Primega Group Acquires China Wangmao Liquor Industry Group to Enter the Premium Baijiu Market and Drive Diversified Growth

HONG KONG, Aug. 18, 2025 (GLOBE NEWSWIRE) — Primega Group (NASDAQ: ZDAI) has officially announced the signing of a memorandum of understanding with China Wangmao Liquor Industry Group Co. Limited, planning to acquire the company through an equity purchase. This marks a significant step in Primega Group’s journey toward diversified business development while showcasing its strategic planning and innovation capabilities in new business sectors.

Entering the Premium Baijiu Market: A New Chapter in Diversification

Primega Group, a leading holding company registered in the Cayman Islands, primarily operates through its Hong Kong subsidiary, Primega Construction, focusing on eco-friendly transportation services and the recycling of construction waste. Building on its stable business foundation, the company is now officially entering the premium Baijiu (Chinese distilled liquor) market through this acquisition, further expanding its business portfolio.

China Wangmao Liquor Industry Group, a renowned producer and seller of sauce-flavor Baijiu, boasts excellent brand influence, a mature membership-based business model, and significant innovation in digital operations. This acquisition aims to integrate China Wangmao Liquor’s strengths in branding, product offerings, digital operations, and omnichannel resources with Primega Group’s capital strength and technical expertise, creating synergies to drive rapid growth in the Baijiu industry.

Empowering Traditional Industries: Intelligent Technology Leading the Future

Primega Group is committed to transforming traditional industries through intelligent technologies to create sustainable value. After the acquisition, the company plans to retain China Wangmao Liquor Industry Group’s independent brand operations while leveraging Primega Group’s resources to comprehensively upgrade the brand. The two companies will jointly launch new premium product lines, with a particular focus on expanding into Southeast Asian and North American markets, promoting the global presence of Chinese sauce-flavor Baijiu.

In addition, Primega Group will leverage its expertise in digital technology and capital operations to enhance China Wangmao Liquor Industry Group’s internal operations, optimize its supply chain, and modernize its production facilities. By integrating resources from both sides, the partnership aims to reduce production and logistics costs, improve profit margins, and create long-term stable returns for shareholders.

Strategic Significance and Future Outlook

Primega Group believes this acquisition will significantly enhance its competitiveness in the premium consumer goods sector while injecting new growth momentum into its capital market performance. Looking ahead, the company will continue to focus on innovations in hotel marketing software, digital supply chain platforms, artificial intelligence (AI) and Internet of Things (IoT) integrations, cloud computing, and intelligent engineering equipment. These efforts aim to empower traditional industries with intelligent technologies to drive sustainable development and value creation.

The transaction is expected to proceed following due diligence, the signing of formal agreements, and the completion of equity transfers. Primega Group and China Wangmao Liquor Industry Group will work together to build a leading domestic premium sauce-flavor Baijiu brand and further penetrate international markets.

This strategic acquisition not only represents an important step in Primega Group’s diversification efforts but also highlights its solid progress in exploring new fields. Moving forward, Primega Group will continue to drive development through innovation, striving to become a leading integrated enterprise in the industry.

About Primega Group

Primega Group is a holding company registered in the Cayman Islands. Its Hong Kong subsidiary, Primega Construction Co. Limited, specializes in eco-friendly transportation services and the recycling of construction waste. The company focuses on technological innovation, transforming industries such as hospitality and retail, empowering traditional sectors, and promoting sustainable value creation.

About China Wangmao Liquor Industry Group Co. Limited

China Wangmao Liquor Industry Group is a company specializing in the production and sales of sauce-flavor Baijiu. With strong brand power, a digital operational model, and a membership-based strategy, the group occupies a key position in the premium Baijiu market.

The company has demonstrated strong innovation capabilities in the digital consumption ecosystem by building a “digital liquor trading platform.” This platform offers NFT-linked digital and physical liquor collectibles, an AR customization experience system (allowing users to participate in liquor formula and packaging design via mobile devices), and other services aimed at redefining the liquor industry.

In the field of biotechnology, the company has partnered with the Liquor Association to:

Establish a molecular marker database for sauce-flavor compounds (covering 1,287 aromatic substances).

Develop customized liquor yeast (with the first “low-intoxication” sauce-flavor Baijiu currently undergoing market testing).

Through this collaboration, the two companies aim to create the world’s first “Baijiu digital ecosystem matrix,” combining traditional brewing craftsmanship with cutting-edge biotechnology and artificial intelligence. This initiative is expected to redefine the value standards of the premium sauce-flavor Baijiu industry.

Three Key Value Drivers of the Partnership

Technical Barriers: Establishing a full-chain moat from brewing patents to intelligent equipment.

Model Innovation: Pioneering a “physical consumption + digital assets” dual-driven model.

Valuation Reconstruction: Benchmarking against Pop Mart’s operational and technology-driven approach, with significant potential for PE multiple growth.



For more information, please contact:
Celestia Investor Relations
Email: [email protected]

Wrap Technologies Secures $4.5M in Private Placement to Accelerate Emerging Counter-Drone Technologies and Dual-Use Go-to-Market Strategy

Key Financing Highlights:

  • Accelerates Counter-UAS Fielding: Proceeds are expected to advance Wrap’s recently announced Wrap-Merlin and Wrap-PANDA programs, which repurpose existing BolaWrap® 150 inventory into new counter-drone capabilities, enabling rapid progression from development to field application.
  • Dual-Use Pathway: Supports both Wrap’s continued law enforcement go-to-market strategy and near-term commercial wins in federal sales, where counter-UAS demand is accelerating. Wrap believes this “dual use” model positions Wrap to leverage its existing technology base while building a scalable federal government business through primes and strategic Department of Defense (DoD) and Department of Homeland Security (DHS) offices.
  • Expands Market Execution: In parallel, the financing is expected to strengthen Wrap’s law enforcement growth initiatives, including subscription-based solutions (WrapReady and WrapPlus) and its ecosystem of public safety technologies (BolaWrap 150, WrapVision, and WrapReality).
  • WrapVision Expansion: Funds are also expected to advance WrapVision’s offering of North American–made body cameras through third-party partnerships, while building out cost-saving technologies in data processing, migration, and storage—addressing major cost pain points for law enforcement agencies and opening access to adjacent markets such as healthcare where current solutions remain economically prohibitive.

