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Upcoming Infectious Disease & Vaccines FDA decisions & readouts

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET
PDUFA target dates and trial readouts in infectious disease & vaccines, each linked to its primary source. Updated from FDA/SEC/ClinicalTrials.gov; dates can shift.
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PDUFA decisions (5)

PYPD · 2026-11-28
D-PLEX100 - prevention of surgical site infections: Prevention of surgical site infections in patients undergoing abdominal colorectal surgery
INSM · 2027-01-28
ARIKAYCE (amikacin liposome inhalation suspension) - MAC lung disease (sNDA): MAC lung disease, as part of a combination antibacterial drug regimen
GILD · 2027-02-02
Yeztugo (lenacapavir) once-weekly oral: HIV pre-exposure prophylaxis (PrEP)
MRK · 2027-03-22
ENFLONSIA (clesrovimab) - second RSV season (SMART): RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season
MRK · 2027-04-22
IDVYNSO - treatment-naive HIV-1 (P053) and 96-week data (sNDAs): Adults with HIV-1 infection (treatment-naive; 96-week data in virologically suppressed adults)

Trial readouts (12)

VIR · Nov 2026 (est.)
Bulevirtide
AVIR · Dec 2026 (est.)
Bemnifosbuvir-Ruzasvir
TRAW · Dec 2026 (est.)
rigosertib
ALNY · 2026-12-31
elebsiran readout
MIRM · 2026-12-31
AZURE-1 readout
PCVX · 2026-12-31
OPUS-1 readout
SIGA · Jan 2027 (est.)
Tecovirimat Oral Capsule
COGT · Mar 2027 (est.)
CGT9486
VXRT · May 2027 (est.)
VXA-COV2-3.3
CHRS · Sep 2027 (est.)
CHS-1420
MRK · Oct 2027 (est.)
MK-8527
PCVX · 2027-12-31
VAX-31 OPUS-2 and OPUS-3 Phase 3 (adult): adult pneumococcal vaccination

Every upcoming FDA decision date, all therapeutic areas, on the 2026 PDUFA calendar · all conditions

We don't show an approval percentage for these infectious disease & vaccines catalysts: here's why.