Fortress Biotech, Inc. FBIO
Fortress Biotech, Inc. (Nasdaq: FBIO) is a dermatology drug developer. Its lead program, Emrosi (DFD-29) and Journey Medical marketed dermatology portfolio; ZYCUBO (CUTX-101), is in Phase 2 for inflammatory lesions of rosacea (Emrosi); Menkes disease (ZYCUBO). Its next catalyst on record is Triplex: topline data, Phase 2 in adults co-infected with HIV and CMV (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Triplex — topline data, Phase 2 in adults co-infected with HIV and CMV (H2 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Emrosi (minocycline MR 40 mg, DFD-29) | rosacea | small molecule | Approved |
| ZYCUBO (copper histidinate, CUTX-101) | Menkes disease | small molecule | Approved |
| Triplex | cytomegalovirus vaccine/immunotherapy (HIV/CMV co-infection; HSCT) | vaccine | Phase 2 |
| MB-109 (MB-101 CAR T + MB-108 oncolytic virus) | recurrent glioblastoma / high-grade astrocytoma | cell therapy | Phase 1 |
| ATX-04 | Pompe disease (adjunct to ERT) | small molecule | Pre-clinical |
| FB-606 | Duchenne muscular dystrophy | small molecule | Pre-clinical |
Recent results and decisions
- Aug 13, 2026mixed Primary endpoint missed in CARES overall, but prespecified kappa subgroup showed 62% improvement in survival (HR 0.38, nominal p=0.012) and 71% fewer CV hospitalizations (IRR 0.29, nominal p=0.028) vs placebo.
the drug showed clinically meaningful improvement in the prespecified subgroup and was well tolerated
Filing - Aug 13, 2026started Partner Crystalys initiated a Phase 2 study of dotinurad in difficult-to-treat gout in Q2 2026.
In the second quarter of 2026, Crystalys also announced the initiation of a Phase 2 study in difficult-to-treat gout.
Filing - Jan 13, 2026approval FDA approved ZYCUBO for Menkes disease; supporting data showed median OS 177.1 months with early treatment vs 17.6 months for external control (~80% reduction in risk of death); rare pediatric PRV granted.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Approval of ZYCUBO® (copper histidinate), the First and Only Approved Treatment for Menkes Disease in the United States
Filing
4 more on record.
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 2 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.