# June 2026 PDUFA Calendar: FDA Decision Dates & Biotech Catalysts

Canonical URL: https://biopharmsignal.com/pdufa-calendar/2026/june

BioPharmSignal tracks active PDUFA and FDA decision milestones for June 2026.

## PDUFA Events In June 2026

- 2026-06-18 — SPRO — Spero Therapeutics
  Stage: PDUFA
  Summary: Tebipenem HBr (previously SPR994): oral carbapenem treating Bacterial infection, Urinary tract infection
  Company page: https://biopharmsignal.com/company/SPRO
- 2026-06-19 — MRK — Merck
  Stage: PDUFA
  Summary: Welireg/Belzutifan (MK-6482) + Keytruda/Pembrolizumab (MK-3475) (HIF-2α/PD-1 Blockade) treating Adjuvant Clear Cell Renal Cell Carcinoma After Nephrectomy
  Company page: https://biopharmsignal.com/company/MRK
- 2026-06-20 — ACHV — Achieve Life Sciences
  Stage: PDUFA
  Summary: Cytisinicline treating Smoking cessation
  Source: https://biopharmsignal.com/news/ACHV/achieve-life-sciences-reports-first-quarter-2026-financial-results-and-provides-business-updates
  Company page: https://biopharmsignal.com/company/ACHV
- 2026-06-29 — ARQT — Arcutis Biotherapeutics
  Stage: PDUFA
  Summary: ZORYVE® (roflumilast) Cream 0.3% treating Plaque psoriasis (Ages 2 to 5)
  Source: https://biopharmsignal.com/news/ARQT/arcutis-announces-first-quarter-2026-financial-results-and-provides-business-update
  Company page: https://biopharmsignal.com/company/ARQT
- 2026-06-29 — LNTH — Lantheus Holdings
  Stage: PDUFA
  Summary: LNTH-2501 (Ga 68 edotreotide) treating Neuroendocrine tumors (NETs)
  Company page: https://biopharmsignal.com/company/LNTH
- 2026-06-29 — UNCY — Unicycive Therapeutics
  Stage: PDUFA
  Summary: Oxylanthanum Carbonate (OLC) treating Hyperphosphatemia, Chronic kidney disease
  Source: https://biopharmsignal.com/news/UNCY/unicycive-therapeutics-announces-first-quarter-2026-financial-results-and-provides-business-update
  Company page: https://biopharmsignal.com/company/UNCY
- 2026-06-30 — IONS — Ionis Pharmaceuticals, Inc.
  Stage: PDUFA
  Summary: IONIS-APOCIII-LRx (Olezarsen) treating Severe hypertriglyceridemia (sHTG)
  Company page: https://biopharmsignal.com/company/IONS
- 2026-06-30 — VRDN — Viridian Therapeutics
  Stage: PDUFA
  Summary: Veligrotug (formerly VRDN-001) treating Thyroid Eye Disease
  Company page: https://biopharmsignal.com/company/VRDN

## How To Use This Page

Use the event date, ticker, company, and stage to understand which regulatory decisions may matter during the month. Open the company page for recent news and stock context.

## FAQ

### What is listed on the June 2026 PDUFA calendar?

This page lists active BioPharmSignal PDUFA and FDA decision milestones dated in June 2026, including ticker, company, application stage, and available source context.
### Can PDUFA dates change?

Yes. FDA target action dates can move when applications, reviews, labels, or company guidance change. Use the page as a dated research aid and check source links when available.
### How is this different from LiveFeed?

The PDUFA calendar is organized by expected FDA decision date. LiveFeed is organized by newly published biotech news and company updates.