MIAMI, Aug. 18, 2025 (GLOBE NEWSWIRE) — Wrap Technologies, Inc. (NASDAQ: WRAP) (“Wrap” or, the “Company”), a recognized innovator in public safety technology, today announced   that it has executed a securities purchase agreement with certain accredited and institutional investors in a private placement for the purchase and sale of (i) an aggregate of 4,500 shares of the Company’s Series B Preferred Stock, with a stated value of $1,000 per share, convertible into an aggregate of 3,000,000 shares of common stock of the Company at an initial conversion price of $1.50 per share, and (ii) accompanying warrants to purchase up to 3,000,000 shares of common stock, for aggregate gross proceeds of $4.5 million. The conversion of the preferred stock and the exercise of the accompanying warrants are subject to stockholder approval.

The warrants will have an initial exercise price of $1.50 per share, subject to adjustment, and will expire five years from the date of stockholder approval.

The closing of the private placement is subject to customary closing conditions and is expected to occur on or around August 19, 2025. The Company intends to use the net proceeds of the offering for working capital and general corporate purposes.

The securities in the private placement offering were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Pursuant to a registration rights agreement between the Company and the investors, the Company has agreed to file a resale registration statement covering the securities described above.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Wrap Technologies, Inc.

Wrap Technologies, Inc. (Nasdaq: WRAP) is a global leader in innovative public safety technologies and non-lethal tools, delivering cutting-edge technology with exceptional people to address the complex, modern day challenges facing public safety organizations.

Wrap’s BolaWrap® 150 solution leads the world in pre-escalation and beyond, providing law enforcement with a safer choice for nearly every phase of a critical incident.

This innovative, patented device deploys a multi-sensory, cognitive disruption that leverages sight, sound and sensation to expand the pre-escalation period and give officers the advantage and critical time to manage non-compliant subjects before resorting to higher-force options. The BolaWrap 150 is a non-pain-based compliance tool. It does not shoot, strike, shock, or incapacitate—instead, it helps officers strategically operate pre-escalation on the force continuum, reducing the risk of injury to both officers and subjects. Used by over 1,000 agencies across the U.S. and in 60 countries, BolaWrap® is backed by training certified by the International Association of Directors of Law Enforcement Standards and Training (IADLEST), reinforcing Wrap’s commitment to public safety through cutting-edge technology and expert training.

Wrap Reality™ VR is a fully immersive training simulator to enhance decision-making under pressure.

As a comprehensive public safety training platform, it provides first responders with realistic, interactive scenarios that reflect the evolving challenges of modern law enforcement. By offering a growing library of real-world situations, Wrap Reality™ equips officers with the skills and confidence to navigate high stakes encounters effectively, leading to safer outcomes for both responders and the communities they serve.

WrapVision is an all-new body-worn camera and evidence management system built for efficiency.

Designed for efficiency, security, and transparency to meet the rigorous demands of modern law enforcement, WrapVision captures, stores, and helps manage digital evidence with operational security, regulatory compliance and superior video picture quality and field of view.

The WrapVision camera, powered by IONODES boasts cloud integration and adheres to Trade Agreements Act (TAA) compliance requirements and GSA schedule contracts requirements. Crucially, unlike many competitor devices manufactured overseas in foreign, non-compliant, and possibly hostile regions, WrapVision is built right here in North America today, with a critical made-in-America roadmap by the end of 2025. This track helps ensure unparalleled data integrity and helps eliminate critical concerns over unauthorized access or foreign surveillance risks.

Trademark Information

Wrap, the Wrap logo, BolaWrap®, Wrap Reality™ and Wrap Training Academy are trademarks of Wrap Technologies, Inc., some of which are registered in the U.S. and abroad. All other trade names used herein are either trademarks or registered trademarks of the respective holders.

Cautionary Note on Forward-Looking Statements – Safe Harbor Statement

This release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “anticipate,” “should”, “believe”, “target”, “project”, “goals”, “estimate”, “potential”, “predict”, “may”, “will”, “could”, “intend”, and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding the private placement, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom. Moreover, forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to: market and other conditions; the Company’s ability to maintain compliance with the Nasdaq Capital Market’s listing standards; the Company’s ability to successfully implement training programs for the use of its products; the Company’s ability to manufacture and produce products for its customers; the Company’s ability to develop sales for its products; the market acceptance of existing and future products; the availability of funding to continue to finance operations; the complexity, expense and time associated with sales to law enforcement and government entities; the lengthy evaluation and sales cycle for the Company’s product solutions; product defects; litigation risks from alleged product-related injuries; risks of government regulations; the business impact of health crises or outbreaks of disease, such as epidemics or pandemics; the impact resulting from geopolitical conflicts and any resulting sanctions; the ability to obtain export licenses for counties outside of the United States; the ability to obtain patents and defend intellectual property against competitors; the impact of competitive products and solutions; and the Company’s ability to maintain and enhance its brand, as well as other risk factors mentioned in the Company’s most recent annual report on Form 10-K, subsequent quarterly reports on Form 10-Q, and other Securities and Exchange Commission filings. These forward-looking statements are made as of the date of this release and were based on current expectations, estimates, forecasts, and projections as well as the beliefs and assumptions of management. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Investor Relations Contact:

(800) 583-2652
[email protected]



SaverOne Broadens its Relationship with Cemex: An Additional European Cemex Division Deploys SaverOne’s Driver Distraction Prevention System


Marks Continued Growth in SaverOne’s Global Footprint and Further Expansion Within Cemex’s Operations

Petah Tikvah, Israel, Aug. 18, 2025 (GLOBE NEWSWIRE) — SaverOne 2014 Ltd. (Nasdaq: SVRE, TASE: SVRE), a technology company specializing in developing transportation safety solutions, today announced it has signed a new agreement with another division of Cemex in Europe. Under the new agreement, SaverOne will deploy its Driver Distraction Prevention System (DDPS) across Cemex’s fleet in this country.

This new engagement builds on the successful rollout of SaverOne’s Safety solution to prevent driver distraction in global markets, and in particular adding another one of Cemex’s global operations to its expanding customer roster.

Mr. Ori Gilboa, CEO of SaverOne, stated, “We are pleased to further expand our collaboration with Cemex into an additional country, marking another step in our strategic global expansion. It is also a strong vote of confidence in our proven DDPS solution by this key customer with significant experience with our solution in other regions. SaverOne remains committed to supporting Cemex’s safety culture and look forward to further deployments across the Cemex global fleet.”

About Cemex:

Cemex is an industry leading global construction materials and solutions company that is building a better future safely through more sustainable products and solutions. Cemex is committed to achieving carbon neutrality through relentless innovation and industry-leading research and development. Cemex is at the forefront of the circular economy in the construction value chain and is pioneering ways to increase the use of waste and residues as alternative raw materials and fuels in its operations with the use of new technologies.

