Last updated
Revenue
R&D Expenses
Operating CF
Total Assets
Total Liabilities
Equity
Shares Out.
D/E Ratio
Dilution Watch
Financials
52W LOW $2.0052W HIGH $4.53
Volume
146.20 K
Value Traded
1.46 M
Short % Float
22.17%
-1.45%Week
-24.72%1 Month
-37.99%3 Month
-15%6 Month
-95.25%5 Year
-97.72%All Time
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Market Cap
68.04 M
EPS (TTM)
3.35
P/E Ratio
0.61
Ent. Value
-93.54 M
Total Shares
33.35 M
Float Shares
23.04 M
Insiders
30.90%
Institutions
22.71%
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA 2026 | Example Drug Treatment for example condition requiring FDA review | Phase 3 | Small Molecule | Oncology | - |
PoA blends historical approval base rates, trial design score and FDA review track record.
FBIO Catalyst Timeline
Dated clinical, regulatory and corporate events for Fortress Biotech, Inc.
Catalyst Timeline
Dated clinical, regulatory & corporate events for Fortress Biotech, Inc.
699Total events
8Upcoming
216Tier-1 (high impact)
2011 to 2032Coverage
Upcoming catalysts 2
Event history 50
●R&D DayPresentation
Fortress Biotech corporate overview presentation at H.C. Wainwright 28th Annual Global Investment Conference
●R&D DayPresentation
Journey Medical to participate in Lake Street BIG10 Conference (1x1 meetings)
◆Oral PresentationPresentation
Fortress Biotech to participate in fireside chat at A.G.P. Annual Virtual Healthcare Conference
▲FDA ApprovalZYCUBOApprovedFDA Decision
FDA approval of ZYCUBO for Menkes disease
Menkes diseasesource ↗
▲PRV SoldDesignation
Cyprium Therapeutics closed sale of Rare Pediatric Disease Priority Review Voucher for $205 million
◆Oral PresentationPresentation
Fortress Biotech to participate in fireside chat at H.C. Wainwright 2nd Annual Royalty Company Virtual Conference
▲Trial Initiationdotinurad+ allopurinolApprovedTrial
Initiation of Phase 2 study in difficult-to-treat gout
difficult-to-treat goutsource ↗
▲Subgroup AnalysisanselimabClinical Data
Additional prespecified subgroup analyses for anselimab in kappa predominant light chain isotype
AL amyloidosissource ↗
▲PRV SoldDesignation
Cyprium Therapeutics closes sale of Rare Pediatric Disease Priority Review Voucher for $205 million
▲Partnership / LicenseATX-04Corporate
Avenue Therapeutics enters exclusive worldwide license agreement with Duke University for ATX-04
Pompe diseasesource ↗
▲PRV SoldDesignation
Cyprium Therapeutics enters agreement to sell Rare Pediatric Disease Priority Review Voucher for $205 million
◆PDUFA DateCUTX-101ApprovedRegulatory Filing
PDUFA target action date set for CUTX-101 NDA
Menkes diseasesource ↗
▲FDA ApprovalZYCUBOApprovedFDA Decision
FDA approval of ZYCUBO for Menkes disease
Menkes diseasesource ↗
▲PRV GrantedZYCUBOApprovedDesignation
Rare Pediatric Disease Priority Review Voucher granted at approval
Menkes diseasesource ↗
▲FDA ApprovalZYCUBOApprovedFDA Decision
FDA approval of ZYCUBO (copper histidinate) for Menkes disease in pediatric patients
Menkes diseasesource ↗
