TMR

• ANDEMBRY inhibits the top of the HAE cascade by targeting factor XIIa and provides sustained protection from attacks
• Once-monthly dosing reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo
• ANDEMBRY approval expands CSL’s HAE franchise and underscores the company’s legacy of delivering transformational innovations to the HAE community for over four decades

KING OF PRUSSIA, Pa., June 16, 2025 /PRNewswire/ — Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) today announced the U.S. Food and Drug Administration (FDA) approved ANDEMBRY^® (garadacimab-gxii), the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. By targeting factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE, ANDEMBRY inhibits the top of the HAE cascade to prevent HAE attacks. ANDEMBRY, the only treatment to offer once-monthly dosing from the start for all patients, is a subcutaneous self-injection delivered in 15 seconds or less via an autoinjector with a citrate-free formula.

HAE is a rare, chronic, and potentially life-threatening genetic disorder characterized by recurrent and unpredictable attacks of angioedema. Attacks of HAE are often painful and can affect multiple sites of the body, including the abdomen, larynx, face, and extremities. HAE occurs in about 1 in 50,000 people of any ethnic group.

“ANDEMBRY, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method,” said Bill Mezzanotte, MD, Executive Vice President, Head of R&D, CSL. “ANDEMBRY underscores our long-standing and enduring commitment to better the lives of the patients we serve, including those suffering with HAE. I’d like to thank all the physicians, patients and my colleagues who contributed to this exciting milestone for HAE patients and CSL.”

The approval is supported by data from the pivotal placebo-controlled Phase 3 VANGUARD trial evaluating the efficacy and safety of ANDEMBRY. The pivotal study (The Lancet, April 2023) demonstrated that treatment with ANDEMBRY:

• Led to 62 percent of ANDEMBRY-treated patients remaining attack-free throughout the treatment period.
• Reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo.
• Achieved more than 99 percent median reduction and an 88 percent mean reduction in HAE attacks requiring on-demand therapy, compared to placebo.
• Attained more than 99 percent median reduction and a 90 percent mean reduction in moderate or severe attacks, compared to placebo.
• The most common adverse reactions in the pivotal trial (incidence ≥7%) are nasopharyngitis and abdominal pain.

A published interim analysis (Allergy, Oct 2024) of the ongoing open-label extension study (median ANDEMBRY exposure of 13.8 months) showed that ANDEMBRY has a favorable long-term safety profile and provides sustained reductions in HAE attacks. In the pivotal trial and the open-label extension study, injection-site reactions (e.g., injection-site bruising, injection-site erythema, injection-site hematoma, injection-site pruritus, injection-site urticaria) were reported in 23 (14%) patients.

“We’ve made significant progress in treating hereditary angioedema, yet many patients still experience painful and sometimes life-threatening HAE attacks and require frequent injections to manage them,” said Dr. Tim Craig, Professor of Medicine, Pediatrics and Biomedical Sciences at Penn State University. “We now have a new option to manage this condition through a new target, as it allows us for the first time to inhibit the top of the HAE cascade by targeting factor XIIa.”

“ANDEMBRY, a novel once-monthly subcutaneous treatment that inhibits factor XIIa, is a welcome addition to the HAE treatment landscape,” said Anthony J. Castaldo, CEO and Chairman of the Board, US HAE Association and HAE International. “People with HAE now have another choice for lessening the burden associated with this lifelong condition and realizing the community’s shared goal of experiencing life to the fullest.”

This regulatory approval for ANDEMBRY is another crucial step in building toward the global availability of ANDEMBRY, which was recently approved in Australia, the United Kingdon (UK), the European Union (EU), Japan, Switzerland, and United Arab Emirates. 

CSL Behring will launch ANDEMBRY commercially immediately, with availability before the end of June. Healthcare professionals and patients interested in learning more about ANDEMBRY or accessing the therapy are encouraged to utilize ANDEMBRY Connect^SM, designed to offer comprehensive support and assistance through various programs. For more information, call 844-423-4273 or visit www.ANDEMBRY.com. 

