Celcuity’s Phase 3 VIKTORIA-2 Trial of Gedatolisib as a First-Line Treatment for HR+/HER2- Advanced Breast Cancer Expanding to Include Endocrine-Sensitive Patients

Rhea-AI Summary

Celcuity (Nasdaq: CELC) updated its Phase 3 VIKTORIA-2 trial of gedatolisib as first-line therapy for HR+/HER2- advanced breast cancer. The trial now includes separate studies for endocrine-resistant and endocrine-sensitive patients, each with independent statistical plans and PFS primary endpoints.

According to Celcuity, prior Phase 1b data in endocrine-sensitive patients treated with gedatolisib plus palbociclib and letrozole showed median PFS of 48.6 months, median OS of 77.3 months, and a 79% objective response rate. The company also submitted its first patent application for a subcutaneous gedatolisib formulation and is developing it to demonstrate clinical equivalence to the current IV form.

Positive

• VIKTORIA-2 expanded to include endocrine-sensitive HR+/HER2- advanced breast cancer patients in first-line setting
• Separate studies with independent statistical plans and PFS primary endpoints for endocrine-resistant and endocrine-sensitive cohorts
• Efficacy analyses to use full intent-to-treat populations combining PIK3CA wild-type and mutant patients
• Phase 1b gedatolisib triplet in endocrine-sensitive patients: median PFS 48.6 months, OS 77.3 months, ORR 79%
• Type B FDA meeting held to gain alignment on VIKTORIA-2 protocol amendments
• First patent application filed for subcutaneous gedatolisib formulation to enable injection instead of infusion

Negative

• None.

News Market Reaction – CELC

+8.23%

40 alerts

+8.23% Session close to close

+6.1% Peak Tracked

-2.3% Trough Tracked

$6.67B Market Cap

0.6x Rel. Volume

In the May 14 session, CELC gained 8.23%, reflecting a notable positive market reaction. Argus tracked a peak move of +6.1% during that session. Argus tracked a trough of -2.3% from its starting point during tracking. Our momentum scanner triggered 40 alerts that day, indicating elevated trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

The stock moved +8.2% in the session following this news. A strong positive reaction aligns with the...

Analysis

The stock moved +8.2% in the session following this news. A strong positive reaction aligns with the pattern seen after prior gedatolisib milestones, where clinical updates and regulatory steps often coincided with gains averaging 3.38% for similar trial news. However, investors have also encountered secondary offerings via an effective $400,000,000 ATM shelf, and prior moves have sometimes faded. Sustainability would depend on future VIKTORIA-2 execution, regulatory interactions, and how quickly any financing capacity is utilized.

Key Figures

Median PFS: 48.6 months Median OS: 77.3 months Objective response rate: 79% +1 more

4 metrics

Median PFS 48.6 months Endocrine-sensitive HR+/HER2- ABC, Phase 1b gedatolisib triplet

Median OS 77.3 months Endocrine-sensitive HR+/HER2- ABC, Phase 1b gedatolisib triplet

Objective response rate 79% Endocrine-sensitive HR+/HER2- ABC, Phase 1b gedatolisib triplet

Annual late-stage patients 90,000 women Estimated yearly HR+/HER2- advanced breast cancer diagnoses

Previous Clinical trial Reports

5 past events · Latest: May 01 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 01	Phase 3 topline data	Positive	+15.4%	Positive topline VIKTORIA-1 PIK3CA mutant results with significant PFS benefit.
Mar 09	Phase 3 data publication	Positive	+3.2%	Publication of VIKTORIA-1 PIK3CA WT cohort showing strong PFS and ORR results.
Jan 20	NDA acceptance	Positive	-1.5%	FDA acceptance of gedatolisib NDA with Priority Review and RTOR designation.
Dec 11	Conference data update	Positive	-1.0%	Updated VIKTORIA-1 subgroup data with large PFS gains presented at SABCS.
Nov 26	Conference presentation notice	Positive	+0.8%	Announcement of upcoming SABCS oral presentation on updated VIKTORIA-1 results.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Clinical trial and regulatory milestones for gedatolisib often led to positive reactions, but there are notable instances where strong data or design updates were followed by modest declines.

Recent Company History

Over the past several months, Celcuity has reported multiple key clinical trial milestones for gedatolisib in HR+/HER2- advanced breast cancer. These include updated VIKTORIA-1 data with substantial progression-free survival benefits, FDA acceptance of a gedatolisib NDA with Priority Review and a July 17, 2026 PDUFA date, and positive topline results in the PIK3CA mutant cohort. Price reactions to these events ranged from modest gains to double-digit increases, with occasional small pullbacks, showing generally favorable but not uniformly positive responses to clinical news.

