AMGEN (AMGN) Company Report

The FDA granted accelerated approval to Bayer’s Hyrnuo for adults with locally advanced or metastatic non-squamous NSCLC harboring rare HER2 mutations, showing 71% objective response rate in patients without prior HER2-targeted therapy and 38% in those previously treated with HER2-targeting ADCs.
Bayer estimates up to 84,000 U.S. patients are diagnosed annually with NSCLC harboring HER2 mutations, highlighting Hyrnuo’s market potential.
The FDA also approved a companion diagnostic by Life Technologies to identify eligible patients for Hyrnuo treatment.
The FDA granted full approval to Amgen’s Imdelltra for extensive-stage small cell lung cancer after progression on platinum-based chemotherapy, demonstrating a 40% reduction in risk of death and over five months survival extension versus standard chemotherapy.

2 days ago

Morningstar

Amgen gains FDA full approval for IMDELLTRA in ES-SCLC

AMGN

Product Launch

The FDA granted full approval to IMDELLTRA® (tarlatamab-dlle) for adult patients with extensive-stage small cell lung cancer after platinum-based chemotherapy.
Phase 3 DeLLphi-304 showed a 40% risk reduction in death (median OS: 13.6 vs 8.3 months; HR 0.60; P < 0.001) compared to standard chemotherapy.
NCCN updated its guidelines to include tarlatamab as the only Category 1 preferred treatment option in this setting.
Safety in DeLLphi-304: fewer Grade ≥ 3 adverse events with IMDELLTRA (54% vs 80%); CRS was primarily low grade with no Grade 4 or 5 events.

2 days ago

Press Release

Amgen sees unmet needs driving interest in new TED therapies

AMGN

Physicians recognize Tepezza as a major advance in active thyroid eye disease but note remaining gaps for patients with milder disease or treatment contraindications.
Concerns over hearing loss, cost, and access fuel demand for alternative treatment modalities and earlier intervention.
Subcutaneous Tepezza SC, slated for a 2026 launch, is preferred for its convenience and potential to expand patient eligibility.
Emerging agents—linsitinib, veligrotug, efgartigimod, and satralizumab—are gaining traction for their novel mechanisms and safety profiles.
Most specialists anticipate further Tepezza uptake in the next six months and a moderate-to-high impact from new therapies over three to five years.

Nov 12, 2025, 2:25 PM

Press Release

Immix Biopharma appoints CCO to lead NXC-201 launch

AMGN

Management Change

Hiring

Product Launch

Michael Grabow named Chief Commercial Officer to drive U.S. launch and commercial build-out of NXC-201 for relapsed/refractory AL Amyloidosis.
Grabow brings over 25 years of biopharmaceutical commercialization experience, including leading the go-to-market strategy and launch of MODEYSO® at Chimerix.
NXC-201 is a BCMA-targeted CAR-T cell therapy with a digital filter, has RMAT and Orphan Drug Designation in the U.S. and EU, and is being evaluated in the registrational NEXICART-2 Phase 1/2 trial.

Nov 12, 2025, 1:45 PM

Press Release

Metagenomi reports Q3 2025 results and pipeline prioritization

AMGN

Earnings

CEO Change

Board Change

$184.1 million in cash, cash equivalents and marketable securities as of September 30, 2025, expected to support operations into 4Q 2027.
25% workforce reduction and strategic refocus on the wholly-owned MGX-001 hemophilia A program and select cardiometabolic collaborations.
MGX-001 preclinical data demonstrated curative FVIII activity in non-human primates; pre-IND meeting slated for 4Q 2025 and IND/CTA submissions in 4Q 2026.
Jian Irish appointed as CEO, Willard Dere as Board Chair, with founder Brian Thomas remaining on the Board.

