ENFLONSIA (clesrovimab) is a Merck & Co., Inc. program in RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season. Its PDUFA date is Mar 22, 2027, the FDA's goal date to complete review of the application. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
Indication under review: RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season. Sponsor: Merck & Co., Inc. (MRK). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
| Fund | Shares | Value at quarter end | Filing |
|---|---|---|---|
| OrbiMed Advisors | 663,400 | $85.2 million | filed August 14, 2026 |
13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.
ENFLONSIA (clesrovimab)'s PDUFA date is Mar 22, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.
No FDA decision for ENFLONSIA (clesrovimab) is in our archive yet.
In our records ENFLONSIA (clesrovimab) is under review or in development for RSV lower respiratory tract disease in children under 2 at increased risk, through their second RSV season.
Merck & Co., Inc. (MRK).
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.