Key Terms

progression-free survival, overall survival, objective response rate, intent-to-treat, +4 more

8 terms

progression-free survival medical

"demonstrating clinically meaningful improvement in progression-free survival (“PFS”)"

Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.

overall survival medical

"median progression free survival was 48.6 months, median overall survival was 77.3 months"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

objective response rate medical

"median overall survival was 77.3 months, and the objective response rate was 79%"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

intent-to-treat medical

"evaluate the entire intent-to-treat population (combined WT and mutant type (“MT”))"

A method for analyzing clinical trial results that counts every participant in the group they were originally assigned to, regardless of whether they completed the treatment or followed instructions. Like grading a class by the seats students were assigned rather than who finished the exam, it preserves the trial’s original comparisons and gives a realistic, often more conservative, estimate of how a drug or device performs in real-world use — information investors use to judge reliability and regulatory risk.

RECIST 1.1 medical

"The primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria"

RECIST 1.1 is a standardized set of rules used in cancer clinical trials to measure how solid tumors respond to treatment by tracking changes in size on medical scans. Think of it as a consistent ruler and scorecard that tells doctors and regulators whether a drug is shrinking tumors, keeping them stable, or allowing them to grow. Investors care because RECIST-based results are common primary endpoints that influence regulatory decisions, trial success, and a therapy’s commercial prospects.

blinded independent central review medical

"per RECIST 1.1 criteria, as assessed by blinded independent central review (“BICR”)."

Blinded independent central review is a quality-control step in clinical trials where outside medical experts, who do not know which patients received the experimental therapy, re-examine key measurements (like scans or lab results) to prevent bias. Think of it as neutral referees watching game footage without knowing the teams, which gives investors greater confidence that the trial results are fair, more reliable for regulators, and less likely to be overturned or disputed.

Type B meeting regulatory

"Celcuity conducted a Type B meeting with the U.S. Food and Drug Administration"

A Type B meeting is a formal, scheduled discussion between a drug or medical-device developer and a health regulator to resolve key mid‑ or late‑stage development issues such as clinical trial plans, interpretation of results, or steps needed for approval. Like a mid‑project review with an inspector, the meeting’s outcome can meaningfully change the timeline, cost and risk for a candidate: a clear, positive outcome lowers uncertainty for investors, while requests for more data or changes can signal delays and extra expense.

subcutaneous formulation medical

"its first patent application for a subcutaneous formulation of gedatolisib"

A subcutaneous formulation is a medicine prepared to be injected just under the skin, where it is absorbed into the body more slowly than an intravenous dose. For investors, this matters because subcutaneous versions often allow treatment at home or in a clinic instead of a hospital, improving patient convenience, lowering administration costs, expanding market access, and potentially increasing sales and competitive advantage compared with treatments that require more complex or frequent medical visits.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office

MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced updates to the Phase 3 VIKTORIA-2 clinical trial of gedatolisib as a first-line treatment for patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”) locally advanced or metastatic breast cancer (“ABC”).

Following last year’s announcement and subsequent data presentation demonstrating clinically meaningful improvement in progression-free survival (“PFS”) for patients treated with gedatolisib combined with palbociclib and fulvestrant compared to those treated with fulvestrant in the PIK3CA wild-type (“WT”) cohort of the VIKTORIA-1 Phase 3 study, several important elements of the VIKTORIA-2 clinical trial protocol have been amended. First, in addition to evaluating patients in the first-line setting with endocrine-resistant HR+/HER2- ABC, VIKTORIA-2 will now include a separate study to evaluate the safety and efficacy of patients in the first-line setting who have endocrine-sensitive HR+/HER2- ABC. Second, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized to a treatment arm. Third, efficacy analyses for both Study 1 and Study 2 of VIKTORIA-2 will evaluate the entire intent-to-treat population (combined WT and mutant type (“MT”)) enrolled in their respective study. Each study will have independent statistical analysis plans that will include separate primary endpoints. The primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by blinded independent central review (“BICR”).

Prior to finalizing the amended Phase 3 trial design, Celcuity conducted a Type B meeting with the U.S. Food and Drug Administration (the “FDA”) to obtain their feedback and to gain alignment on these planned amendments.