▲PRV GrantedZYCUBOApprovedDesignation
Rare Pediatric Disease Priority Review Voucher issued upon ZYCUBO approval
Menkes diseasesource ↗
●EU MAA SubmissionanselimabEx-US Regulatory
AstraZeneca submitted regulatory application for anselamimab in EU
●PMDA MilestoneanselimabEx-US Regulatory
AstraZeneca submitted regulatory application for anselamimab in Japan
▲FDA Filing AcceptedCUTX-101ApprovedRegulatory Filing
FDA accepts Class 1 resubmission of CUTX-101 NDA
Menkes diseasesource ↗
●NDA SubmissionCUTX-101ApprovedRegulatory Filing
Sentynl resubmitted revised NDA for CUTX-101
Menkes diseasesource ↗
▲AcquiredUNLOXCYTApprovedCorporate
Checkpoint Therapeutics acquired by Sun Pharma; Fortress receives ~$28M at closing
oncologysource ↗
▲Full ResultsEmrosiApprovedClinical Data
New pooled Phase 3 data analysis presented at Fall Clinical demonstrating Emrosi's superiority over Oracea and placebo
rosaceasource ↗
●Trial Initiationdotinurad+ allopurinolApprovedTrial
Dotinurad advancing in two Phase 3 clinical trials for gout
goutsource ↗
▲First Patient Doseddotinurad+ allopurinolApprovedTrial
First patients dosed in Phase 3 RUBY study of dotinurad for hyperuricemia associated with gout
goutsource ↗
▼Complete Response LetterCUTX-101ApprovedFDA Decision
FDA issued Complete Response Letter for CUTX-101 NDA
Menkes diseasesource ↗
▼Complete Response LetterCUTX-101ApprovedFDA Decision
FDA issued CRL for CUTX-101 NDA
Menkes diseasesource ↗
◆Oral PresentationPresentation
Corporate overview presentation at H.C. Wainwright 27th Annual Global Investment Conference
▲FDA Filing AcceptedCUTX-101ApprovedRegulatory Filing
FDA accepted NDA filing for priority review of CUTX-101
Menkes diseasesource ↗
◆PDUFA DateRegulatory Filing
PDUFA action date for a third recently approved medicine in Q3 2025
◆Timing GuidancePresentation
Up to three regulatory approvals on NDAs and BLAs in next 12 months
◆Timing GuidanceDFD-29ApprovedPresentation
Potential NDA approval for DFD-29 within next 12 months
◆Timing GuidancecosibelimabFiledPresentation
Potential BLA approval for cosibelimab within next 12 months
◆Timing GuidanceCUTX-101ApprovedPresentation
Potential NDA approval for CUTX-101 within next 12 months
▲AcquiredCorporate
Checkpoint Therapeutics acquired by Sun Pharma; Fortress received ~$28M at closing
Past FDA Catalysts and PDUFA Decisions
How FBIO actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| 2026-01-13 | CUTX-101 (copper histidinate) | PDUFA Date Approved | PDUFA |
Reaction: 30 trading days around the event · Event Move: close to close on decision day · Best Trade: peak run-up from entry 10 days before the decision
Drug Pipeline Intelligence
D28 / 100
Pipeline Score
$10M
Pipeline Value
$69M
Commercial Value
Fair Value
Valuation Signal
3
Drugs Scored
0.5x
rNPV / MCap
Top 75%
Micro Cap(rank 494 of 658)
Percentile Rank
Fortress Biotech, Inc. faces pipeline headwinds (28/100), with $206M risk-adjusted pipeline value, led by CK-101 in Lung Neoplasms (Phase 1).
