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Nuvectis Pharma Rises in Pre-Market Following FDA Orphan Drug Designation for NXP800, Fueling Optimism Ahead of Key Clinical Data

Global Markets News

Nuvectis Pharma (NASDAQ: NVCT) has achieved a significant milestone with the U.S. Food and Drug Administration (FDA) granting Orphan Drug Designation for its lead candidate, NXP800. This designation, specifically for the treatment of ARID1a-deficient ovarian, fallopian tube, and primary peritoneal cancers, marks a critical step forward in Nuvectis’s mission to address unmet needs in oncology. Orphan Drug Designation: A Strategic Advantage The FDA’s Orphan Drug Designation is awarded to drugs that show promise in treating rare diseases affecting fewer than 200,000 people in the U.S. For Nuvectis, this designation not only validates the potential of NXP800 but also provides several strategic benefits. These include tax credits for clinical trial costs, exemption from certain FDA fees, and potentially seven years of market exclusivity upon approval. NXP800 targets ARID1a-deficient cancers, a subset of ovarian cancers that present significant treatment challenges. The Orphan Drug Designation underscores the importance of this candidate in potentially offering a new, more effective treatment option for patients with this specific genetic mutation. Background and Market Impact This latest achievement builds on Nuvectis Pharma’s earlier successes. Earlier this year, the FDA granted Fast Track Designation to NXP800 for its development in platinum-resistant, ARID1a-mutated ovarian cancer. The Fast Track status, combined with the Orphan Drug Designation, highlights the urgent need for innovative treatments in this space and positions NXP800 as a potential game-changer in oncology. Financial analysts have taken note of Nuvectis’s progress. H.C. Wainwright recently reiterated its buy rating for Nuvectis, setting a price target of $21. This optimistic outlook reflects the market’s confidence in the company’s strategic direction, particularly as it prepares to release key clinical data later this year. Anticipation for Upcoming Results The next few months are expected to be pivotal for Nuvectis Pharma. The company is poised to share updates from its ongoing Phase 1b clinical trial of NXP800, which targets patients with platinum-resistant, ARID1a-mutated ovarian cancer. This trial is being closely watched, as positive results could significantly advance the development of NXP800, bringing it closer to pivotal trials and eventual regulatory approval. Additionally, Nuvectis is also conducting a Phase 1a dose escalation study for NXP900, its second key candidate, which targets YES1/SRC-driven tumors. Updates from this study are expected to provide further insights into the safety and potential efficacy of NXP900. ### Nuvvectis' Full announcment, titled " Nuvectis Pharma Announces Orphan Drug Designation Granted by the FDA for NXP800 for the Treatment of ARID1a-deficient Ovarian, Fallopian Tube, and Primary Peritoneal Cancers" was published on August 29th, 2024. ### This article is for informational purposes only and is not intended to serve as financial, investment or any form of professional advice, recommendation or endorsement. Please review the full documentation detailing financial compensation disclosures and disclaimers the article is subject to. https://justpaste.it/fcm9n/pdf. Global Markets News Network is a commercial digital brand compensated to provide coverage of innovative companies and industries and it is thus subject to conflicts of interest. Contact Details Global Markets News News Coverage ronald@futuremarketsresearch.com

