CELC Celcuity Inc.
Price Chart
Executive Summary
Celcuity reported Q1 2026 GAAP EPS of -$0.97, a 9.0% miss vs consensus of -$0.89, with net loss widening to $52.8M from $37.0M a year ago. The key catalyst is the positive Phase 3 VIKTORIA-1 topline data in the PIK3CA mutant cohort, supporting an sNDA submission in Q3 2026 ahead of the July 17 PDUFA date for the wild-type NDA. The stock's move will be driven by the clinical progress and regulatory timeline, not the earnings miss, as the company remains pre-revenue.
Actionable Insight
The earnings miss is immaterial for a pre-revenue biotech — the stock will trade on the VIKTORIA-1 data readout and the July 17 PDUFA date. Monitor ASCO 2026 presentation on June 2 for detailed efficacy/safety data, which could further derisk the sNDA path. The expanded VIKTORIA-2 study adds first-line optionality, extending the addressable market.
Key Facts
- GAAP EPS -$0.97 vs consensus -$0.89 (9.0% miss); net loss $52.8M vs $37.0M YoY
- Phase 3 VIKTORIA-1 PIK3CA mutant cohort met primary endpoint with statistically significant PFS improvement vs alpelisib
- FDA Priority Review for gedatolisib NDA in PIK3CA wild-type ABC; PDUFA date July 17, 2026
- sNDA submission for PIK3CA mutant cohort planned for Q3 2026
- Cash, equivalents, and investments of $387.1M expected to fund operations through 2027
- VIKTORIA-2 expanded to include Study 2 evaluating gedatolisib as first-line treatment in endocrine-sensitive HR+/HER2- ABC
Financial Impact
Net loss widened by $15.8M YoY to $52.8M; operating expenses increased 40% to $50.5M driven by commercial launch preparation
Risk Factors
- FDA could issue a Complete Response Letter (CRL) on July 17, delaying or denying approval
- Commercial launch costs will accelerate cash burn; need for additional financing before 2027
- Competitive landscape includes Novartis's Piqray and other PI3K/AKT/mTOR inhibitors
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295313 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
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Jun 11, 2026
3d ago
|
Institutional Cluster
| $89.78 awaiting T+1 | awaiting T+1 | — | $88.55 (−1.37%) |
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Jun 8, 2026
6d ago
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8-K
| $87.39 awaiting T+1 | awaiting T+1 | — | $88.55 (+1.33%) |
|
Jun 5, 2026
10d ago
|
424B5
| $92.47 awaiting T+1 | awaiting T+1 | — | $88.55 (−4.24%) |
|
Jun 4, 2026
11d ago
|
Press Release
| $92.47 $88.28 | ▼ −4.53% | ▼ −1.93% | $88.55 (−4.24%) |
|
Jun 3, 2026
12d ago
|
Press Release
| $88.95 $92.47 | ▼ −3.96% | ▼ −3.56% | $88.55 (+0.45%) |
|
Jun 3, 2026
12d ago
|
424B5
| $88.95 $92.47 | ▼ −3.96% | ▼ −3.56% | $88.55 (+0.45%) |
|
Jun 2, 2026
13d ago
|
8-K
| $91.42 $88.95 | ▼ −2.70% | ▼ −2.01% | $88.55 (−3.14%) |
|
May 14, 2026
4w ago
|
Press Release
| $137.68 $132.18 | ▼ −3.99% | ▼ −3.93% | $88.55 (−35.68%) |
|
May 7, 2026
5w ago
|
Press Release
| $130.71 $131.06 | ▲ +0.27% | ▼ −0.56% | $88.55 (−32.25%) |
|
May 4, 2026
5w ago
|
144
| $144.98 $141.69 | ▼ −2.27% | ▼ −3.06% | $88.55 (−38.92%) |
US Market Status
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