Amgen Stops Phase 1 For One BiTE Molecule While Resuming Dosing For Another, Plans Second Drug Substance Plant
Amgen Stops Phase 1 For One BiTE Molecule While Resuming Dosing For Another, Plans Second Drug Substance Plant
During the latest quarterly update,Amgen Inc(NASDAQ:AMGN) disclosed that it is resuming dosing for pavurutamab (AMG 710) but halted enrollment to a trial for AMG 427. Both were BiTE molecules with extended half-lives.It said in February that it’d paused enrollment in the Phase I study for pavurutamab to discuss with the FDA “protocol modifications to optimize safety monitoring and mitigation with the FDA.”Pavurutamab is under development for relapsed or refractory multiple myeloma.Acute myeloid leukemia candidate, AMG 427, was moved into a phase 1 study in 2018. Last week, Amgen updated the ClinicalTrials.gov listing for the therapy to “active, not recruiting” without explaining the decision to stop enrolling new patients.The Company also said it would invest close to $550 million in a drug substance plant in Holly Springs, North Carolina, marking its second drug manufacturing announcement in a little more than a month.The North Carolina facility will create more than 350 jobs. Construction will start in 2021 and be completed by 2029.Amgen posted a fall in Q2 profit to $464 million from $1.80 billion a year earlier.Price Action:AMGN shares are down 6.4% at $228.44 during the market session on the last check Wednesday.
在最近的季度更新中，安進公司(納斯達克市場代碼：AMGN)披露，它正在恢復帕烏魯塔單抗(AMG 710)的劑量，但暫停了AMG 427的試驗登記。這兩種都是半衰期延長的BITE分子。該公司在2月份表示，已經暫停了Paurutamab第一階段研究的登記，以便與FDA討論“修改協議，以優化安全監測和緩解與FDA的關係”。Pavurutamab正在開發中，用於治療復發或難治性多發性骨髓瘤。急性髓系白血病候選藥物AMG427在2018年被轉移到一期研究中。上週，安進公司將該療法的ClinicalTrials.gov名單更新為“有效，而不是招募”，但沒有解釋停止招收新患者的決定。該公司還表示，將投資近5.5億美元在北卡羅來納州霍利斯普林斯(Holly Springs)的一家制藥廠，這是該公司在一個多月內第二次宣佈藥物生產。北卡羅來納州的工廠將創造350多個就業機會。建設將於2021年開工，2029年完工。安進公佈第二季度利潤從去年同期的18億美元降至4.64億美元。價格行動：在週三尾盤交易時段，AMGN股價下跌6.4%，至228.44美元。
譯文內容由第三人軟體翻譯。