📅 Calendar

FDA Calendar & Catalysts

PDUFA dates, conference catalysts, and key regulatory milestones. These are the dates you can actually circle.

February 2026 PDUFAs

This Month
Feb
21
VNDA Vanda Pharmaceuticals
Bysanti
Bipolar I depression / Schizophrenia
Feb
25
ETON Eton Pharmaceuticals
ET-600
—
Feb
28
BMRN BioMarin Pharmaceutical
Palynziq
Phenylketonuria (PKU) — adolescent expansion
Feb
28
ASND Ascendis Pharma
TransCon CNP
Achondroplasia in children

March 2026 PDUFAs

Next Month
Mar
16
ALDX Aldeyra Therapeutics
Reproxalap
—
Mar
28
RCKT Rocket Pharmaceuticals
KRESLADI
Severe Leukocyte Adhesion Deficiency-I (LAD-I)

Conference Catalysts

Feb
25–28
49th Macula Society Annual Meeting
San Diego, CA
OCUL explicitly flagged this for detailed SOL-1 data. If you're watching retina comps, this is the next "facts > vibes" moment.

Upcoming Data Catalysts

Ticker Company Catalyst Timing Notes
CMPS Compass Pathways FDA Pre-NDA Meeting Near-term Rolling submission discussion; NDA target Q4 2026
OCUL Ocular Therapeutix SOL-1 Detailed Data Feb 25–28 Macula Society; next read on wet AMD commercial thesis
HELP Helus Pharma HLP004 Phase 2 Topline (GAD) Q1 2026 Builds on SPL026 MDD learnings; new lead asset
IRON Disc Medicine Late-stage Data Q4 2026 Traditional approval path; FDA decision ~mid-2027
PLYX Polaryx Therapeutics SOTERIA Phase 2 Initiation 1H 2026 Basket trial: CLN2, CLN3, Krabbe, Sandhoff
KRYS Krystal Biotech CF FDA Trial Design Alignment 1H 2026 Hinge catalyst for pipeline value. See Pipeline Tracker