About HAE 
HAE is a rare and potentially life-threatening genetic condition that occurs in about 1 in 10,000 to 1 in 50,000 people. HAE is caused by deficient or dysfunctional C1INH, a protein in the blood that helps to control inflammation. Inadequate amounts of properly functioning C1INH can lead to the accumulation of fluid in body tissues, causing considerable swelling referred to as angioedema. HAE attacks can affect many parts of the body, including the face, abdomen, larynx, and extremities. Patients who have abdominal attacks of HAE can experience extreme pain, diarrhea, nausea, and vomiting caused by swelling of the intestinal wall. HAE attacks that involve the face or throat can result in airway closure, asphyxiation and, if left untreated, death.

About ANDEMBRY
ANDEMBRY is a novel monoclonal antibody inhibiting factor XIIa (anti-FXIIa mAb) that has completed the Phase 3 pivotal study as a new type of once-monthly subcutaneous prophylactic treatment for attacks related to HAE, a form of bradykinin-mediated angioedema. ANDEMBRY is CSL’s first homegrown recombinant monoclonal antibody to gain FDA approval. It was discovered and optimized by scientists at CSL’s Bio21-based research site, with formulation and manufacturing for the clinical programs completed at the CSL Broadmeadows Biotech Manufacturing Facility. ANDEMBRY uniquely inhibits the plasma protein, FXIIa. FXII is the first protein activated in the HAE pathway, initiating the cascade of events leading to an HAE attack. By targeting activated FXII (FXIIa), ANDEMBRY inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators.

About the VANGUARD Trial 
The multicenter, randomized, double-blind, parallel-group VANGUARD trial evaluated the efficacy and safety of ANDEMBRY, an investigational first-in-class monoclonal antibody, as a prophylactic treatment for patients with hereditary angioedema. Patients aged 12 years and older with HAE type I or II underwent screening and a run-in study period to verify a baseline attack rate. Patients were randomized 3:2 to receive a loading dose of 400 mg followed by 200 mg of ANDEMBRY monthly (n=39) or volume matched placebo monthly (n=25) subcutaneously. After the six-month treatment period, patients were given the opportunity to continue into the open-label extension study, which is currently ongoing.

The ongoing open-label extension of the Phase 3 VANGUARD study is evaluating the long-term safety and efficacy of ANDEMBRY (200 mg monthly) for the prophylactic treatment of hereditary angioedema attacks.

IMPORTANT SAFETY INFORMATION

What is ANDEMBRY?
ANDEMBRY^® (garadacimab-gxii) injection, for subcutaneous use, is a prescription medication used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.

It is not known if ANDEMBRY is safe and effective in children under 12 years of age.

What should I tell my healthcare provider before using ANDEMBRY?
Before using ANDEMBRY, tell your healthcare provider about any medical condition you may have, especially if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed. It is not known if ANDEMBRY can harm your unborn baby or if ANDEMBRY passes into breastmilk. Talk to your healthcare provider about the best way to feed your baby while using ANDEMBRY.

Tell your healthcare provider about all medications you take, including prescription medicines, over-the-counter treatments, vitamins, and herbal supplements.

How should I use ANDEMBRY? 
Use ANDEMBRY exactly as instructed by your healthcare provider. Detailed instructions for use can be found in the patient information section of the full prescribing information.

ANDEMBRY is given as an injection under your skin (subcutaneous) by you or a caregiver. Your healthcare provider should show you or your caregiver how to prepare and inject your dose of ANDEMBRY before you inject yourself for the first time. Do not try to inject ANDEMBRY unless you have been trained by your healthcare provider.

What are the possible side effects of ANDEMBRY?
The most common side effects of ANDEMBRY include:

• Redness, itchiness, and bruising (injection-site reactions)
• Stomach (abdominal) pain
• Runny or stuffy nose, sneezing, watery eyes (nasopharyngitis)

Please see full prescribing information for ANDEMBRY, including patient information and instructions for use.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

You can also report side effects to CSL Behring’s Pharmacovigilance Department at 1-866-915-6958.

About CSL
CSL (ASX:CSL; USOTC:CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.

For more information about CSL, visit www.CSL.com.

