamond Mine Project was published, offering a Preliminary Economic Assessment (PEA). The PEA showed promising economic potential with a post-tax Internal Rate of Return (IRR) of 65% and a post-tax Net Present Value (NPV) of USD 95.1 million at a 10% discount rate over a projected 7-year mine life. (Available here: https://tinyurl.com/yvy8p6xs).

These reports also noted that the estimated value of diamonds recovered from bulk samples and run of mine production of the Meya River domain which were sold at public auctions is USD 380 per carat.  This estimation excluded the sale of the 476ct Meya Prosperity diamond (USD 34 664 per carat) or several subsequent large stones found due to their distinct nature. The valuation matrix currently used to assess Trustco’s 19.5% stake in Meya Mining, at USD 110 million, may be adjusted in the future to account for these historical exceptional finds. Shareholders are advised that this could affect future valuations.

The 391.47-carat diamond was part of a 515-carat rough diamond recovered in the Meya River kimberlite domain on Tuesday, 20 August 2024

Meya Mining is now focused on improving its recovery process to prevent breakages of large diamonds in the future. The company is working with its engineering and processing partners to upgrade the plant and increase its capacity to recover large diamonds intact. This discovery strengthens Trustco’s Mining portfolio but also highlights Sierra Leone’s position as a key player in the global diamond market.

About Trustco:

Trustco Group Holdings Ltd is an investment entity headquartered in Windhoek, Namibia, which manages a diverse portfolio of investments spanning the insurance, real estate, non-deposit taking financial services, micro-finance, education, and mining sectors. Decisions are biased towards generational investment performance alongside shareholder wealth creation, and short-term hurdles are viewed as catalysts for future growth.

Since inception in 1992, Trustco’s investment portfolio has delivered strong returns with a CAGR of 68.97%, with a well-balanced asset mix, with a current average weighting of 34% in US Dollar based assets, while the remaining 66% is invested in Namibia Dollar (1 NAD = 1 ZAR) based assets. Trustco enjoys the backing of a wide range of coinvestors, including 3 610 from Namibia, 1 443 from abroad, and 94 from institutional entities.

About Namibia:

Namibia is a Southern African country with a population of approximately three million and a GDP per capita of USD 5 031 in 2022. The country is endowed with rich natural resources, with  recent major discoveries of oil and gas reserves, lithium deposits and rare earth minerals that are vital for technology demand globally, with developments also underway in its green hydrogen projects. The Namibian government has heralded these discoveries as a transformative period, holding the potential to double the nation’s GDP by 2040.

The country’s economy expanded by 4.2% in 2023 and is projected to expand by 3.7% in 2024, following a recovery of 5.3% in 2022 from the COVID-19 pandemic. With its wealth of natural resources, pro-business environment, political stability and increasingly skilled workforce, Namibia offers attractive investment prospects across all sectors.

Forward-Looking Statements:

All statements made in this media release with respect to Trustco’s current plans, estimates, strategies beliefs and other statements that are not historical facts, including statements regarding Trustco’s plans to upgrade its ADR program and the results of such an upgrade, are forward-looking statements. In some cases, you can identify forward-looking statements because they contain words such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would,” or the negative of these words or other similar terms or expressions. Such statements reflect the current views of management and are subject to a number of risks and uncertainties. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on these forward-looking statements. The statements are based on many assumptions and factors, including general economic and market conditions, industry conditions, and operating factors. Any changes in such assumptions or factors could cause actual results to differ materially from current expectations.

Media Contact

Organization: Trustco Group Holdings

Contact Person: Neville Basson

Website: https://www.tgh.na

Email: Send Email

Contact Number: +264612754501

Address: 2 Keller Street, Trustco House

Address 2: Windhoek

City: Windhoek

State: Khomas

Country: Namibia

Release Id: 21102418730

The post MEYA MINING’S 391-CARAT DIAMOND RECOVERY MARKS MEGA CLIPPIR DISCOVERY appeared on King Newswire. It is provided by a third-party content provider. King Newswire makes no warranties or representations in connection with it.

