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NOVATO, Calif., July 24, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, today reported the grant of 65,886 restricted stock units of the company's common stock to 39 newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company's board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of July 16, 2026, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

Posted by Defense World Staff on Jul 22nd, 2026

Fifth Third Bancorp bought a new stake in Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE – Free Report) during the first quarter, according to the company in its most recent disclosure with the Securities & Exchange Commission. The institutional investor bought 110,272 shares of the biopharmaceutical company’s stock, valued at approximately $2,310,000. Fifth Third Bancorp owned about 0.11% of Ultragenyx Pharmaceutical at the end of the most recent reporting period.

Several other hedge funds also recently bought and sold shares of RARE. Leonteq Securities AG increased its position in shares of Ultragenyx Pharmaceutical by 288.5% during the first quarter. Leonteq Securities AG now owns 1,795 shares of the biopharmaceutical company’s stock valued at $38,000 after acquiring an additional 1,333 shares during the last quarter. Danske Bank A S acquired a new position in shares of Ultragenyx Pharmaceutical in the 3rd quarter worth approximately $39,000. Aster Capital Management DIFC Ltd acquired a new position in shares of Ultragenyx Pharmaceutical in the 4th quarter worth approximately $56,000. Smartleaf Asset Management LLC boosted its position in shares of Ultragenyx Pharmaceutical by 43.2% during the 4th quarter. Smartleaf Asset Management LLC now owns 2,489 shares of the biopharmaceutical company’s stock worth $57,000 after purchasing an additional 751 shares during the period. Finally, Empowered Funds LLC purchased a new position in shares of Ultragenyx Pharmaceutical during the 4th quarter worth approximately $66,000. Hedge funds and other institutional investors own 97.67% of the company’s stock.

Ultragenyx Pharmaceutical Stock Up 0.3% NASDAQ:RARE opened at $28.62 on Wednesday. The company has a fifty day simple moving average of $27.36 and a two-hundred day simple moving average of $24.57. The company has a market cap of $2.82 billion, a price-to-earnings ratio of -4.68 and a beta of 0.31. Ultragenyx Pharmaceutical Inc. has a 52 week low of $18.29 and a 52 week high of $39.89.

Ultragenyx Pharmaceutical (NASDAQ:RARE – Get Free Report) last announced its quarterly earnings data on Tuesday, May 5th. The biopharmaceutical company reported ($1.84) earnings per share (EPS) for the quarter, missing the consensus estimate of ($1.49) by ($0.35). Ultragenyx Pharmaceutical had a negative net margin of 91.03% and a negative return on equity of 1,024.42%. The company had revenue of $136.00 million during the quarter, compared to analyst estimates of $158.19 million. During the same quarter in the previous year, the business posted ($1.57) earnings per share. The firm’s revenue was down 2.2% on a year-over-year basis. On average, analysts expect that Ultragenyx Pharmaceutical Inc. will post -4.53 EPS for the current year.

Wall Street Analysts Forecast Growth RARE has been the topic of a number of research analyst reports. Cantor Fitzgerald boosted their target price on Ultragenyx Pharmaceutical from $84.00 to $96.00 and gave the company an “overweight” rating in a research report on Thursday, May 21st. Morgan Stanley lifted their price objective on Ultragenyx Pharmaceutical from $50.00 to $67.00 and gave the company an “overweight” rating in a research note on Thursday, April 16th. The Goldman Sachs Group downgraded Ultragenyx Pharmaceutical from a “buy” rating to a “neutral” rating and cut their price objective for the company from $61.00 to $25.00 in a report on Tuesday, March 24th. Guggenheim cut their price objective on Ultragenyx Pharmaceutical from $52.00 to $43.00 and set a “buy” rating on the stock in a report on Friday, May 8th. Finally, Royal Bank Of Canada increased their target price on Ultragenyx Pharmaceutical from $35.00 to $40.00 and gave the stock an “outperform” rating in a research note on Tuesday, July 7th. One research analyst has rated the stock with a Strong Buy rating, fourteen have given a Buy rating, two have issued a Hold rating and one has issued a Sell rating to the company. According to data from MarketBeat.com, Ultragenyx Pharmaceutical currently has a consensus rating of “Moderate Buy” and a consensus target price of $58.41.