Nov 11, 2025, 9:02 PM

Press Release

Amarin highlights REDUCE-IT aspirin analysis showing VASCEPA’s cardiovascular benefits

AMGN

Post hoc analysis of REDUCE-IT shows icosapent ethyl reduced primary adverse CV events by 28% (ARR 5.9%, NNT 17) in baseline aspirin users (n=6,179; P<0.0001)
Total (first + subsequent) primary endpoint events in aspirin users were cut by 36% (RR 0.64; 95% CI: 0.56–0.74; P<0.0001)
In the secondary prevention subgroup (n=4,867 aspirin users), icosapent ethyl reduced total primary events by 39% (RR 0.61; 95% CI: 0.53–0.70; P<0.0001)
Safety profile in aspirin users mirrored the overall study, with no incremental safety concerns identified
FDA’s updated fibrate labeling confirms neutral CV benefit with statins, highlighting the need for therapies like VASCEPA for residual risk reduction

Nov 9, 2025, 9:15 PM

Press Release

Amgen reports Repatha reduces first major cardiovascular events by 25%

AMGN

In the Phase 3 VESALIUS-CV trial of over 12,000 high-risk adults without prior heart attack or stroke, Repatha achieved a 25% relative reduction in first major adverse cardiovascular events (3-P MACE) and a 36% reduction in heart attack risk versus placebo.
In a lipid sub-study, median LDL-C levels were lowered to 45 mg/dL with Repatha compared to 109 mg/dL on placebo.
No new safety signals were identified and tolerability remained consistent with current U.S. prescribing information.

Nov 8, 2025, 3:15 PM

Press Release

Xencor reports Q3 2025 financial results

AMGN

Earnings

Ended Q3 with $633.9 M in cash, cash equivalents and marketable securities, down from $706.7 M at December 31, 2024.
Q3 revenue of $21.0 M vs $17.8 M in Q3 2024; net loss narrowed to $6.0 M (–$0.08 per share) from $46.3 M (–$0.72).
R&D and G&A expenses were $54.4 M and $14.2 M, respectively, compared to $58.2 M and $14.8 M in the prior year period.
Other income rose to $41.5 M in Q3 from $7.8 M, driven primarily by unrealized gains on marketable equity securities.
Maintains guidance to end 2025 with $570 M–$590 M in cash and equivalents, funding operations into 2028.

Nov 5, 2025, 9:01 PM

Press Release

Amgen reports Q3 2025 results

AMGN

Earnings

Guidance Update

Product Launch

Amgen delivered 12% year-over-year revenue growth to $9.6 billion, with 14% volume growth, maintained a 47% Non-GAAP operating margin, and generated $4.2 billion in free cash flow.
Raised full-year 2025 guidance to $35.8 billion–$36.6 billion in revenues and $20.60–$21.40 in non-GAAP EPS.
Repatha sales grew 40% to $794 million and EVENITY grew 36% to $541 million in Q3; launched AmgenNow offering Repatha at $239/mo (~60% below list).
Advanced pipeline: VESALIUS-CV trial met dual primary MACE endpoints (full results at AHA); MariTide phase 3 studies fully enrolled (~5,000 patients); Imdelltra submission accepted with PDUFA date Dec 18, 2025.

Nov 4, 2025, 9:30 PM

Transcript

Amgen reports Q3 2025 results

AMGN

Earnings

Guidance Update

New Projects/Investments

Revenues of $9.6 billion, up 12% YoY, driven by 14% volume growth; 16 products grew double digits and 14 are annualizing at over $1 billion in sales.
Delivered a 47% non-GAAP operating margin and $4.2 billion free cash flow, and raised full-year guidance to $35.8–$36.6 billion in revenues and $20.60–$21.40 non-GAAP EPS.
Key franchise performance: Repatha sales of $794 million (+40%), annualizing at ~$3 billion; Evenity $541 million (+36%); Prolia $1.1 billion (+9%); biosimilars up >50%, annualizing ~$3 billion.
Advanced pipeline milestones: Vesalius CV trial met dual MACE endpoints; Tezspire approved in CRSwNP; PDUFA dates set for Uplizna in GMG (Dec 14) and Imdelltra in small cell lung cancer (Dec 18); MariTide, Olpasiran, and Xaliritamab progressing in phase 3.
Investing in growth and returns: 2025 capex of $2.2–$2.3 billion, over $3 billion in U.S. manufacturing investments, $6 billion debt retired YTD, and Q3 dividend up 6% to $2.38 per share.

Nov 4, 2025, 9:30 PM

Transcript

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