Relmada Therapeutics
Develops NDV-01 for NMIBC and sepranolone for Prader-Willi syndrome.
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Profile
Develops NDV-01, an intravesical sustained-release gemcitabine/docetaxel formulation for non-muscle-invasive bladder cancer, and sepranolone for Prader-Willi syndrome. The clinical-stage company has no approved commercial products and has paused further REL-1017 work.
Builds an oncology-and-CNS pipeline around NDV-01 and sepranolone. NDV-01 is a sustained-release intravesical formulation of gemcitabine and docetaxel for non-muscle-invasive bladder cancer, while sepranolone is being prepared for a Phase 2 Prader-Willi syndrome study. Neither candidate is approved for sale, and the company has no commercial products.
NDV-01 is advancing toward planned Phase 3 RESCUE paths: an intermediate-risk adjuvant study and a high-risk second-line study for BCG-unresponsive disease. Its licensed worldwide rights exclude Israel, India, and South Africa. Further work on the former CNS candidate REL-1017 was paused after a 2024 interim analysis, placing the new clinical programs at the center of the pipeline.
Company facts
Key statistics
Year to date −0.8% · Average volume (30d) 1.3M
Analysts
Ratings
Target range
Latest analyst notes
| Date | Firm | Action | Prior rating | Rating | Prior target | Target |
|---|---|---|---|---|---|---|
| Jun 18, 2026 | H.C. Wainwright | Target | $12 | |||
| Mar 13, 2026 | Mizuho Securities | Target | $10 | |||
| Jan 23, 2026 | Leerink Partners | Upgrade | Market Perform | Outperform | $8 | |
| Dec 21, 2025 | Jefferies | Target | $8 | $9 | ||
| Nov 19, 2025 | Mizuho | Upgrade | Neutral | Outperform |
Earnings
EPS
Revenue
History
| Report date | EPS est | EPS | Surprise | Revenue est | Revenue | Surprise | Next session |
|---|---|---|---|---|---|---|---|
| Aug 6, 2026Q2 FY26 | −$0.20 | −$0.11 | +44.9% | — | — | — | −8.01% |
| May 12, 2026Q1 FY26 | −$0.18 | −$0.22 | −22.2% | — | — | — | +0.54% |
| Mar 19, 2026Q4 FY25 | −$0.14 | −$0.27 | −92.9% | — | — | — | −2.88% |
| Nov 13, 2025Q3 FY25 | −$0.04 | −$0.30 | −650.0% | — | — | — | +1.80% |
Financial highlights
| 12 quarters | Q1 FY25 | Q2 FY25 | Q3 FY25 | Q4 FY25 | Q1 FY26 | Q2 FY26 | |
|---|---|---|---|---|---|---|---|
| Revenue | $0 | $0 | $0 | $0 | $0 | $0 | |
| Gross profit | $0 | $0 | $0 | $0 | $0 | $0 | |
| Operating income | −$18.2M | −$10.2M | −$10.3M | −$20.3M | −$19.5M | −$15.0M | |
| Net income | −$17.6M | −$9.9M | −$10.1M | −$19.9M | −$19.1M | −$12.9M | |
| Diluted EPS | −$0.58 | −$0.30 | −$0.30 | −$0.29 | −$0.22 | −$0.11 | |
| Gross margin | — | — | — | — | — | — | |
| Operating margin | — | — | — | — | — | — |
Fiscal years (4-quarter sums)FY21 $0 · FY22 $0 · FY23 $0 · FY24 $0 · FY25 $0
Balance sheet, Jun 30, 2026Cash & short-term investments $217.7M · Total debt $0 · Total assets $219.1M · Shareholders' equity $206.6M
Dividends
No dividends on record.
Ownership
Shares outstanding 104.89M · Float 90.42M · 86.2% free float
Top shareholders13F · 13D/G · Form 4
| Holder | Shares | % outstanding | Form | Filed |
|---|---|---|---|---|
| Jupiter Topco LLC | 11.16M | 10.64% | 13F | Aug 14, 2026 |
| Janus Henderson Group PLC | 7.44M | 10.10% | 13G | Feb 6, 2026 |
| Squadron Master Fund LP | 7.40M | 9.90% | 13G | Feb 17, 2026 |
| BlackRock, Inc. | 7.35M | 7.00% | 13G | Jul 29, 2026 |
| Squadron Capital Management LLC | 7.35M | 7.01% | 13F | Aug 14, 2026 |
Insider tradesForm 4
| Date | Insider | Role | Shares | Avg price |
|---|---|---|---|---|
| Dec 15, 2025 | Maged Shenouda | officer: Chief Financial Officer | +11,665 | $4.12 |
| Dec 15, 2025 | Sergio Traversa | director, officer: Chief Executive Officer | +27,500 | $4.12 |
| Nov 5, 2025 | Paul Edward Kelly | director, officer: Chief Operating Officer | +90,000 | $2.20 |
| Nov 5, 2025 | Sergio Traversa | director, officer: Chief Executive Officer | +272,500 | $2.20 |
| Nov 5, 2025 | Chuck Ence | officer: CAO and COO | +136,000 | $2.20 |
Peers
- Johnson & Johnson
Intravesical gemcitabine system in BCG-unresponsive HR-NMIBC
- CG Oncology
Phase 3 intravesical therapy across two NMIBC risk settings
- UroGen Pharma
Approved intravesical therapy for recurrent LG-IR-NMIBC
- ImmunityBio
Approved IL-15 therapy with BCG for BCG-unresponsive NMIBC
- enGene Therapeutics
Pivotal Phase 2 non-viral gene therapy for BCG-unresponsive NMIBC
- Protara Therapeutics
Phase 2 intravesical cell therapy for CIS-positive NMIBC
CompareAfter-hours close
| Company | Price | Change | |||||
|---|---|---|---|---|---|---|---|
| Relmada Therapeutics | $4.33 | −0.12% | $454.2M | — | — | — | — |
| Johnson & Johnson | $268.40 | +0.13% | $645.95B | 31.1 | 22.4 | 6.6 | +6.6% |
| CG Oncology | $73.91 | −0.57% | $6.56B | — | — | 1,052.8 | — |
| UroGen Pharma | $43.62 | −0.02% | $2.13B | — | 35.5 | 11.3 | +199.2% |
| ImmunityBio | $8.07 | +0.25% | $8.43B | — | — | 50.9 | +93.9% |
| enGene Therapeutics | $1.83 | +0.08% | $122.3M | — | — | — | — |
| Protara Therapeutics | $3.82 | +0.26% | $214.7M | — | — | — | — |
| Median | 31.1 | 28.9 | 31.1 | +93.9% |