Media Contacts
Valerie Bomberger
CSL
Office: +1 610-291-5388 
Mobile: +1 267-280-3829 
Email: [email protected] 

Etanjalie Ayala 
CSL Behring
Mobile: +1 610 297 1069 
Email: [email protected]

Greg Healy
CSL
Mobile: +1 610-906-4564
Email: [email protected]

In Australia: 
Kim O’Donohue
CSL
Mobile: +61 449 884 603
Email: [email protected]

Brett Foley
CSL
Mobile: +61 461 464 708
Email: [email protected]

Investors Contact
Chris Cooper
CSL
Mobile: +61 455 022 740
Email: [email protected]

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SOURCE CSL

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BENTON HARBOR, Mich., June 16, 2025 /PRNewswire/ — The Whirlpool Corporation board of directors has appointed Judith K. Buckner, president of Reynolds Cooking & Baking, to the board, effective immediately. Buckner will serve on the corporate governance and nominating committee and the human resources committee.

“Judith is a highly respected leader who knows how to create a positive impact in all aspects of the business and we are excited to have her joining our board,” said Marc Bitzer, chairman and CEO of Whirlpool Corporation. “Her vast experience in the kitchen category will be an incredible asset as Whirlpool Corporation continues to focus on improving life at home for consumers around the world.”

Buckner was named president of Reynolds Cooking & Baking in 2022, having previously served as president of the Presto Products business unit of Reynolds Consumer Products, Inc., as well as the senior vice president of business transformation at Reynolds Consumer Products, Inc. and the vice president of operations and engineering for the Hefty Waste Bags & Food Bags. Buckner joined Reynolds Consumer Products, Inc. in 2000 as an engineering manager and has held various positions of increasing responsibility in manufacturing, operations and engineering.

Buckner graduated from Purdue University with a degree in chemical engineering.

About Whirlpool Corporation
Whirlpool Corporation (NYSE: WHR) is a leading home appliance company, in constant pursuit of improving life at home. As the only major U.S.-based manufacturer of kitchen and laundry appliances, the company is driving meaningful innovation to meet the evolving needs of consumers through its iconic brand portfolio, including Whirlpool, KitchenAid, JennAir, Maytag, Amana, Brastemp, Consul, and InSinkErator. In 2024, the company reported approximately $17 billion in annual sales – close to 90% of which were in the Americas – 44,000 employees, and 40 manufacturing and technology research centers. Additional information about the company can be found at WhirlpoolCorp.com.

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SOURCE Whirlpool Corporation

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TORONTO, June 16, 2025 /CNW/ – Collective Mining Ltd. (NYSE: CNL) (TSX: CNL) (“Collective” or the “Company”) is pleased to announce the voting results from its Annual General Meeting of Shareholders (“Meeting”) held on June 16, 2025.

Shareholders voted in favour of all matters of business before the Meeting. Each of those matters is set out in detail in the Management Information Circular published in connection with the Meeting, which is available at Sedar+ and www.collectivemining.com. 

A total of 49,069,143 common shares, representing approximately 57.8% of the Company’s outstanding common shares, were voted by proxy at the Meeting. Shareholders voted in favour of appointing BDO Canada LLP as auditors of the Company (99.9% in favour).

Shareholders also voted on the following matters at the Meeting:

Election of Directors

The following nominees listed in the Management Information Circular were elected as directors of the Company until the next annual meeting of shareholders or until their successors are elected or appointed, with the votes being cast by ballot and the results being as follows:

About Collective Mining Ltd.

To see our latest corporate presentation and related information, please visit www.collectivemining.com.

Founded by the team that developed and sold Continental Gold Inc. to Zijin Mining for approximately $2 billion in enterprise value, Collective is a gold, silver, copper and tungsten exploration company with projects in Caldas, Colombia. The Company has options to acquire 100% interests in two projects located directly within an established mining camp with ten fully permitted and operating mines.

The Company’s flagship project, Guayabales, is anchored by the Apollo system, which hosts the large-scale, bulk-tonnage and high-grade gold-silver-copper-tungsten Apollo system. The Company’s objectives are to improve the overall grade of the Apollo system by systematically drill testing newly modeled potentially high-grade sub-zones, expand the Apollo system by stepping out along strike to the north and expanding the newly discovered high-grade Ramp Zone along strike and to depth, and drill a series of less advanced or newly generated targets including Trap, the Knife and X. 

