Moderna Inc.’s phase III win with its COVID-19 vaccine candidate, mRNA-1273, lifted spirits while validating the Cambridge, Mass.-based firm’s platform, as Wall Street buzzed with comparisons between the prospects that have yielded late-stage data thus far.
Arena Pharmaceuticals Inc. CEO Amit Munshi said “a cluster of patients in a single clinical site” skewed results of the phase IIb study testing etrasimod in atopic dermatitis (AD), and caused the selective S1P modulator to miss its primary endpoint.
Enthusiasm stayed high but abated somewhat throughout the day as Wall Street took in the positive interim phase III results from Biontech SE and Pfizer Inc. with the COVID-19 vaccine candidate BNT-162b2.
Talk turned skeptical well before lunchtime in the meeting of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee to consider Biogen Inc.’s aducanumab for Alzheimer’s disease, and it stayed that way until the end, when panelists voted thumbs down.
Shares of Bluebird Bio Inc. (NASDAQ:BLUE) sank 16.6%, or $9.72, to close at $48.83 as Wall Street reacted to news that the U.S. regulatory filing for Lentiglobin in sickle cell disease (SCD) will be delayed. Previously expected in the second half of next year, the filing won’t happen until late 2022.
The FDA posted briefing documents related to the Nov. 6 meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, and Wall Street’s opinion turned out decidedly mixed regarding the odds for aducanumab, the anti-amyloid beta monoclonal antibody for Alzheimer’s disease from Cambridge, Mass.-based Biogen Inc. and Eisai Co. Ltd., of Tokyo.
Despite bad news from a phase I/II dose-escalation trial in relapsed/refractory metastatic pancreatic cancer, Bellicum Pharmaceuticals Inc. is staying in the game, albeit with far fewer employees.
With avacopan’s PDUFA date in anti-neutrophil cytoplasmic antibody-associated vasculitis (ANCA vasculitis) set for next summer, Chemocentryx Inc. rolled out long-awaited, COVID-19-delayed top-line findings from the company’s phase II, 390-patient Aurora study testing the compound for hidradenitis suppurativa (HS).
