Organogenesis Holdings Inc. ORGO
Organogenesis Holdings Inc. (Nasdaq: ORGO) is a dermatology drug developer. Its lead program, ReNu, is in Phase 3 for wound healing (type 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.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Apligraf | venous leg ulcers and diabetic foot ulcers | cell therapy | Approved |
| PuraPly AM | antimicrobial barrier for wounds | biologic-other | Approved |
| PuraPly XT | antimicrobial barrier for wounds | biologic-other | Approved |
| CYGNUS Matrix | wound healing | biologic-other | Approved |
| Affinity | wound healing and soft tissue repair | biologic-other | Approved |
| NuShield | wound healing and soft tissue repair | biologic-other | Approved |
| Dermagraft | diabetic foot ulcers | cell therapy | Approved |
| ReNu | wound healing | cell therapy | Phase 3 |
Recent results and decisions
- Aug 6, 2026n/a Organogenesis entered into an at-the-market sales agreement for up to $75 million of Class A common stock with BTIG and Citizens JMP Securities.
The Corporation may offer and sell Shares having an aggregate offering price of up to $75,000,000.
Filing
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.