Celcuity Announces FDA Acceptance of New Drug Application for Gedatolisib in HR+/HER2-/PIK3CA Wild-Type Advanced Breast Cancer

Rhea-AI Summary

Celcuity (Nasdaq: CELC) announced FDA acceptance of its New Drug Application for gedatolisib to treat HR+/HER2-/PIK3CA wild-type advanced breast cancer. The FDA granted Priority Review, assigned a PDUFA goal date of July 17, 2026, and accepted the NDA under the FDA’s Real-Time Oncology Review (RTOR) program. The submission uses data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial. Gedatolisib is an investigational multi-target PI3K/AKT/mTOR (PAM) inhibitor that targets all four Class I PI3K isoforms and both mTOR complexes. The program previously received Breakthrough Therapy and Fast Track designations.

Positive

• FDA Priority Review designation for gedatolisib
• PDUFA goal date set to July 17, 2026
• NDA submitted via RTOR to potentially shorten review time
• Submission based on Phase 3 VIKTORIA-1 PIK3CA wild-type cohort
• Gedatolisib holds both Breakthrough Therapy and Fast Track designations
• Multi-target PAM inhibition shown in nonclinical and early clinical data

Negative

• Gedatolisib remains investigational; FDA acceptance does not guarantee approval
• Submission targets the PIK3CA wild-type cohort only, limiting the labeled population
• No efficacy or safety figures were included in this announcement

News Market Reaction

-1.47%

1 alert

-1.47% News Effect

On the day this news was published, CELC declined 1.47%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

PDUFA goal date: July 17, 2026 Review designation: Priority Review Trial phase: Phase 3 +4 more

7 metrics

PDUFA goal date July 17, 2026 FDA Priority Review for gedatolisib NDA in HR+/HER2-/PIK3CA WT ABC

Review designation Priority Review Granted for gedatolisib NDA based on Phase 3 VIKTORIA-1 data

Trial phase Phase 3 VIKTORIA-1 PIK3CA wild-type cohort supporting the NDA

Current price $106.96 CELC price before NDA acceptance news on 2026-01-20

52-week range $7.575–$116.44 Low and high levels prior to this announcement

Market cap $4,949,173,863 Equity value before FDA NDA acceptance headline

Volume vs average 403,920 vs 737,062 Today’s volume compared with 20-day average volume

Market Reality Check

Price: $112.12 Vol: Volume 403,920 is below 2...

low vol

$112.12 Last Close

Volume Volume 403,920 is below 20-day average of 737,062 (relative volume 0.55x). low

Technical Trading above 200-day MA of $48.27, reflecting a strong pre-news uptrend.

Peers on Argus

CELC gained 1.6% while only one momentum peer, IBRX, appeared, rising 21.0099995...

1 Up

CELC gained 1.6% while only one momentum peer, IBRX, appeared, rising 21.0099995136261%. Other biotech peers showed mixed, smaller moves, pointing to a stock-specific reaction.

Common Catalyst Both CELC and IBRX are oncology names with FDA-focused headlines, but only CELC reported an NDA acceptance with Priority Review.

Historical Context

5 past events · Latest: Dec 11 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 11	Phase 3 update	Positive	-1.0%	Updated Phase 3 VIKTORIA-1 efficacy and QoL data at SABCS.
Nov 26	Conference preview	Neutral	+0.8%	Announcement of upcoming SABCS oral presentation on VIKTORIA-1 data.
Nov 26	Investor conference	Neutral	+1.3%	Participation in Evercore healthcare conference with a CEO fireside chat.
Nov 17	NDA submission	Positive	-0.5%	Completion of gedatolisib NDA submission under FDA RTOR program.
Nov 12	Earnings & trial data	Positive	+7.6%	Q3 2025 results plus detailed VIKTORIA-1 efficacy and cash runway through 2027.

Pattern Detected

Clinical and regulatory milestones for gedatolisib have produced mixed reactions, with some strong rallies but also occasional sell-the-news declines despite positive data.