Cemex offers cement, ready-mix concrete, aggregates, and urbanisation solutions in growing markets around the world, powered by a multinational workforce focused on providing a superior customer experience, enabled by digital technologies.

For more information please visit: www.cemex.com

About the SaverOne System

SaverOne’s system is installed in vehicles to solve the problem of driver distraction as a result of drivers using distracting applications on their mobile phones while driving in a way that endangers their safety and the safety of their passengers. This phenomenon is considered one of the leading causes of global road accidents. According to the US National Highway Traffic Safety Administration, the annual cost of road accidents just in the United States stands at about $870 billion each year, excluding the costs of serious injury or death, with a quarter of those accidents estimated to be related to the use of the mobile phones while driving. SaverOne’s technology specifically recognizes the driver area in the vehicle. It prevents the driver from accessing distracting applications such as messaging while allowing others (navigation as an example) without user intervention or consent, creating a safer driving environment.

SaverOne’s primary target markets include commercial and private vehicle fleets interested in reducing potential damages and significant costs, vehicle manufacturers interested in integrating safety solutions into their vehicles, and insurance and leasing companies. SaverOne initially addresses car fleets with a focus on the Israeli, European, and US markets and other markets worldwide. SaverOne believes that an increased focus on monitoring and prevention of cellular distraction systems in vehicles, driven by upcoming expected EU regulation, will likely have a dramatic positive impact on the demand for its systems in the future.

The Company’s strategy is to provide its technology to customers in the aftermarket and address OEM vehicle manufacturers to integrate the Company’s protection technologies during the vehicle manufacturing process.  

About SaverOne

SaverOne is a technology company that designs, develops, and commercializes OEM and aftermarket solutions and technologies to lower the risk of and prevent vehicle accidents. SaverOne’s initial product line is a suite of solutions that saves lives by preventing car accidents resulting from distraction from using mobile phones while driving. SaverOne is also developing a sensor system for early location and direction detection under all visibility conditions of vulnerable road users (VRU) through their cellphone footprint.
Learn more at https://saver.one/

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act and other securities laws that are subject to substantial risks and uncertainties. All statements, besides those of historical fact, contained in this press release are forward-looking. Forward-looking statements contained in this press release include but are not limited to, statements regarding SaverOne’s strategic and business plans, technology, relationships, objectives, and expectations for its business, the impact of trends on and interest in its business, intellectual property or product and its future results, operations, and financial performance and condition and may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions. However, not all
forward-looking statements contain these words. Forward-looking statements are based on SaverOne’s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions about future events that may not prove accurate. Many factors could cause SaverOne’s actual activities or results to differ materially from those anticipated in such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the ability of our technology to substantially improve the safety of drivers; our ability to protect our patented technology from infringement by third parties; SaverOne’s planned level of revenues and capital expenditures and its ability to continue as a going concern; SaverOne’s ability to maintain its listing on the Nasdaq Capital Market; the ability of SaverOne’s technology to substantially improve the safety of drivers; its ability to market and sell its products; its plans to continue to invest in research and development to develop technology for both existing and new products; SaverOne’s intention to advance its technologies and commercialization efforts in Europe and globally; acceptance of its business model by investors; the ability to correctly identify and enter new markets; the impact of competition and new technologies; general market, political and economic conditions in the countries in which SaverOne operates; projected capital expenditures and liquidity; SaverOne’s intention to retain key employees, and its belief that it will maintain good relations with all employees; a resurgence of the COVID-19 pandemic and its impact on business and industry; as well as other risks and uncertainties, including, but not limited to, the risks detailed in the Company’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (the “SEC”) on March 21, 2025  and in subsequent filings with the SEC. Forward-looking statements in this announcement are made as of this date, and SaverOne undertakes no duty to update such information except as required under applicable law.

International Investor Relations Contact:

Ehud Helft
+1 212 378 8040
[email protected]



AEHL Signs Strategic Agreement with BitGo to Advance Bitcoin Acquisition and Security

New York, NY, Aug. 18, 2025 (GLOBE NEWSWIRE) — Antelope Enterprise Holdings Limited (NASDAQ: AEHL, or the “Company”), today announced that its Bitcoin strategy has officially entered the second phase with the Company signing a formal cooperation agreement with BitGo, a global leader in digital asset custody. Under the agreement, AEHL will complete account opening and Bitcoin purchases on the BitGo platform, with the acquired Bitcoin stored on-chain and safeguarded through a multi-signature private key management mechanism to ensure asset security and compliance.

CEO Ms. Tingting Zhang, stated: “Partnering with BitGo and implementing on-chain storage for Bitcoin represents a key strategic decision by the Company toenhance asset security, transparency, and compliance. BitGo is one of the world’s largest and the leading U.S.-based digital asset custodians, holding Qualified Custodian status in the United States. It is alsolicensed and regulated in South Dakota and New York State, and registered with FinCEN as a Money Services Business. Its Singapore subsidiary holds a Major Payment Institution license from MAS, and its infrastructure has completed the SOC 2 Type 2 security audit. The scale of digital assests under BitGo’s management has grown from approximately $60 billion at the beginning of the year to over $100 billion in the first half of 2025, serving more than 1,500 institutional clients worldwide, and positioning the company as a global leader in digital asset infrastructure.”

AEHL will leverage its expertise in digital asset trading, cross-border settlement, and compliance to efficiently execute the Bitcoin purchases. All acquisitions will be fully verifiable on-chain, and any use of funds will require strict authorization procedures, thereby minimizing risks and ensuring the security of funds and assets.

The current market environment provides strong support for AEHL’s strategy. Bitcoin’s price has steadily surpassed $120,000, with a total market capitalization exceeding $2.4 trillion, making its position as the fifth-largest asset globally. U.S. regulations are becoming increasingly clear , crypto asset ETF inflows continue to strengthen, and institutional demand is growing rapidly. The Company believes these trends will further enhance the global recognition of digital assets and create favorable conditions for long-term capital appreciation.

“We are not merely entering the Bitcoin market; we are building a future-oriented digital capital structure rooted in institutional discipline, transparency, and security,” Ms. Zhang continued. “We firmly believe that Bitcoin’s scarcity and the global consensus it represents will form an essential part of future capital markets, and AEHL is committed to being a determined builder and long-term holder in this transformation.”

