Benzinga | Aug 4, 2021 02:44PM EDT

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.