CELC Celcuity Inc.
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Executive Summary
Celcuity announced strong clinical results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial, with gedatolisib showing a median PFS of 16.6 months versus 1.9 months for fulvestrant, alongside FDA acceptance of its NDA with Priority Review and a PDUFA date of July 17, 2026. However, the company reported a widening net loss of $177.0 million in 2025 compared to $111.8 million in 2024, driven by higher R&D and G&A expenses ahead of a potential 2026 launch.
Key Financial Metrics
Actionable Insight
The strong clinical data and FDA Priority Review support potential approval and commercialization upside in 2026, but near-term financials reflect heavy pre-launch investment. Traders should monitor topline results from the PIK3CA mutant cohort expected in Q2 2026 and any updates on commercial readiness.
Key Facts
- FDA accepted NDA for gedatolisib with Priority Review; PDUFA date set for July 17, 2026
- Phase 3 VIKTORIA-1 trial in PIK3CA WT HR+/HER2- ABC showed median PFS of 16.6 months vs 1.9 months (HR=0.14)
- Median time to definitive deterioration in well-being was 23.7 months vs 4.0 months (HR=0.39)
- Full-year 2025 net loss was $177.0 million ($3.79/share), up from $111.8 million ($2.83/share) in 2024
- R&D expenses rose to $145.0 million in 2025 from $104.2 million in 2024, driven by commercial prep and trial activities
- Cash, cash equivalents, and short-term investments totaled $441.5 million at year-end, sufficient to fund operations through 2027
Financial Impact
Increased operating expenses led to a 58% YoY increase in net loss, but cash runway extends to 2027
Risk Factors
- Topline results from the PIK3CA mutant cohort in Q2 2026 may not replicate the wild-type cohort's success
- High operating losses and stock-based compensation could pressure sentiment if cash burn accelerates
- Regulatory risk that FDA may not approve gedatolisib despite Priority Review
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3262558 |
Filters
| Type | Now | ||||
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Jun 8, 2026
1d ago
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8-K
| $87.39 awaiting T+1 | awaiting T+1 | — | $88.88 (+1.71%) |
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Jun 5, 2026
5d ago
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424B5
| $92.47 awaiting T+1 | awaiting T+1 | — | $88.88 (−3.89%) |
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Jun 4, 2026
6d ago
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Press Release
| $92.47 $88.28 | ▼ −4.53% | ▼ −1.93% | $88.88 (−3.89%) |
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Jun 3, 2026
7d ago
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Press Release
| $88.95 $92.47 | ▼ −3.96% | ▼ −3.56% | $88.88 (+0.08%) |
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Jun 3, 2026
7d ago
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424B5
| $88.95 $92.47 | ▼ −3.96% | ▼ −3.56% | $88.88 (+0.08%) |
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Jun 2, 2026
8d ago
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8-K
| $91.42 $88.95 | ▼ −2.70% | ▼ −2.01% | $88.88 (−2.78%) |
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May 14, 2026
26d ago
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Press Release
| $137.68 $132.18 | ▼ −3.99% | ▼ −3.93% | $88.88 (−35.45%) |
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May 7, 2026
4w ago
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Press Release
| $130.71 $131.06 | ▲ +0.27% | ▼ −0.56% | $88.88 (−32.01%) |
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May 4, 2026
5w ago
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144
| $144.98 $141.69 | ▼ −2.27% | ▼ −3.06% | $88.88 (−38.70%) |
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May 1, 2026
5w ago
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Press Release
| $144.98 $141.69 | ▼ −2.27% | ▼ −3.06% | $88.88 (−38.70%) |
US Market Status
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