July 30 Clinical Quick Takes: Biogen, Alkermes MS candidate superior to Tecfidera; plus Amgen, Lilly and more

Biogen, Alkermes Phase III MS candidate beats Tecfidera
Biogen Inc. (NASDAQ:BIIB) and Alkermes plc (NASDAQ:ALKS) said diroximel fumarate (BIIB098) met the primary endpoint in the Phase III EVOLVE-MS-2 trial: superiority to Biogen’s Tecfidera dimethyl fumarate for reducing the number of days of self-reported GI symptoms with intensity scores ≥2 in relapsing-remitting multiple sclerosis (p=0.0003). The PDUFA date is in 4Q19. If approved, Biogen will market the small molecule prodrug of monomethyl fumarate (MMF), which has a mechanism similar to Tecfidera's, as Vumerity.

Amgen reports tumor responses for KRAS inhibitor
Amgen Inc. (NASDAQ:AMGN) reported in its 2Q19 earnings presentation Tuesday that AMG 510 led to tumor responses in colorectal and appendiceal cancer patients in a Phase I trial. Data reported in June at the American Society of Clinical Oncology (ASCO) meeting showed the G12C-mutant KRAS inhibitor led to stable disease in 13 out of 18 evaluable CRC patients. ...