“We are excited to expand the VIKTORIA-2 study to include patients with endocrine-sensitive HR+/HER2- ABC. For patients with endocrine-sensitive HR+/HER2- advanced breast cancer who received gedatolisib in combination with palbociclib and letrozole in our Phase 1b clinical trial, median progression free survival was 48.6 months, median overall survival was 77.3 months, and the objective response rate was 79%,” said Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity. “These results are very encouraging and compare favorably to published data for the current standard-of-care regimens for these patients.”

“Results from the PIK3CA wild-type and mutation cohort of our VIKTORIA-1 study demonstrated the benefit of gedatolisib combination treatment in HR+/HER2- ABC in the second-line setting,” said Brian Sullivan, CEO and co-founder of Celcuity. “Developing the gedatolisib triplet for nearly all patients in the first-line setting, irrespective of their endocrine sensitivity or PIK3CA status, offers the potential to advance the standard of care for the approximately 90,000 women each year who are diagnosed with late-stage HR+/HER2- ABC.”

Gedatolisib Subcutaneous Formulation

To support its long-term lifecycle development plan, Celcuity also announced that it submitted to the United States Patent and Trademark Office (“USPTO”) its first patent application for a subcutaneous formulation of gedatolisib that would enable a patient to receive gedatolisib as an injection as an alternative to an infusion. Development of the subcutaneous gedatolisib formulation is ongoing with the goal of demonstrating clinical equivalence to the current intravenous formulation of gedatolisib. The subcutaneous formulation is aimed to support potential future indications for gedatolisib regimens that may result in duration of treatment periods greater than several years.

“As we initiate pivotal studies for indications that may offer several years of progression-free survival benefit, development of a subcutaneous formulation of gedatolisib would particularly benefit patients who may potentially be receiving treatment with gedatolisib for extended time periods,” said Brian Sullivan, CEO and co-founder of Celcuity.

About HR+/HER2- Breast Cancer

Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.¹ More than two million breast cancer cases were diagnosed globally in 2022.¹ While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.² HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.²

Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (“PAM”), are primary oncogenic drivers of HR+/HER2- ABC.³ Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.^4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.⁸  Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research.

About the Phase 3 VIKTORIA-2 Study

VIKTORIA-2 is a Phase 3, global, open-label, randomized, clinical trial designed to evaluate the efficacy and safety of gedatolisib plus palbociclib and endocrine therapy as first-line treatment for patients with HR+/HER2- ABC. Patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control.

Study 1 is expected to enroll approximately 440 patients with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and fulvestrant (Arm A) compared to ribociclib combined with fulvestrant (Arm B).

Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of gedatolisib combined with palbociclib and letrozole (Arm C) compared to ribociclib combined with letrozole (Arm D).

The clinical trial primary endpoints for the VIKTORIA-2 clinical trial are PFS, per RECIST 1.1 criteria, as assessed by BICR.

This global trial is expected to enroll subjects at up to 200 clinical sites across North America, Europe, and Asia-Pacific.

About Gedatolisib

Gedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.^9,10,11 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.¹¹ Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib’s comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA MT and WT breast tumor cells in nonclinical studies and early clinical data.^11,12

The FDA has accepted and granted Priority Review of Celcuity’s New Drug Application (“NDA”) for gedatolisib in patients with HR+/HER2-/PIK3CA WT advanced breast cancer and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026.

About Celcuity

Celcuity is a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications. Our lead therapeutic candidate is gedatolisib, a kinase inhibitor of the PAM pathway that binds to all class I PI3K isoforms and the mTOR complexes, mTORC1 and mTORC2. By targeting all class I PI3K isoforms and mTORC1/2, gedatolisib induces comprehensive inhibition of the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. Our Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has reported detailed results for Study 1, which evaluated patients with PIK3CA WT tumors, and announced topline results for Study 2, which evaluated patients with PIK3CA MT tumors. Our Phase 3 clinical trial, VIKTORIA-2, is ongoing and incorporates two independent studies, Study 1 and Study 2, evaluating two separate cohorts of patients with ABC who are treatment-naive in the advanced setting. Study 1 is evaluating gedatolisib combined with palbociclib and fulvestrant as first-line treatment for patients with endocrine-resistant HR+/HER2- ABC. Study 2 is evaluating gedatolisib combined with palbociclib and letrozole as first-line treatment for patients with endocrine-sensitive HR+/HER2- ABC. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. More detailed information about Celcuity’s active clinical trials can be found at ClinicalTrials.gov. Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at www.celcuity.com. Follow us on LinkedIn and X.