Commercial products (revenue basis: trailing 4 quarters of total revenue (10-K and 10-Q), to Jun 2026; product lines: last four quarters to Jun 2026 (10-K and 10-Q)) Revenue $68.5M x 1.0 = $69M
| Product | Revenue | Prior period | Change |
|---|---|---|---|
| Emrosi | $24M | - | - |
| Qbrexza | $23M | $25M | -9.2% |
| Accutane | $13M | $15M | -16.2% |
| Foam Franchise Products | $5M | - | - |
| Eurax | $0M | - | - |
| Drug | Indication | Phase | PTRS | rNPV | Status | Enroll | Velocity | Design | Est. Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|
| CK-101 Small moleculeCompletedNCT02926768 | Lung Neoplasms | Phase 1 | COMPLETED | 136 | Jun 1, 2022 |
Clinical Trial Results
Readouts, endpoints and source filings for every FBIO program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
| DFD-29 | Phase 3 | 2023-08-14 | Positive topline results from two Phase 3 clinical trials evaluating DFD-29 demonstrated achievement of co-primary and all secondary endpoints versus placebo and Oracea (doxycycline) with no significant safety issues.Read More | Fortress Biotech Reports Second Quarter 2023 Financial Results and Recent Corporate Highlights Total net revenue was $17.4 million in the second quarter of 2023, a 40% increase from $12.4 million in the first quarter of Read More |
Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Jin DavidOfficer (Chief Financial Officer) | Grant/Award | 2,967 1,251,571 held | $2.18 | 04/01/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in FBIO
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| Opaleye Management Inc. | 0.2 % (-50 %) | 2.72 M | 890.00 K | -14.59% ( -152.00 K) |
FBIO Institutional Ownership Trends
Options Data
Option Volume
Open Interest
Call OI
Put OI
Put-Call Ratio
OI 30-day avg
Today vs avg
Option Volume
Call Vol
Put Vol
Put-Call Ratio
Vol 30-day avg
Today vs avg
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2026-11-20 | ||||||||||||
Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
CallsPutsLog scale
Competitive positioning
How FBIO ranks across every disease it competes in
Competitive Position is a premium feature
See how FBIO ranks against every competitor across each disease it develops in: phase, best drug, trials and likelihood of approval.
Start free trialFBIO News
FBIOJourney Medical Corporation to Participate in September 2026 Investor Conferences
Journey Medical Corporation will participate in two investor conferences in September 2026. CEO Claude Maraoui will represent the company at the Lake Street Capital Markets 10th Annual Best Ideas Growth Conference and the H.C. Wainwright 28th Annual Global Investment Conference. A webcast of the H.C. Wainwright presentation will be available on the company's website.
Read more →FBIOFortress Biotech to Present at the H.C. Wainwright 28th Annual Global Investment Conference
Fortress Biotech, Inc. will present a corporate overview at the H.C. Wainwright 28th Annual Global Investment Conference. The presentation will be available for on-demand viewing starting September 11, 2026. Additionally, the company will participate in one-on-one meetings during the conference from September 14-16, 2026, highlighting its commitment to engaging with investors.
Read more →FBIOFortress Biotech Reports Second Quarter 2026 Financial Results and Recent Corporate Highlights
Fortress Biotech reported a 14% increase in net revenue for Q2 2026, totaling $18.7 million. The company highlighted significant advancements, including Crystalys Therapeutics' $130 million financing for dotinurad and Journey Medical's expansion of Emrosi's payer access. However, Fortress also reported a net loss of $(2.5) million and noted that anselamimab did not meet its primary endpoint in a clinical trial.
Read more →FBIOFortress Biotech and Subsidiary Urica Therapeutics Announce Crystalys Therapeutics’ $130 Million Series B Financing
Urica Therapeutics, a subsidiary of Fortress Biotech, announced the closure of a $130 million Series B financing for Crystalys Therapeutics. This funding will support the late-stage clinical development of dotinurad, an oral URAT1 inhibitor for gout. The financing aims to facilitate ongoing clinical trials and commercialization efforts, potentially benefiting millions of gout patients.
Read more →FBIOFortress Biotech to Participate in A.G.P.’s Annual Virtual Healthcare Conference
Fortress Biotech, Inc. will participate in A.G.P.'s Annual Virtual Healthcare Conference on May 20, 2026. CEO Lindsay A. Rosenwald will engage in a fireside chat during the event. Fortress focuses on acquiring and advancing biopharmaceutical assets to enhance shareholder value through various revenue streams.
