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Viatris Announces Positive Results from Phase 3 Study of Investigational XULANE LO™ Low Dose Patch for Birth Control in Women of Childbearing Potential

PR Newswire

Treatment With XULANE LO Low Estrogen Dose Achieved Primary and All Secondary Efficacy and Safety Endpoints

Results Demonstrated Potential Best-In-Class Patch Performance 


New Drug Application Submission to U.S. FDA Anticipated in the Second Half of 2025


PITTSBURGH
, May 8, 2025 /PRNewswire/ — Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced positive results of its Phase 3 study (NCT05139121) evaluating the contraceptive efficacy and safety of investigational XULANE LO low dose weekly dermal patch of 150 mcg norelgestromin and 17.5 mcg ethinyl estradiol per day in women of childbearing potential. The study evaluated women of childbearing potential (N=1,272) for up to 13 cycles (12,591 safety evaluable cycles and 9,105 efficacy evaluable cycles) across 81 investigative sites throughout the U.S., Puerto Rico and Canada.

In this study, XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile. In particular:

  • With a Pearl Index (PI) of 4.14, the study demonstrated contraceptive efficacy. This primary efficacy endpoint was measured in eligible women aged 16 to 35 with a body mass index <30 mg/m
    2
    and at least one efficacy evaluable cycle. Additionally, the cumulative probability of pregnancy over 13 cycles was 3.7%.

  • A favorable safety and tolerability profile was observed with most treatment emergent adverse events (TEAEs) reported as mild-to-moderate. Favorable cycle control was also observed with generally low unscheduled bleeding and spotting events.
  • The study demonstrated a potential best-in-class patch adhesion profile with very few patches (1.3%) completely detaching over the seven-day wearing period and <1% of subjects reporting severe local application site reactions.

“We are pleased with the profile our investigational XULANE LO low dose patch demonstrated in this Phase 3 study,” said Viatris Chief R&D Officer Philippe Martin. “The data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance.” 

The Company plans to submit a New Drug Application to the U.S. Food and Drug Administration (FDA) in the second half of 2025.


About the Phase 3 Study Design (NCT05139121)


The multicenter, open-label, single-arm study, evaluated the contraceptive efficacy of investigational XULANE LO low dose patch when used over thirteen 28-day cycles in 1,272 healthy, post-menarcheal, pre-menopausal, heterosexually active female subjects of childbearing potential who are at least 16 years of age.

About Viatris

Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life’s moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world’s most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X (formerly Twitter).

Forward-Looking Statements
This press release includes statements that constitute “forward-looking statements.” These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding the outcomes of clinical trials; NDA submission to FDA anticipated in the second half of 2025; XULANE LO demonstrated a favorable efficacy and safety profile with no new safety concerns identified as well as a potential best-in-class patch performance profile; and the data underscores our confidence in the potential of XULANE LO to address an important need for women seeking a reversible birth control method that offers a lower dosage of estrogen in a weekly patch with potential best-in-class adhesion performance. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris’ ability to bring new products to market; products in development that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris’ or its partners’ ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris’ failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with the Company’s manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris’ or its partners’ customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for the Company’s products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris’ filings with the Securities and Exchange Commission (“SEC”). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC’s Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

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SOURCE Viatris Inc.

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Bridge Specialty Group acquires the assets of Tim Parkman, Inc.

DAYTONA BEACH, Fla., May 08, 2025 (GLOBE NEWSWIRE) — J. Scott Penny, chief acquisitions officer of Brown & Brown, Inc. (NYSE:BRO), and Timothy Parkman, owner of Tim Parkman, Inc. (“TPI”), today announced that a Bridge Specialty Group company and subsidiary of Brown & Brown, Inc. has acquired the assets of TPI.

Established in 2002, TPI is a full-service wholesale insurance brokerage located in Clinton, Mississippi. TPI was founded with a mission to provide all customers with consistently superior service while sustaining positive underwriting results. Initially focused on personal lines, TPI has expanded into commercial lines and leverages its proprietary state-of-the-art technology platform to deliver premier service to its network of over 5,000 retail agents. TPI will continue to operate from Clinton, Mississippi, under the leadership of President Mike Leach. Tim Parkman will continue with the business, providing oversight and support. Mike Leach will report to Jason Haupt, regional president of Bridge Specialty Group’s Mid-Atlantic and Delta region.

