# BioPharmSignal PDUFA Calendar

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

BioPharmSignal PDUFA Calendar tracks upcoming FDA target action dates and regulatory decision milestones for biotech and pharma companies.

## How To Use The Calendar

- Search by ticker to narrow the month.
- Review the date, company, stage, status, and milestone summary.
- Open the company page or source URL when more context is available.
- Pair the calendar with LiveFeed to see whether news is changing the setup before the FDA date.

## Current Month Events (2026-08)

- 2026-08-02 — REPL — Replimune Group
  Stage: PDUFA
  Status: active
  Summary: FDA granted accelerated approval to TUDRIQEV plus nivolumab. FDA granted accelerated approval for TUDRIQEV in combination with nivolumab for adults with unre...
  Source: https://ir.replimune.com/news-releases/news-release-details/replimune-announces-fda-accelerated-approval-tudriqevtm
- 2026-08-05 — MRNA — Moderna, Inc.
  Stage: PDUFA
  Status: active
  Summary: FDA approved mFLUSIVA for adults aged 50 and older. FDA granted traditional approval for adults aged 50–64 and accelerated approval for adults aged 65 and ol...
  Source: https://investors.modernatx.com/news/news-details/2026/Moderna-Receives-U-S--FDA-Approval-for-Influenza-Vaccine-mFLUSIVA/default.aspx
- 2026-08-13 — LNTH — Lantheus Holdings, Inc.
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA target action date for the MK-6240 NDA in Alzheimer's disease diagnostics.
  Source: https://investor.lantheus.com/news-releases/news-release-details/lantheus-announces-fda-acceptance-new-drug-application-mk-6240
- 2026-08-17 — BMY — BMYBristol-Myers Squibb Company
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA target action date for the iberdomide, daratumumab and dexamethasone combination NDA.
  Source: https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Iberdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx
- 2026-08-17 — MRK — Merck
  Stage: PDUFA
  Status: active
  Summary: Original PDUFA date superseded by early approval. FDA had assigned August 17 as the target action date for the supplemental applications. The agency approved...
  Source: https://www.merck.com/news/fda-grants-priority-review-for-keytruda-pembrolizumab-and-keytruda-qlex-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-with-padcev-enfortumab-vedotin-ejfv-for-cisplati/
- 2026-08-22 — CAPR — Capricor Therapeutics
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA target action date for the Class 2 resubmission of the deramiocel BLA.
  Source: https://www.capricor.com/investors/news-events/press-releases/detail/338/capricor-therapeutics-announces-establishment-of-new-pdufa
- 2026-08-23 — RARE — Ultragenyx Pharmaceutical
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA target action date for the DTX401 BLA.
  Source: https://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-announces-us-fda-acceptance-and-priority-review
- 2026-08-24 — BIIB — Biogen
  Stage: PDUFA
  Status: active
  Summary: Original PDUFA date superseded by early approval. FDA had extended the PDUFA action date from May 24 to August 24 after determining that additional informati...
  Source: https://stagemedia-us.eisai.com/2026-05-08-Update-on-FDA-Priority-Review-of-LEQEMBI-R-IQLIK-TM-lecanemab-irmb-Subcutaneous-Injection-as-a-Starting-Dose-for-Early-Alzheimers-Disease
- 2026-08-25 — JAZZ — Jazz Pharmaceuticals
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA target action date for the zanidatamab combinations sBLA.
  Source: https://investor.jazzpharma.com/news-releases/news-release-details/jazz-pharmaceuticals-announces-fda-acceptance-and-priority-0/
- 2026-08-27 — GILD — Gilead Sciences
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. PDUFA action date for the once-daily bictegravir and lenacapavir single-tablet regimen NDA.
  Source: https://www.gilead.com/news/news-details/2026/u-s--fda-grants-priority-review-of-new-drug-application-for-gileads-once-daily-hiv-treatment-of-bictegravir-plus-lenacapavir
- 2026-08-31 — PTGX — Protagonist Therapeutics Inc
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. Protagonist disclosed an August 2026 PDUFA goal month. The structured Event Date uses August 31 as the month-end representation of thi...
  Source: https://www.sec.gov/Archives/edgar/data/1377121/000110465926055629/tm2613550d1_ex99-1.htm
- 2026-08-31 — REGN — Regeneron Pharmaceuticals
  Stage: PDUFA
  Status: active
  Summary: FDA decision expected. Regeneron disclosed an August 2026 FDA target action month. The structured Event Date uses August 31 as the month-end representation o...
  Source: https://newsroom.regeneron.com/news-releases/news-release-details/garetosmab-biologics-license-application-accepted-fda-priority/