Read more →FBIOFortress Biotech Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
Fortress Biotech announced its financial results for Q1 2026, reporting a net income of $108.4 million and the FDA approval of ZYCUBO for the treatment of Menkes disease. The company also highlighted the successful sale of its Rare Pediatric Disease Priority Review Voucher for $205 million. With ongoing development initiatives and expectations for increased royalty revenue, Fortress is strategically positioned to enhance shareholder value. CEO Lindsay A. Rosenwald emphasized the company’s focus on strengthening its balance sheet and expanding its pipeline through acquisitions.
Read more →FBIOJourney Medical Corporation Reports First Quarter 2026 Financial Results and Recent Corporate Highlights
Journey Medical Corporation reported a 21% increase in revenues for Q1 2026, totaling $16.0 million, driven by strong sales of Emrosi®. The company narrowed its net loss to $2.2 million, reflecting improved financial performance. With a cash position of $27 million, Journey Medical is well-positioned for future growth, especially with expanding prescription demand for Emrosi®.
Read more →FBIOFortress Biotech to Participate in the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference
Fortress Biotech, Inc. will participate in the H.C. Wainwright 2nd Annual Royalty Company Virtual Conference on May 6, 2026. CEO Lindsay A. Rosenwald will engage in a fireside chat at the event. Fortress Biotech focuses on acquiring and advancing biopharmaceutical assets to enhance shareholder value through various revenue streams.
Read more →FBIO▼ -11.5%on this news
Fortress Biotech Reports 2025 Financial Results and Recent Corporate Highlights
Fortress Biotech reported significant financial results for 2025, highlighting the FDA approval of ZYCUBO® for Menkes disease and the $205 million sale of a Rare Pediatric Disease Priority Review Voucher. The acquisition of Checkpoint Therapeutics by Sun Pharma further strengthens Fortress's revenue model. Additionally, the progression of dotinurad into Phase 3 indicates ongoing advancements in their clinical portfolio.
Read more →FBIOFortress Biotech’s Subsidiary Cyprium Therapeutics Closes Sale of Rare Pediatric Disease Priority Review Voucher for $205 Million
Fortress Biotech's subsidiary, Cyprium Therapeutics, has successfully sold its Rare Pediatric Disease Priority Review Voucher for $205 million. This transaction is expected to provide significant financial benefits to Fortress, allowing for further investments in its diverse portfolio. The sale follows recent FDA approvals for multiple products, highlighting the company's growth and strategic direction.
Read more →FBIOUPDATE: Fortress Biotech’s Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
Fortress Biotech's subsidiary, Cyprium Therapeutics, has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher for $205 million. This transaction follows the FDA approval of ZYCUBO for Menkes disease. Cyprium will also receive royalties and milestone payments from Sentynl Therapeutics, which has taken over ZYCUBO's commercialization.
Read more →FBIOFortress Biotech’s Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
Fortress Biotech's subsidiary, Cyprium Therapeutics, has entered into a definitive agreement to sell its Rare Pediatric Disease Priority Review Voucher for $205 million. This PRV was awarded following the FDA approval of ZYCUBO for Menkes disease. Cyprium is also set to receive tiered royalties and milestone payments from Sentynl Therapeutics, which has taken over ZYCUBO's commercialization. The transaction is subject to customary closing conditions.
Read more →FBIOAvenue Therapeutics Enters into Exclusive Worldwide License Agreement for ATX-04 for the Treatment of Pompe Disease
Avenue Therapeutics has secured an exclusive worldwide license for ATX-04, a selective β2-adrenergic agonist, from Duke University. This drug, currently in clinical development for Pompe disease, has shown significant improvements in muscle function and response to enzyme replacement therapy. The agreement allows Avenue to advance ATX-04 through late-stage clinical development, with potential applications in related neuromuscular conditions.
