Amgen Inc - AMGN STOCK NEWS

Amgen and AstraZeneca announced positive top-line results from the Phase 3 WAYPOINT trial of TEZSPIRE in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The trial showed statistically significant and clinically meaningful reductions in both nasal polyp size and nasal congestion compared to placebo. The study evaluated TEZSPIRE's efficacy in adults with severe CRSwNP who remained symptomatic despite standard intranasal corticosteroid treatment. The safety profile was consistent with previous findings.

Amgen (NASDAQ:AMGN) reported strong Q3 2024 financial results with total revenues increasing 23% to $8.5 billion. Product sales grew 24%, driven by 29% volume growth, partially offset by 2% lower net selling price. Ten products delivered double-digit sales growth, including Repatha, TEZSPIRE, and BLINCYTO. The company reported $1.2 billion in rare disease product sales. GAAP EPS increased 62% to $5.22, while Non-GAAP EPS rose 13% to $5.58. Free cash flow generation was $3.3 billion, up from $2.5 billion in Q3 2023. The company updated its full-year 2024 guidance, expecting total revenues between $33.0-33.8 billion.

Amgen (NASDAQ:AMGN) has announced its fourth quarter 2024 dividend payment. The company's Board of Directors has declared a dividend of $2.25 per share. Shareholders who are recorded as stockholders at the close of business on November 18, 2024, will receive the dividend payment on December 9, 2024.

Amgen (NASDAQ:AMGN) has scheduled its third quarter 2024 financial results announcement for Wednesday, October 30, 2024, after U.S. market close. The company will host a conference call at 4:30 p.m. ET featuring Chairman and CEO Robert A. Bradway and senior management. The call will be webcast live and accessible to investors, media, and the public through Amgen's website. The webcast recording will remain available for replay for at least 90 days post-event.

Amgen (NASDAQ:AMGN) presented positive Phase 3 data for UPLIZNA® (inebilizumab-cdon) in treating generalized myasthenia gravis (gMG) at AANEM 2024. The MINT study met its primary endpoint, showing a statistically significant change in MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) at Week 26. The trial included both AChR+ and MuSK+ patients, with continued improvement through Week 26. Notably, corticosteroid use was tapered down during the study.

Key secondary endpoints also showed significant improvements, including changes in QMG scores and MG-ADL scores for specific patient populations. The safety profile was consistent with previous findings. MINT is the largest placebo-controlled gMG clinical trial for a biologic therapy, enrolling 238 adults. Amgen plans to file for approval in the U.S. and other key markets based on these results.

Amgen (NASDAQ: AMGN) has partnered with actress and entrepreneur La La Anthony to share her personal journey with plaque psoriasis and encourage open dialogue between patients and doctors about the disease's impact on daily life. La La, one of over 6 million Americans with plaque psoriasis, offers an intimate look at how the condition affects her personal and professional life in a new interactive video.

The campaign aims to raise awareness about the challenges of managing plaque psoriasis and the importance of finding suitable treatment options. La La emphasizes the need for patients to be vocal about how treatments impact their lifestyle. The initiative also highlights that plaque psoriasis is an autoimmune disease starting with internal inflammation, not just a skin condition.

Amgen's partnership with La La Anthony supports their commitment to helping plaque psoriasis patients access affordable treatment options, including Otezla® (apremilast), an oral medication that addresses underlying inflammation.

Amgen (NASDAQ:AMGN) announced that TEPEZZA® (teprotumumab) has been approved in Japan for the treatment of active Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare. TED is a serious, progressive autoimmune disease affecting approximately 25,000 - 35,000 people in Japan. TEPEZZA is the first and only medicine approved in Japan to treat active TED.

The approval was based on the positive results of the OPTIC-J Phase 3 study, where 89% of patients treated with TEPEZZA showed clinically meaningful improvement in proptosis compared to 11% with placebo. TEPEZZA received orphan drug designation in Japan, allowing for a faster regulatory review. A separate trial for chronic TED patients in Japan is ongoing.

This marks TEPEZZA's first approval in Asia, offering a nonsurgical and nonsteroidal option that treats a root cause of TED. TEPEZZA is also approved in the United States, Brazil, and Saudi Arabia, and is under review in Europe, Canada, and Australia.

Amgen (NASDAQ:AMGN) has announced a webcasted conference call for the investment community on Tuesday, September 24, 2024, at 1:30 p.m. PT. The call will focus on discussing new topline clinical data from the rocatinlimab (AMG 451/KHK4083) and UPLIZNA® (inebilizumab-cdon) Phase 3 programs.

Jay Bradner, executive vice president of Research and Development and chief scientific officer at Amgen, along with other team members, will participate in the call. The webcast will be accessible to news media, investors, and the general public via Amgen's website at www.amgen.com under the Investors section.

The webcast will be archived and available for replay for at least 90 days after the event. Information about presentation times, webcast availability, and links can be found on Amgen's Investor Relations Events Calendar.

Amgen (NASDAQ: AMGN) announced new data presentations at the European Society for Medical Oncology (ESMO) Congress 2024, showcasing its oncology pipeline and portfolio. Key presentations include:

1. Phase 1b study results of LUMAKRAS® plus Vectibix® with FOLFIRI for first-line KRAS G12C-mutated metastatic colorectal cancer.

2. Phase 1 data on AMG 193, an MTA-cooperative PRMT5 inhibitor, selected for a presidential symposium.

3. First-in-human study of xaluritamig for metastatic castration-resistant prostate cancer.

The presentations cover various cancer types, including colorectal, lung, prostate, and gastric cancers, using molecularly targeted therapies. This diverse data set reflects Amgen's strategy to advance multiple modalities for difficult-to-treat cancers, showcasing their leadership in oncology research.