Amgen Inc - AMGN STOCK NEWS

Amgen (NASDAQ: AMGN) has scheduled its first quarter 2025 financial results announcement for Thursday, May 1, 2025, after market close. The company will host a conference call with the investment community at 4:30 p.m. ET.

Key highlights:

• Leadership Participation: Robert A. Bradway, chairman and chief executive officer, along with other senior management team members will lead the discussion
• Public Access: The event will be accessible to news media, investors, and the general public
• Webcast Details: Live audio will be streamed on www.amgen.com under the Investors section
• Replay Availability: The webcast recording will remain accessible for at least 90 days after the event

Interested parties can find additional information about presentation times and webcast links on Amgen's Investor Relations Events Calendar on their website.

Amgen (NASDAQ: AMGN) has announced a $900 million expansion of its Ohio manufacturing facility, which will create 350 new jobs, bringing the total employment to 750 positions and total investment in Central Ohio to over $1.4 billion.

The expansion builds upon Amgen's initial entry into Ohio in June 2021, when it established a state-of-the-art biomanufacturing facility that created 400 jobs. This investment is part of Amgen's broader U.S. manufacturing strategy, which includes nearly $5 billion in direct capital expenditures since 2017, generating approximately $12 billion in additional downstream output to the U.S. economy.

The Ohio expansion enhances Amgen's global biomanufacturing network and follows the company's recent announcement of a $1 billion investment for a second manufacturing plant in Holly Springs, NC.

Amgen (NASDAQ:AMGN) announced significant breakthrough in their Phase 3 DeLLphi-304 clinical trial for IMDELLTRA® (tarlatamab-dlle), a treatment for small cell lung cancer (SCLC). The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in overall survival (OS) compared to standard-of-care chemotherapy.

The global Phase 3 trial focused on patients who progressed on or after a single line of platinum-based chemotherapy. The study compared IMDELLTRA against local standard-of-care treatments including topotecan, lurbinectedin, and amrubicin depending on the region. The safety profile remained consistent with previously known data.

Dr. Jay Bradner, Executive VP of Research and Development at Amgen, emphasized the overwhelming clinical benefit for patients with this aggressive malignancy. Detailed trial results are scheduled for presentation at an upcoming medical congress.

Amgen (NASDAQ:AMGN) has received FDA approval for UPLIZNA as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a chronic immune-mediated inflammatory condition affecting multiple organs. The FDA granted Breakthrough Therapy Designation for this indication.

The approval is supported by the MITIGATE trial, which demonstrated an 87% reduction in flare risk versus placebo. UPLIZNA, a CD19+ B-Cell targeted therapy, showed effectiveness in achieving corticosteroid-free, flare-free complete remission.

This marks UPLIZNA's second FDA-approved indication, following its June 2020 approval for NMOSD treatment. Amgen is also pursuing regulatory approval for generalized myasthenia gravis (gMG), with submission planned for H1 2025.

Amgen (NASDAQ:AMGN) announced positive 52-week data from the Phase 3 MINT trial for UPLIZNA® in treating generalized myasthenia gravis (gMG). The trial demonstrated significant improvement in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG using just two doses yearly after initial loading.

Key findings include:

• 72.3% of AChR+ patients on UPLIZNA achieved ≥3 point improvement in MG-ADL score vs 45.2% for placebo
• Significant change in baseline MG-ADL score (adjusted difference -2.8)
• 69.2% of UPLIZNA patients improved ≥3 points in QMG score vs 41.8% for placebo

The trial was notable as the first Phase 3 study for a biologic incorporating corticosteroid tapering in its protocol. No new safety concerns were identified, with common adverse events including infusion-related reactions, nasopharyngitis, and urinary tract infections. Regulatory filing is expected to complete in H1 2025.

Amgen (NASDAQ: AMGN) and Kyowa Kirin announced positive results from the ROCKET Phase 3 clinical program for rocatinlimab, their investigational therapy for moderate to severe atopic dermatitis. The IGNITE study, involving 769 adults, met all primary and secondary endpoints with statistical significance across two dose strengths.

Key results at week 24 for the higher dose group showed:

• 42.3% of patients achieved EASI-75 (29.5% difference vs placebo)
• 23.6% achieved vIGA-AD score of 0/1 (14.9% difference vs placebo)
• 22.7% achieved rIGA score of 0/1 (14.4% difference vs placebo)

The SHUTTLE study, testing rocatinlimab with topical treatments in 746 adults, also met its endpoints. Common side effects included pyrexia, chills, and headache, with gastrointestinal ulceration events occurring in less than 1% of patients. Additional studies ASCEND, ASTRO, and ORBIT are ongoing to evaluate long-term maintenance and effects in adolescent patients.

Amgen (NASDAQ:AMGN) has announced its quarterly dividend payment for Q2 2025. The company's Board of Directors has declared a dividend of $2.38 per share. The dividend will be distributed on June 6, 2025, to stockholders who are recorded in the company's books as of the close of business on May 16, 2025.

Amgen (NASDAQ:AMGN) and AstraZeneca announced positive results from the Phase 3 WAYPOINT trial for TEZSPIRE® (tezepelumab-ekko) in treating chronic rhinosinusitis with nasal polyps (CRSwNP).

The trial demonstrated significant improvements in key metrics:

• Reduced nasal polyp severity with a Nasal Polyp Score decrease of -2.065
• Improved nasal congestion with a score reduction of -1.028
• Decreased need for nasal polyp surgery by 98%
• Reduced systemic corticosteroid use by 88%

Improvements were observed as early as week two for nasal congestion and week four for polyp score, with effects sustained through week 52. The safety profile aligned with its approved severe asthma indication, with common adverse events including COVID-19, nasopharyngitis, and upper respiratory tract infection.

Amgen (NASDAQ: AMGN) has announced its participation in the 45th Annual TD Cowen Health Care Conference scheduled for March 5, 2025, at 9:10 a.m. ET. Jay Bradner, executive vice president of Research and Development, will engage in a fireside chat during the conference.

The presentation will be accessible through a live webcast available to investors, media, and the general public. The webcast can be accessed on www.amgen.com under the Investors section, along with other management presentations from investor and medical conferences. The webcast recording will remain available for replay for a minimum of 90 days following the event.