Category: 3. Business

Lundin Mining Announces TSX Approval for a Normal Course Issuer Bid

December 11, 2025

VANCOUVER, BC, Dec. 11, 2025 /CNW/ – (TSX: LUN) (Nasdaq Stockholm: LUMI) Lundin Mining Corporation (“Lundin Mining” or the “Company”) announces that the Toronto Stock Exchange (the “TSX”) has accepted the notice of Lundin Mining’s intention to renew its normal course issuer bid (the “NCIB”). Unless otherwise stated, all values presented are in United States dollars.

The Company is committed to delivering shareholder returns through a balanced approach of dividends and share buybacks, with a total annual allocation of approximately $220 million. As part of its shareholder distribution policy (see news release dated March 26, 2025), the Company will pay a quarterly dividend of C$0.0275 per common share of the Company (the “Common Shares”) while allocating up to approximately $150 million per annum in share buybacks through the Company’s NCIB. If the Company allocates less than $150 million in share buybacks in a calendar year, the shortfall will be distributed as a special dividend. If applicable, the special dividend will be paid alongside the regular 4th-quarter dividend.

Under the Company’s previous NCIB that commenced on December 16, 2024 and expires on December 15, 2025, the Company sought and received approval from the TSX to acquire up to 57,597,388 Common Shares. As of December 5, 2025, the Company acquired 17,474,000 Common Shares in the market for cancelation at an average price of C$13.09 per Common Share. Such amount includes the purchase of 14,229,000 Common Shares since January 1, 2025 in accordance with the Company’s 2025 shareholder distribution policy.

Normal Course Issuer Bid

The approval of the NCIB allows the Company to purchase up to 67,723,868 Common Shares, representing 10% of the 855,770,029 issued and outstanding Common Shares as of December 4, 2025, minus those Common Shares beneficially owned, or over which control or direction is exercised by the Company, the senior officers and directors of the Company and every shareholder who owns or exercises control or direction over more than 10% of the outstanding Common Shares, over a period of twelve months commencing on December 16, 2025. The NCIB will expire no later than December 15, 2026.

All purchases made pursuant to the NCIB will be made on the open market through the facilities of the TSX, other designated exchanges and/or alternative Canadian trading systems or by such other means as may be permitted by applicable securities laws. In accordance with TSX rules, any daily purchases (other than pursuant to a block purchase exemption) on the TSX under the NCIB are limited to a maximum of 624,337 Common Shares, which represents 25% of the average daily trading volume of 2,497,350 Common Shares on the TSX for the six months ended November 30, 2025. The price that Lundin Mining will pay for Common Shares in open market transactions will be the market price at the time of purchase.

In connection with the NCIB renewal, Lundin Mining entered into an automatic share purchase plan (“ASPP”) with its designated broker to allow for the repurchase of Common Shares at times when the Company ordinarily would not be active in the market due to its own internal trading blackout periods, insider trading rules or otherwise (any such period being a “Blackout Period”). Before entering a Blackout Period, the Company may, but is not required to, instruct the designated broker to make purchases under the NCIB in accordance with the terms of the plan. At this time, the Company has not instructed the broker to actively repurchase Common Shares. Purchases made pursuant to the plan, if any, will be made by the Company’s designated broker based upon the parameters prescribed by the TSX, applicable Canadian securities laws and the terms of the written agreement entered between the Company and its designated broker. Outside of these Blackout Periods, Common Shares will be purchasable by Lundin Mining at its discretion under its NCIB.

The ASPP will terminate on the earliest of the date on which: (i) the purchase limit under the NCIB has been reached; (ii) the NCIB expires; and (iii) the ASPP otherwise terminates in accordance with its terms. The ASPP constitutes an “automatic plan” for purposes of applicable Canadian securities legislation and the agreement governing the plan has been pre-cleared by the TSX.

The actual number of Common Shares that may be purchased and the timing of such purchases will be determined by the Company. Decisions regarding purchases will be based on market conditions, share price, best use of available cash, and other factors. Any Common Shares that are purchased under the NCIB will be cancelled.