Steve Boyd, president of Bridge Specialty Group, stated, “We are excited to welcome the TPI team to Bridge Specialty Group. TPI’s specialized product suite and broad distribution footprint in Mississippi and the Gulf States are a great complement to Bridge Specialty Group’s offerings today.”

Tim Parkman said, “TPI has always been about people — our agents, carriers and team members. With Bridge Specialty, we’re joining an organization that shares our vision and brings added resources to help us achieve even more together. We’re incredibly excited for what lies ahead.”

About Bridge Specialty Group, LLC

Bridge Specialty Group is a leading global insurance wholesaler with access to over 230 admitted, excess and surplus lines and Lloyd’s markets that support over $7 billion premium book. With more than 50 locations and 2,000 teammates throughout the United States, United Kingdom, Europe and Asia, Bridge Specialty Group holds market recognition that enables us to connect retail partners with tailored insurance solutions through our specific practice groups, including property, casualty, executive risk, personal lines, public entity,
transportation, workers’ compensation, Farm and Ranch and Environmental.

About Brown & Brown, Inc.

Brown & Brown, Inc. (NYSE: BRO) is a leading insurance brokerage firm providing enhanced customer-centric risk management solutions since 1939. With a global presence spanning 500+ locations and a team of more than 17,000 professionals, we are dedicated to delivering scalable, innovative strategies for our customers at every step of their growth journey. Learn more at BBrown.com.

This press release may contain certain statements relating to future results, which are forward-looking statements, including those associated with this acquisition. These statements are not historical facts but instead represent only Brown & Brown’s current belief regarding future events, many of which, by their nature, are inherently uncertain and outside of Brown & Brown’s control. It is possible that Brown & Brown’s actual results and financial condition may differ, possibly materially, from the anticipated results and financial condition indicated in these forward-looking statements. Further information concerning Brown & Brown and its business, including factors that potentially could materially affect Brown & Brown’s financial results and condition, as well as its other achievements, is contained in Brown & Brown’s filings with the Securities and Exchange Commission. Such factors include those factors relevant to Brown & Brown’s consummation and integration of the announced acquisition, including any matters analyzed in the due diligence process and material adverse changes in the business and financial condition of the seller, the buyer, or both, and their respective customers. All forward-looking statements made herein are made only as of the date of this release, and Brown & Brown does not undertake any obligation to publicly update or correct any forward-looking statements to reflect events or circumstances that subsequently occur or of which Brown & Brown hereafter becomes aware.

For more information:

R. Andrew Watts
Chief financial officer
(386) 239-5770



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Kennametal to Attend KeyBanc Capital Markets Industrials & Basic Materials Conference

PR Newswire


PITTSBURGH
, May 8, 2025 /PRNewswire/ — Kennametal Inc. (NYSE: KMT) announced today that they will attend the KeyBanc Capital Markets Industrials & Basic Materials Conference in Boston, MA.

Details of the conference are as follows:

           When:   

Wednesday, May 28, 2025

           Attendees:

Patrick Watson, Vice President and Chief Financial Officer

Michael Pici, Vice President, Investor Relations

John Witt, Vice President Finance and Corporate Controller


About Kennametal

With over 85 years as an industrial technology leader, Kennametal Inc. delivers productivity to customers through materials science, tooling and wear-resistant solutions. Customers across aerospace and defense, earthworks, energy, general engineering and transportation turn to Kennametal to help them manufacture with precision and efficiency. Every day approximately 8,400 employees are helping customers in nearly 100 countries stay competitive. Kennametal generated $2 billion in revenues in fiscal 2024. Learn more at www.kennametal.com. Follow @Kennametal: Instagram, Facebook, LinkedIn and YouTube.

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SOURCE Kennametal Inc.

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CGI secures 10-year contract extension with Colorado Parks and Wildlife

PR Newswire

Agency will enhance financial sustainability and operational efficiency with deployment of CGI Advantage® Performance Budgeting  


DENVER
, May 8, 2025 /PRNewswire/ — CGI (TSX: GIB.A) (NYSE: GIB), one of the world’s largest independent technology and professional services companies, today announced the award of a 10-year contract extension with Colorado Parks and Wildlife (CPW). The ongoing partnership underscores CGI’s commitment to supporting CPW’s mission through advanced performance budgeting and transformed operational solutions.

