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.
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.
Key Financial Metrics
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
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3295313 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Aug 26, 2026 5w ago | 8-K | $95.08 $84.00 | ▼ −11.65% | ▼ −12.86% | $72.51 (−23.74%) |
Jul 15, 2026 11w ago | 144 | $91.51 $92.08 | ▼ −0.62% | ▲ +1.72% | $72.51 (+20.76%) |
Jul 14, 2026 11w ago | Press Release | $91.51 $92.08 | ▲ +0.62% | ▼ −1.72% | $72.51 (−20.76%) |
Jun 11, 2026 16w ago | Institutional Cluster | $89.49 $113.51 | ▲ +26.84% | ▲ +24.95% | $72.51 (−18.97%) |
Jun 8, 2026 16w ago | 8-K | $92.59 $115.72 | ▲ +24.98% | ▲ +23.53% | $72.51 (−21.69%) |
Jun 5, 2026 17w ago | 424B5 | $88.28 $108.58 | ▲ +23.00% | ▲ +21.13% | $72.51 (−17.86%) |
Jun 4, 2026 17w ago | Press Release | $92.47 $107.95 | ▲ +16.74% | ▲ +18.11% | $72.51 (−21.59%) |
Jun 3, 2026 17w ago | Press Release | $88.95 $107.95 | ▼ −21.36% | ▼ −22.36% | $72.51 (+18.48%) |
Jun 3, 2026 17w ago | 424B5 | $88.95 $107.95 | ▼ −21.36% | ▼ −22.36% | $72.51 (+18.48%) |
Jun 2, 2026 17w ago | 8-K | $91.42 $104.49 | ▲ +14.30% | ▲ +15.86% | $72.51 (−20.68%) |
US Market Status
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