About Lundin Mining

Lundin Mining is a Canadian mining company headquartered in Vancouver, Canada with four operating mines in Brazil, Chile and the USA. We produce commodities that support modern infrastructure and electrification. Built for growth, ready for opportunity, our strategic vision is to become a top ten global copper producer. To get there, we are executing a clear growth strategy, which includes advancing one of the world’s largest copper, gold, and silver projects in the Vicuña District on the border of Argentina and Chile, where we hold a 50% interest. With a legacy of value creation in the base metals sector, Lundin Mining has a proven track record of resource growth, operational excellence, and responsible development. We are committed to safety, sustainability, and delivering long-term value for stakeholders. Lundin Mining’s shares trade on the Toronto Stock Exchange (LUN) and Nasdaq Stockholm (LUMI). Learn more at www.lundinmining.com.

The information in this release is subject to the disclosure requirements of Lundin Mining under the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below on December 11, 2025 at 16:00 Pacific Time.

Cautionary Statement in Forward-Looking Information

Certain of the statements made and information contained herein is “forward-looking information” within the meaning of applicable Canadian securities laws. All statements other than statements of historical facts included in this document constitute forward-looking information, including but not limited to statements with respect to Lundin Mining’s shareholder distribution policy, including the payment of quarterly or special dividends, proposed NCIB, the Company’s pre-defined plan with its broker to allow for the repurchase of Common Shares and the timing, number and price of Common Shares that may be purchased under the NCIB. Words such as “believe”, “expect”, “anticipate”, “contemplate”, “target”, “plan”, “goal”, “aim”, “intend”, “continue”, “budget”, “estimate”, “may”, “will”, “can”, “could”, “should”, “schedule” and similar expressions identify forward-looking information.

 Forward-looking information is necessarily based upon various estimates and assumptions including, without limitation, the expectations and beliefs of management; assumed and future price of copper, zinc, gold, nickel and other metals; anticipated costs; ability to achieve goals; the prompt and effective integration of acquisitions; that the political environment in which the Company operates will continue to support the development and operation of mining projects; the Company will continue to pay dividends in accordance with its current shareholder distribution policy; the Common Shares will, from time to time, trade below their value; the Company will complete purchases of Common Shares pursuant to the NCIB; and assumptions related to the factors set forth below. While these factors and assumptions are considered reasonable by Lundin Mining as at the date of this document in light of management’s experience and perception of current conditions and expected developments, these statements are inherently subject to significant business, economic and competitive uncertainties and contingencies. Known and unknown factors could cause actual results to differ materially from those projected in the forward-looking statements and undue reliance should not be placed on such statements and information. Such factors include, but are not limited to: the market price of the Common Shares being too high to ensure that purchases benefit the Company and its shareholders; factors affecting the payment of dividends; and other risks and uncertainties, including but not limited to those described in the “Risks and Uncertainties” section of the Company’s MD&A for the three and nine months ended September 30, 2025 and the “Risks and Uncertainties” section of the Company’s Annual Information Form for the year ended December 31, 2024, which are available on SEDAR+ at www.sedarplus.ca under the Company’s profile.

All of the forward-looking information in this document are qualified by these cautionary statements. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated, forecasted or intended and readers are cautioned that the foregoing list is not exhaustive of all factors and assumptions which may have been used. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking information. There can be no assurance that the Common Shares will, from time to time, trade below their value and that the Company will complete purchases of Common Shares pursuant to the NCIB, or that dividends will continue to be paid in the future or on the same terms currently intended by the Company. Accordingly, there can be no assurance that forward-looking information will prove to be accurate and forward-looking information is not a guarantee of future performance. Readers are advised not to place undue reliance on forward-looking information. The forward-looking information contained herein speaks only as of the date of this document. The Company disclaims any intention or obligation to update or revise forward ‐ looking information or to explain any material difference between such and subsequent actual events, except as required by applicable law.

 

SOURCE Lundin Mining Corporation

Pakistan’s Minister of State for Crypto and Blockchain, Bilal Bin Saqib, stated that Pakistan considers Bitcoin and digital assets to be crucial aspects that will play a significant role in the country’s new financial system, benefiting its 240 million population. This perspective highlights the potential for Pakistani officials to consider regulating the crypto market.

This outlook was noted at the Bitcoin MENA Conference a few days after Saqib shared a statement dated Tuesday this week, declaring that the country can no longer rely on outdated economic models. Therefore, according to him, “a new engine”, which he referred to as digital assets, is needed to boost economic growth. 

Saqib refers to digital assets as essential aspects for Pakistan’s new financial system

During a discussion in Abu Dhabi, the senior official argued that they do not view Bitcoin, digital assets, and blockchain as speculative tools, but as an important part of their infrastructure. 