August 29, 2024 08:20 AM Eastern Daylight Time

Brief Filed in Opposition to Warren Buffett’s Attempt to Get Lawsuit Dismissed

NLPC

On Monday the National Legal and Policy Center filed its brief in federal court in Omaha, Nebraska opposing Warren Buffett ‘s and Berkshire Hathaway ‘s motion to dismiss NLPC’s lawsuit filed in May to hold them accountable for having NLPC’s Chairman, Peter Flaherty, arrested at Berkshire’s 2023 Annual Meeting. Mr. Flaherty’s presentation, as part of the meeting agenda, supported NLPC’s shareholder proposal to have the positions of Chairman and CEO be held by separate individuals, as a matter of good corporate governance. As part of his presentation, Mr. Flaherty criticized Mr. Buffett’s billions of dollars of support to the Bill and Melinda Gates Foundation, which promotes the controversial Critical Race Theory teaching that “math is inherently racist,” and a Gender Identity Toolbox, “which asserts that gender is a result of socially and culturally constructed ideas.” Mr. Flaherty also pointed out Bill Gates ‘s relationship with convicted sex offender Jeffrey Epstein, which had been reported in a Wall Street Journal story two days before the meeting. As he spoke, Buffett cut Flaherty’s microphone and ordered his security guards to eject Mr. Flaherty from the arena, who had an Omaha Police officer arrest Flaherty on the spot. “The silencing and arrest of a shareholder who was speaking in favor of a shareholder proposal has never before occurred at an annual meeting of a public company in the United States,” Flaherty said. “We look forward to having our day in court to hold Mr. Buffett and Berkshire Hathaway accountable for their actions,” said NLPC Counsel Paul Kamenar. It is expected that the federal court will rule in the coming weeks on Berkshire’s motion to dismiss. Click here for NLPC’s Brief. Click here for Exhibit #1 (charge dismissal document). Click here for Exhibit #2 (meeting transcript) Click here for Exhibit #3 (Flaherty Declaration) Click here for NLPC’s original Complaint (May 3, 2024) Founded in 1991, the National Legal and Policy Center promotes ethics in public life through research, investigation, education and legal action. Contact Details National Legal and Policy Center Dan Rene +1 202-329-8357 drene@nlpc.org Company Website http://www.nlpc.org

August 21, 2024 02:00 PM Eastern Daylight Time

Federated Indians of Graton Rancheria Supports California Governor Newsom’s Call to Halt Tribal Gaming Projects That Are Contrary to U.S. Department of Interior Precedent

Federated Indians of Graton Rancheria

California Governor Gavin Newsom’s Office urged the Department of the Interior not to move forward with new casino projects proposed by the Koi Nation of Northern California and the Scotts Valley Band of Pomo Indians at locations outside of their aboriginal homelands. In a letter to Assistant Secretary Bryan Newland, the Governor’s Office notes that both projects are far outside the aboriginal territory of the Koi Nation and the Scotts Valley Band and the Department of the Interior has failed to consider reasonable alternative locations within their Lake County homelands. The Governor’s Office also expressed concern that the Department of the Interior could stretch the limits of what is allowed under the Indian Gaming Regulatory Act to move these proposed casino projects forward, sidestepping the state and ignoring the concerns of other tribes and local communities. “ The Federated Indians of Graton Rancheria appreciates Governor Newsom’s support in protecting tribal sovereignty against Interior’s unexplained rush to move these projects forward while ignoring the concerns of local tribes,” said Federated Indians of Graton Rancheria Chairman Greg Sarris. “We have repeatedly explained to Interior that these projects will have devastating impacts to the rights and cultural resources of our Tribe and others in whose ancestral territory these prospective projects are located. Interior Secretary Deb Haaland has ultimate responsibility for these decisions and needs to ensure that Interior is working to protect the interests of all tribes.” *** About the Federated Indians of Graton Rancheria Graton Rancheria is a federally recognized Indian tribe comprised of Coast Miwok and Southern Pomo Indians. Legislation restoring federal recognition to the Federated Indians of Graton Rancheria was signed into law in December 2000. Tribal lands are located in Rohnert Park, Sonoma County, CA. For more information, visit www.gratonrancheria.com. # # # Contact Details Landis Communications Inc. Brianne Miller +1 650-575-7727 graton@landispr.com Company Website https://gratonrancheria.com/