“Performance Budgeting has been instrumental in allowing CPW to manage its financial resources,” said Chuck Brown, Colorado Parks and Wildlife Budget and Policy Analyst. “CGI’s continued support will deliver the tools and insights needed to optimize our budgeting processes, ensure financial compliance, and sustain our commitment to the state’s conservation and recreational goals.”

Under this extended contract, CGI will continue providing its innovative cloud-based CGI Advantage Performance Budgeting (PB) solution with enhancements, including advanced analytics and reporting capabilities, comprehensive testing tools to ensure system reliability, outcomes, and performance, and improved data visualization and reporting. CGI will also deliver expert Testing as a Service (TaaS) to support improved quality assurance and system integrity.

The integration of these solutions with CGI Advantage Financial Management will enhance CPW’s business intelligence, enabling the alignment of performance budget forecasts with actuals, and ensuring rigorous tracking of compliance on awards and grants. This comprehensive approach supports CPW’s objective of achieving financial sustainability and operational efficiency. Furthermore, the system will seamlessly integrate with the State’s financial application, Colorado Operations Resource Engine (CORE), ensuring continuous operations on a trusted platform.

In addition to these technological advancements, CGI’s partnership with CPW has also featured significant community engagement. Over the years, CGI has participated in 10 community volunteer events with CPW, including three Earth Day celebrations. These events, held two to three times annually, bring together volunteers from each organization and highlight the collaborative spirit and a shared commitment to community service.

“CGI is committed to driving the success of CPW’s vital work in preserving Colorado’s natural resources and fostering community involvement,” said John Manta, Senior Vice-President of CGI’s Midwest operations. “Our commitment to continuous innovation, coupled with our active involvement in community service, reflects our dedication to supporting CPW’s mission and making a positive impact in the communities we call home.”

Colorado Parks and Wildlife, a state agency managing 43 state parks and over 350 wildlife areas, relies heavily on diverse funding sources. More than 90 percent of its budget comes from non-tax revenues, including hunting and fishing license sales, park passes and fees, registration fees, and federal excise taxes on hunting and fishing gear.

About CGI Advantage
CGI Advantage is a unified ERP platform featuring a powerful combination of modern technology and built-for-government solutions. This secure, intuitive platform organically meets state and local government requirements and streamlines financial management, human resources, performance budgeting, procurement, and business intelligence operations. A proven solution, CGI Advantage is based on more than 46 years of public sector expertise and is supported by an active client community that values innovation and access to CGI’s global network of experts. Learn more at cgi.com/advantage.

About CGI
Founded in 1976, CGI is among the largest independent technology and professional services companies in the world. With 94,000 consultants and professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from strategic IT and business consulting to systems integration, managed IT and business process services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results. CGI Fiscal 2024 reported revenue is CA$14.68 billion and CGI shares are listed on the TSX (GIB.A) and the NYSE (GIB). Learn more at cgi.com. 

Stock Market Symbols

GIB (NYSE)

GIB.A (TSX)

www.cgi.com/newsroom

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SOURCE CGI Technologies and Solutions, Inc.

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TransUnion Declares First Quarter 2025 Dividend of $0.115 per Share

CHICAGO, May 08, 2025 (GLOBE NEWSWIRE) — TransUnion (NYSE: TRU) today announced that its Board of Directors declared a cash dividend of $0.115 per share for the first quarter 2025. The dividend will be payable on June 6, 2025, to shareholders of record on May 22, 2025.

About TransUnion (NYSE: TRU)

TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world.

http://www.transunion.com/business

E-mail   [email protected]
     
Telephone   312-985-2860

 



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Class Action Filed Against Fluence Energy, Inc. (FLNC) – May 12, 2025 Deadline to Join – Contact The Gross Law Firm

PR Newswire


NEW YORK
, May 8, 2025 /PRNewswire/ — The Gross Law Firm issues the following notice to shareholders of Fluence Energy, Inc. (NASDAQ: FLNC).

Shareholders who purchased shares of FLNC during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.

CONTACT US HERE:

https://securitiesclasslaw.com/securities/fluence-energy-loss-submission-form/?id=147302&from=4

CLASS PERIOD:
October 28, 2021 to February 10, 2025

ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) Fluence’s relationship with its founders and largest sources of revenue, Siemens AG and The AES Corporation, was poised to decline; (2) Siemens Energy, Siemens AG’s U.S. affiliate, had accused the Company of engineering failures and fraud; (3) Fluence’s margins and revenue growth were inflated as Siemens and AES were moving to divest; and (4) based on the foregoing, defendants lacked a reasonable basis for their positive statements related to Fluence’s battery energy storage business, as well as related financial results, growth, and prospects.