Saqib further explained that they are not just distractions but play a significant role in establishing the basis for a new financial system for developing nations.

Saqib, who was recently appointed Chairman of the Pakistan Virtual Assets Regulatory Authority (PVARA) and previously served as Special Assistant to the Prime Minister on Blockchain and crypto matters, highlighted that he is working towards a major goal of transforming the largest unregulated cryptocurrency markets into a favourable investment environment.

According to him, Pakistan has the potential to develop a regulated crypto ecosystem as soon as possible, given that 70% of the population belongs to the 30-year-old age group, rather than becoming a late adopter.

“My message is straightforward,” he stated. “If El Salvador can achieve this with 6 million people, just think about what Pakistan could accomplish with a population 40 times larger and one of the fastest-growing digital sectors in Asia.” 

Following the senior official’s argument, analysts weighed in on the situation. They pointed out that Pakistan is increasingly becoming one of the fastest-growing cryptocurrency markets globally. 

Their remarks came after the country moved up six spots to solidify its top position as the third in Chainalysis’ 2025 Global Crypto Adoption Index. 

Pakistan positions itself as a hub for digital assets 

Earlier this month, Saqib informed reporters that the country is preparing to establish a strategic Bitcoin reserve. He also noted that Pakistan is working towards adopting more supportive policies specifically for cryptocurrency. 

This move sparked excitement among individuals who are advocates of cryptocurrencies. To further illustrate their commitment to exploring the crypto ecosystem, Pakistan reported allocating 2,000 megawatts of additional electricity to support Bitcoin mining activities and the construction and operation of AI data centres that same month. This time round, the country embraced national efforts essential to enable it to go digital.

This move triggered reports to reach out to financial leaders in the country to explain this plan further. Respondingly, they mentioned that this plan aims to attract significant foreign investment and create new high-tech jobs by diverting excess power supply to AI and crypto initiatives.

To position itself as a hub for digital assets, Pakistan notified international crypto firms in September that they are accepting applications for licenses under the country’s new federal regulations. For leading exchanges and service providers interested in exploring the market, the PVARA advised them to begin submitting their interest.

If you’re reading this, you’re already ahead. Stay there with our newsletter.

Kromek

Guy’s and St Thomas’ NHS Foundation Trust

Kromek

Diamond Light Source

(Bloomberg) — Asian stocks opened higher after US shares and a broader gauge of global equities hit fresh records, helped by the Federal Reserve’s third consecutive interest-rate cut.

MSCI Inc.’s gauge of Asian shares was up 0.5% in early trading, with benchmarks in Japan and Australia rallying about 1%. Shares of SoftBank Group Corp. jumped more than 5% after people with knowledge of the matter said it is studying potential acquisitions including data center operator Switch Inc.

The S&P 500 climbed 0.2% on Thursday. Despite the record highs, some caution for tech names persisted, as Broadcom Inc.’s shares slid in late trading after the chipmaker’s outlook for artificial intelligence revenue failed to meet investors’ lofty expectations. US stock futures were lower on Friday, with contracts on the tech-heavy Nasdaq 100 down 0.2%.

“The momentum should continue into year-end. With rate cuts underway, a new Fed chair on deck, and earnings trending higher, the bull market looks positioned to extend into 2026,” said Gina Bolvin, President of Bolvin Wealth Management Group. “As more companies adopt AI, participation should broaden and sectors beyond the Magnificent Seven may start to show strength.”

Thursday’s action lifted the MSCI All Country World Index — one of the broadest measures of the stock market — to a new closing high. The move placed the global equity benchmark on track for its best year since 2019.

In Asia, Thailand markets will be in focus after Prime Minister Anutin Charnvirakul moved to dissolve parliament, setting the stage for an early election after reports of a key political party backing his minority government moving to withdraw its support.

Yields on 10-year Treasuries edged slightly lower Friday after a small gain on Thursday. Data showed that initial jobless claims rose more than expected in the Dec. 6 week. An index of the dollar, meanwhile, traded around a two-month low.

Elsewhere, copper climbed to a fresh record high and most other industrial metals rose as the Fed delivered the widely expected interest-rate cut and upgraded its growth forecast for the US economy. Gold and silver edged lower in Asia after rising in the previous session. Oil rose and Bitcoin flip-flopped in a tight range around $93,000.