August 20, 2024 04:48 PM Pacific Daylight Time

NAVEX Announces 13th Annual NAVEX Next Risk & Compliance Virtual Conference

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, today announced its thirteenth annual NAVEX Next Risk and Compliance Virtual Conference, scheduled for Thursday, September 19, 2024. One of this year’s keynote sessions will feature Cy Wakeman, a New York Times best-selling author and Global Gurus’ 2023 World’s #1 Leadership Guru, recognized for her reality-based approach to leadership. Backed by over 25 years of unparalleled experience partnering with top brands spanning all industries, Wakeman will deliver a provocative keynote on how an over-emphasis on creating employee engagement can negatively impact company performance. NAVEX Next is one of the largest risk and compliance conferences in the world, attracting over 110,000 professionals since its inception in 2012. It brings together practical guidance and best practices for industry professionals across disciplines and departments including risk management, compliance, legal, human resources/training, audit, IT, privacy, supply chain and procurement. In all, NAVEX Next 2024 features 28 session speakers representing companies such as The Coca-Cola Company, CDL Nuclear Technologies, and CBRE. The prestigious lineup will share their expertise in building ethical cultures, risk mitigation, and smart governance. The agenda features 15 sessions diving into critical challenges and opportunities compliance professionals face today. Sessions include: The EU Regulatory Survival Guide: Your Essential Guide to EU Compliance Behind the Label: Ensuring Human Rights in Your Global Supply Chain AI Governance & Risk Management Compliance Diagnostics in US Healthcare CCO 3.0: How Compliance and Risk Work in Harmony NAVEX Next will end with a keynote session by Alison Taylor, Clinical Associate Professor at NYU Stern School of Business and Executive Director of Ethical Systems, on building ethical cultures. She has spent the past two decades consulting with multinational companies on anti-corruption, human rights, and stakeholder engagement, including as a Senior Advisor at sustainability non-profit BSR, a member of the board at Venture ESG, and a Sustainability Advisor at Zai Lab, KKR, and Pictet Group. The NAVEX Next virtual conference is free of charge and open to anyone interested in expanding their knowledge and enhancing their organization’s risk and compliance programs. It offers a low-pressure environment for attendees to engage with today’s biggest GRC challenges. Click here to register and to access the full agenda and profiles of all scheduled speakers. NAVEX is the recognized leader in risk and compliance management software and services, empowering thousands of customers around the world to manage and mitigate risks with confidence. NAVEX’s mission is to help customers promote ethical, inclusive workplace cultures, protect their brands, and preserve the environment through sustainable business practices. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details NAVEX +1 617-388-5773 MediaRelations@navex.com Company Website https://navex.com

August 13, 2024 09:00 AM Eastern Daylight Time

K3 Holdings and Alpine LA Properties Congratulate Team USA for Winning Paris Olympics Medal Count

K3 Holdings

K3 Holdings, a privately held real estate investment firm with extensive holdings throughout the United States and Alpine LA Properties, a leasing company providing newly remodeled apartments at affordable rates in Los Angeles, congratulated Team USA for their outstanding performance in the Paris Olympics. Following more than two weeks of competition and lifetimes of preparation, athletes representing the United States won 126 medals (40 gold) leading all other countries at the conclusion of the games in Paris. "Congratulations to Team USA for showcasing the true spirit of excellence and determination, bringing home the most medals and making us all proud,” stated Michael Kadisha, a Principal of K3 Holdings. "Winning the most medals is a triumph of skill and perseverance, and more so, a testament to the unity and resilience that define the American spirit. Dedication, hard work, and a never-give-up attitude leads to greatness, and we are all inspired by the performance of our athletes in Paris.” "In sports, as in life, the way we handle victory says as much about us as the victory itself. Gratitude and humility elevate every achievement. Winning with grace and losing with dignity are the hallmarks of true champions,” Michael Kadisha continued. “The K3 Holdings and Alpine teams were impressed at how Team USA proved themselves to be real winners by celebrating their victories while honoring their opponents with respect and gratitude.” The Olympics serve as a unique platform where nations from every corner of the globe come together in a spirit of friendly competition. Beyond the medals and records, the Olympics foster an environment where cultural exchange and mutual understanding thrive. In a world often divided by differences, the Olympics create a space where adversaries can engage in dialogue, learn from one another, and find common ground through shared values of sportsmanship and respect. "The Olympics is a powerful testament to how people from diverse cultures and backgrounds can come together to achieve greatness," stated Nathan Kadisha, a K3 Principal. "The actions of Olympic athletes in Paris show us that dedication, perseverance, and mutual respect transcend borders and ideologies. These are the values that can truly unite us and drive real change beyond the games." “We are excited that Los Angeles will be hosting the Olympics four years from now,” Michael Kadisha said. “By watching athletes from rival nations compete with honor and integrity, in our own community, we will once again be reminded that even in competition, there is room for cooperation, empathy, and the possibility of resolving conflicts peacefully.” ### For more information or to schedule an interview with a K3 spokesperson, please contact Dan Rene at 202-329-8357 or dan@danrene.com Contact Details K3 Holdings/Alpine LA Properties Dan Rene +1 202-329-8357 dan@danrene.com Company Website https://k3holdings.com/

