SOPHIA Positions MacroGenics' Margetuximab For Role In HER2-Positive Breast Cancer

07 Feb 2019

• By Emily Hayes

MacroGenics' BLA for full approval in the US is under way and the company already has established a manufacturing facility in preparation for a launch.

MacroGenics Inc.'s positive Phase III SOPHIA study sets its margetuximab up for a role in treating third-line-plus HER2-positive metastatic breast cancer (mBC) with potential to expand to earlier lines and other cancers. It also bodes well for the company's antibody engineering platform.

MacroGenics reported on Feb. 6, to great fanfare, positive progression-free survival (PFS) data in SOPHIA, which tested margetuximab with chemo versus Roche's pioneering HER2 therapy Herceptin (trastuzumab) with chemo...

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In Brief: Nicox Extends Cash Runway As Kowa Advances NCX 470 In Japan

29 May 2025

• By Sushmita Panda

Eye drug is already in Phase III trials elsewhere, with results due in Q3. Nicox could earn up to a further €24.5m in milestones and royalties from Kowa alliance.

GSK’s Bet On Spero’s Oral cUTI Antibiotic Poised To Pay Off With New Phase III Data

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• By Joseph Haas

Spero and partner GSK have Phase III non-inferiority data to support approval of tebipenem as the first oral antibiotic for complicated urinary tract infections.