Celcuity Expands VIKTORIA-2 Trial as Shares Trade Below Analyst Targets

Key Takeaways

• VIKTORIA-2 (NCT06757634) is Phase 3, RECRUITING, with estimated enrollment 1,180 and start date July 24, 2025.
• May 14, 2026 company release: Study 1 ~440 endocrine-resistant patients; Study 2 ~740 endocrine-sensitive patients.
• Study 2 compares gedatolisib + palbociclib + letrozole versus ribociclib + letrozole control in treatment-naive endocrine-sensitive disease.
• VIKTORIA-1 trial NCT05501886 remains ACTIVE_NOT_RECRUITING on ClinicalTrials.gov and is the nearer catalyst for many models.

What did Celcuity announce about VIKTORIA-2 on May 14, 2026?

In a May 14, 2026 GlobeNewswire release, Celcuity said VIKTORIA-2 is expanding to include endocrine-sensitive patients as a first-line gedatolisib regimen in HR+/HER2- locally advanced or metastatic breast cancer.

A companion Q1 2026 corporate update said the Phase 3 program now has two studies with independent statistical analysis plans and primary endpoints for each intent-to-treat population.

Study 1 (ongoing) evaluates gedatolisib with palbociclib and fulvestrant in about 440 endocrine-resistant patients. Study 2 evaluates gedatolisib with palbociclib and letrozole in about 740 treatment-naive endocrine-sensitive patients.

How is VIKTORIA-2 designed on ClinicalTrials.gov?

NCT06757634 titles the study as a Phase 3 trial of gedatolisib as first-line treatment for HR-positive, HER2-negative advanced breast cancer (VIKTORIA-2).

Registry details list status RECRUITING, estimated enrollment 1,180, and an actual start date of July 24, 2025. Patients are assigned by endocrine sensitivity to Study 1 or Study 2, then randomized 1:1 to investigational treatment or standard-of-care control.

• Drug: gedatolisib (pan-PI3K/mTOR / PAM-pathway inhibitor).
• Partners in regimen: CDK4/6 inhibitor plus endocrine therapy.
• Primary endpoint focus (company description): progression-free survival by blinded independent central review.
• Sponsor: Celcuity Inc.

Where does the VIKTORIA-1 trial fit?

The VIKTORIA-1 trial (NCT05501886) evaluates gedatolisib plus fulvestrant with or without palbociclib versus standard-of-care for HR+/HER2- advanced breast cancer and is listed ACTIVE_NOT_RECRUITING.

For BD and investors, VIKTORIA-1 remains the nearer efficacy signal that can re-rate the PAM-inhibitor thesis before VIKTORIA-2’s larger first-line datasets mature.

Do not confuse NCT identifiers: an older link to NCT05544500 in secondary copy pointed at an unrelated completed chewing-gum concentration study and is discarded here.

What else did the May update flag for lifecycle planning?

Celcuity said it filed a USPTO patent application for a subcutaneous gedatolisib formulation intended as an injection alternative to infusion, with development aimed at showing clinical equivalence to the intravenous form for long-duration regimens.

That formulation is investigational. It does not change the current VIKTORIA-2 intravenous trial design described on ClinicalTrials.gov.

What remains unproven?

Neither VIKTORIA-2 Study 2 nor VIKTORIA-1 has an FDA-approved gedatolisib label based on these sources. Cross-arm CDK4/6 choices differ by study and are not head-to-head marketing claims.

Retail share-price gaps versus unnamed analyst targets are omitted because they were not verified from an SEC filing in this rewrite.

Estimated U.S. incidence figures in company releases are sponsor context, not FDA findings.

How should BD teams underwrite gedatolisib risk?

Price VIKTORIA-1 readout timing separately from VIKTORIA-2 enrollment. A positive NCT05501886 package can support partnering talks before Study 2 in NCT06757634 reaches primary completion.

Model two CDK4/6 backbones and two endocrine partners when sizing cost of goods and site burden. Protocol amendments that add hundreds of patients also add monitoring, drug supply, and statistical complexity.

Ask for the independent statistical analysis plans named in the May 14, 2026 release before accepting a single blended success probability across Study 1 and Study 2.

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Frequently Asked Questions

Primary Sources

1. GlobeNewswire: Celcuity VIKTORIA-2 expansion (May 14, 2026)
2. GlobeNewswire: Celcuity Q1 2026 update
3. ClinicalTrials.gov NCT06757634 (VIKTORIA-2)
4. ClinicalTrials.gov NCT05501886 (VIKTORIA-1 trial)