CELC PRESS-RELEASE SEC Filing Analysis

Latest settled — T+5d ⚠ clustered

CELC ▼ -13.34% at T+5d

LONG call ✗ call lost -13.34% · α vs SPY -16.28% · entry $144.98 → $125.64

Next anchor: T+20d in 12d

Currently $140.34 · -3.20% from $144.98 entry

Entry anchored
May 1, 2026
via day open

T+1d

-2.27%

call -2.27% · α -3.06%

$141.69

settled 16d ago

T+5d

-13.34%

call -13.34% · α -16.28%

$125.64

settled 12d ago

T+20d

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call — · α —

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in 12d

T+60d

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Executive Summary

Celcuity announced positive topline Phase 3 VIKTORIA-1 results for gedatolisib in PIK3CA mutant HR+/HER2- advanced breast cancer, showing statistically significant PFS improvement vs alpelisib. The FDA has granted Priority Review for the NDA with a PDUFA date of July 17, 2026, and the company plans to file an sNDA. This is a major de-risking event for gedatolisib and Celcuity's lead asset.

Actionable Insight

This filing is strongly positive. Monitor the ASCO presentation for detailed data (hazard ratios, magnitude of benefit) and the PDUFA date (July 17, 2026) for potential approval. Consider accumulating ahead of these catalysts; any delay or negative committee review could introduce volatility.

Key Facts

Positive Phase 3 VIKTORIA-1 results: gedatolisib triplet (gedatolisib + fulvestrant + palbociclib) showed statistically significant improvement in PFS vs alpelisib + fulvestrant in PIK3CA mutant HR+/HER2- advanced breast cancer.
Gedatolisib doublet also showed statistically significant PFS improvement vs alpelisib + fulvestrant.
FDA granted Priority Review for gedatolisib NDA in PIK3CA wild-type advanced breast cancer, with PDUFA goal date July 17, 2026.
Celcuity plans to submit these data as a supplemental NDA to the FDA and to other regulatory authorities.
Results to be presented as late-breaking oral abstract at ASCO 2026 (May 29-June 2).

Financial Impact

Positive Phase 3 data and Priority Review significantly increase probability of approval and commercial potential for gedatolisib; peak sales potential in HR+/HER2- breast cancer could be multi-billion dollars.

revenuevaluationregulatory probability

Risk Factors

Potential for FDA advisory committee concerns or complete response letter despite positive data.
Competitive landscape: alpelisib, AKT inhibitors, other PI3K/mTOR agents.
Manufacturing or safety issues that could delay approval.

Market Snapshot

Exchange

Nasdaq

Sector

Services-Medical Laboratories

Analyst Consensus

88% bullish (17 analysts)

Documents Analyzed

This report is based on 1 press release from GlobeNewswire.

Document	Accession Number
PRESS-RELEASE Data (Synthetic)	press-3286249

5 reports for CELC

T+1T+5T+20T+60

Filters

Reports for CELC — sortable, filterable
	Type				Now
May 14, 2026 6d ago	Press Release BULLISH ★ 7/10	$134.57 awaiting T+5	awaiting T+5	—	$140.34 (+4.29%)
May 7, 2026 13d ago	Press Release NEUTRAL ★ 3/10	$130.71 $124.47	▼ −4.77%	▼ −6.28%	$140.34 (+7.37%)
May 4, 2026 16d ago	144 NEUTRAL ★ 2/10	$144.98 $125.64	▼ −13.34%	▼ −16.28%	$140.34 (−3.20%)
May 1, 2026 19d ago	Press Release BULLISH ★ 8/10	$144.98 $125.64	▼ −13.34%	▼ −16.28%	$140.34 (−3.20%)
Mar 25, 2026 8w ago	Press Release MIXED ★ 8/10	$114.81 $112.63	▼ −1.90%	▼ −3.53%	$140.34 (+22.24%)

US Market Status

Market Closed — Opens Thu (< 1m)

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