Recent Company History

Over the last six months, Celcuity has steadily advanced gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer. Key steps included breakthrough Phase 3 VIKTORIA-1 data, an NDA submission under FDA RTOR on Nov 17, 2025, and multiple data updates at ESMO and SABCS. Reactions varied: some positive clinical readouts led to pullbacks, while the Q3 2025 update with detailed efficacy and a clear NDA plan saw a 7.56% gain. Today’s FDA NDA acceptance with Priority Review builds directly on this progression.

Regulatory & Risk Context

Active S-3 Shelf · $400,000,000

Shelf Active

Active S-3 Shelf Registration 2026-01-09

$400,000,000 registered capacity

An effective S-3ASR filed on 2026-01-09 allows Celcuity to offer up to $400,000,000 of common stock via an at-the-market program with Jefferies, plus other securities in future offerings. Usage count is currently 0, but the filing increases potential financing and dilution capacity.

Market Pulse Summary

This announcement highlights FDA acceptance of the gedatolisib NDA with Priority Review and a July 1...

Analysis

This announcement highlights FDA acceptance of the gedatolisib NDA with Priority Review and a July 17, 2026 PDUFA date, building on prior positive VIKTORIA-1 Phase 3 results. Historically, similar clinical and regulatory catalysts have produced varied stock reactions. Investors may track upcoming FDA interactions, any additional data releases, and potential use of the effective S-3ASR for up to $400,000,000 in offerings as key factors shaping the story from here.

Key Terms

New Drug Application, Priority Review, PDUFA, Real-Time Oncology Review, +4 more

8 terms

New Drug Application regulatory

"has accepted for filing its New Drug Application (“NDA”) for gedatolisib"

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

Priority Review regulatory

"The FDA granted Priority Review and assigned a Prescription Drug User Fee"

Priority review is a regulatory fast-track that shortens the time an agency spends evaluating a drug, vaccine or medical device application so a decision comes sooner than normal. For investors, it matters because a faster review is like an express lane to market: it can speed revenue potential and reduce regulatory uncertainty, but it does not guarantee approval and still requires the product to meet safety and effectiveness standards.

PDUFA regulatory

"assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

Real-Time Oncology Review regulatory

"under the FDA’s Real-Time Oncology Review (“RTOR”) program, which is intended"

A regulatory process in which reviewers assess clinical data and application materials for a cancer therapy as they are submitted, instead of waiting for a complete package. By allowing questions to be answered and issues resolved during the submission rather than afterward, it can speed up decisions and reduce surprise delays. For investors, that means greater predictability around potential approvals or setbacks and a faster path to a drug reaching the market, similar to editing a book chapter-by-chapter rather than after the whole manuscript is finished.

Breakthrough Therapy regulatory

"Gedatolisib previously received both Breakthrough Therapy and Fast Track"

A breakthrough therapy is a regulatory designation granted to an experimental drug or treatment when early clinical evidence indicates it could offer a substantial improvement over existing options for a serious or life‑threatening condition. For investors it matters because the label brings faster, more intensive interaction with regulators and can shorten development and review time—like a VIP fast‑track toward potential approval, reducing time and risk before a product can reach the market.

Fast Track regulatory

"previously received both Breakthrough Therapy and Fast Track designations"

A fast track designation is a regulatory label that speeds up the review and communication between a drug developer and regulators for treatments addressing serious illnesses or unmet medical needs. For investors, it matters because it can shorten development time and reduce regulatory delays—like getting a VIP lane at the airport—raising the chance of earlier market access and potential revenue, though it does not guarantee approval.