As a Nasdaq-listed Company, AEHL will continue to fulfill its information disclosure obligations by regularly updating the market on its purchase schedules, holdings, average acquisition prices, and on-chain storage arrangements, while also actively pursue strategic expansion opportunities in the Web3 and crypto-finance sectors.

About Antelope Enterprise Holdings Limited

Antelope Enterprise Holdings Limited engages in energy infrastructure solutions through natural gas power generation via its wholly owned subsidiary AEHL US LLC (“AEHL US”) and holds a 51% ownership position in Hainan Kylin Cloud Services Technology Co. Ltd (“Kylin Cloud”), which operates a livestreaming e-commerce business in China. Kylin Cloud provides access to over 800,000 hosts and influencers. For more information, please visit our website at https://aehltd.com.

Safe Harbor Statement

Certain of the statements made in this press release are “forward-looking statements” within the meaning and protections of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions, and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause the actual results, performance, capital, ownership or achievements of the Company to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Forward-looking statements in this press release include, without limitation, the continued stable macroeconomic environment in the PRC, the consumer and technology sectors continuing to exhibit sound long-term fundamentals, and our ability to continue to grow our business management, information system consulting, and online social commerce and live streaming business. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “will,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “estimate,” “continue,” “plan,” “point to,” “project,” “could,” “intend,” “target” and other similar words and expressions of the future.

All written or oral forward-looking statements attributable to us are expressly qualified in their entirety by this cautionary notice, including, without limitation, those risks and uncertainties described in our annual report on Form 20-F for the year ended December 31, 2024 and otherwise in our SEC reports and filings. Such reports are available upon request from the Company, or from the Securities and Exchange Commission, including through the SEC’s Internet website at http://www.sec.gov. We have no obligation and do not undertake to update, revise or correct any of the forward-looking statements after the date hereof, or after the respective dates on which any such statements otherwise are made.

Contact Information:
Antelope Enterprise Holdings Limited
Xiaoying Song,
Chief Financial Officer
[email protected]

WFS Investor Relations Inc.
Janice Wang
Email: [email protected]
+1 628 283 9214



SHAREHOLDER ALERT: Purcell & Lefkowitz LLP Announces Shareholder Investigation of Blue Ridge Bankshares, Inc. (NYSE American: BRBS)

PR Newswire


NEW YORK
, Aug. 18, 2025 /PRNewswire/ — Purcell & Lefkowitz  LLP announces that it is investigating Blue Ridge Bankshares, Inc. (NYSE American: BRBS) on behalf of the company’s shareholders.  The investigation seeks to determine whether Blue Ridge Bankshares’s directors breached their fiduciary duties in connection with recent corporate actions.

If you are a shareholder of Blue Ridge Bankshares, Inc. and are interested in obtaining additional information about your rights and options, please visit us at: https://pjlfirm.com/blue-ridge-bankshares-inc/ 

You may also contact Robert H. Lefkowitz, Esq. either via email at [email protected] or by telephone at 212-725-1000.  One of our attorneys will personally speak with you about the case at no cost or obligation.

Purcell & Lefkowitz LLP is a law firm exclusively committed to representing shareholders nationwide who are victims of securities fraud, breaches of fiduciary duty and other types of corporate misconduct. For more information about the firm and its attorneys, please visit https://pjlfirm.com.   Attorney advertising. Prior results do not guarantee a similar outcome. 

 

Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/shareholder-alert-purcell–lefkowitz-llp-announces-shareholder-investigation-of-blue-ridge-bankshares-inc-nyse-american-brbs-302531776.html

SOURCE Purcell & Lefkowitz LLP

Autonomix Medical, Inc. to Participate in Virtual Investor Webinar Hosted by Ladenburg Thalmann & Co. Inc.

Live video webcast on Thursday, August 21

st

at 1:00 PM ET


Register here

THE WOODLANDS, TX, Aug. 18, 2025 (GLOBE NEWSWIRE) —
Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company focused on advancing precision nerve-targeted treatments, today announced that Brad Hauser, President and Chief Executive Officer will participate in a virtual investor webinar hosted by Ladenburg Thalmann on Thursday, August 21, 2025 and 1:00 PM ET.

The webinar will be moderated by Jeffrey S. Cohen, Managing Director and Director of Equity Research of Ladenburg Thalmann. Following the discussion, there will be a question and answer session. Interested participants may pre-submit questions to [email protected] ahead of the event.

To register for the webinar, please click here. The webinar will also be accessible on the Events page in the Investors section of the Company’s website (www.autonomix.com)

About Autonomix Medical, Inc.

Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body.

We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States.

For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook.

Investor and Media Contact

JTC Team, LLC
Jenene Thomas
(908) 824-0775
[email protected]



PharmaCyte Biotech, Inc. Announces $7 Million Capital Raise Led by Existing Investors

PharmaCyte Biotech, Inc. Announces $7 Million Capital Raise Led by Existing Investors

LAS VEGAS–(BUSINESS WIRE)–
PharmaCyte Biotech, Inc. (Nasdaq:PMCB) (“PharmaCyte” or the “Company”) announced today that it has entered into a securities purchase agreement for a $7.0 million financing with existing investors involving the sale of 7,000 shares of its newly designated Series C convertible preferred stock (“preferred stock”), with a stated value of $1,000 per share, convertible into an aggregate of 7,000,000 shares of its common stock and unregistered common stock purchase warrants to purchase up to an aggregate of 7,000,000 shares of its common stock in a private placement. The private placement is expected to close on or about August 19, 2025, subject to the satisfaction of customary closing conditions.

GP Nurmenkari Inc. is acting as the sole placement agent for the private placement.

“This financing, priced at a premium to our current market price and led by our existing investors, reflects strong confidence in PharmaCyte’s future,” said Josh Silverman, Interim Chief Executive Officer of PharmaCyte. “It meaningfully strengthens our balance sheet, positions us to enhance shareholder value, and enables us to continue pursuing strategic alternatives that we believe can maximize long-term returns for our stockholders.”

The shares of preferred stock have a conversion price of $1.00 per share of common stock and accrue a 7.0% quarterly dividend payable in cash. The warrants have an exercise price of $1.00 per common share, are exercisable immediately and are exercisable for a term of five years from the date of issuance. The securities in the private placement were offered and sold in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the “Securities Act”), pursuant to the exemption for transactions by an issuer not involving any public offering under Section 4(a)(2) of the Securities Act and Rule 506 of Regulation D of the Securities Act and in reliance on similar exemptions under applicable state laws. Accordingly, the shares of common stock issuable upon conversion or exercise of the preferred stock and warrants offered and sold in the private placement may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon conversion of the preferred stock and exercise of the warrants issued in connection with the private placement.