DEADLINE: May 12, 2025 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/fluence-energy-loss-submission-form/?id=147302&from=4

NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of FLNC during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is May 12, 2025. There is no cost or obligation to you to participate in this case.

WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company’s stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: [email protected]
Phone: (646) 453-8903

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SOURCE Gross Law Firm

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Class Action Filed Against Zenas BioPharma, Inc. (ZBIO) Seeking Recovery for Investors – Contact The Gross Law Firm

PR Newswire


NEW YORK
, May 8, 2025 /PRNewswire/ — The Gross Law Firm issues the following notice to shareholders of Zenas BioPharma, Inc. (NASDAQ: ZBIO).

Shareholders who purchased shares of ZBIO during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery.

CONTACT US HERE:
https://securitiesclasslaw.com/securities/zenas-biopharma-inc-loss-submission-form/?id=147319&from=4 

CLASS PERIOD: This lawsuit is on behalf of persons who purchased or otherwise acquired Zenas BioPharma securities pursuant and/or traceable to the registration statement and related prospectus issued in connection with Zenas BioPharma’s September 2024 initial public offering.

ALLEGATIONS: The complaint alleges that during the class period, Defendants issued materially false and/or misleading statements and/or failed to disclose that: (1) Zenas BioPharma materially overstated the amount of time that it would be able to fund its operations using existing cash and expected net proceeds from the IPO; and (2) as a result, defendants’ public statements were materially false and misleading at all relevant times and negligently prepared.

DEADLINE: June 16, 2025 Shareholders should not delay in registering for this class action. Register your information here: https://securitiesclasslaw.com/securities/zenas-biopharma-inc-loss-submission-form/?id=147319&from=4 

NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of ZBIO during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. The deadline to seek to be a lead plaintiff is June 16, 2025. There is no cost or obligation to you to participate in this case.

WHY GROSS LAW FIRM? The Gross Law Firm is a nationally recognized class action law firm, and our mission is to protect the rights of all investors who have suffered as a result of deceit, fraud, and illegal business practices. The Gross Law Firm is committed to ensuring that companies adhere to responsible business practices and engage in good corporate citizenship. The firm seeks recovery on behalf of investors who incurred losses when false and/or misleading statements or the omission of material information by a company lead to artificial inflation of the company’s stock. Attorney advertising. Prior results do not guarantee similar outcomes.

CONTACT:

The Gross Law Firm
15 West 38th Street, 12th floor
New York, NY, 10018
Email: [email protected] 
Phone: (646) 453-8903

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SOURCE Gross Law Firm

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Monopar Presents ALXN1840 Late-Breaker Data at EASL 2025

WILMETTE, Ill., May 07, 2025 (GLOBE NEWSWIRE) — Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage biopharmaceutical company focused on developing innovative treatments for patients with unmet medical needs, is presenting today data on the long term efficacy and safety of its ALXN1840 (tiomolybdate choline) drug candidate for Wilson disease at the European Association for the Study of the Liver (“EASL”) International Liver Congress 2025, one of the most prominent global conferences in liver disease. Monopar’s late-breaker poster presentation is available at the following link: https://www.monopartx.com/pipeline/ALXN1840/EASL-poster-may-2025.

The poster supports the potential use of ALXN1840 as a therapeutic option for Wilson disease, a rare and progressive genetic condition in which the body’s pathway for removing excess copper is compromised, leading to damage from toxic copper build-up in tissues and organs such as the liver and brain. Efficacy data were pooled and analyzed from three clinical trials: Phase 2 WTX101-201, Phase 2 ALXN1840-WD-205, and Phase 3 WTX101-301 (n=255). For safety analysis, data from the Phase 2 ALXN1840-WD-204 trial were also included (n=266). The median treatment duration with ALXN1840 was 961 days (2.63 years) and 943.5 days (2.58 years) for the efficacy and safety datasets, respectively. The data presented highlight the following:

  • Sustained improvements from baseline in the Unified Wilson Disease Rating Scale (“UWDRS”) Part II (patient-reported symptoms) and Part III (clinician-assessed symptoms);
  • Increased copper mobilization as evidenced by a sustained increase in dNCC (directly measured non-ceruloplasmin-bound copper);
  • Improvements on the Clinical Global Impression – Improvement (“CGI-I”) scale for ALXN1840 compared to standard of care;
  • Improvement in the New Wilson Index (based on bilirubin, AST, INR, leukocytes, and albumin) for patients treated with ALXN1840;
  • Higher patient-reported convenience and effectiveness of ALXN1840 compared to standard of care, including those who transitioned from standard of care to ALXN1840 in the extension portion of the Phase 3 clinical trial; and
  • Fewer than 5% of patients experienced a drug-related serious adverse event (“SAE”), with no cases of a drug-related renal or urinary system SAE.

“These data show that the long-term efficacy, safety, and convenience profile of ALXN1840 are very encouraging and that ALXN1840 has the potential to provide a meaningful benefit to Wilson disease patients’ daily lives,” said Dr. Karl Weiss, Medical Director of Salem Medical Center Heidelberg, and lead author of the presentation at EASL.

About Monopar Therapeutics Inc.  

Monopar Therapeutics is a clinical-stage biopharmaceutical company with late-stage ALXN1840 for Wilson disease, and radiopharmaceutical programs including Phase 1-stage MNPR-101-Zr for imaging advanced cancers, and Phase 1a-stage MNPR-101-Lu and late preclinical-stage MNPR-101-Ac225 for the treatment of advanced cancers. For more information, visit: www.monopartx.com.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of these forward-looking statements include statements concerning: that Monopar’s poster supports the potential use of ALXN1840 as a therapy for Wilson disease; and that ALXN1840 has the potential to provide a meaningful benefit to Wilson disease patients’ daily lives. The forward-looking statements involve risks and uncertainties including, but not limited to: uncertainties related to the regulatory process that Monopar intends to initiate related to ALXN1840 and the outcome thereof; the rate of market acceptance and competitiveness in terms of pricing, efficacy and safety, of any products for which Monopar receives marketing approval, and Monopar’s ability to competitively market any such products as compared to larger pharmaceutical firms; Monopar’s ability to raise sufficient funds in order for the Company to support continued preclinical, clinical, regulatory, precommercial and commercial development of its programs and to make contractual milestone payments, as well as its ability to further raise additional funds in the future to support any existing or future product candidate programs through completion of clinical trials, the approval processes and, if applicable, commercialization; and the significant general risks and uncertainties surrounding the research, development, regulatory approval, and commercialization of imaging agents and therapeutics. Actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Monopar’s filings with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Monopar undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Any forward-looking statements contained in this press release represent Monopar’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

CONTACT:   

Monopar Therapeutics Inc. 
Investor Relations   
Quan Vu
Chief Financial Officer
[email protected] 

Follow Monopar on social media for updates:   
X: @MonoparTx  LinkedIn: Monopar Therapeutics  



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Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment

Final Data From the Phase 3 MYR301 Study Demonstrated Longer Treatment With Bulevirtide Was Associated With Sustaining Undetectability After Stopping Treatment

– 90% of Adults with Chronic Hepatitis Delta Virus (HDV) who Achieved Undetectable HDV RNA at 96 Weeks of Treatment with Bulevirtide Remained Undetectable for Almost 2 Years After Stopping Treatment –

FOSTER CITY, Calif.–(BUSINESS WIRE)–
Gilead Sciences Inc. (Nasdaq: GILD) today announced final results from the pivotal Phase 3 MYR301 study revealing that 36% (23 out of 64) of adults living with chronic hepatitis delta virus (HDV) treated with the first-in-class entry inhibitor bulevirtide at either a 2 mg or 10 mg dose maintained virologic suppression for almost two years after stopping treatment after achieving undetectable HDV RNA at end of treatment (EOT). In participants who sustained undetectability for one year after end of therapy, no relapses occurred in the second year of follow-up. In addition, sustained post-treatment undetectable HDV RNA was more frequent in participants with longer on-treatment HDV RNA undetectability at end of treatment: 90% (9/10) of those who had HDV RNA undetectability for ≥ 96 weeks at end of treatment remained HDV undetectable off-treatment. These new data, presented at the European Association for the Study of the Liver (EASL) Congress 2025, show the potential value of bulevirtide monotherapy for some adults living with chronic HDV, even after treatment has ended.