Check Out Our Latest Stock Report on RARE

Insider Buying and Selling In other news, EVP Karah Herdman Parschauer sold 1,899 shares of the business’s stock in a transaction dated Monday, June 15th. The stock was sold at an average price of $24.62, for a total transaction of $46,753.38. Following the completion of the transaction, the executive vice president directly owned 94,462 shares of the company’s stock, valued at approximately $2,325,654.44. The trade was a 1.97% decrease in their ownership of the stock. The sale was disclosed in a filing with the SEC, which can be accessed through the SEC website. Also, Director Corazon (Corsee) D. Sanders sold 2,000 shares of the company’s stock in a transaction that occurred on Monday, June 15th. The stock was sold at an average price of $25.05, for a total transaction of $50,100.00. Following the sale, the director owned 21,095 shares in the company, valued at $528,429.75. The trade was a 8.66% decrease in their ownership of the stock. The disclosure for this sale is available in the SEC filing. Over the last quarter, insiders have sold 19,319 shares of company stock worth $476,837. 5.20% of the stock is owned by corporate insiders.

Ultragenyx Pharmaceutical Profile (Free Report)

Ultragenyx Pharmaceutical Inc is a biopharmaceutical company focused on developing and commercializing therapies for rare and ultra-rare genetic disorders. Since its founding in 2010 and headquarters in Novato, California, the company has built expertise in protein replacement therapies, small molecules and gene therapy approaches to address high-unmet medical needs. Ultragenyx applies a precision medicine model, leveraging both in-house research and strategic collaborations to advance its product pipeline from discovery through regulatory approval.

The company’s commercial portfolio includes Crysvita (burosumab-tmyl) for X-linked hypophosphatemia, Mepsevii (vestronidase alfa-vjbk) for mucopolysaccharidosis VII and Dojolvi (triheptanoin) for long-chain fatty acid oxidation disorders.

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SAN DIEGO, July 15, 2026 (GLOBE NEWSWIRE) -- Johnson Fistel, PLLP is investigating potential claims on behalf of current, long-term shareholders of Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) against certain of its officers and directors for alleged breaches of fiduciary duty.

Shareholders who have held Ultragenyx shares continuously since prior to August 3, 2023, may have standing to seek corporate governance reforms, the return of funds back to the company, and a court-approved incentive award, all at no cost to them.

What Should Ultragenyx Shareholders Do?
If you have held Ultragenyx shares continuously since prior to August 3, 2023, you may have standing to seek corporate governance reforms at Ultragenyx, including improvements to internal controls, transparency, and executive oversight.

To learn more, visit: https://www.johnsonfistel.com/investigations/ultragenyx-pharmaceutical-inc/ or contact Johnson Fistel, PLLP at [email protected] or (619) 814-4471.There is no cost or obligation to you.

What Is Johnson Fistel Investigating?
A previously filed securities class action complaint alleges that Ultragenyx and certain of its executives made materially false and misleading statements, and/or failed to disclose material adverse facts, concerning setrusumab and the Company's Phase III ORBIT study in patients with osteogenesis imperfecta.

According to the complaint, Ultragenyx allegedly created the false impression that it possessed reliable information concerning the effects of setrusumab while minimizing the risk that the ORBIT study would fail to achieve a statistically significant reduction in annualized fracture rate. The complaint further alleges that the Company's optimism concerning the ORBIT study and its interim analysis benchmark was misplaced because the threshold figures were based on Phase II results that lacked a placebo control group for appropriate comparison.

The complaint alleges that, as a result, defendants' positive statements concerning Ultragenyx's business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

About Johnson Fistel, PLLP | Top Law Firm, Securities Fraud, Investor Rights:
Johnson Fistel, PLLP is a nationally recognized shareholder rights law firm with offices in California, New York, Georgia, Idaho, and Colorado. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits. We also extend our services to foreign investors who have purchased on U.S. exchanges. For more information about the firm and how we may be able to help you recover your losses, please visit www.johnsonfistel.com.

Achievements:
In 2024, Johnson Fistel was ranked in the Top 10 Plaintiff Law Firms by ISS Securities Class Action Services. The firm has recovered approximately $90,725,000 for aggrieved clients in cases where it served as lead or co-lead counsel, marking the eighth time it has been recognized among the top U.S. plaintiffs' securities law firms.

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Contact:
Johnson Fistel, PLLP
501 W. Broadway, Suite 800
San Diego, CA 92101
James Baker, Investor Relations or Frank J. Johnson, Esq.
(619) 814-4471
[email protected] or [email protected]

Ultragenyx (RARE) saw its shares surge in the last session with trading volume being higher than average. The latest trend in earnings estimate revisions may not translate into further price increase in the near term.

June 19, 2026 16:30 ET  | Source: Ultragenyx Pharmaceutical Inc.

NOVATO, Calif., June 19, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for rare and ultra-rare diseases, today reported the grant of 44,409 restricted stock units of the company’s common stock to 15 newly hired non-executive officers of the company. The awards were approved by the compensation committee of the company’s board of directors and granted under the Ultragenyx Employment Inducement Plan, with a grant date of June 16, 2026, as an inducement material to the new employees entering into employment with Ultragenyx in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock units vest over four years, with 25% of the underlying shares vesting on each anniversary of the grant date, subject to the employee being continuously employed by the company as of such vesting dates.