This press release is not an offer to sell, or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Safe Harbor

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that express the current beliefs and expectations of PharmaCyte’s management and Board of Directors. Any statements contained in this press release which do not describe historical facts are forward-looking statements subject to risks and uncertainties that could cause actual results, performance, and achievements to differ materially from those discussed in such forward-looking statements. These statements include, without limitation, PharmaCyte’s ability to satisfy closing conditions with respect to the private placement, the completion of the private placement, and the anticipated use of proceeds with respect to the private placement. Factors that could affect our actual results are included in the periodic reports on Form 10-K and Form 10-Q that we file with the U.S. Securities and Exchange Commission. These forward-looking statements are made only as of the date hereof, and we undertake no obligation to update or revise the forward-looking statements, except as otherwise required by law, whether as a result of new information, future events or otherwise.

Investor Contact:

CORE IR

[email protected]

Media Contact:

Jules Abraham

CORE IR

Telephone: 917.885.7378

Email: [email protected]

 

KEYWORDS: United States North America Nevada

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health

MEDIA:

Fubo’s Molotov Secures First Major Sports Rights Distribution Deal With Ligue 1 Carriage in France

Fubo’s Molotov Secures First Major Sports Rights Distribution Deal With Ligue 1 Carriage in France

PARIS–(BUSINESS WIRE)–
FuboTV Inc. (d/b/a/ Fubo) (NYSE: FUBO), the leading sports-first live TV streaming platform, announced today that Molotov, its subsidiary in France, has entered into a non-exclusive carriage agreement with Ligue 1 for the 2025/2026 season. Molotov, France’s leading live TV streaming platform, has partnered with Ligue 1+, the new official broadcast service for Ligue 1 McDonald’s, France’s professional soccer league.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250818568979/en/

The partnership significantly expands the premium sports content available to Molotov subscribers in France.

Customers who subscribe to Ligue 1+ on Molotov will be able to enjoy eight of the nine live matches each gameday, with a delayed broadcast of the additional match. As part of the agreement, subscribers will also have access to exclusive shows, in-depth game analysis, documentaries, match replays and club-specific programming.

This collaboration is part of Molotov’s strategy to combine the best in sports with its already robust French entertainment lineup. Molotov is currently the only streaming platform to offer an extensive library of French television channels and Ligue 1 McDonald’s within the same ecosystem.

In addition to Ligue 1+, Molotov streams major world-class sports competitions including FIFA World Cup 2026 and Coupe de France through its carriage of channels such as TF1, M6, France TV and more.

About Molotov

Molotov is France’s leading live TV platform that is revolutionizing access to television and content, available on all screens and connected devices (TechCrunch). Molotov offers an integrated experience combining, in a single interface, linear and non-linear programs from nearly 200 publishers and television channels. Founded by JeanDavid Blanc (tech veteran also founder of AlloCiné) and Pierre Lescure (co-founder of Canal+), Molotov is part of Fubo, the world’s leading sports-first live TV streaming platform, since December 2021. Molotov was named to the French Tech 120 government index, was among the 10 Top LinkedIn Start-ups 2020, and awarded four times “Best application of the year” by users of the App Store (Apple), Google Play (Android) and by AppAnnie.

About Fubo

With a global mission to aggregate the best in TV, including premium sports, news and entertainment content, through a single app, FuboTV Inc. (d/b/a Fubo) (NYSE: FUBO) aims to transcend the industry’s current TV model. Ranked among The Americas’ Fastest-Growing Companies 2025 by the Financial Times, the company operates Fubo in the U.S., Canada and Spain and Molotov in France.

In the U.S., Fubo is a sports-first cable TV replacement product aggregating more than 400 live sports, news and entertainment networks and is the only live TV streaming platform with every English-language Nielsen-rated sports channel (source: Nielsen Total Viewers, 2024). Leveraging Fubo’s proprietary data and technology platform optimized for live TV and sports viewership, subscribers can engage with the content they are watching through an intuitive and personalized streaming experience. Fubo has continuously pushed the boundaries of live TV streaming, and was the first virtual MVPD to launch 4K streaming, MultiView and personalized game alerts.

Learn more at https://fubo.tv

Fubo Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of FuboTV Inc. (“Fubo”) that involve substantial risks and uncertainties. All statements contained in this press release that do not relate to matters of historical fact are forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including statements regarding our business strategy and plans, partnerships, sports programming and live events, and distribution. The words “could,” “will,” “plan,” “intend,” “anticipate,” “approximate,” “expect,” “potential,” “believe” or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that Fubo makes due to a number of important factors, including but not limited to the following: our ability to achieve or maintain profitability; risks related to our access to capital and fundraising prospects to fund our financial operations and support our planned business growth; our revenue and gross profit are subject to seasonality; our operating results may fluctuate; our ability to effectively manage our growth; risks related to the transactions contemplated by our business combination agreement with The Walt Disney Company and Hulu, LLC; the long-term nature of our content commitments; our ability to renew our long-term content contracts on sufficiently favorable terms; our ability to attract and retain subscribers; obligations imposed on us through our agreements with certain distribution partners; our ability to license streaming content or other rights on acceptable terms; the restrictions imposed by content providers on our distribution and marketing of our products and services; our reliance on third party platforms to operate certain aspects of our business; risks related to the difficulty in measuring key metrics related to our business; risks related to preparing and forecasting our financial results; risks related to the highly competitive nature of our industry; risks related to our technology, as well as cybersecurity and data privacy-related risks; risks related to ongoing or future legal proceedings; and other risks, including the effects of industry, market, economic, political or regulatory conditions, future exchange and interest rates, and changes in tax and other laws, regulations, rates and policies. Further risks that could cause actual results to differ materially from those matters expressed in or implied by such forward-looking statements are discussed in our Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 filed with the Securities and Exchange Commission (“SEC”) and our other periodic filings with the SEC. We encourage you to read such risks in detail. The forward-looking statements in this press release represent Fubo’s views as of the date of this press release. Fubo anticipates that subsequent events and developments will cause its views to change. However, while it may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing Fubo’s views as of any date subsequent to the date of this press release.

