Celcuity Inc. Achieves Major Milestone with Positive Phase 3 VIKTORIA-1 Results in PIK3CA Mutant Breast Cancer

Key Highlights for Investors

• Celcuity’s Phase 3 VIKTORIA-1 trial met its primary endpoint in the PIK3CA mutant cohort, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients with hormone receptor positive (HR+), HER2 negative (HER2-), PIK3CA mutant advanced breast cancer.
• Gedatolisib triplet regimen (gedatolisib + fulvestrant + palbociclib) outperformed the current standard of care (alpelisib + fulvestrant) in terms of PFS.
• The gedatolisib doublet regimen (gedatolisib + fulvestrant) also showed significant improvement in PFS versus alpelisib + fulvestrant, though it was a secondary endpoint.
• Safety profile for both gedatolisib regimens was manageable and no new safety signals were reported.
• Detailed results will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting on June 2, 2026.
• Celcuity intends to submit a supplemental New Drug Application (sNDA) to the FDA and to other regulatory authorities based on these results.
• The FDA has already granted Priority Review for gedatolisib in PIK3CA wild-type ABC, with a PDUFA date of July 17, 2026.
• These positive results may support broader use of gedatolisib in both PIK3CA mutant and wild-type HR+/HER2- advanced breast cancer and could support expansion into other cancer types involving the PI3K/AKT/mTOR (PAM) pathway.

Detailed Analysis

Clinical Trial Results and Implications

Celcuity Inc. announced that its pivotal Phase 3 trial, VIKTORIA-1, has achieved its primary endpoint in patients with HR+/HER2-, PIK3CA mutant locally advanced or metastatic breast cancer who had progressed after CDK4/6 inhibitor and aromatase inhibitor therapy. The gedatolisib-based regimens (triplet and doublet) demonstrated statistically significant and clinically meaningful improvements in progression-free survival compared to the current standard of care (alpelisib + fulvestrant).

Both gedatolisib regimens were generally well tolerated, with manageable safety profiles and no new safety signals. This is a key differentiator, as previous attempts to comprehensively block the PI3K/AKT/mTOR pathway have struggled with excessive toxicity. Gedatolisib’s multitarget approach (inhibiting all four class I PI3K isoforms, mTORC1, and mTORC2) appears to overcome adaptive resistance seen with single-node inhibitors, potentially offering a new standard of care in the second-line setting for this patient population.

Market and Regulatory Impact

• Regulatory Pathway:
  Celcuity will submit these new data as a supplemental NDA to the FDA and file with other global regulatory agencies, potentially accelerating the path to approval and commercialization for this indication.
• Broader Impact:
  The Phase 3 data may have implications beyond HR+/HER2- advanced breast cancer, as the company is exploring gedatolisib in other cancers involving the PAM pathway. This could significantly expand the addressable market.
• Market Opportunity:
  HR+/HER2- breast cancer is the most common subtype, representing around 70% of cases, with approximately 40% having PIK3CA mutations. There is a substantial unmet need, especially for patients progressing on first-line therapies.
• Upcoming Catalysts:
  – Presentation of full data at the 2026 ASCO Annual Meeting on June 2, 2026.
  – PDUFA date for PIK3CA wild-type cohort (already under Priority Review) is July 17, 2026.
  – Potential sNDA submission and regulatory decisions later in 2026.

Strategic and Management Perspectives

Sara Hurvitz, MD, a principal investigator, emphasized that VIKTORIA-1 is the first Phase 3 study to show that comprehensive PAM pathway blockade can significantly improve outcomes for PIK3CA mutant HR+/HER2- breast cancer patients compared to agents targeting only PI3Kα or AKT. Igor Gorbatchevsky, MD, Celcuity CMO, stated these results highlight gedatolisib’s potential as a transformative therapy, including in PIK3CA wild-type disease. Chairman and CEO Brian Sullivan noted that this breakthrough comes after nearly two decades of attempts to comprehensively inhibit this pathway in solid tumors without excessive toxicity.

The company is also developing gedatolisib in other solid tumors, including ongoing trials in first-line HR+/HER2- ABC and metastatic castration-resistant prostate cancer, further expanding its strategic options.

Potential Share Price Sensitivity and Investor Considerations

• Positive Phase 3 data are typically highly price sensitive, as they can underpin regulatory approvals and future revenue streams.
• Regulatory milestones (sNDA submission, PDUFA date, global filings) and major conference presentations (ASCO 2026) are potential catalysts that could move the share price in the near term.
• Broader applicability of gedatolisib (both PIK3CA mutant and wild-type, and other tumor types) could significantly increase the drug’s market potential, representing substantial upside if further studies are successful.
• Investors should be aware of risks: Topline results are subject to further review and regulatory outcomes, and there is competition from other targeted therapies. Delays or negative surprises in regulatory review could negatively impact share value.

Upcoming Events

• ASCO 2026 Oral Abstract Session: June 2, 2026, 9:45 AM–12:45 PM CDT. Full data release expected online and at the conference.
• PDUFA date for PIK3CA wild-type NDA: July 17, 2026.

About Celcuity and Gedatolisib

Celcuity is a clinical-stage biotechnology company focused on targeted therapies for solid tumors, led by gedatolisib—a potent, multi-target PI3K/mTOR inhibitor designed to block the PAM pathway comprehensively. Gedatolisib’s unique mechanism and favorable early clinical safety profile distinguish it from other therapies that target only a single node of the pathway. The company is headquartered in Minneapolis and has additional ongoing clinical trials in other oncology indications.

Disclaimer: This article is for informational purposes only and does not constitute investment advice. Investors should perform their own due diligence and consult with a qualified financial advisor before making investment decisions. The information is based on public filings and is subject to change. Forward-looking statements are subject to risks and uncertainties as described in Celcuity’s SEC filings and press releases.

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