About Ultragenyx Pharmaceutical Inc.
Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultrarare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.

Contact Ultragenyx
Investors & Media
Joshua Higa
(415) 475-6370

NOVATO, Calif., April 29, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel products for serious rare and ultra-rare genetic diseases, today announced that it will host a conference call at 5:00 p.m.

First quarter total revenue of $136 million, Crysvita® revenue of $93 million and Dojolvi® revenue of $18 million

For the quarter ended March 2026, Ultragenyx (RARE - Free Report) reported revenue of $136 million, down 2.4% over the same period last year. EPS came in at -$1.84, compared to -$1.57 in the year-ago quarter.

The reported revenue represents a surprise of -15.66% over the Zacks Consensus Estimate of $161.26 million. With the consensus EPS estimate being -$1.55, the EPS surprise was -18.96%.

While investors scrutinize revenue and earnings changes year-over-year and how they compare with Wall Street expectations to determine their next move, some key metrics always offer a more accurate picture of a company's financial health.

Since these metrics play a crucial role in driving the top- and bottom-line numbers, comparing them with the year-ago numbers and what analysts estimated about them helps investors better project a stock's price performance.

Here is how Ultragenyx performed in the just reported quarter in terms of the metrics most widely monitored and projected by Wall Street analysts:

Revenues- Dojolvi: $18 million compared to the $20.67 million average estimate based on six analysts. The reported number represents a change of +5.8% year over year.Revenues- Evkeeza: $18 million versus $16.22 million estimated by six analysts on average. Compared to the year-ago quarter, this number represents a +63.2% change.Revenues- Mepsevii: $7 million versus the six-analyst average estimate of $9.37 million. The reported number represents a year-over-year change of -16.5%.Revenues- Total Crysvita Revenue: $93 million compared to the $114.17 million average estimate based on five analysts.Revenues- Product sales: $89 million versus $94.98 million estimated by four analysts on average. Compared to the year-ago quarter, this number represents a -2.7% change.Revenues- Royalty revenue: $47 million versus the four-analyst average estimate of $62.78 million.View all Key Company Metrics for Ultragenyx here>>>

Shares of Ultragenyx have returned +8.5% over the past month versus the Zacks S&P 500 composite's +9.5% change. The stock currently has a Zacks Rank #3 (Hold), indicating that it could perform in line with the broader market in the near term.

Key Takeaways Ultragenyx Q1 revenues fell 2% as Crysvita sales declined due to seasonal and ordering effects.RARE saw Evkeeza sales jump 64% on new country launches and early access demand.Ultragenyx expects FDA decisions on UX111 and DTX401 later in 2026 amid other pipeline progress. Ultragenyx Pharmaceutical (RARE - Free Report) reported first-quarter 2026 loss of $1.84 per share, wider than the Zacks Consensus Estimate of a loss of $1.55. The company had incurred a loss of $1.57 per share in the year-ago quarter.

Ultragenyx’s total revenues amounted to $136 million in the reported quarter, which declined 2% year over year due to lower product sales. The top line missed the Zacks Consensus Estimate of $161 million.

The company markets four drugs, namely Crysvita, Mepsevii, Dojolvi and Evkeeza. Crysvita is approved for treating X-linked hypophosphatemia, an inherited disorder and tumor-induced osteomalacia, an ultra-rare disease. Mepsevii is approved to treat Mucopolysaccharidosis VII, also known as Sly syndrome. Dojolvi is approved for treating all forms of long-chain fatty acid oxidation disorders. Evkeeza is indicated for homozygous familial hypercholesterolemia (HoFH).

In 2022, Ultragenyx announced a license and collaboration agreement with Regeneron Pharmaceuticals (REGN - Free Report) for Evkeeza, which is approved in multiple geographies as a first-in-class therapy for use together with diet and other low-density lipoprotein-cholesterol-lowering therapies to treat adults and adolescents aged 12 years and older with HoFH. Per the deal, RARE has obtained the rights to develop, commercialize and distribute Evkeeza outside the United States. The regions include the European Economic Area. The collaboration with Regeneron for Evkeeza gives Ultragenyx a fourth approved product that adds to the top line. However, REGN solely commercializes Evkeeza in the United States.

RARE’s Q1 Results in DetailCrysvita’s total revenues were $93 million, down 10% year over year, due to expected seasonality in the U.S. and Canada and ordering patterns in Brazil. Crysvita’s net product revenues in the first quarter of 2026 included $39 million from North America, $46 million from Latin America and Turkey, and $8 million from Europe.