Investor Contacts

Ameet Padte, Fubo

[email protected]

JCIR for Fubo

[email protected]

Media Contacts

Jennifer L. Press, Fubo

[email protected]

Bianca Illion, Fubo

[email protected]

KEYWORDS: France Europe

INDUSTRY KEYWORDS: Mobile/Wireless Technology Sports General Sports Entertainment Telecommunications Audio/Video General Entertainment TV and Radio Internet

MEDIA:

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24/7 concierge: Zoom’s agentic AI and virtual agent now extends to Zoom Phone, helping businesses capture more calls and opportunities

  • Zoom Virtual Agent expands to Zoom Phone, enabling a new concierge use case that delivers personalized support with agentic concierge capabilities to automate routine calls and streamline frontline service across departments
  • Zoom AI Companion enhances agentic scheduling to coordinate meetings end-to-end, finding the best time, contacting attendees, tracking responses, and recommending next steps without the back-and-forth
  • Zoom Hub launches, providing a centralized workspace to create, find, and manage Zoom files
  • Zoom Team Chat adds AI Companion to mobile for easier catch-up, and quick document summaries without needing to open the file in the Zoom Workplace desktop app, saving time and boosting productivity

SAN JOSE, Calif., Aug. 18, 2025 (GLOBE NEWSWIRE) — Zoom Communications, Inc. (NASDAQ: ZM) today announced a new concierge use case for Zoom Virtual Agent, now integrated with Zoom Phone, giving businesses a smarter way to answer calls and better support callers from the start. Zoom also announced the launch of Zoom Hub, a centralized content center to help users organize, manage, and create Zoom assets, and enhanced AI features across Zoom Meetings and Team Chat to help teams work faster and stay aligned in real time.

A 24/7 AI receptionist that does more than route calls

Zoom Virtual Agent, now integrated with Zoom Phone, provides an elevated concierge experience that goes beyond basic call answering services or auto-attendants. As your newest front desk team member, the concierge greets callers, speaks naturally, processes input, and initiates the most appropriate next step. From booking appointments to providing updates and routing to the right person without phone trees or long hold times, it helps organizations reduce missed calls and deliver a more professional first impression.

“When someone calls your business, it should feel easy and personal from the first hello. By combining AI that can listen, understand, and take action with the reach of Zoom Phone, our concierge virtual agent provides seamless and personalized support to all callers,” said Smita Hashim, chief product officer at Zoom. “Whether a customer is calling to schedule an appointment, check an order status, or check product availability, Zoom’s concierge is available 24×7 and can deliver answers instantly, escalating to live employees only when needed. The result is a faster, more personalized, and more scalable experience for everyone.”

Admins can save time and avoid tech headaches by easily deploying the concierge within minutes using a no-code configuration. By uploading documents or pointing to a website, teams can quickly train the concierge to greet callers and respond to real-world questions. Built to work with diverse audiences, it supports natural, multilingual conversations in English, Spanish, French, German, Portuguese, and Japanese, with more on the way, and is available 24/7 so callers get a fast, consistent experience any time of the day.

Zoom Virtual Agent (ZVA) concierge supports a wide range of use cases, including:

  • Healthcare: In fast-paced care settings, ZVA concierge can help patients get connected with the care they need quickly. It can route calls to the right department, answer common questions like “Are you accepting new patients?”, and let patients book appointments by phone, even after hours, freeing staff to focus on care delivery.
  • Retail: When customers call with specific needs like finding the right product for a project or checking if an item is in stock, ZVA concierge can answer their questions, confirm if an item is in stock (even down to the aisle), schedule pickup, and more, all without requiring human assistance.
  • Manufacturing: For companies juggling service requests and product support, ZVA concierge can capture customer requests, guide them through troubleshooting over the phone, and direct them to the right team, day or night, without manual intake.
  • Financial services: Personalized service is critical in financial conversations. ZVA concierge can greet clients, gather information about why they’re calling, and resolve the request on the spot, like providing application updates, or connect them to the right advisor with all the details already captured, reducing wait times while providing a high-touch experience.

The Zoom Virtual Agent phone concierge capability is available today. To learn more or request a demo, visit zoom.com.

Agentic meeting scheduling without the back and forth

The AI Companion meeting scheduling skill uses agentic AI to eliminate the friction of finding a time that works for everyone, whether scheduling with colleagues or external partners. Instead of juggling calendars, tracking multiple time zones, and managing out-of-office notices, AI Companion instantly analyzes all of these factors to surface the most convenient options.

Once a preferred time is selected, AI Companion takes over the coordination process, reaches out to invitees directly, sends meeting requests, and keeps a real-time pulse on responses, whether via email or Zoom Team Chat. If a proposed time no longer works, it immediately suggests an alternative, ensuring the conversation keeps moving and the meeting is confirmed quickly.

This end-to-end automation prevents scheduling delays and missed opportunities. AI Companion acts as a dedicated meeting coordinator, removing tedious back-and-forth, reducing scheduling errors, and giving teams more time to focus on the discussion itself, not the logistics.

A new asset hub to stay organized and work efficiently

Zoom Hub, now generally available, introduces a streamlined way for users to stay organized and take action across Zoom Workplace. As a central destination within Zoom Workplace, Zoom Hub works with AI Companion to help users create content more efficiently, while also bringing together Zoom meeting recordings, meeting summaries, docs, whiteboards, clips, and more, eliminating the need to jump between tools or hunt for files.

  • Stay organized, with the ability to view your Zoom assets in one place and organize assets by folder.
  • Catch up and prepare for meetings easily by searching for files by meeting.
  • Kickstart drafts with AI Companion in Zoom Hub, including Zoom docs or data tables, whiteboards, and clips.

A chat experience that works smarter with AI

Zoom Team Chat users can now work smarter on the go with AI Companion built right into the Team Chat compose bar and a refreshed mobile experience, making it easier to draft messages and catch up on unread messages. When using Team Chat in the Zoom Workplace desktop app, users can now see a summary of a document by selecting the summarize icon when hovering over the file card without having to open the file, helping save more time.

Additionally, to help improve AI Companion’s ability to handle agentic tasks like meeting scheduling and translating conversations into actionable outcomes for users, Zoom will be among the first to integrate OpenAI’s GPT-5 into its AI stack.

Zoom AI Companion’s new agentic capabilities and enhancements help users save time in the workday and are included at no additional cost with paid Zoom Workplace plans. These updates reinforce Zoom’s commitment to building a truly AI-first collaboration platform that helps teams work faster, stay aligned, and focus on what matters most.

To learn more about Zoom Workplace, visit the Zoom website.

About Zoom

Zoom’s mission is to provide an AI-first work platform for human connection. Reimagine teamwork with Zoom Workplace — Zoom’s open collaboration platform with AI Companion that empowers teams to be more productive. Together with Zoom Workplace, Zoom’s Business Services for sales, marketing, and customer experience teams, including Zoom Contact Center, strengthen customer relationships throughout the customer lifecycle. Founded in 2011, Zoom is publicly traded (NASDAQ:ZM) and headquartered in San Jose, California. Get more information at zoom.com.

