Amylyx’s fortunes shift again
FDA approval of the company’s ALS project seems assured, but pledges of withdrawal on phase 3 failure come with caveats.
Go or no go? Bristol’s Tyk2 test
A green light from the FDA is expected for deucravacitinib, while Amylyx, Ferring and Oncopeptides head for panels.
Go or no go? The FDA’s Amylyx dilemma
June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.
Flotations tank in the first quarter
A correction – as long as it is not too severe – might not be a bad thing for the sector.
Amylyx faces an uphill battle
Briefing documents show why the FDA should await more data on the ALS project, but will it bow to patient pressure?