Mepsevii product revenues decreased 13% year over year to $7 million in the reported quarter. Dojolvi product revenues were $18 million, up 6%, driven by new patient demand. Evkeeza recorded sales of $18 million in the first quarter, up 64%, driven by increased demand from new country launches and early access.

Year to date, shares of Ultragenyx have gained 8.7% against the industry’s 2.4% decline.

Image Source: Zacks Investment Research

Operating expenses of $305 million in the quarter rose 8% year over year due to increased investments in multiple late-stage pipeline programs and marketing costs for approved drugs. Operating expenses included research and development (R&D) expenses of $187 million (up 13%), selling, general and administrative (SG&A) expenses of $88 million (up 1%) and cost of sales of $30 million (up 3%).

Cash, cash equivalents and marketable securities amounted to $534 million as of March 31, 2026, compared with $737 million as of Dec. 31, 2025.

RARE Reiterates 2026 Financial GuidanceUltragenyx continues to expect total revenues in 2026, excluding potential revenues from new product launches, between $730 million and $760 million, which suggests growth of approximately 8-13% compared to 2025.

Crysvita revenues in 2026 are expected to be in the range of $500-$520 million, indicating growing underlying global demand partially offset by the expected timing of ordering patterns in Brazil. On the other hand, Dojolvi revenues are expected to be between $100 million and $110 million in 2026.

RARE’s Key Pipeline UpdatesIn April 2026, the FDA accepted the resubmitted biologics license application (BLA) seeking accelerated approval of UX111 for the treatment of MPS IIIA. The application included extensive long-term data with follow-up of up to eight years. The data showed sustained clinical benefits compared with the decline seen in natural history studies, along with durable treatment effects across multiple clinical measures and biomarkers, while maintaining an acceptable safety profile. A final decision from the regulatory body is expected on Sept. 19, 2026.

Ultragenyx’s GTX-102, an investigational antisense oligonucleotide, is being developed in the pivotal phase III Aspire study for treating Angelman syndrome (AS) patients with a genetically confirmed diagnosis of UBE3A deletion. Top-line data is expected in the second half of 2026. Enrollment in the phase II/III Aurora study is currently ongoing to evaluate the safety and efficacy of GTX-102 for treating other AS genotypes in other patient age groups, with the first patient dosed in October 2025. This additional study aims to enable treatment for a broader range of AS patients.

The FDA has also accepted for review Ultragenyx’s BLA for its investigational AAV8 gene therapy, DTX401, to treat glycogen storage disease type Ia. A final decision from the FDA is expected on Aug. 23, 2026. The regulatory body also recently informed RARE that an Advisory Committee meeting is not anticipated at this time. Ultragenyx is also evaluating UX701, an investigational AAV9 gene therapy, in a phase I/II/III Cyprus2+ study to treat Wilson disease and expects to share top-line data later in 2026.

RARE’s Zacks Rank & Stocks to ConsiderUltragenyx currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals (CPRX - Free Report) and Inovio Pharmaceuticals (INO - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 EPS have declined from $2.82 to $2.79. CPRX shares have gained 32.3% year to date.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for Inovio Pharmaceuticals’ 2026 loss per share have narrowed from $1.26 to $1.06. INO shares have plunged 34.5% year to date.

Inovio Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 57.94%.

May 06, 2026 16:30 ET  | Source: Ultragenyx Pharmaceutical Inc.

NOVATO, Calif., May 06, 2026 (GLOBE NEWSWIRE) -- Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development and commercialization of novel therapies for serious rare and ultra-rare genetic diseases, today announced that Howard Horn, the company's Chief Financial Officer and Executive Vice President and Joshua Higa, Chief of Staff and Vice President of investor relations, will participate in a fireside at Bank of America’s 2026 Healthcare Conference on Tuesday, May 12, 2026, at 2:20 PM PT.

The live and archived webcast of the panel will be accessible from the company’s website at https://ir.ultragenyx.com/events-presentations.

About Ultragenyx Pharmaceutical Inc.

Ultragenyx is a biopharmaceutical company committed to bringing novel products to patients for the treatment of serious rare and ultra-rare genetic diseases. The company has built a diverse portfolio of approved therapies and product candidates aimed at addressing diseases with high unmet medical need and clear biology for treatment, for which there are typically no approved therapies treating the underlying disease.

The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time- and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.

For more information on Ultragenyx, please visit the company's website at: www.ultragenyx.com.