The tech sector also continues to be on traders’ radar after dominating much of the recent market action following Oracle Corp.’s results — which brought worries about valuations and whether heavy spending on AI infrastructure will pay off back into focus.

While the sector has powered the global equities rally this year, overspending fears and lofty valuations have prompted some investors to rotate into other areas. Nvidia Corp. fell 1.6% on Thursday while the Magnificent Seven index of US tech giants dropped 0.6%.

“The effect of Oracle has been greater than the Fed. This already tells us everything as we’ve been witnessing a strong concentration and one theme — AI — leading the market,” said Alberto Tocchio, a portfolio manager at Kairos Partners. “This doesn’t mean that AI is gone or it’s a bubble, but we need to focus on a wider scale.”

Delivering a third consecutive cut, Fed Chair Jerome Powell suggested the Fed had now done enough to help stabilize the threat to employment while leaving rates high enough to continue weighing on price pressures. Traders stuck to bets on two cuts in 2026, even as the Fed’s new projections signaled only one such move.

“The Fed’s ‘hawkish-but-bullish’ cut last night reinforces this: stronger 2026 growth, faster disinflation,” said Florian Ielpo, head of macro at Lombard Odier Investment Managers. “Cuts are continuing, but they’re no longer automatic — and that’s usually a constructive backdrop for equities.”

Some of the main moves in markets:

Stocks

S&P 500 futures were little changed as of 9:22 a.m. Tokyo time Japan’s Topix rose 1.7% Australia’s S&P/ASX 200 rose 1% Euro Stoxx 50 futures rose 0.9% Currencies

The Bloomberg Dollar Spot Index was little changed The euro was little changed at $1.1744 The Japanese yen was little changed at 155.64 per dollar The offshore yuan was little changed at 7.0515 per dollar Cryptocurrencies

Bitcoin fell 0.3% to $92,569.93 Ether fell 0.3% to $3,241.07 Bonds

The yield on 10-year Treasuries was little changed at 4.15% Japan’s 10-year yield was unchanged at 1.930% Australia’s 10-year yield was little changed at 4.72% Commodities

West Texas Intermediate crude rose 0.6% to $57.92 a barrel Spot gold was little changed This story was produced with the assistance of Bloomberg Automation.

–With assistance from Joanna Ossinger and Richard Henderson.

©2025 Bloomberg L.P.

Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development. Follow her on Mastodon and Bluesky. You can reach Helen on Signal at hbranswell.01.

A single-dose oral antibiotic from a new class of drugs was as effective as the previous standard of care at treating uncomplicated urogenital gonorrhea, a study published Thursday in The Lancet reported. If approved for use, zoliflodacin would be a welcome addition to an armamentarium that contains precious few tools to treat Neisseria gonorrhoeae, the wily bacterium that causes the infection.

In fact, the world should learn soon if zoliflodacin, which is being developed as part of a private-public partnership, will be deployed in the fight against gonorrhea. The Food and Drug Administration set a decision date of Dec. 15 to tell the drug’s developers — Innoviva Specialty Therapeutics and the Global Antibiotic Research & Development Partnership, or GARDP — whether it will approve zoliflodacin.

Earlier Thursday, the FDA approved an extension of the license for GSK’s drug Blujeba (gepotidacin) to allow its use in the treatment of uncomplicated urogenital gonorrhea. Earlier this year the antibiotic was approved for the treatment of uncomplicated urinary tract infections.

UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing*

First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG

THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA^® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.

“This approval marks a significant advancement for people living with gMG,” said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. “By selectively targeting CD19-positive B cells, UPLIZNA offers a new approach to treatment that addresses a biological root cause of disease. UPLIZNA is conveniently dosed twice a year and delivers durable efficacy, helping people manage debilitating symptoms that can compromise daily function – including trouble breathing, speaking and seeing.”

gMG is a rare, unpredictable, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness.^1-3 The disease is thought to be primarily driven by AChR and MuSK autoantibodies, which are produced by CD19+ B cells, particularly plasmablasts and some plasma cells.^1-3 Myasthenia gravis impacts approximately 80,000 to 100,000 people in the U.S.^4,5

The approval of UPLIZNA for gMG is supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a steroid taper into its protocol. Patients on steroids at baseline began tapering at Week 4 to reach prednisone 5 mg per day by Week 24. By Week 26, 87.4% of patients taking UPLIZNA and 84.6% of those taking placebo had reduced their steroid dose to 5 mg or less per day.⁶

“UPLIZNA showed strong efficacy at 26 weeks in both AChR+ and MuSK+ patients, with AChR+ patients continuing to improve through 52 weeks in MINT,” said Richard J. Nowak, M.D., M.S., global principal investigator and director of the Myasthenia Gravis Clinic at Yale University. “MINT also uniquely required steroid tapering, recognizing that long-term steroid use adds to the overall burden of disease. This approval brings a new first-in-class approach to gMG, expanding treatment options for clinicians and patients.”