Zoom Public Relations

Travis Isaman
[email protected]



European Commission Grants Approval of OGSIVEO® (nirogacestat) for the Treatment of Adults with Desmoid Tumors

OGSIVEO is the first and only therapy to receive marketing authorization in the EU for the treatment of desmoid tumors

STAMFORD, Conn., Aug. 18, 2025 (GLOBE NEWSWIRE) — SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany, announced today that the European Commission (EC) granted marketing authorization for OGSIVEO® (nirogacestat), an oral gamma secretase inhibitor, as monotherapy for the treatment of adults with progressing desmoid tumors who require systemic treatment. OGSIVEO is the first and only therapy approved in the European Union (EU) to treat desmoid tumors.

“Desmoid tumors can have a profound impact on people’s lives and are difficult to manage due to their invasive nature and high rates of recurrence. Until now, there have been no approved medicines in Europe,” said Bernd Kasper, M.D., Ph.D., Professor, University of Heidelberg, Mannheim Cancer Center, Mannheim, Germany, and principal investigator of the DeFi trial. “OGSIVEO is a highly innovative therapy with efficacy data demonstrating both meaningful antitumor activity and a significant improvement in desmoid tumor symptoms, including a significant reduction in pain which is the most debilitating symptom reported by patients.”

“This approval is a long-awaited advance for desmoid tumor patients, their families and physicians in Europe,” said Lynne Hernandez, Executive Director of the Desmoid Tumor Research Foundation. “It is our hope that patients will benefit from greater awareness of desmoid tumors, faster diagnoses, and better outcomes now that there is an approved treatment.”

Desmoid tumors are rare, locally aggressive tumors that form in the connective tissues of the body.1,2 Approximately 1,300 to 2,300 new cases of desmoid tumors are diagnosed annually in the EU.3,4,5 These tumors can cause severe pain, limited function, loss of mobility, disfigurement and fatigue.1,6-10 They are challenging to manage because of their unpredictable nature and high rate of recurrence, which can significantly impact an individual’s quality of life.2,7,8,11,12 Desmoid tumor experts and treatment guidelines now recommend medical therapy as first-line intervention instead of surgery for most tumor locations requiring treatment.13,14

“We would like to extend our gratitude to the patients, families, investigators, and advocacy organizations who helped make this EC approval possible,” said Danny Bar-Zohar, MD, CEO of Healthcare and Executive Board Member at Merck KGaA, Darmstadt, Germany. “OGSIVEO is already established as the standard of care systemic therapy for desmoid tumors in the U.S., and our goal is to bring the same treatment benefits to patients in Europe. Following last month’s EC approval of our therapy for patients with NF1-PN, we are in the unique position of launching two innovative treatments — underscoring our commitment to the rare tumor patient community.”

The EC approval of OGSIVEO is based on results from the Phase 3 DeFi trial, which enrolled 142 adult patients with progressing desmoid tumors and met the primary endpoint of improving progression-free survival (PFS). OGSIVEO demonstrated a statistically significant improvement over placebo with a 71% reduction in the risk of disease progression (hazard ratio (HR) = 0.29 (95% CI: 0.15, 0.55); p< 0.001). OGSIVEO also demonstrated a significant improvement in objective response rate (ORR). The confirmed ORR based on RECIST v1.1 was 41% with OGSIVEO versus 8% with placebo (p<0.001); the complete response rate was 7% in the OGSIVEO arm and 0% in the placebo arm. The median time to first response was 5.6 months with OGSIVEO and 11.1 months with placebo. Additionally, OGSIVEO demonstrated early and sustained improvement in patient-reported outcomes (PROs), including pain (p<0.001), desmoid tumor-specific symptoms (p<0.001), physical/role functioning (p<0.001), and overall health-related quality of life (p≤0.01).13

OGSIVEO exhibited a manageable safety and tolerability profile. The most common adverse reactions reported in 88 patients receiving OGSIVEO across all studies (69 patients from DeFi and 19 patients from early phase studies) were diarrhea (85%), rash (65%), ovarian toxicity in women of childbearing potential (60%) nausea (59%), fatigue (50%), hypophosphataemia (50%), headache (40%) and stomatitis (40%).13

About the DeFi Trial

DeFi (NCT03785964) was a global, randomized (1:1), multicenter, double-blind, placebo-controlled pivotal Phase 3 trial that evaluated the efficacy, safety and tolerability of nirogacestat in adult patients with progressing desmoid tumors. The double-blind phase of the study randomized 142 patients (nirogacestat, n=70; placebo n=72) to receive 150 mg of nirogacestat or placebo twice daily. Key eligibility criteria included tumor progression by ≥20% as measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1) within 12 months prior to screening. The primary endpoint was progression-free survival, as assessed by blinded independent central review, or death by any cause. Secondary and exploratory endpoints included safety and tolerability measures, objective response rate, duration of response, changes in tumor volume assessed by magnetic resonance imaging (MRI), and changes in patient-reported outcomes. DeFi also included an open-label extension phase.

About Desmoid Tumors

Desmoid tumors are rare, locally aggressive tumors of the soft tissues that can be serious, debilitating, and, in rare cases when vital structures are impacted, life-threatening.1,2

Desmoid tumors are most commonly diagnosed in patients between the ages of 20 and 44 years, with a two-to-three times higher prevalence in females.3,11 It is estimated that there are 1,300-2,300 new desmoid tumor cases diagnosed per year in the European Union. 3,4,5

Although desmoid tumors do not metastasize, they can be associated with recurrence rates of up to 77% after surgical resection.11,12 Desmoid tumor experts and treatment guidelines now recommend systemic therapies as first-line intervention for most tumor locations requiring treatment.14,15

About OGSIVEO

®

(nirogacestat)

OGSIVEO® (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor approved in the United States and European Union as monotherapy for the treatment of adult patients with progressing desmoid tumors who require systemic treatment.