Contacts Ultragenyx Pharmaceutical, Inc.
Investors
Joshua Higa
[email protected]

Ultragenyx Pharmaceutical Inc. (RARE) Presents at Bank of America Global Healthcare Conference 2026 Transcript

New York, New York--(Newsfile Corp. - June 1, 2026) - Kuehn Law, PLLC, a shareholder litigation law firm, is investigating whether certain officers and directors of Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE) breached their fiduciary duties to shareholders.

According to a federal securities lawsuit, Insiders at Ultragenyx Pharmaceutical caused the company to misrepresent or fail to disclose the true state of setrusumab's potential and the risk inherent in the study protocols put forth; notably, that, while setrusumab does increase material bone density, this increase does not correlate to a decrease in annualized fracture rates.

If you currently own RARE and purchased prior to August 03, 2023 please contact Justin Kuehn, Esq. by email at [email protected] or call (833) 672-0814. Kuehn Law pays all case costs and does not charge its investor clients. Shareholders should contact the firm immediately as there may be limited time to enforce your rights.

Why Your Participation Matters:

As a shareholder your voice matters, and by getting involved, you contribute to the integrity and fairness of the financial markets. Your investment. Your voice. Your future.™

For additional information, please visit Shareholder Derivative Litigation - Kuehn Law.

Attorney advertising. Prior results do not guarantee similar outcomes.

Contacts:
Kuehn Law, PLLC
Justin Kuehn, Esq.
53 Hill Street, Suite 605
Southampton, NY 11968
[email protected]
(833) 672-0814

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/299740

Source: Kuehn Law, PLLC

New Phase 3 MITIGATE Open-Label Extension Data Support the Long-Term Safety Profile and Sustained Results of UPLIZNA® in IgG4-RD

Real-World Evidence Supports TAVNEOS® Efficacy and Safety Profile with Reduced Steroid Use in ANCA-Associated Vasculitis

, /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of new data across rare autoimmune and inflammatory diseases at the European Alliance of Associations for Rheumatology (EULAR) 2026 Congress, taking place from June 3-6 in London.

New data from the Phase 3 MITIGATE trial of UPLIZNA® (inebilizumab) provide insights into the biology of immunoglobulin G4-related disease (IgG4-RD),1 while additional analyses support its long-term safety profile and sustained results in IgG4-RD.2 Additionally, new real-world evidence on TAVNEOS® (avacopan) further support its established efficacy and safety profile with reduced steroid use in people living with anti-neutrophil cytoplasmic antibodies (ANCA)-associated vasculitis.3

"Patients living with rare autoimmune diseases still face significant unmet medical needs despite advances in treatment, with conditions often being difficult to diagnose and challenging to manage," said Paul Burton, M.D., Ph.D., chief medical officer at Amgen. "The data we're presenting at EULAR deepen our understanding of disease biology and demonstrate the strength of our portfolio of options for patients with these conditions, reflecting our commitment to advancing the science and delivering meaningful progress for patients."

Key presentations include:

Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period (OLP) of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST

IgG4-RD is a chronic and debilitating condition, marked by recurrent, unpredictable flares that can potentially impact multiple organs.4,5 New Phase 3 MITIGATE data further support the longer-term clinical profile of UPLIZNA.

Key findings include:

In the first year of the OLP, these data demonstrated sustained results and disease control with continued UPLIZNA treatment in patients with IgG4-RD. No patients (0%) who received UPLIZNA in the randomized controlled period (RCP) and continued with UPLIZNA in the OLP (N=56) experienced a flare, and 71.4% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2 5.9% of patients who received placebo in the RCP and transitioned to UPLIZNA in the OLP (N=51) experienced a flare, and 41.2% achieved flare-free, glucocorticoid-free complete remission at year 1 of the OLP.2 Safety results were consistent with the established safety profile of UPLIZNA. The most common adverse events in the OLP were COVID-19, upper respiratory tract infection, cough and influenza.2 Across the combined RCP and OLP period, median total UPLIZNA treatment exposure was 2.2 years among participants who received ≥1 dose of inebilizumab.2 "For clinicians, a sustained reduction in flares and timely intervention are central to improving long-term outcomes," said John Stone, M.D., M.P.H., principal investigator and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair in Medicine at the Massachusetts General Hospital. "The new MITIGATE data reinforce the long-term safety and efficacy profile of UPLIZNA while advancing our understanding of how IgG4-RD progresses over time. These findings may help clinicians identify opportunities for earlier intervention and reduce avoidable flares."

Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the Phase 3 MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST

The first-of-its-kind natural history analysis reinforced the chronic and unpredictable nature of IgG4-RD, underscoring widespread and diverse multi-organ involvement and the need for earlier intervention and more comprehensive monitoring and risk stratification.