August 12, 2024 11:30 AM Eastern Daylight Time

Open Letter Demands ‘Newsroom Reset’, Pushes for Adoption of Pro-Democracy Election Coverage Guidelines

Media and Democracy Project

Today, the Media and Democracy Project (MAD), along with 3,258 individuals, sent an open letter to executives, publishers, and union leaders of major media organizations urging them to adopt pro-democracy election coverage guidelines ( PDF ) that center fact-based reporting, push back against election lies, and uplift voting. MAD’s proposed guidelines respectfully request newsrooms switch their focus from polls and drama to candidates’ policies, past-governance, and behavior. “It’s time that newsrooms start to cover elections like they matter more than sports scores,” said Brian Hansbury, cofounder of MAD. “Our democratic institutions are under attack and it’s incumbent on newsrooms to recalibrate their political coverage to adopt and adhere to practices that are pro-truth, pro-voting, and pro-democracy.” MAD’s guidelines contain 18 recommendations organized into three categories—a focus on substantive issues coverage, extensive reporting on threats to democracy, and protecting Americans against the spread of disinformation. The guidelines provide specific actions reporters and editors can take to ensure practices that help voters make informed decisions at the ballot box. They include: Prioritize substantive coverage of the issues that matter to voters' lives; Make headlines accurate and informative, not clickbait; Stop making predictions and pushing polls at the expense of issue coverage; Celebrate and uplift election workers, voters, and the election process; Don’t set aside moral judgment when covering obvious lies and bigotry; Hold politicians to account for their positions, statements, and behavior, as well as those of their party’s leader; Expose candidates who foment political violence. The open letter emphasizes how crucial it is for voters to understand what’s at stake in November and the damaging impact that election lies have already had on our democracy. For instance, lies about the 2020 election have caused a spike in death threats for election officials and poll workers, making it difficult to recruit and retain them. Half of all female state legislators are considering leaving public office due to increased intimidation. Meanwhile, Trump allies are preparing plans like Project 2025, which would harm millions of Americans and cripple our democratic system. With 3,258 signatures and counting, the letter includes signatories such as Ruth Ben-Ghiat, NYU Professor of History and author of Strongmen: Mussolini to the Present and the Lucid newsletter, who stated, "It's never been more important for news organizations to analyze the threats to U.S. democracy in clear and precise terms. Americans deserve to know the scale and nature of the challenges we face this November and beyond." The rights and freedoms that Americans cherish are at risk. As an essential pillar of democracy, journalists and the news media have a moral responsibility to inform Americans about anti-democratic extremist movements. Another signatory, Mark Jacob, former Chicago Tribune editor and author of the Stop the Presses newsletter, said, “The news media know it's their job to warn people when a hurricane is bearing down on them. But when a fascist assault on our democracy is bearing down on them, the media sometimes think it would be biased to warn people about it. That has to change before it's too late.” It’s more important than ever for journalists, editors, and their publishers to step up and put the public before profit, democracy before tyranny, and truth before lies. "Democracy is at stake–and as the open letter so powerfully demands, we need our news media to step up and be responsible,” said Norm Ornstein, political scientist and Senior Fellow Emeritus at the American Enterprise Institute. To learn more about this effort advocating for pro-democracy election coverage, and see who else signed the open letter visit MAD’s website. The Media and Democracy Project: MAD is a non-partisan, all-volunteer, grassroots organization focused on strengthening a free and independent media in the public interest. MAD aims to improve our national discourse so that American voters can engage in informed decision-making. As part of that goal, MAD has an interest in the responsibility of journalists and media to report fully, accurately, and fairly on the electoral process and the outcome of elections. Additional information is available at www.MediaAndDemocracyProject.Org. Contact Details Aaron Alberico +1 202-744-0786 aalberico@raynoravenue.com Company Website https://www.mediaanddemocracyproject.org/