Forward-Looking Statements

This press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of clinical trial data; the status and timing of the FDA’s review of our NDA for gedatolisib, including the PDUFA goal date assigned by the FDA; the market opportunity for gedatolisib; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; our strategy, marketing and commercialization plans, including the benefits of strategic decisions regarding studies and trials; other expectations with respect to gedatolisib including future subcutaneous formulations of gedatolisib; our anticipated use of cash; and the strength of our balance sheet. Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our clinical results are based on an ongoing analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our clinical trials or the FDA’s review of our NDA for gedatolisib; our ability to obtain and maintain regulatory approvals to commercialize gedatolisib, and the market acceptance of gedatolisib; the development of therapies and tools competitive with gedatolisib; and our ability to access capital upon favorable terms. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2025, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

References:

1. Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660.
2. National Cancer Institute. Surveillance, Epidemiology and End Results Program (accessed July 2025).
   https://seer.cancer.gov/statfacts/html/breast-subtypes.html
3. Alves, C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. https://doi.org/10.3390/ijms24054522
4. United States Package Insert, US FDA, ITOVEBI
5. United States Package Insert, US FDA, PIQRAY
6. United States Package Insert, US FDA, TRUCAP
7. United States Package Insert, US FDA, AFINITOR
8. Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30
9. Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. https://doi.org/10.1021/jm901830p
10. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. https://doi.org/10.1158/1078-0432.CCR-10-1694
11. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. https://doi.org/10.1038/s41523-024-00648-0
12. Layman, R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. https://doi.org/10.1016/S1470-2045(24)00034-2
    
    

Contacts: 

For Investors: 
Brian Sullivan, bsullivan@celcuity.com
Vicky Hahne, vhahne@celcuity.com  
(763) 392-0123  
Jodi Sievers, jsievers@celcuity.com
(415) 494-9924

For Media:
Sam Brown LLC
Laura Morgan, lauramorgan@sambrown.com
(951) 333-9110

FAQ

What did Celcuity (CELC) announce about the Phase 3 VIKTORIA-2 trial on May 14, 2026?

Celcuity announced protocol amendments to expand the Phase 3 VIKTORIA-2 gedatolisib trial as first-line treatment for HR+/HER2- advanced breast cancer. According to Celcuity, VIKTORIA-2 now includes separate studies for endocrine-resistant and endocrine-sensitive patients, each with independent statistical plans and progression-free survival primary endpoints.

How is the VIKTORIA-2 trial design changing for endocrine-sensitive HR+/HER2- breast cancer patients (CELC)?

VIKTORIA-2 now includes a dedicated study for endocrine-sensitive HR+/HER2- advanced breast cancer patients in the first-line setting. According to Celcuity, patients are manually assigned by endocrine sensitivity to Study 1 or Study 2, then randomized to treatment arms, with intent-to-treat efficacy analyses and separate primary endpoints.

What prior clinical results support gedatolisib in endocrine-sensitive HR+/HER2- breast cancer for Celcuity (CELC)?

Phase 1b results showed gedatolisib plus palbociclib and letrozole produced median PFS of 48.6 months in endocrine-sensitive HR+/HER2- patients. According to Celcuity, the same regimen achieved median overall survival of 77.3 months and a 79% objective response rate, which it notes compare favorably to published standard-of-care data.

How will PIK3CA status be handled in the Phase 3 VIKTORIA-2 gedatolisib trial for Celcuity (CELC)?

VIKTORIA-2 efficacy analyses will evaluate combined PIK3CA wild-type and mutant patients within each study’s intent-to-treat population. According to Celcuity, both the endocrine-resistant and endocrine-sensitive studies will have independent statistical analysis plans and separate primary endpoints focused on progression-free survival by blinded independent central review.

What is Celcuity (CELC) planning with the subcutaneous formulation of gedatolisib?

Celcuity is developing a subcutaneous gedatolisib formulation and has filed its first related patent application. According to Celcuity, the aim is to demonstrate clinical equivalence to the current intravenous formulation and support long-term treatment regimens where patients may receive gedatolisib over several years.

Did Celcuity (CELC) engage the FDA on the amended VIKTORIA-2 trial design for gedatolisib?

Yes, Celcuity held a Type B meeting with the FDA before finalizing the amended Phase 3 VIKTORIA-2 design. According to Celcuity, the goal was to obtain regulatory feedback and alignment on key protocol changes, including patient cohorts, statistical analysis plans, and primary efficacy endpoints.