Catalyst calendar
Upcoming FDA decision dates
20 FDA decisions are expected over the next year for the biotech companies we cover; 15 have a set PDUFA date, the day by which FDA has said it will act. The next is the FDA decision on Bepirovirsen (Ionis Pharmaceuticals) on Oct 26.
Firm dates · a specific day set by the company or regulator
Next 30 days
- Oct 26in 13 daysBepirovirsen · FDA decision · Chronic hepatitis B
- Nov 1in 19 daysMitapivat · FDA decision (supplemental application) · Sickle cell disease
Next 60 days
- Nov 14in 32 daysAficamten · FDA decision (supplemental application) · Obstructive HCM
- Nov 14in 32 daysIvonescimab · FDA decision · Non-small cell lung cancer · EGFRm+ · second-line or later
- Nov 22in 40 daysDeramiocel · FDA decision · Duchenne muscular dystrophy cardiomyopathy
- Nov 28in 46 daysD-PLEX 100 · FDA decision · Surgical site infection prevention · colorectal surgery
Next 90 days
- Dec 27in 75 daysRelutrigine · FDA decision · SCN2A and SCN8A developmental and epileptic encephalopathy
- Jan 6in 85 daysANKTIVA · FDA decision (supplemental application) · NMIBC · BCG-unresponsive, papillary disease without CIS
Later
- Jan 29in 108 daysUlixacaltamide · FDA decision · Essential tremor
- Feb 4in 114 daysInfigratinib · FDA decision · Achondroplasia
- Feb 12in 122 daysTinlarebant · FDA decision · Stargardt disease (STGD1)
- Feb 27in 137 daysZipalertinib · FDA decision · EGFR ex20ins NSCLC · relapsed
- Mar 10in 148 daysNTLA-2002 · FDA decision · Hereditary angioedema
- May 8in 207 daysEncaleret · FDA decision · Autosomal dominant hypocalcemia type 1
- May 8in 207 days
Estimated timing · a month, quarter, half-year or year-end the company gave
Expected in October 2026
- October 2026
Expected in Q4 2026
- Q4 2026FDA decision on Optune Lua PMA for NSCLC brain metastases
Expected in H1 2027
- H1 2027Nomlabofusp · FDA decision · Friedreich's ataxia
- H1 2027QTORIN rapamycin · FDA decision · Microcystic lymphatic malformations
Expected in Q3 2027
- Q3 2027