August 12, 2024 09:00 AM Eastern Daylight Time

NAVEX to Demystify IT Risk Communication at ISACA GRC Conference

NAVEX Global

NAVEX, the global leader in integrated risk and compliance management software, will deliver a key session at the upcoming ISACA Governance, Risk, and Control (GRC) Conference in Austin, Texas, August 12-14, 2024. The session, " Getting Our Wires Crossed: How to Speak IT Risk as a Compliance Professional," will be presented by Kyle Martin, Vice President of GRC Solutions at NAVEX, and Robert Clark, Chief Audit and Compliance Officer at Howard University. In an era where cybersecurity threats and regulatory pressures are at an all-time high, the ability to effectively communicate IT risks across organizational silos has become a critical skill for compliance professionals. Attendees can join the session, CS 7–4, on August 13th at 11:00 to gain valuable insights into: Understanding and translating risk and compliance terminology. Evaluating program maturity levels and their organizational implications. Assessing risks and controls across all business facets, including third-party risk management. Crafting compelling IT risk reports for executive teams and board directors. "In today's interconnected business environment, the ability to translate IT risk insights into compelling narratives for CEOs is no longer optional—it's essential," said Kyle Martin. "As a result, this session aims to empower compliance professionals with the tools they need to navigate this critical intersection confidently." The ISACA GRC Conference, now in its 11th year, brings together leading minds in governance, risk management, and control to provide world-class content and practical guidance. NAVEX's participation underscores its commitment to advancing the field of integrated risk and compliance management. For more information about NAVEX's participation in the ISACA GRC Conference 2024 or to schedule an interview with the speakers, please contact Senior Public Relations Manager, Scott Levesque at scott.levesque@navex.com. NAVEX is trusted by thousands of customers worldwide to help them achieve the business outcomes that matter most. As the global leader in integrated risk and compliance management software and services, we deliver solutions through the NAVEX One platform, the industry’s most comprehensive governance, risk and compliance (GRC) information system. For more information, visit NAVEX.com and our blog. Follow us on Twitter and LinkedIn. Contact Details Navex Global scott.levesque@navex.com Company Website https://navex.com

August 06, 2024 08:00 AM Eastern Daylight Time

Former U.S. Comptroller General Walker Elected Federal Fiscal Sustainability Foundation Chairman