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ZainTECH partners with the UL Solutions on Smart Building Assessment, becomes the first regional ICT entity to achieve SPIRE™ Qualified Company certification

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  • SPIRE is the first comprehensive smart building assessment program that empowers building owners and managers to identify, prioritize, and promote smart building performance
  • ZainTECH’’s SPIRE™ Qualified Company designation further strengthens its credibility in the smart building sector, offering strategic assessment services to clients

Junaid Mohioddin – Tech consultant at UL Solutions, Jason Pelski – Smart Building Ecosystems Commercial and Partnership Leader at UL Solutions, Andrew Hanna – CEO of ZainTECH, Jomy Joseph – Regional Director and GM – MEA at UL Solutions, Maatje Rencken – VP of Digital Solutions at ZainTECH

Dubai, United Arab Emirates, 21st October 2024, ZainTECH, the integrated digital solutions arm of Zain Group, has entered a strategic partnership with UL Solutions to become the first ICT company in the region to be designated as a SPIRE™ Qualified Company by UL Solutions. This achievement positions ZainTECH as a trusted provider and the go-to source of quality, verified smart building digital solutions, utilizing its own SPIRE™ Qualified Assessors, thereby solidifying its leadership in the smart building sector.

SPIRE, developed by the Telecommunications Industry Association (TIA) and UL Solutions, is the world’s first smart building assessment program that offers a holistic evaluation of a building’s technology and operational performance.

UL Solutions, a global leader in applied safety science, brings unparalleled expertise, allowing ZainTECH to distinguish itself as a company committed to excellence in smart building innovation. The SPIRE program evaluates building performance across six key pillars: power and energy, health and well-being, life and property safety, connectivity, cybersecurity, and sustainability. Through the SPIRE Smart Building Verified Assessment, buildings can earn a Smart Building Verified Mark, validating their advanced capabilities.

ZainTECH’s designation as a SPIRE™ Qualified Company by UL Solutions enhances its ability to serve the diverse needs of clients, further establishing its position as a prominent solutions provider in the regional smart building ecosystem.

Andrew Hanna, CEO of ZainTECH, commented on the partnership: “The smart environments—whether cities, buildings, or workspaces—are central to our portfolio of operations, and we understand the value of delivering solutions that are independently validated. Partnering with globally recognized entities like UL Solutions reinforces our commitment to providing clients with reliable, high-quality services. The SPIRE™ accreditation provides our growing customer base in the regions to achieve a third-party performance verification of their smart buildings.”

Scott Weiskopf, director of the Ecosystem and New Solutions group at UL Solutions, explained, “Smart buildings must deliver on experiences that enhance user outcomes. By assessing and validating key operational criteria of smart buildings, the UL Verified SPIRE Smart Buildings™ rating program helps verify building performance that could impact asset value. We applaud ZainTECH for becoming a SPIRE™ Qualified Company and partnering with UL Solutions to empower building owners and operators to optimize smart building innovation and operations.”

As a designated SPIRE™ Qualified Assessor, qualified ZainTECH staff are now equipped to offer building assessments, assuring clients of reliable and certified assessment services. In addition to now being a SPIRE™ Qualified Company, ZainTECH has capabilities to address industry challenges, such as aging infrastructure, maintenance backlogs, labor shortages, and operational inefficiencies, helping to create dynamic, future-ready workplaces.

ZainTECH’s digital solutions portfolio spans the entire IT stack, providing the foundation for smart, connected commercial and urban environments. Through strategic partnerships and advisory, ZainTECH has strengthened its digital solutions offerings, providing optimized infrastructure and facilities management to their customers, further demonstrating its leadership in the smart infrastructure space.

About ZainTECH

ZainTECH is a regional integrated digital solutions provider, unifying Zain Group’s ICT assets to offer a unique value proposition of comprehensive digital solutions and services under one roof. The company is positioned to drive the transformation of enterprise and government customers in the MENA region by providing a center of excellence and managed solutions across the ICT stack, including cloud, cybersecurity, modern infrastructure, big data, IoT, AI, smart cities, drones and robotics, and emerging technologies.

ZainTECH leverages Zain’s global reach, unique regional footprint, and infrastructure across its operations in Kuwait, Saudi Arabia, Bahrain, Jordan, Iraq, and the United Arab Emirates, as well as in other key markets in the Middle East.

ZainTECH forms a key pillar in the evolution of Zain’s core telecom business to maximize value and build on the company’s many strengths to selectively create and invest in growth verticals beyond standard mobile services. This ultimately supports Zain’s vision of becoming a leading ICT and digital lifestyle provider.

For more information, please visit www.zaintech.com

For any information regarding this PR please reach out to info@zexprwire.com

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