At Week 26, UPLIZNA demonstrated a 1.9-point difference in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score compared with placebo (-4.2 vs. -2.2; p<0.0001).⁶ Benefits in the AChR+ patient subgroup continued through Week 52 – the longest randomized-controlled period for a Phase 3 trial in gMG – with an exploratory analysis of AChR+ patients showing a 2.8-point difference in MG-ADL for UPLIZNA compared with placebo (-4.7 vs. -1.9; 95% CI: −3.9 to −1.7).⁶

“Managing a rare and chronic illness can mean facing unpredictable relapsing symptoms and demanding treatment schedules,” said Samantha Masterson, president and chief executive officer of the Myasthenia Gravis Foundation of America. “This approval marks an important milestone, offering durable efficacy and a dosing schedule that provides people living with generalized myasthenia gravis six months of treatment-free time between maintenance doses.”

This is the third indication for UPLIZNA, which was previously approved by the FDA for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) in June 2020, and for the treatment of adult patients with Immunoglobulin G4-related disease (IgG4-RD) in April 2025.

The most common adverse reactions in gMG were headache and infusion-related reactions.⁷ 

Amgen is committed to supporting patients with gMG and helping appropriate patients with access to UPLIZNA. Patients and caregivers who need support, tools, or resources can contact Amgen By Your Side.

*After two initial loading doses.

About the Myasthenia Gravis Inebilizumab Trial (MINT)
MINT is a randomized, double-blind, placebo-controlled, parallel-group trial (NCT04524273) designed to evaluate the efficacy and safety of UPLIZNA in adults with gMG. The trial enrolled 238 adults with gMG, including 190 patients who are AChR+ and 48 patients who are MuSK+.⁶

Eligibility criteria at screening and randomization included a Myasthenia Gravis Foundation of America (MGFA) classification of II, III or IV disease, MG-ADL score between 6 and 10 with greater than 50% of this score attributed to non-ocular items, or an MG-ADL score of at least 11, and a Quantitative Myasthenia Gravis (QMG) score of at least 11.⁶ Participants had to have been receiving a stable dose of steroids and/or nonsteroidal immunosuppressive therapy (or both) at the time of randomization.⁶

The primary endpoint was change from baseline in MG-ADL score at Week 26 in the combined study population.⁶ Key secondary endpoints included change from baseline in QMG scores in the combined study population; change from baseline in MG-ADL score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort; and change from baseline in QMG score at Week 26 for the AChR+ cohort and separately the MuSK+ cohort.⁶ MINT also includes an optional three-year open-label treatment period.

Key findings from MINT include:⁶

Primary Endpoint:

• A 1.9-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) (p<0.0001) at Week 26 for the combined study population.

Key Secondary Endpoints:

• A 2.5-point difference in the QMG score for UPLIZNA (-4.8) compared to placebo (-2.3) (p=0.0002) at Week 26 for the combined treated population.
• A 1.8-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.4) (p=0.0015) at Week 26 for the AChR+ population.
• A 2.5-point difference in the QMG score for UPLIZNA (-4.4) compared to placebo (-2.0) (p=0.0011) at Week 26 for the AChR+ population.
• A 2.2-point difference in the MG-ADL score for UPLIZNA (-3.9) compared to placebo (-1.7) (p=0.0297) at Week 26 for the MuSK+ population.
• A 2.3-point difference in the QMG score for UPLIZNA (-5.2) compared to placebo (-3.0) (p=0.1326) at Week 26 for the MuSK+ population; this difference was not statistically significant.

Additional Exploratory Endpoints:

• A 2.8-point difference (95% CI: −3.9 to −1.7) in the MG-ADL score for UPLIZNA (-4.7) compared with placebo (-1.9) at Week 52 for the AChR+ population.
• A 4.3-point difference (95% CI: −5.9 to −2.8) in the QMG score for UPLIZNA (-5.8) compared with placebo (-1.4) at Week 52 for the AChR+ population.
• 87.4% of UPLIZNA patients and 84.6% of those taking placebo reduced their steroid dose to 5 mg or less per day by Week 26.

