Amgen Inc - AMGN STOCK NEWS

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.

Amgen (NASDAQ:AMGN) presented new data for IMDELLTRA™ (tarlatamab-dlle), a first-in-class DLL3-targeting BiTE® molecule, at the 2024 World Conference on Lung Cancer. The DeLLphi-303 study showed promising results for IMDELLTRA in combination with PD-L1 inhibitors as first-line maintenance therapy in ES-SCLC. Key findings include:

- Disease control rate of 62.5% for both IMDELLTRA plus durvalumab and atezolizumab
- 9-month overall survival of 91.8% with durvalumab and 86.7% with atezolizumab
- Manageable safety profile with no new safety concerns

Extended follow-up data from the DeLLphi-301 Phase 2 study demonstrated sustained anticancer activity in previously treated ES-SCLC patients, with a 40% objective response rate and median overall survival of 15.2 months.

Amgen (NASDAQ:AMGN) has announced its participation in the 2024 Wells Fargo Healthcare Conference on Thursday, Sept. 5, 2024 at 9:30 a.m. ET. Peter Griffith, executive vice president and CFO, and Jay Bradner, executive vice president of Research and Development and CSO, will represent Amgen at the event.

The presentation will be webcast live and made available to the public, media, and investors. The webcast can be accessed on Amgen's website (www.amgen.com) under the Investors section. Amgen's Investor Relations Events Calendar provides details on presentation times and webcast links. The webcast will be archived for at least 90 days after the event for later viewing.

Amgen (NASDAQ:AMGN) is set to participate in the Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, Sept. 4, 2024, at 9:15 a.m. ET. Robert A. Bradway, Amgen's chairman and CEO, will be presenting at the event.

The presentation will be webcast live and made available to the public, media, and investors. Interested parties can access the webcast through Amgen's website (www.amgen.com) under the Investors section. The company's Investor Relations Events Calendar provides details on presentation times and webcast links.

This webcast, along with other selected presentations on Amgen's business developments, will be archived and available for replay for at least 90 days after the event.

Amgen (NASDAQ:AMGN) announced that Otezla® (apremilast) is now available in the U.S. for pediatric use, following FDA approval for treating moderate to severe plaque psoriasis in children and adolescents ages 6 and older weighing at least 20 kg. This marks the first and only FDA-approved oral medication for this condition in this patient population.

The approval was based on the SPROUT Phase 3 study, which demonstrated significant efficacy with a 33.1% sPGA response for Otezla versus 10.8% for placebo. The safety profile was consistent with that observed in adult patients. Dosage is weight-based, with 20 mg or 30 mg administered twice daily after initial titration.

This expansion of Otezla's use represents a new treatment option for younger patients with plaque psoriasis, potentially offering relief to many who previously had choices.