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 - May 14, 2026submitted Partner AstraZeneca disclosed regulatory submissions in the EU and Japan for anselamimab based on the prespecified CARES subgroup analysis (ex-US regulatory action).
AstraZeneca indicated that the company plans to submit the prespecified subgroup analysis from the CARES trials to regulatory authorities and disclosed regulatory submissions in the EU and Japan.
Filing
5 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.