MG-ADL scale, which assesses the impact of gMG on daily functions of 8 signs or symptoms that are typically affected in gMG. Each item is assessed on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. The total MG-ADL score ranges from 0 to 24, with higher scores indicating more impairment.

The QMG score is a 13-item categorical grading system that quantitively measures disease impairment by mainly assessing muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no impairment weakness and a score of 3 represents severe impairment weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment.

About Generalized Myasthenia Gravis (gMG)
gMG is a rare, unpredictable, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness, trouble breathing, difficulty swallowing, and impaired speech and vision.^1-3

Approximately 85% of patients with myasthenia gravis have the generalized form, or gMG.^8,9 The prevalence and incidence of gMG are increasing worldwide.⁹ There are between 80,000 and 100,000 patients with myasthenia gravis in the U.S.^4,5 Approximately 85% of patients with myasthenia gravis have detectable antibodies against AChR, and approximately 7% have detectable antibodies against MuSK.¹⁰ Global prevalence is estimated at 2-36 cases per 100,000.¹¹  The disease is more frequently seen in young women (age 20-30) and men aged 50 years and older.^9,11

B cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by AChR and MuSK autoantibodies which are produced by CD19+ B cells, particularly plasmablasts and some plasma cells. These antibodies target and disrupt critical proteins in the neuromuscular junction.^1-3

About UPLIZNA^® (inebilizumab-cdon)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects in gMG is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.

UPLIZNA^® (inebilizumab-cdon) U.S. INDICATION

INDICATIONS 
UPLIZNA^® (inebilizumab-cdon) is indicated in adult patients for the treatment of: anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD); Immunoglobulin G4-related disease (IgG4-RD); anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive (Ab+) generalized myasthenia gravis (gMG).

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS 
UPLIZNA^® (inebilizumab-cdon) is contraindicated in patients with a history of a life-threatening infusion reaction to UPLIZNA, active hepatitis B infection, or active or untreated latent tuberculosis.

WARNINGS AND PRECAUTIONS

• Infusion Reactions: Infusion reactions, including anaphylaxis, can occur. Symptoms can include headache, nausea, somnolence, dyspnea, fever, myalgia, rash, or palpitations. Infusion reactions were observed in 9.3%, 7.4%, and 10.1% of patients treated with UPLIZNA during the randomized controlled periods (RCPs) of Study 1 in patients with NMOSD, Study 2 in patients with IgG4-RD, and Study 3 in patients with gMG, respectively. Infusion reactions were most common with the first infusion but were also observed during subsequent infusions.

  Administer pre-medication with a corticosteroid, an antihistamine, and an antipyretic. For life-threatening infusion reactions, immediately and permanently stop UPLIZNA and administer appropriate supportive treatment. For less severe infusion reactions, management may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.

• Infections: Serious, including life-threatening or fatal, bacterial, fungal, and new or reactivated viral infections have been observed during and following completion of treatment with B-cell depleting therapies, including UPLIZNA. The most common infections reported by UPLIZNA-treated patients in the NMOSD randomized and open-label clinical trial periods for NMOSD were urinary tract infection (20%), nasopharyngitis (13%), upper respiratory tract infection (8%), and influenza (7%). In the IgG4-RD RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection, influenza, and pneumonia. In the gMG RCP, the most common infections reported by UPLIZNA-treated patients were urinary tract infection and nasopharyngitis. Delay UPLIZNA administration in patients with an active infection until the infection is resolved.
  
  Possible Increased Risk of Immunosuppressant Effects with Other Immunosuppressants: If combining UPLIZNA with another immunosuppressive therapy, consider the potential for increased immunosuppressive effects.
  
  Hepatitis B Virus (HBV) Reactivation: HBV reactivation has been observed with B-cell-depleting therapies, including UPLIZNA. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with B-cell depleting therapies. HBV reactivation was observed in a patient treated with UPLIZNA during the gMG clinical trial and in the postmarketing setting. Patients with active or chronic HBV infection were excluded from clinical trials. Perform HBV screening in all patients before initiation of treatment. Do not administer to patients with active HBV confirmed by positive results for HBsAg and anti-HB tests. For patients who are negative for HBsAg and positive for HBcAb, or who are carriers of HBV (i.e., HBsAg+), consult liver disease experts before starting and during treatment.
  