Key findings include:

Dynamic patterns of organ involvement over time, including the emergence of new organ manifestations and biological signals that may precede disease flares.1 CD19+ B cells were the first biomarker to rise ahead of a flare, followed by increases in total IgG and IgG subsets within the 30-day window preceding a flare.1 An additional exploratory combined analysis (Abstract #POS0089) of clinical trial RCP and OLP data in MITIGATE (N=119) showed how long-term use of UPLIZNA resulted in mostly mild immunoglobulin (Ig) reduction, with no significant association between these Ig reductions and occurrence of infections or serious infections. The incidence of infections and serious infections did not increase with each additional year of UPLIZNA treatment.

Real-World Evidence Supports TAVNEOS Efficacy, Safety and Reduced Steroid Use

The AQUARIUS analyses (Abstracts #POS01356 and #POS08673), conducted at Massachusetts General Hospital and Northwestern University, evaluated the largest U.S. real-world cohort to date of patients with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) treated with TAVNEOS (n=159). The findings provide new insights into clinical outcomes in patients with ANCA-associated vasculitis and are consistent with the established clinical efficacy and safety profile of TAVNEOS in patients with severe active GPA or MPA.3,6

"Real-world experience with TAVNEOS across two large healthcare systems demonstrates that many patients can achieve meaningful disease control with reduced reliance on glucocorticoids when considering prior standard-of-care glucocorticoid regimens," said Naomi Patel, M.D., rheumatologist at Massachusetts General Hospital and study investigator. "Because prolonged steroid use carries significant risks for patients, these findings are encouraging and also suggest that shorter steroid tapers (e.g., < 2 months) may reduce overall glucocorticoid exposure without compromising effectiveness outcomes."

Key findings include:

Results highlighted variability in glucocorticoids (GCs) tapering strategies in real world practice and showed that many patients were able to taper to very low or no doses of GCs quickly.3 Observations underscored the complexity of managing ANCA-associated vasculitis and pointed to opportunities to further optimize treatment approaches to reduce steroid exposure while maintaining disease control.3,6 The safety profile observed in this real-world setting was consistent with the established safety profile in patients with severe active GPA or MPA.3,6 Among patients who experienced hepatic adverse events, all hepatic abnormalities were resolved. "People living with ANCA-associated vasculitis often have limited treatment options and may rely heavily on steroids for disease control," said Joyce Kullman, executive director, Vasculitis Foundation. "Given the challenges associated with long-term steroid use, these new data reinforce that TAVNEOS can help patients achieve disease control with reduced steroid use. For the vasculitis community, this may represent a step toward reducing treatment burden over time."

For more information on the full list of Amgen abstracts and presentation times, see below.

All Amgen-sponsored abstracts being presented at EULAR:

UPLIZNA® (inebilizumab)

Long-term Efficacy and Safety of Inebilizumab in IgG4-Related Disease: Primary Results from Year 1 of the Open-Label Period of the Phase 3 MITIGATE Trial
Abstract #POS0440, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Immunogenicity and Impact of Anti-drug Antibodies on the Efficacy and Pharmacokinetics of Inebilizumab In MITIGATE, a Phase 3 Trial in IgG4-Related Disease
Abstract #POS0432, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Atypical IgG4-Related Disease: Re-Examining the Entry Criteria of the 2019 ACR/EULAR Classification Criteria
Abstract #POS0439, Poster View 1 (Poster View Presentation), Wednesday, June 3 from 3:30–4:30 p.m. BST Natural History of IgG4-RD: Patterns of Organ Involvement and Flare-associated Biomarker Changes in the MITIGATE Trial
Abstract #OP052, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 4:30–4:40 p.m. BST Serum IgG4 Elevation in IgG4-Related Disease: A Marker of Disease Phenotype and Organ Involvement
Abstract #OP056, Basic and Clinical Abstract Sessions: Insights in Other Diseases (Oral Abstract Presentation), Wednesday, June 3 from 5:10–5:20 p.m. BST Long-term Inebilizumab Treatment Results in Mild Immunoglobulin Reduction but No Increase in Infection Risk
Abstract #POS0089, Basic and Clinical Poster Tours: From Treatment to Outcome in Other Diseases (Poster Tour Presentation), Thursday, June 4 from 9:30–9:36 a.m. BST TAVNEOS (avacopan)