“HDV is the most severe form of viral hepatitis with more rapid progression towards liver cancer and liver-related death. Previous data have demonstrated the potential of bulevirtide as a safe and effective treatment option and, as EASL and the European Medicines Agency guidelines recommend, continued treatment is encouraged as long as people are experiencing a clinical benefit,” said Professor Heiner Wedemeyer, Head and Chair of the Department of Gastroenterology, Hepatology, Infectious Diseases and Endocrinology at Hannover Medical School. “With today’s results, we’re now seeing the potential of bulevirtide to maintain virologic suppression and normalize markers of liver inflammation for a subset of people living with HDV, demonstrating a durable response, even after treatment cessation.”

The findings (LBO-004) build on data, presented at The Liver Meeting® 2024, hosted by the American Association for the Study of Liver Diseases (AASLD), from MYR301 which demonstrated a subset of participants treated with bulevirtide monotherapy had undetectable HDV RNA 48 weeks after stopping treatment. Today’s presentation adds further insight by not only showing the durability of response post-treatment, but that sustained undetectability was more frequent in people with longer, on-treatment HDV RNA undetectability at the time of bulevirtide discontinuation. Furthermore, post-treatment hepatic serious adverse events (SAEs) were reported in 14% (20/142) of participants but were resolved in 85% (17/20) of these participants, most of whom restarted bulevirtide therapy.

“At Gilead, we are committed to advancing research and exploring the full potential of bulevirtide as a monotherapy, in combination, and at different doses, to help improve outcomes for people living with chronic HDV,” said Anu Osinusi, Vice President, Clinical Research for Hepatitis, Respiratory and Emerging Viruses at Gilead. “Previous results from MYR301 demonstrated the potential benefits of long-term treatment with bulevirtide. With this new data, we now have valuable insight into the durability of the response even after treatment has ended.”

HDV affects an estimated 4.5% of people living with chronic hepatitis B (HBV), with an estimated global prevalence of 12 million people. Bulevirtide 2 mg remains the only approved treatment for adults with chronic HDV and compensated liver disease in the European Economic Area (EEA), the UK, Switzerland and Australia and is not approved in the U.S. or elsewhere. Bulevirtide 10 mg is an investigational product and is not approved anywhere.

For more information on the EASL Congress 2025 and Gilead’s presentations, please visit the congress website.

Marketing Authorization

In July 2023, the European Commission (EC) granted full Marketing Authorization (MA) for Hepcludex® (bulevirtide) 2 mg for the treatment of adults with chronic HDV and compensated liver disease. Bulevirtide was initially granted a conditional MA from the EC in July 2020 to provide people living with HDV urgent access to treatment. Bulevirtide’s conditional MA license in the UK was converted to a full MA in August 2023, and a full MA was granted in Switzerland in February 2024. In regions where bulevirtide is not approved, including the U.S., bulevirtide 2 mg is an investigational product. In these regions, health authorities have not established the safety and efficacy of bulevirtide. Bulevirtide 10 mg is an investigational product and is not approved anywhere globally.

About MYR301

MYR301 is a Phase 3 clinical trial evaluating the long-term efficacy and safety of bulevirtide in 150 people living with chronic HDV randomly allocated to treatment with bulevirtide 2 mg once daily (n=49), 10 mg once daily (n=50) or no antiviral treatment (delayed treatment, n=51). Primary efficacy and safety data was assessed at Week 48. After Week 48, participants in the delayed treatment group of the study were switched to bulevirtide 10 mg once daily for an additional 96 weeks. The total duration of treatment across all groups in the study is 144 weeks. The primary endpoint, combined response, is defined as an undetectable HDV RNA or ≥2log10 IU/ml decline from baseline and ALT normalization at Week 48. Secondary endpoints at Week 48 include undetectable HDV RNA (key secondary endpoint), ALT normalization, and a change from baseline in liver stiffness measured by transient elastography.