Federal Fiscal Sustainability Foundation

The Federal Fiscal Sustainability Foundation (FFSF), a non-partisan, non-profit organization dedicated to restoring fiscal sanity and sustainability in Washington, D.C., today announced the election of former U.S. Comptroller General David M. Walker as its Chairman. Walker and the entire Board are committed to securing a sustainable financial future for America and all Americans by advocating for a Fiscal Responsibility Amendment to the U.S. Constitution that is ratified by State Conventions of pledged delegates like the 21st Amendment. The FFSF Board is comprised of esteemed leaders, including a former Vice Chairman of the Joint Chiefs of Staff, a former state Attorney General, distinguished economic scholars, political leaders, and other thought leaders. The foundation’s founder, David Biddulph, tirelessly works to preserve the American Dream for his granddaughters and future generations, free from the burden of a crippling national debt. “FFSF is empowering citizens to shape our nation's financial future. We're advocating for a Fiscal Responsibility Amendment to the U.S. Constitution,” explained David Biddulph. “Traditional attempts to control government growth and debt have failed, making our mission more critical than ever. We are thrilled to have Dave Walker serve as our Chairman in these essential efforts.” Dave Walker is a seasoned public servant with a distinguished career spanning multiple presidential administrations from Reagan to the current Administration. He has received three Presidential appointments from Presidents Reagan, Bush (41), and Clinton with unanimous confirmation by the U.S. Senate each time. Walker has served as CEO of three federal agencies, two non-profits, and as a Partner and Global Managing Director for Arthur Andersen. His extensive board and advisory committee experience includes Social Security and Medicare, the United Nations, the Defense Business Board, and No Labels. Article V of the Constitution provides a pathway for change through a Convention of States, initiated by two-thirds of the states and ratified by three-quarters of the states. Despite the support of more than 34 states beginning in 1979, Congress has failed to act. Consequently, FFSF is pursuing legal action against Congress to compel action and is seeking a legislative fix introduced in Congress last year (H.C.R. 24) to mandate that Congress fulfill its Article V obligations. “The ticking federal debt bomb threatens our collective future. Failure to act will have serious adverse consequences for our economic security, national security, international standing, and domestic tranquility over time," Walker said. A Constitutional amendment is the only way to force current and future Congresses to restore fiscal sanity and sustainability." "The federal government just passed $35 trillion in debt, up from $5.7 trillion in 2000 and less than $1 trillion in 1979. Washington has lost control of the nation’s finances. It’s time for a Fiscal Responsibility Constitutional Amendment," Walker continued. ### For more information or to schedule an interview with Dave Walker or another FFSF spokesperson, please contact Dan Rene at 202-329-8357 or dan@danrene.com Contact Details Federal Fiscal Sustainability Foundation Dan Rene +1 202-329-8357 dan@danrene.com

July 30, 2024 09:40 AM Eastern Daylight Time

Leaders in Real Estate Weigh in on National Rent Cap Proposals

K3 Holdings

K3 Holdings, a privately held real estate investment firm with extensive holdings throughout the United States issued a statement today regarding the recent proposal by the President of the United States to implement a national cap of 5% on annual rent increases. While leaders of K3 Holdings and Alpine LA Properties commend the White House's effort to address the escalating costs of housing, leaders believe that the proposed one-size-fits-all approach falls short in addressing the complexities of housing affordability across diverse regions. "Rent control policies, like the proposed national cap, are intended to stabilize housing expenses for tenants. However, the effectiveness of such policies, especially at a national level, remains a contentious issue," said Michael Kadisha, Principal of K3 Holdings. "While rent stabilization can provide much-needed stability to tenants, the recent White House proposal overlooks the crucial ties to economic metrics and the diverse circumstances of renters and property managers." Housing markets vary significantly across the United States, and what works in one region may not be suitable for another. Existing local rent control measures reflect regional nuances but would fall short if implemented on a national scale. "In addition to relieving pressure on renters, it is essential to recognize that landlords also face increasing costs in maintaining properties," added Nathan Kadisha, Principal of K3 Holdings. "While rent controls might stabilize or reduce rent increases, they do little to address the rising operational costs landlords face, such as maintenance, utilities, insurance, and other expenses." Market dynamics heavily influence rent prices, with supply and demand playing critical roles. Policies that discourage new construction or renovations due to stringent rent caps could exacerbate housing shortages, driving rents even higher in the long run. “Effective policy making demands a balanced approach —one that prioritizes stability, fairness, and inclusivity,” Nathan Kadisha continued. “By fostering collaboration between policymakers, tenants, landlords, and other stakeholders, we can work towards building stronger communities where safe, stable, and affordable housing is accessible to all.” “As property managers, K3 Holdings stands ready to engage in constructive dialogue and collaboration towards these shared goals. Together, we can envision a future where housing insecurity is a thing of the past, and every individual and family can thrive in a home they can afford,” Michael Kadisha said. “By striving for comprehensive, locally adaptable solutions, we can pave the way towards a more equitable housing landscape for all Americans.” ### For more information or to schedule an interview with a K3 spokesperson, please contact Dan Rene at 202-329-8357 or dan@danrene.com Contact Details Dan Rene +1 202-329-8357 dan@danrene.com

July 25, 2024 02:15 PM Eastern Daylight Time

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