Reliability and Content Validity of a Definition of Severe Active Granulomatosis with Polyangiitis and Microscopic Polyangiitis
Abstract #POS0627, Poster View I (Poster View Presentation), Wednesday, 3 June at 4:20 p.m. BST Clinical Outcomes by Glucocorticoid Duration in Individuals with Granulomatosis with Polyangiitis and Microscopic Polyangiitis Treated with Avacopan in a Real-World Setting in Two Large Healthcare Systems
Abstract #POS0867, Poster View IV (Poster View Presentation), Thursday, 4 June at 4:00 p.m. BST One Year Real-World Effectiveness and Safety with Avacopan in Granulomatosis with Polyangiitis and Microscopic Polyangiitis in Two Large Healthcare Systems
Abstract #POS0135, Clinical Poster Tours: New frontiers in Small Vessel Vasculitis and Behcet's (Poster View Presentation), Thursday, 4 June from 1:36-1:42 p.m. BST KRYSTEXXA (pegloticase)

Association of Pegloticase-Induced Remission with Patient-Reported Quality of Life Outcomes in the MIRROR Randomized Controlled Trial
Abstract #POS0841, Poster View IV (Poster View Presentation), Wednesday, June 3 at 3:30 p.m. BST Reduction of Gout Flares with Pegloticase in Patients with or without Tophi at Baseline: A Post Hoc Analysis of the MIRROR Trial
Abstract #POS0421, Poster View I (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST Differences in Gout Management and Outcomes in Patients Referred From Primary Care to Rheumatology
Abstract #POS0843, Poster View IV (Poster View Presentation), Thursday, June 4 at 4:00 p.m. BST Baseline Predictors of Gout Remission During Intensive Urate-Lowering with Pegloticase: Post Hoc Analysis of the MIRROR Randomized Trial
Abstract #POS0169, Basic and Clinical Poster Tours: Advances in Gout and Crystal Disease (Poster Tour Presentation), Thursday, June 4 from 4:48–4:54 p.m. BST A Phase 4, Randomized, Double-blind Multicenter Non-inferiority Trial Evaluating the Efficacy and Safety of Intravenous Pegloticase Administered Every 4 Weeks vs Every 2 Weeks with Weekly Methotrexate
Abstract #OP0294, Basic and Clinical Abstract Session: Beyond Hyperuricemia - New Insights into Gout Detection (Oral Abstract Presentation), Friday, June 5 from 9:05–9:15 a.m. BST OTEZLA (apremilast)

Efficacy of Apremilast in Early Oligoarticular Psoriatic Arthritis by Baseline Active Joint Count: A Post Hoc Analysis of the FOREMOST Study
Abstract #POS0490, Poster View I (Poster View Presentation), Wednesday, 3 June from 3:30-4:50 p.m. BST Partner-Led Abstracts

The Sjögren's Tool for Assessing Response (STAR) Demonstrates its Ability to Accurately Detect Treatment Efficacy in 15 Recent RCTs in Sjögren's Disease
Abstract #OP0125, Clinical Abstract Sessions: Positive Clinical Trials - A New Era in Sjögren's Disease (Oral Abstract Presentation), Wednesday, 3 June from 4:40-4:50 p.m. BST About UPLIZNA® (inebilizumab)
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 IgG4-RD is unknown. After two initial infusions, patients need one dose of UPLIZNA every six months.7

About TAVNEOS® (avacopan)
TAVNEOS is an orally administered small molecule indicated as an adjunctive treatment for adult patients with severe active ANCA-associated vasculitis (GPA/MPA). It is a selective complement 5a receptor (C5aR) antagonist that targets inflammation by blocking the activity of C5a, a key driver of neutrophil activation. By inhibiting C5aR, TAVNEOS helps reduce inflammation while preserving other complement system functions. The precise mechanism by which TAVNEOS exerts its therapeutic effects in ANCA-associated vasculitis has not been fully established.8

UPLIZNA® (inebilizumab-cdon) U.S. 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).

UPLIZNA U.S. 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

TAVNEOS (avacopan) U.S. INDICATION
TAVNEOS (avacopan) is indicated as an adjunctive treatment of adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with polyangiitis [GPA] and microscopic polyangiitis [MPA]) in combination with standard therapy including glucocorticoids. TAVNEOS does not eliminate glucocorticoid use.

TAVNEOS U.S. IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Serious hypersensitivity to avacopan or to any of the excipients.