  Progressive Multifocal Leukoencephalopathy (PML): Although no confirmed cases of PML were identified in UPLIZNA clinical trials, JC virus infection resulting in PML has been observed in patients treated with other B-cell-depleting antibodies and other therapies that affect immune competence. In UPLIZNA clinical trials one subject died following the development of new brain lesions for which a definitive diagnosis could not be established, though the differential diagnosis included an atypical NMOSD relapse, PML, or acute disseminated encephalomyelitis. At the first sign or symptom suggestive of PML, withhold UPLIZNA and perform an appropriate diagnostic evaluation. MRI findings may be apparent before clinical signs or symptoms. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
  
  Tuberculosis 
  Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating UPLIZNA. Consider anti-tuberculosis therapy prior to initiation of UPLIZNA in patients with a history of latent active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consult infectious disease experts regarding whether initiating anti-tuberculosis therapy is appropriate before starting treatment.
  
  Vaccinations 
  Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of UPLIZNA. The safety of immunization with live or live-attenuated vaccines following UPLIZNA therapy has not been studied, and vaccination with live-attenuated or live vaccines is not recommended during treatment and until B-cell repletion.
  
  Vaccination of Infants Born to Mothers Treated with UPLIZNA During Pregnancy 
  In infants of mothers exposed to UPLIZNA during pregnancy, do not administer live or live-attenuated vaccines before confirming recovery of B-cell counts in the infant. Depletion of B cells in these exposed infants may increase the risks from live or live-attenuated vaccines. Non-live vaccines, as indicated, may be administered prior to recovery from B-cell and immunoglobulin level depletion, but consultation with a qualified specialist should be considered to assess whether a protective immune response was mounted.

• Reductions in Immunoglobulins: There may be a progressive and prolonged hypogammaglobulinemia or decline in the levels of total and individual immunoglobulins such as immunoglobulins G and M (IgG and IgM) with continued UPLIZNA treatment. Monitor the levels of quantitative serum immunoglobulins during treatment with UPLIZNA, especially in patients with opportunistic or recurrent infections, and until B-cell repletion after discontinuation of therapy. Consider discontinuing UPLIZNA therapy if a patient with low immunoglobulin G or M develops a serious opportunistic infection or recurrent infections, or if prolonged hypogammaglobulinemia requires treatment with intravenous immunoglobulins.

• Fetal Risk: Based on animal data, UPLIZNA can cause fetal harm due to B-cell lymphopenia and reduce antibody response in offspring exposed to UPLIZNA even after B-cell repletion. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other B-cell-depleting antibodies during pregnancy. Advise females of reproductive potential to use effective contraception while receiving UPLIZNA and for at least 6 months after the last dose.

ADVERSE REACTIONS

• The most common adverse reactions (at least 10% of patients treated with UPLIZNA and greater than placebo): urinary tract infection and arthralgia in NMOSD; urinary tract infection and lymphopenia in IgG4-RD; headache and infusion-related reactions in gMG.

Please see UPLIZNA® full Prescribing Information.

About Amgen 
Amgen discovers, develops, manufactures and delivers innovative medicines to help millions of patients in their fight against some of the world’s toughest diseases. More than 40 years ago, Amgen helped to establish the biotechnology industry and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today. Amgen is advancing a broad and deep pipeline that builds on its existing portfolio of medicines to treat cancer, heart disease, osteoporosis, inflammatory diseases and rare diseases.

In 2024, Amgen was named one of the “World’s Most Innovative Companies” by Fast Company and one of “America’s Best Large Employers” by Forbes, among other external recognitions. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average^®, and it is also part of the Nasdaq-100 Index^®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.

For more information, visit Amgen.com and follow Amgen on X, LinkedIn, Instagram, YouTube and Threads. 

Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla^® (apremilast), our acquisitions of ChemoCentryx, Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon’s business, performance and opportunities, and any potential strategic benefits, synergies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on our business, outcomes, progress, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions, including those resulting from geopolitical relations and government actions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected. We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected. A breakdown, cyberattack or information security breach of our information technology systems could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Our business and operations may be negatively affected by the failure, or perceived failure, of achieving our sustainability objectives. The effects of global climate change and related natural disasters could negatively affect our business and operations. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Amgen, Thousand Oaks Elissa Snook, 609-251-1407 (media)Annik Allen, 917-288-9136 (media)Casey Capparelli, 805-447-1746 (investors) 

References

1. Yi JS, Guptill JT, Stathopoulos P, Nowak RJ, O’Connor KC. B cells in the pathophysiology of myasthenia gravis. Muscle Nerve. 2018;57(2):172-184.
2. Willcox HN, Newsom-Davis J, Calder LR. Cell types required for anti-acetylcholine receptor antibody synthesis by cultured thymocytes and blood lymphocytes in myasthenia gravis. Clin Exp Immunol. 1984;58:97-106.
3. Stathopoulos P, Kumar A, Nowak RJ, O’Connor KC. Autoantibody-producing plasmablasts after B cell depletion identified in muscle-specific kinase myasthenia gravis. JCI Insight. 2017;2(17):e94263.
4. Ye Y, Murdock DJ, Chen C, Liedtke W, Knox CA. Epidemiology of myasthenia gravis in the United States. Front Neurol. 2024;15:1339167.
5. Rodrigues E, Umeh E, Aishwarya, Navaratnarajah N, Cole A, Moy K. Incidence and prevalence of myasthenia gravis in the United States: a claims-based analysis. Muscle Nerve. 2024;69(2):166-171.
6. Nowak R, Benatar M, Ciafaloni E, et al. A phase 3 trial of inebilizumab in generalized myasthenia gravis. N Engl J Med. 2025;392(23):2309-2320.
7. Amgen Inc. UPLIZNA (inebilizumab-cdon) US prescribing information. Revised December 2025.
8. Lazaridis K, Tzartos SJ. Autoantibody specificities in myasthenia gravis: implications for improved diagnostics and therapeutics. Front Immunol. 2020;11:212.
9. Dresser L, Wlodarski R, Rezania K, Soliven B. Myasthenia gravis: epidemiology, pathophysiology and clinical manifestations. J Clin Med. 2021;10(11):2235.
10. Hehir MK, Silvestri NJ. Generalized myasthenia gravis: classification, clinical presentation, natural history, and epidemiology. Neurol Clin. 2018;36:253-260.
11. Bubuioc AM, Kudebayeva A, Turuspekova S, Lisnic V, Leone MA. The epidemiology of myasthenia gravis. J Med Life. 2021;14(1):7-16.

View original content to download multimedia:https://www.prnewswire.com/news-releases/fda-approves-uplizna-for-adults-with-generalized-myasthenia-gravis-302639699.html

SOURCE Amgen

Elon Musk is partnering with the government of El Salvador to bring his artificial intelligence company’s chatbot, Grok, to more than 1 million students across the country, according to a Thursday announcement by xAI. Over the next two years, the plan is to “deploy” the chatbot to more than 5,000 public schools in an “AI-powered education program”.

xAI’s Grok is more known for referring to itself as “MechaHitler” and espousing far-right conspiracy theories than it is for public education. Over the past year, the chatbot has spewed various antisemitic content, decried “white genocide” and claimed Donald Trump won the 2020 election.

Nayib Bukele, El Salvador’s president, is now entrusting the chatbot to create curricula in classrooms across the country. Bukele has long embraced technology, making El Salvador the first county in the world to use bitcoin as legal tender, and being one of the first Central American presidents to use Twitter, now X, as a platform. He is also known for ruling with an iron fist and working with Trump to incarcerate deportees to El Salvador’s notorious Cecot prison.

“El Salvador doesn’t just wait for the future to happen; we build it,” Bukele said in a statement about the partnership with xAI. “This partnership is destined to deliver something rather extraordinary for all of humanity.”

Musk touted his partnership with Bukele on Thursday. On X, between posts about “white genocide” and blaming asylum seekers for crime, Musk posted comments about Grok being spread throughout El Salvador’s schools.

He reposted positively to a comment from Katie Miller, the wife of Trump’s senior adviser Stephen Miller, in which she wrote: “If we are serious about restoring education to math, science and English – why would we allow left leaning liberal [sic] AI our kids? This unlocks non-woke educational tools for our kids.”

xAI is not the first artificial intelligence company to introduce chatbots to public schools. OpenAI announced a partnership with Estonia in February where it could provide all students and teachers in the country’s secondary school system with a customized ChatGPT. Students in rural Colombia also started using Meta’s AI chatbots in 2023 and within a year, teachers began blaming the tech for low grades and failing exams, according to Rest of World.