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FBIOP
distress 6/10 · elevated risk$18.90+1%today-10% from 52w high
Lead: Menkes disease
Revenue
$16M
Liquidity
$256M
Runway
—
Shares 1y
+1074%
Price & events
+50.1% over 6M
CatalystRating changeDilutionFinancingdashed = today
+0.6%
1D
+0.4%
1W
-5.1%
1M
+40.7%
3M
+50.1%
6M
+167.7%
1Y
+135.4%
2Y
+6.4%
5Y
+50.3%
All
Overview
- Market Cap
- $1.56B
- Enterprise Value
- $1.34B
- Volume
- 3.00K
- 52 Week Range
- $6.53 – $21.08
- Total Shares
- 82.47M
- Float Shares
- 23.09M
- % Held by Insiders
- 0.00%
- % Held by Institutions
- 0.00%
- RVOL
- 0.19x
- Beta
- 1.21
Pipeline · 0 trials · 0 upcoming
| Readout | Phase | Drug | Indication | Enroll | Status |
|---|---|---|---|---|---|
| No pipeline trials tracked. | |||||
Catalyst news & presentations · 10
- 2026-03-30partnershipSale of Rare Pediatric Disease Priority Review Voucher for $205M gross proceedsSEC 8-K
- 2026-02-22partnershipEntered into asset purchase agreement to sell Rare Pediatric Disease Priority Review Voucher for $205 million.SEC 8-K
- January 14, 2026PDUFAPDUFACUTX-101 · FDA target action date for NDA decisionSEC 8-K
- 2025-11-14regulatory submissionFiled (NDA/BLA)CUTX-101 · Sentynl resubmitted NDA to FDASEC 8-K
- 2025-10-01crlCUTX-101 · FDA issued CRL due to cGMP deficiencies at manufacturing facilitySEC 8-K
- 2025-09-30crlCUTX-101 · Complete response letter citing cGMP issues at manufacturing siteSEC 8-K
- September 30, 2025PDUFAPDUFACUTX-101 · Target action date for CUTX-101 NDA extended to September 30, 2025SEC 8-K
- June 30, 2025PDUFAPDUFACUTX-101 · Target action date for NDA reviewSEC 8-K
- 2025-01-16pdufa extensionCUTX-101 · FDA extended target action date for CUTX-101 NDA to September 30, 2025SEC 8-K
- 2023-12-01partnershipCUTX-101 · Sentynl assumed full development and commercialization; Cyprium eligible for milestones and royaltiesSEC 8-K
Approved drugs (0)
- none — clinical-stage
Capital structure — dilution & financing
🔒 Top holders — Pro
Institutional ownership + quarter-over-quarter accumulation/trimming.
Upgrade to ProWall St ratings
no consensus
- no recent rating changes
Competitors — Menkes disease
- none identified
Recent news
Not financial advice. Data: ClinicalTrials.gov, SEC EDGAR, FINRA, Nasdaq, Yahoo.