Go or no go? August FDA decisions for Axsome, Sanofi and Merck
Axsome and Sanofi face FDA verdicts in depression and Pompe disease respectively, while a Keytruda combo ups the ante in kidney cancer.
Smaller companies set for third-quarter catalysts
The third quarter will see important data for Travere, Radius and Sio Gene, among other small developers.
Go or no go? Ardelyx and Chemocentryx among those waiting FDA decisions
Big regulatory events for July include a panel for Fibrogen's roxadustat and decision time for Albireo; elsewhere, Jak inhibitor delays could persist.
Biotech’s important upcoming data
Late-stage data are expected for Apellis; Ionis and Biogen tackle ALS; and Mirati awaits combination results.
Key third-quarter readouts for big pharma
Abbvie expects more Rinvoq data in ulcerative colitis while Astrazeneca takes on myasthenia gravis, and gene therapy is in play for Pfizer and Roche.
Arcus nears crunch time for Gilead opt-in
The anti-Tigit MAb domvanalimab will generate key clinical results any day; will they be good enough for Gilead to opt in?
Go or no go? Aducanumab’s day of reckoning
Next month the FDA will determine Biogen’s fate in Alzheimer’s, while Ascendis and Novo Nordisk also await Pdufa decisions.
Validation for a drug class, and for Sanofi
If imminent results of Sanofi’s amcenestrant in Ameera-3 are positive Serds could finally see late-stage validation.
Go or no go? Apellis and Heron head for the finish line
May will see US FDA decisions for Apellis, Heron and Bristol Myers Squibb, while Provention Bio is set for a panel meeting.
