Brepocitinib is a Roivant Sciences Ltd., Roivant/Priovant program in dermatomyositis. The FDA approved it on Aug 27, 2026. 2 FDA decisions on record below. Every date links its source.
PFE catalyst hub · ROIV catalyst hub
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approvals tracked on pdufa.bio: dermatomyositis (approved Aug 27, 2026); dermatomyositis (DM) (approved Aug 27, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Roivant Sciences Ltd., Roivant/Priovant (PFE, ROIV). Market-cap tier at the time we tracked it: Large. We track 3 catalyst events for this program: 0 upcoming and 3 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 |
|---|---|---|---|
| Perceptive Advisors | 8,085,461 | $286.1 million | filed August 14, 2026 |
| Baker Bros. Advisors | 4,716,831 | $166.9 million | filed August 14, 2026 |
| Cormorant Asset Management | 475,000 | $16.8 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.
No upcoming catalyst is on our calendar for Brepocitinib; 2 FDA decisions are on record below.
On Aug 27, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Brepocitinib is FDA-approved for dermatomyositis (approved Aug 27, 2026); dermatomyositis (DM) (approved Aug 27, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Roivant Sciences Ltd., Roivant/Priovant (PFE, ROIV).
Yes. The FDA approved an application for Brepocitinib on Aug 27, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.