PI3K/AKT/mTOR medical

"a PI3K/AKT/mTOR (“PAM”) inhibitor that potently targets all four Class I"

A cellular signaling pathway made of proteins called PI3K, AKT and mTOR that helps control cell growth, survival and metabolism; think of it as a central control system that tells cells when to divide, store energy or self-repair. It matters to investors because drugs or diagnostics that affect this pathway are key targets in cancer and other diseases, so progress, trial results or regulatory changes around these targets can strongly influence a biotech or pharmaceutical company’s value.

mTORC1 medical

"targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce"

mTORC1 is a protein complex that acts like a cellular control center, sensing nutrient and energy levels and telling cells when to grow, divide, or conserve resources. It matters to investors because drugs or therapies that block or tweak this control center can slow cancer growth, treat metabolic and age‑related diseases, or cause side effects, so companies targeting mTORC1 can have substantial therapeutic and commercial potential.

AI-generated analysis. Not financial advice.

• FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026
  

MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced breast cancer (“ABC”). The FDA granted Priority Review and assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of July 17, 2026.

The NDA was submitted under the FDA’s Real-Time Oncology Review (“RTOR”) program, which is intended to facilitate shorter regulatory review periods. Gedatolisib previously received both Breakthrough Therapy and Fast Track designations based on promising preliminary clinical data. The submission is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.

“The FDA’s acceptance of our New Drug Application for gedatolisib and the assignment of a PDUFA goal date is a pivotal milestone in our efforts to bring a much-needed new treatment option to patients with HR+/HER2- advanced breast cancer,” said Brian Sullivan, CEO and co-founder of Celcuity. “We believe the robust clinical dataset underlying this submission demonstrates the practice changing potential of gedatolisib. We are looking forward to collaborating with the FDA throughout the review process as we work towards a potential approval and commercial launch.”

Gedatolisib

Gedatolisib is an investigational, multi-target PI3K/AKT/mTOR (“PAM”) inhibitor that potently targets all four Class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.^1,2,3 As a multi-target PAM inhibitor, gedatolisib’s mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.² Inhibition of only a single PAM component results in cross-activation of the uninhibited components, which limits the suppression of PAM pathway activity. Gedatolisib’s comprehensive PAM pathway inhibition enables full suppression of the PAM pathway by minimizing the adaptive cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated comparable potency and cytotoxicity in PIK3CA-mutant and wild-type breast tumor cells in nonclinical studies and early clinical data.^3,4

About Celcuity

Celcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades 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. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- ABC, has completed enrollment and the company has reported detailed results for the PIK3CA wild-type cohort and has completed enrollment of patients for the PIK3CA mutant cohort. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- ABC, is currently enrolling patients. A Phase 1/2 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; our expectations regarding the timing of and our ability to obtain FDA approval under the RTOR program and to commercialize gedatolisib; and other expectations with respect to gedatolisib. 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 our interpretation of such data may change; unforeseen delays in the review of our NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. 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, 2024, 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. 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
2. 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
3. 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
4. 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

View source version of release on GlobeNewswire.com

Contacts: 

Celcuity Inc. 
Brian Sullivan, bsullivan@celcuity.com 
Vicky Hahne, vhahne@celcuity.com 
(763) 392-0123 

ICR Healthcare
Patti Bank, patti.bank@icrhealthcare.com
(415) 513-1284

FAQ

What did Celcuity (CELC) announce about gedatolisib on January 20, 2026?

Celcuity announced FDA acceptance of the NDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer and confirmed Priority Review with a PDUFA date of July 17, 2026.

What regulatory pathways did the FDA grant to Celcuity for gedatolisib (CELC)?

The FDA granted Priority Review, accepted the NDA under RTOR, and the program previously received Breakthrough Therapy and Fast Track designations.

On what clinical data did Celcuity base the NDA for gedatolisib (CELC)?

The NDA is based on clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial.

What is gedatolisib's mechanism and how is it different from other PAM inhibitors?

Gedatolisib is an investigational multi-target PI3K/AKT/mTOR (PAM) inhibitor that targets all four Class I PI3K isoforms plus mTORC1 and mTORC2, aiming for broader PAM pathway blockade than single-target agents.

When is the FDA decision expected for gedatolisib (CELC)?

The FDA assigned a PDUFA goal date of July 17, 2026 for the gedatolisib NDA review.