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Upcoming Infectious Disease & Vaccines FDA decisions & readouts

PDUFA target dates and trial readouts in infectious-disease and vaccine disease, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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Trial readouts (24)

IVVD · Aug 2026 (est.)
VYD2311 — COVID-19
MIRM · Aug 2026 (est.)
Brelovitug — Chronic Hepatitis D Infection
BIVI · Aug 2026 (est.)
NE3107 — Long COVID
AVIR · Sep 2026 (est.)
Bemnifosbuvir-Ruzasvir — HEPATITIS C VIRUS CHRONIC INFECTION
TRAW · Nov 2026 (est.)
rigosertib — Influenza
VIR · Nov 2026 (est.)
Bulevirtide — Viral Hepatitis
EVO · Nov 2026 (est.)
JST-018 — Antiviral Drug
ENTA · Dec 2026 (est.)
Zelicapavir — RSV Infection
AVIR · Dec 2026 (est.)
Bemnifosbuvir-Ruzasvir — HEPATITIS C VIRUS CHRONIC INFECTION
TRAW · Dec 2026 (est.)
rigosertib — Influenza
VIR · Dec 2026 (est.)
Tobevibart — Viral Hepatitis
ABUS · Dec 2026 (est.)
AB-729 — Chronic Hepatitis B
VIR · Dec 2026 (est.)
Tobevibart — Viral Hepatitis
NBP · 2026-H1
TJ003234 — Coronavirus Disease 2019 COVID-19
PCVX · 2026-H2
31-valent pneumococcal conjugate vaccine — Pneumococcal Vaccines
PCVX · Jan 2027 (est.)
31-valent pneumococcal conjugate vaccine — Pneumococcal Vaccines
PCVX · Mar 2027 (est.)
31-valent pneumococcal conjugate vaccine — Pneumococcal Vaccines
ALGS · Mar 2027 (est.)
ALG-000184 — Chronic Hepatitis B Infection
MIRM · Jun 2027 (est.)
BJT-778 — Chronic Hepatitis D Infection
MIRM · Aug 2027 (est.)
Brelovitug — Chronic Hepatitis D
ACXP · Sep 2027 (est.)
Ibezapolstat — Clostridium Difficile Infection Recurrence
MRK · Oct 2027 (est.)
MK-8527 — Human Immunodeficiency Virus (HIV)
ANTX · Dec 2027 (est.)
Epetraborole — Mycobacterium Abscessus Infection
PCVX · Dec 2027 (est.)
31-valent pneumococcal conjugate vaccine — Pneumococcal Vaccines
We don't show an approval percentage for these infectious disease & vaccines catalysts — here's why.