Fortress Biotech Inc.
FBIO evidence brief
What we can confirm
- BioSniper Score:
- 6.6 / 10
- Market Cap:
- $84.0M
- Lead Asset:
- mb-101 (Phase 1)
What it means
What to watch
Prepared research question
What matters most for FBIO—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · FBIO
Fortress Biotech Inc. (FBIO) is a biopharmaceutical company that develops and commercializes therapies through a network of subsidiaries and partnerships, with a focus on oncology, rare diseases, and infectious diseases.
Key risk: Dependence on partners
BioSniper Score
Based on 4 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 4 pipeline candidates · 2 catalysts for Fortress Biotech Inc..
Fortress Biotech Inc. (FBIO) is a biopharmaceutical company that develops and commercializes therapies through a network of subsidiaries and partnerships, with a focus on oncology, rare diseases, and infectious diseases.
- Cash & equivalents of $196.6M as of 2026-06-30 [sec].
- Net income of -$0.5M as of 2026-06-30 [sec].
- Shareholders' equity of $164.1M as of 2026-06-30 [sec].
- Total debt of $40.0M as of 2026-06-30 [sec].
- Key pipeline assets include CAEL-101 (Phase 3 for AL amyloidosis, partnered with AstraZeneca), dotinurad (Phase 3 for gout, via Crystalys), and Triplex (Phase 2 for CMV) [sec_mda · as of 2026-08-13].
What works
- Fortress has a history of successful asset monetization, including the sale of Caelum to AstraZeneca for up to $182 million in potential payments and the sale of a Rare Pediatric Disease Priority Review Voucher for $205 million [sec_mda · as of 2026-03-31].
- The company maintains a diversified pipeline with multiple programs in late-stage development, such as CAEL-101 in Phase 3 for AL amyloidosis and dotinurad in Phase 3 for gout, which may reduce single-asset risk [sec_mda · as of 2026-08-13].
- Fortress has secured royalty streams from partnered products, including a 2.5% royalty on UNLOXCYT net sales from Sun Pharma and a 3% royalty on future net sales of dotinurad from Crystalys [sec_mda · as of 2026-08-13].
What to weigh
- Fortress reported a net loss of $0.5M as of 2026-06-30, indicating ongoing unprofitability [sec].
- The company's financial performance is heavily dependent on milestone and royalty payments from partners, which are uncertain and may not materialize as expected [sec_mda · as of 2026-08-13].
- Several key pipeline assets, such as CAEL-101 and dotinurad, are controlled by external partners (AstraZeneca and Crystalys), limiting Fortress's direct influence over their development and commercialization [sec_mda · as of 2026-08-13].
Catalyst timeline
- 2031-01-12 · Patent_Expiry · COPPER HISTIDINATE — Patent expiry for NDA211241, which may affect exclusivity for ZYCUBO.
- 2039-01-07 · Patent_Expiry · MINOCYCLINE HYDROCHLORIDE — Patent expiry for NDA219015, which may affect related product exclusivity.
Risks & what to watch (3)›
Key risks
- Dependence on partners — Key assets are controlled by AstraZeneca and Crystalys, limiting Fortress's control over development and commercialization [sec_mda · as of 2026-08-13].
- Uncertain milestone payments — Future revenue relies on milestone and royalty payments that may not be achieved [sec_mda · as of 2026-08-13].
- Net loss position — Company reported a net loss of $0.5M as of 2026-06-30, indicating ongoing unprofitability [sec].
What to watch
- Topline data from the Phase 2 Triplex trial for CMV in HIV-coinfected adults, anticipated in mid 2026 [sec_mda · as of 2026-05-14].
- Progress of the two global Phase 3 CARES trials for CAEL-101 in AL amyloidosis [sec_mda · as of 2026-08-13].
- Advancement of dotinurad Phase 3 trials (RUBY and TOPAZ) for gout, supported by Crystalys's $130 million Series B financing [sec_mda · as of 2026-08-13].
- Potential milestone payments from AstraZeneca for CAEL-101, totaling up to $295 million [sec_mda · as of 2026-08-13].
Sources: Pipeline · SEC MD&A · Generated October 10, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.67 · 0% dilution
Lead: Phase 2
4 candidates
2 upcoming, next in ~1551d
No insider transactions in the last 180 days
Catalysts
Pipeline
Financials
Short Interest
as of May 21, 2026- % of float
- 18.1%
- Days to cover
- 10.4
- Shares short
- 4,649,541
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
FBIO short interestGovernance
Frequently asked questions
What is the AI investment thesis for Fortress Biotech Inc.?
Fortress Biotech Inc. (FBIO) is a biopharmaceutical company that develops and commercializes therapies through a network of subsidiaries and partnerships, with a focus on oncology, rare diseases, and infectious diseases.
What is Fortress Biotech Inc.'s lead drug candidate?
Fortress Biotech Inc.'s most advanced tracked candidate is mb-101 (Phase 1) for recurrent or refractory glioblastoma (GBM) and other malignant brain tumors.
What is Fortress Biotech Inc.'s next catalyst?
Fortress Biotech Inc.'s next tracked catalyst is a Patent_Expiry event — "Patent_Expiry: NDA211241" — expected January 12, 2031.
Who is the CEO of Fortress Biotech Inc.?
Dr. Lindsay Allan Rosenwald M.D. is the chief executive officer of Fortress Biotech Inc. (FBIO).
Where is Fortress Biotech Inc. headquartered?
Fortress Biotech Inc. (FBIO) is headquartered in Bay Harbor Islands, FL, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.