About Gilead Sciences in Liver Disease

For decades, Gilead has pioneered the way forward to improve the lives of people living with liver disease around the world. The company has helped to transform hepatitis C from a chronic condition into a curable condition. For individuals living with hepatitis B or hepatitis delta (HDV), Gilead’s focus on advancing medicines drives hope that today’s research will turn into tomorrow’s cures. Beyond viral hepatitis, Gilead is working to deliver advanced treatments for people living with primary biliary cholangitis. The commitment of Gilead does not stop there. Through ground-breaking science and collaborative partnerships, the company strives to create healthier futures for everyone living with liver disease. Gilead remains devoted to a future without liver disease.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving bulevirtide; uncertainties relating to regulatory applications and related filing and approval timelines, including additional pending and potential applications for bulevirtide; and the risk that any such approvals, if granted, may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing bulevirtide for the treatment of HDV; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Hepcludex®, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

Blair Baumwell, Media

[email protected]

Jacquie Ross, Investors

[email protected]

KEYWORDS: United States North America California

INDUSTRY KEYWORDS: Research Infectious Diseases Hospitals Biotechnology Other Health Health Pharmaceutical General Health Science

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Global Mofy AI Limited Announces Closing of $4 Million Private Placement Financing

BEIJING, April 22, 2025 (GLOBE NEWSWIRE) — Global Mofy AI Limited (the “Company” or “Global Mofy”) (Nasdaq: GMM), a generative AI-driven technology solutions provider engaged in virtual content production and the development of 3D digital assets for use in the broader digital content industry, today announced the successful closing of its previously announced private placement financing (the “Offering”) on April 22, 2025.

In connection with the closing of the Offering, the Company issued an aggregate of 2,030,460 Class A ordinary shares, par value $0.00003 per share (each, a “Class A Ordinary Share”), and 2,030,460 warrants (each, a “Warrant”), each to purchase one Class A Ordinary Share at an initial exercise price of $2.36 per share, subject to reset and adjustment, pursuant to the securities purchase agreement dated April 15, 2025, by and between the Company and the participating investors. The Warrants are exercisable upon issuance and will expire five years from the issuance date.

The Company received gross proceeds of approximately $4 million from the Offering, before deducting customary fees and expenses. The net proceeds from the Offering are expected to be used for general corporate purposes, including working capital, product development, and continued investment in the Company’s AI-powered platforms, including its newly launched Gauss AI Lab.

“The successful closing of this financing further strengthens our ability to deliver innovation across our AI-driven technology platforms,” said Haogang Yang, CEO of Global Mofy. “This capital will support our strategic growth initiatives and accelerate development efforts as we continue to advance next-generation digital content solutions and expand our position in the rapidly evolving digital ecosystem.”

The securities described above have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), and 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. The Company has agreed to file a registration statement with the U.S. Securities and Exchange Commission (SEC) covering the resale of the Class A Ordinary Shares and Class A Ordinary Shares issuable upon the exercise of the Warrants issued in this Offering.

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

About Global Mofy AI Limited

Global Mofy AI Limited (Nasdaq: GMM) is a generative AI-driven technology solutions provider engaged in virtual content production, and the development of digital assets for the digital content industry. Utilizing its proprietary “Mofy Lab” technology platform, which consists of interactive 3D and artificial intelligence (“AI”) technology, the Company creates high-definition virtual versions of a wide range of physical world objects in 3D ranging from characters, objects to scenes and more. The digital assets can be used in different applications, including movies, TV series, AR/VR, animation, advertising, gaming, and more. Global Mofy is one of the leading digital asset banks in China, which consists of more than 100,000 high-precision 3D digital assets. For more information, please visit www.globalmofy.cn/ or ir.globalmofy.cn.

Forward-Looking Statement

This press release contains forward-looking statements. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. When the Company uses words such as “may,” “will,” “intend,” “should,” “believe,” “expect,” “anticipate,” “project,” “estimate” or similar expressions that do not relate solely to historical matters, it is making forward-looking statements. These forward-looking statements include, without limitation, the Company’s statements regarding the expected trading of its Ordinary Shares on the Nasdaq Capital Market and the closing of the Offering. Forward-looking statements are not guarantees of future performance and involve risks and uncertainties that may cause the actual results to differ materially from the Company’s expectations discussed in the forward-looking statements. These statements are subject to uncertainties and risks including, but not limited to, the uncertainties related to market conditions and the completion of the initial public offering on the anticipated terms or at all, and other factors discussed in the “Risk Factors” section of the registration statement filed with the SEC. For these reasons, among others, investors are cautioned not to place undue reliance upon any forward-looking statements in this press release. Additional factors are discussed in the Company’s filings with the SEC, which are available for review at www.sec.gov. The Company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date hereof.

For more information, please contact:

Global Mofy AI Ltd.
Investor Relations Department
[email protected]