Read more →FBIOFortress Biotech's Subsidiary Cyprium Therapeutics Enters into Agreement to Sell Rare Pediatric Disease Priority Review Voucher for $205 Million
Fortress Biotech's subsidiary, Cyprium Therapeutics, announced a $205 million agreement to sell a Rare Pediatric Disease Priority Review Voucher after receiving FDA approval for its drug, ZYCUBO, for Menkes disease. The sale demonstrates Cyprium's ability to execute value-generating corporate transactions and signals the company's ongoing progress in developing therapies for rare diseases. Insights from Fortress CEO Lindsay Rosenwald highlight the company’s strong position following three FDA approvals in the past 15 months. The transaction is subject to customary closing conditions.
Read more →FBIO▼ -7.1%on this news· ran to -22% by day 1
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
Fortress Biotech and Cyprium Therapeutics have announced the FDA approval of ZYCUBO (copper histidinate) as the first treatment for Menkes disease in pediatric patients. The approval includes a Rare Pediatric Disease Priority Review Voucher, which will be transferred to Cyprium. ZYCUBO has demonstrated significant improvements in overall survival rates for treated patients compared to untreated controls. However, the treatment carries risks of copper accumulation and various adverse reactions.
Read more →FBIO▲ +13.3%on this news
Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission
Fortress Biotech and Cyprium Therapeutics announced the FDA's acceptance of the NDA resubmission for CUTX-101, aimed at treating Menkes disease in children. The resubmission is classified as Class 1, with a PDUFA action date set for January 14, 2026. The NDA follows a complete response letter from the FDA that raised concerns about manufacturing compliance but did not question the drug's efficacy or safety.
Read more →FBIO▲ +13.3%on this newsshared move
Fortress Biotech and Cyprium Therapeutics Announce FDA Acceptance of CUTX-101 NDA Resubmission New PDUFA Target Action Date of January 14, 2026 set by FDA
Fortress Biotech, Inc. and its subsidiary Cyprium Therapeutics announced the FDA's acceptance of the NDA resubmission for CUTX-101, intended for treating Menkes disease. The new PDUFA target action date is set for January 14, 2026. Sentynl Therapeutics, having taken over the development responsibilities, resubmitted the NDA after addressing previous compliance concerns. The therapy shows promise, demonstrating significant improvements in survival for pediatric patients, while the collaboration could yield substantial financial benefits for Cyprium.
Read more →FBIO▲ +5.2%on this news
Fortress Biotech Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights
Fortress Biotech reported promising financial results for Q3 2025, with a 20.5% increase in net revenue to $17.6 million compared to the previous year. Significant corporate highlights include the acquisition of Checkpoint Therapeutics by Sun Pharma, bringing Fortress ~$28 million and potential future royalties. The company is also advancing dotinurad in two Phase 3 trials and is poised to resubmit a New Drug Application for CUTX-101. Despite these positives, Fortress faces uncertainties related to future revenue streams and product development phases.
Read more →FBIOFortress Biotech and Subsidiary Urica Therapeutics Announce First Patients Dosed in Crystalys Therapeutics’ Global Phase 3 Trials of Dotinurad for the Treatment of Gout
Fortress Biotech's subsidiary, Urica Therapeutics, has initiated Phase 3 trials for dotinurad, a new treatment for gout. The RUBY and TOPAZ studies will evaluate the drug's safety and efficacy in patients with hyperuricemia and tophaceous gout, respectively. This marks a critical advancement in addressing unmet needs in gout treatment.
Read more →FBIO▼ -30.7%on this news
Fortress Biotech and Subsidiary Urica Therapeutics Announce Crystalys Therapeutics’ $205 Million Series A Financing
Urica Therapeutics, a subsidiary of Fortress Biotech, announced that Crystalys Therapeutics has closed a $205 million Series A financing to advance Phase 3 clinical trials for dotinurad, a next-generation URAT1 inhibitor for gout. The financing was co-led by notable investors and aims to expedite the drug's development in the U.S. and Europe. Fortress Biotech will benefit from an equity stake and future royalties from dotinurad's sales.
Read more →About Fortress Biotech, Inc.
Headquarters1111 KANE CONCOURSE, BAY HARBOR ISLANDS, FL, 33154
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