Management, insiders, a strategic investor and close family and friends own 44.5% of the outstanding shares of the Company and as a result, are fully aligned with shareholders. The Company is listed on both the NYSE American and TSX under the trading symbol “CNL”.

Information Contact:

Follow Executive Chairman Ari Sussman (@Ariski73) on X

Follow Collective Mining (@CollectiveMini1) on X, (Collective Mining) on LinkedIn, and (@collectivemining) on Instagram

FORWARD-LOOKING STATEMENTS 

This news release contains “forward-looking statements” and “forward-looking information” within the meaning of applicable securities legislation (collectively, “forward-looking statements”). All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussion with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often, but not always using phrases such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates”, or “believes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate, among other things, to: the anticipated advancement of mineral properties or programs; future operations; future recovery metal recovery rates; future growth potential of Collective; and future development plans.

These forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment regarding future events including the direction of our business. Management believes that these assumptions are reasonable. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others: risks related to the speculative nature of the Company’s business; the Company’s formative stage of development; the Company’s financial position; possible variations in mineralization, grade or recovery rates; actual results of current exploration activities; conclusions of future economic evaluations; fluctuations in general macroeconomic conditions; fluctuations in securities markets; fluctuations in spot and forward prices of gold, precious and base metals or certain other commodities; fluctuations in currency markets; change in national and local government, legislation, taxation, controls regulations and political or economic developments; risks and hazards associated with the business of mineral exploration, development and mining (including environmental hazards, industrial accidents, unusual or unexpected formation pressures, cave-ins and flooding); inability to obtain adequate insurance to cover risks and hazards; the presence of laws and regulations that may impose restrictions on mining; employee relations; relationships with and claims by local communities and indigenous populations; availability of increasing costs associated with mining inputs and labour; the speculative nature of mineral exploration and development (including the risks of obtaining necessary licenses, permits and approvals from government authorities); and title to properties, as well as those risk factors discussed or referred to in the annual information form of the Company dated March 24, 2025. Forward-looking statements contained herein are made as of the date of this news release and the Company disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results, except as may be required by applicable securities laws. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements and there may be other factors that cause results not to be anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking statements.

SOURCE Collective Mining Ltd.

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EL SEGUNDO, Calif., June 16, 2025 /PRNewswire/ — Millennium Space Systems, a Boeing Company, delivered two space vehicles for NASA’s Tandem Reconnection and Cusp Electrodynamics Reconnaissance Satellites (TRACERS) mission to Vandenberg Space Force Base Friday, marking a key milestone in preparation for launch later this year.

“Millennium is incredibly proud of our team and partners at the University of Iowa, Southwest Research Institute, and NASA, for reaching this milestone and getting TRACERS to the launch site,” said Richard Prasad, TRACERS program manager, Millennium Space Systems. “Progressing to final integration at launch site showcases the confidence from all parties that both the TRACERS space vehicles and the Millennium Mission Operations Center (MOC) are ready for launch and the start of operations. We’re all excited to see TRACERS on-orbit.”

The TRACERS mission will measure the connection between solar wind and the magnetic field surrounding Earth. With the completion of rigorous tests, including environmental, mechanical and systems verification, the space vehicles are now prepared to travel through Earth’s polar cusp region over the north and south magnetic poles. Ultimately, the mission will enhance our understanding of space weather and its potential impacts on critical technologies such as satellites, communications networks and power grids.

“Delivering TRACERS demonstrates how the same approach we use for national security missions can support cutting-edge science,” said Tony Gingiss, CEO, Millennium Space Systems. “The ability to deliver high-performance spacecraft is critical, not just for advancing scientific understanding and enabling future space weather forecasting, but also, for strengthening space resilience and readiness in support of national defense objectives.”

The launch window is set to open in Summer 2025, with specific timing dependent on mission readiness and other logistics.

About Millennium Space Systems
‍Millennium Space Systems, a Boeing Company, is a small satellite prime, delivering high-performance constellation solutions for National Security Space. Founded in 2001, the company’s active production lines and 80% vertical integration enable the rapid delivery of small satellites across missions and orbits – LEO, MEO and GEO. For more information, visit www.millennium-space.com.

Media Contact
Michael Atchue, Communications Manager
E-mail: [email protected]

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SOURCE Millennium Space Systems

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