Amgen Inc. AMGN, -0.67% said Tuesday that the regulatory review of its supplemental new drug application seeking full approval of Lumakras resulted in a “complete response letter” from the U.S. Food and Drug Administration. A CRL means the application will not be approved in its current form. The biotechnology company said the FDA also issued a new postmarketing requirement of an additional study to support full approval, to be completed no later than February 2028. The NDA for Lumakras was based on result ...

Amgen Inc. (NASDAQ:AMGN) 6th Annual Evercore ISI HealthCONx Conference November 29, 2023 9:10 AM ET Company Participants Peter Griffith - EVP and CFO Paul Burton - Chief Medical Officer Justin Claeys - VP, IR Conference Call Participants Umer Raffat - Evercore ISI Umer Raffat It’s pleasure to have Amgen management with us today. I feel like between Sean [ph] and myself covering Amgen for, like, 14 years now, I have not seen this type of setup come up in terms of pipeline readouts for Amgen, in a long time. ...

Q3 ’23 Earnings Call Safe Harbor Statement Thispresentationcontainsforward-lookingstatementsthatarebasedonthecurrentexpectationsandbeliefsofAmgen. Allstatements,otherthanstatementsofhistoricalfact,arestatementsthatcouldbedeemedforward-looking statements,includinganystatementsontheoutcome,benefitsandsynergiesofcollaborations,orpotentialcollaborations,withanyothercompany(includingBeiGene,Ltd.orKyowaKirinCo.,Ltd.),theperformanceofOtezla®(apremilast) (includinganticipatedOtezlasalesgrowthandthetimingofnon-GAAPE ...

Amgen Inc. (NASDAQ:AMGN) Q3 2023 Earnings Conference Call October 31, 2023 8:00 AM ET Company Participants Justin Claeys - VP, IR Robert Bradway - Chairman & CEO Murdo Gordon - EVP, Global Commercial Operations Vikram Karnani - Executive, Rare Disease Business David Reese - EVP, Research & Development Peter Griffith - CFO Conference Call Participants Michael Yee - Jefferies Yaron Werber - TD Cowen Terence Flynn - Morgan Stanley Salveen Richter - Goldman Sachs Jay Olson - Oppenheimer Umer Raffat - Evercore I ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ☑ EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ☐ EXCHANGE ACT OF 1934 Commission File Number: 001-37702 Amgen Inc. (Exact name of registrant as specified in its charter) Delaware 95-3540776 (State or other jurisdiction of (I.R.S. Employer incorporation or ...

Amgen Inc. (NASDAQ:AMGN) Amgen Conference Call Following European Society for Medical Oncology Congress 2023 October 24, 2023 8:00 AM ET Company Participants David Reese – Executive Vice President-Research and Development Taofeek Owonikoko – Division Chief-Division of Hematology-Oncology, UPMC Hillman Cancer Ctr. Tarlatamab Jean-Charles Soria – Senior Vice President-Research and Development Kevin Kelly – Chair, Department of Medical Oncology, Sidney Kimmel Medical College Conference Call Participants Salvee ...

Hematology/Oncology Update ESMO 2023 SAFE HARBOR STATEMENT This presentation 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 BeiGene, Ltd. or Kyowa-Kirin Co., Ltd.), the performance of Otezla ...

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