WARNINGS AND PRECAUTIONS

Hepatotoxicity: Serious cases of hepatic injury have been observed in patients taking TAVNEOS, including life-threatening events. In the postmarketing setting, vanishing bile duct syndrome (VBDS) as a consequence of liver injury, including cases with a fatal outcome, has been reported. These events occurred predominantly in Japan in patients aged 65 years and older, but VBDS may affect patients of any age or ethnicity who are receiving TAVNEOS. Obtain liver test panel before initiating TAVNEOS, every 4 weeks after start of therapy for 6 months and as clinically indicated thereafter. For patients of Japanese descent, consider more frequent laboratory testing: every 2 weeks after the start of therapy for the first 3 months, followed by laboratory testing every 4 weeks for the next 3 months of treatment, and as clinically indicated thereafter. If a patient receiving treatment with TAVNEOS presents with an elevation in alanine aminotransferase [ALT] or aspartate aminotransferase [AST] to >3 times the upper limit of normal, evaluate promptly and consider pausing treatment as clinically indicated. If AST or ALT is > 5 times the upper limit of normal (ULN), or ALT or AST > 3 times the ULN with total bilirubin > 2 times the ULN, or alkaline phosphatase ≥ 2 times the ULN, or if the patient has clinical symptoms such as jaundice or pruritus, discontinue TAVNEOS until TAVNEOS-induced liver injury is ruled out. Immediately and permanently discontinue TAVNEOS if VBDS is suspected. TAVNEOS is not recommended for patients with active, untreated, and/or uncontrolled chronic liver disease (e.g., chronic active hepatitis B, untreated hepatitis C, uncontrolled autoimmune hepatitis) and cirrhosis. Consider the risks and benefits before administering this drug to a patient with liver disease. Serious Hypersensitivity Reactions: Cases of angioedema occurred in a clinical trial, including 1 serious event requiring hospitalization. Discontinue immediately if angioedema occurs and manage accordingly. TAVNEOS must not be readministered unless another cause has been established. Hepatitis B Virus (HBV) Reactivation: Hepatitis B reactivation, including life-threatening hepatitis B, was observed in the clinical program. Screen patients for HBV. For patients with evidence of prior infection, consult with physicians with expertise in HBV and monitor during TAVNEOS therapy and for 6 months following. If patients develop HBV reactivation, immediately discontinue TAVNEOS and concomitant therapies associated with HBV reactivation, and consult with experts before resuming. Serious Infections: Serious infections, including fatal infections, have been reported in patients receiving TAVNEOS. The most common serious infections reported in the TAVNEOS group were pneumonia and urinary tract infections. Avoid use of TAVNEOS in patients with active, serious infection, including localized infections. Consider the risks and benefits before initiating TAVNEOS in patients with chronic infection, at increased risk of infection, or who have been to places where certain infections are common. ADVERSE REACTIONS

The most common adverse reactions (≥5% of patients and higher in the TAVNEOS group vs. prednisone group) were nausea, headache, hypertension, diarrhea, vomiting, rash, fatigue, upper abdominal pain, dizziness, blood creatinine increased, and paresthesia. DRUG INTERACTIONS

Avoid co-administration of TAVNEOS with strong and moderate CYP3A4 enzyme inducers. Reduce TAVNEOS dose when co-administered with strong CYP3A4 enzyme inhibitors to 30 mg once daily. Consider dose reduction of CYP3A4 substrates when co-administering TAVNEOS.  Co‑administration of avacopan and 40 mg simvastatin increases the systemic exposure of simvastatin. While taking TAVNEOS, limit simvastatin dosage to 10 mg daily (or 20 mg daily for patients who have previously tolerated simvastatin 80 mg daily for at least one year without evidence of muscle toxicity). Consult the concomitant CYP3A4 substrate product information when considering administration of such products together with TAVNEOS. TAVNEOS is available as a 10 mg capsule.

Please see Full Prescribing Information and Medication Guide for TAVNEOS.

To report a suspected adverse event, call 1-833-828-6367. You may report to the FDA directly by visiting www.fda.gov/medwatch or calling 1-800-332-1088.

About Amgen
Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, inflammatory conditions, rare diseases, heart disease and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. 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, Facebook, TikTok 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.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, Inc., Dark Blue Therapeutics, Ltd. 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, and may result in unanticipated costs, delays or failures to realize the benefits of the transactions. 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.

The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Further, any scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses.

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

References

Stone J, et al. Oral Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #OP052. Stone J, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0440. Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0867. Stone JH, Zen Y, Deshpande V. IgG4-related disease. N Engl J Med. 2012;366(6):539-551. Perugino CA, Stone JH. IgG4-related disease: an update on pathophysiology and implications for clinical care. Nat Rev Rheumatol. 2020;16(12):702-714. Patel, N, et al. Poster Presentation at European Alliance of Associations for Rheumatology (EULAR) 2026 Congress. June 3-6, 2026: Abstract #POS0135. UPLIZNA (inebilizumab) Summary of Product Characteristics (SmPC). Available at Uplizna, INN-inebilizumab. Last accessed May 2026. TAVNEOS (avacopan) Summary of Product Characteristics (SmPC). Available at Tavneos, INN-avacopan. Last accessed May 2026. KRYSTEXXA (pegloticase) Summary of Product Characteristics (SmPC). Available at Krystexxa, INN-pegloticase. Last accessed May 2026. SOURCE Amgen

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