Organogenesis Holdings Inc. ORGO
Organogenesis Holdings Inc. (Nasdaq: ORGO) is a dermatology drug developer. Its lead program, Amnuvx, is in Phase 3 for wound healing (exact indication not specified). Its next catalyst on record is ReNu: PDUFA target action date (April 24, 2027).
Upcoming catalysts
- April 24, 2027ReNu — PDUFA target action date
During June 2026, the FDA accepted the BLA for review and assigned a PDUFA target action date of April 24, 2027.
Next further out: Amnuvx — Completion of Pre-License Inspection remediation (September 30, 2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Apligraf | VLUs and DFUs | cell therapy | Approved |
| Dermagraft | DFUs | cell therapy | Approved |
| PuraPly AM | various wounds | biologic-other | Approved |
| PuraPly XT | various wounds | biologic-other | Approved |
| CYGNUS Matrix | wound healing and surgical applications | biologic-other | Approved |
| Affinity | various wounds and surgical applications | biologic-other | Approved |
| NuShield | various wounds and surgical applications | biologic-other | Approved |
| AmchoThick | various wounds | biologic-other | Approved |
| PuraPly MZ | surgical wounds | biologic-other | Approved |
| PuraPly SX | surgical wounds | biologic-other | Approved |
| Amnuvx | wound healing | cell therapy | Phase 3 |
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 dermatology companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.