Catalyst calendar

Biotech catalysts in November 2026

12 catalysts are dated to November 2026, including 5 FDA decisions. The first with a set day is the FDA decision on Mitapivat (supplemental application) (Agios Pharmaceuticals) on Nov 1. Events placed only in a quarter or half-year are on the 90-day calendar.

Firm dates · a specific day set by the company or regulator

Next 30 days

Nov 1
in 19 days
Mitapivat · FDA decision (supplemental application) · Sickle cell disease
Agios Pharmaceuticals (AGIO)·Source
Nov 1
in 19 days
Neflamapimod · Phase 2a interim results · Nonfluent variant primary progressive aphasia
CervoMed (CRVO)·Source
Nov 8
in 26 days
Velinotamig · Phase 1 results · Autoimmune diseases
Cullinan Therapeutics (CGEM)·Source

Next 60 days

Nov 14
in 32 days
Aficamten · FDA decision (supplemental application) · Obstructive HCM
Cytokinetics (CYTK)·Source
Nov 14
in 32 days
Ivonescimab · FDA decision · Non-small cell lung cancer · EGFRm+ · second-line or later
Summit Therapeutics (SMMT)·Source
Nov 18
in 36 days
AI-Immunology · Results · Autoimmune diseases
Evaxion (EVAX)·Source
Nov 22
in 40 days
Deramiocel · FDA decision · Duchenne muscular dystrophy cardiomyopathy
Capricor Therapeutics (CAPR)·Source
Nov 27
in 45 days
BBP-418 · NDA accepted for review · LGMD2I/R9
BridgeBio Pharma (BBIO)·Source
Nov 28
in 46 days
D-PLEX 100 · FDA decision · Surgical site infection prevention · colorectal surgery
PolyPid (PYPD)·Source

Estimated timing · a month, quarter, half-year or year-end the company gave

Expected in November 2026

early November 2026
EQ504 · Phase 1 start · Ulcerative colitis
Equillium (EQ)·Source
November 2026
CMS final Medicare payment determination for EsoGuard
Lucid Diagnostics (LUCD)·Source
November 2026
PGN-EDODM1 · Phase 2 results (FREEDOM2) · Myotonic dystrophy type 1
PepGen (PEPG)·Source