The FDA and the EMA have granted Orphan Drug designation for OGSIVEO for the treatment of desmoid tumors.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Diarrhea: Diarrhea occurred in 84% of patients treated with OGSIVEO. Grade 3 events occurred in 16% of patients. Monitor patients and manage using antidiarrheal medications. Modify dose as recommended.
  • Ovarian Toxicity: Female reproductive function and fertility may be impaired in patients treated with OGSIVEO. Impact on fertility may depend on factors like duration of therapy and state of gonadal function at time of treatment. Long-term effects on fertility have not been established. Advise patients on the potential risks for ovarian toxicity before initiating treatment. Monitor patients for changes in menstrual cycle regularity or the development of symptoms of estrogen deficiency, including hot flashes, night sweats, and vaginal dryness.
  • Hepatotoxicity: ALT or AST elevations occurred in 30% and 33% of patients, respectively. Grade 3 ALT or AST elevations (>5 × ULN) occurred in 6% and 2.9% of patients. Monitor liver function tests regularly and modify dose as recommended.
  • Non-Melanoma Skin Cancers: New cutaneous squamous cell carcinoma and basal cell carcinoma occurred in 2.9% and 1.4% of patients, respectively. Perform dermatologic evaluations prior to initiation of OGSIVEO and routinely during treatment.
  • Electrolyte Abnormalities: Decreased phosphate (65%) and potassium (22%) occurred in OGSIVEO-treated patients. Phosphate <2 mg/dL occurred in 20% of patients. Grade 3 decreased potassium occurred in 1.4% of patients. Monitor phosphate and potassium levels regularly and supplement as necessary. Modify dose as recommended.
  • Embryo-Fetal Toxicity: Oral administration of nirogacestat to pregnant rats during the period of organogenesis resulted in embryo-fetal toxicity at maternal exposures below human exposure at the recommended dose of 150 mg twice daily. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment with OGSIVEO and for 1 week after the last dose.

ADVERSE REACTIONS

  • The most common (≥15%) adverse reactions were diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection, and dyspnea.
  • Serious adverse reactions occurring in ≥2% of patients were ovarian toxicity (4%).
  • The most common laboratory abnormalities (≥15%) were decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.

DRUG INTERACTIONS

  • CYP3A Inhibitors and Inducers: Avoid concomitant use with strong or moderate CYP3A inhibitors (including grapefruit products, Seville oranges, and starfruit) and strong or moderate CYP3A inducers.
  • Gastric Acid Reducing Agents: Avoid concomitant use with proton pump inhibitors and H2 blockers. If concomitant use cannot be avoided, OGSIVEO can be staggered with antacids (e.g., administer OGSIVEO 2 hours before or 2 hours after antacid use).
  • Consult the full Prescribing Information prior to and during treatment for important drug interactions.

To report suspected adverse reactions, contact SpringWorks Therapeutics at 1-888-400-SWTX (1-888-400-7989) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for OGSIVEO for more information.

About SpringWorks Therapeutics

SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors. We developed and are commercializing the first and only FDA and EC approved medicine for adults with desmoid tumors and the first and only FDA and EC approved medicine for both adults and children with neurofibromatosis type 1 associated plexiform neurofibromas (NF1-PN). We are also advancing a portfolio of novel targeted therapy product candidates for patients with additional rare tumors and hematological cancers.

For more information, visit www.springworkstx.com and follow @SpringWorksTx on X, LinkedInFacebookInstagram and YouTube.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across life science, healthcare and electronics. More than 62,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From providing products and services that accelerate drug development and manufacturing as well as discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2024, Merck KGaA, Darmstadt, Germany, generated sales of € 21.2 billion in 65 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany, operate as MilliporeSigma in life science, EMD Serono in healthcare and EMD Electronics in electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Contacts:

Media

[email protected]

References

  1. Sbaraglia M, Bellan E, Dei Tos AP. The 2020 WHO Classification of Soft Tissue Tumours: News and Perspectives. Pathologica. 2021;113(2):70-84. doi:10.32074/1591-951X-213.
  2. Penel N, Chibon F, Salas S. Adult desmoid tumors: biology, management and ongoing trials. Curr Opin Oncol. 2017;29(4):268-274. doi:10.1097/CCO.0000000000000374.
  3. van Broekhoven DLM, Grünhagen DJ, den Bakker MA, van Dalen T, Verhoef C. Time trends in the incidence and treatment of extra-abdominal and abdominal aggressive fibromatosis: a population-based study. Ann Surg Oncol. 2015;22(9):2817-2823. doi:10.1245/s10434-015-4632-y.
  4. Desmoid Tumor Working Group. The management of desmoid tumours: A joint global consensus-based guideline approach for adult and paediatric patients. Eur J Cancer. 2020;127:96-107. doi:10.1016/j.ejca.2019.11.013.
  5. Eurostat. Population structure and ageing. European Commission. https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Population_structure_and_ageing. Accessed June 12, 2025.
  6. Penel N, Chibon F, Salas S. Adult desmoid tumors: biology, management and ongoing trials. Curr Opin Oncol. 2017;29(4):268-274. doi:10.1097/CCO.0000000000000374.
  7. Constantinidou A, Scurr M, Judson I, Litchman C. Clinical presentation of desmoid tumors. In: Litchman C, ed. Desmoid Tumors. Springer; 2012:chap 2. https://www.researchgate.net/publication/226455135_Clinical_Presentation_of_Desmoid_Tumors. Accessed June 12, 2025.
  8. Bektas, M, et al. Desmoid tumors: a comprehensive review. Adv Therapeutics. 2023. doi.org/10.1007/s12325-023-02592-0.
  9. Husson O, Younger E, Dunlop A, et al. Desmoid fibromatosis through the patients’ eyes: time to change the focus and organisation of care? Support Care Cancer. 2019;27(3):965-980. doi:10.1007/s00520-018-4386-8.
  10. Gounder MM, Maddux L, Paty J, Atkinson TM. Prospective development of a patient-reported outcomes instrument for desmoid tumors or aggressive fibromatosis. Cancer. 2020;126(3):531-539. doi:10.1002/cncr.32555.
  11. Skubitz KM. Biology and treatment of aggressive fibromatosis or desmoid tumor. Mayo Clin Proc. 2017;92(6):947-964. doi:10.1016/j.mayocp.2017.02.012.
  12. Easter DW, Halasz NA. Recent trends in the management of desmoid tumors. Summary of 19 cases and review of the literature. Ann Surg. 1989;210(6):765-769. doi:10.1097/00000658-198912000-00012.
  13. OGSIVEO. EMA. Summary of product characteristics (SmPC). SpringWorks Therapeutics, Inc.
  14. Desmoid Tumor Working Group. The management of desmoid tumours: A joint global consensus-based guideline approach for adult and paediatric patients. Eur J Cancer. 2020;127:96-107. doi:10.1016/j.ejca.2019.11.013.
  15. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Soft Tissue Sarcoma V.2.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed June 12, 2025. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.