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

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FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026...

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Celcuity Inc. received FDA acceptance for its New Drug Application for gedatolisib, targeted for advanced breast cancer, with a PDUFA goal date of July 17, 2026. This Priority Review underscores the drug's potential and could significantly enhance investor confidence and market positioning upon approval.

Sentiment Rationale

Similar FDA prioritization cases have previously led to regulatory approvals and stock price rallies. Celcuity's thorough clinical evidence reinforces optimism among investors.

Trading Thesis

Invest in CELC ahead of the July 2026 PDUFA date for potential upside.

Market-Moving

  • FDA's Priority Review could lead to accelerated sales upon potential approval.
  • Positive clinical data may attract increased investment interest.
  • Market reaction anticipated as PDUFA date approaches.
  • Further collaboration announcements with the FDA could boost stock confidence.

Key Facts

  • FDA accepts NDA for gedatolisib with a PDUFA goal date of July 17, 2026.
  • Gedatolisib targets advanced breast cancer with promising clinical data support.
  • Priority Review approval signifies expedited regulatory process for gedatolisib.
  • The drug enjoys Breakthrough Therapy and Fast Track designations.
  • Positive efficacy data may increase market confidence and anticipated revenue.

Companies Mentioned

  • Celcuity Inc. (CELC): Main focus is on gedatolisib for advanced breast cancer.
  • Pfizer (PFE): Potential competitor with existing breast cancer therapies.

Corporate Developments

The news falls under 'Corporate Developments' due to its significance in obtaining FDA acceptance for an important drug application, affecting Celcuity's strategic positioning and commercial potential.

Celcuity (CELC) Announces FDA Acceptance of New Drug Application for Gedatolisib in Advanced Breast Cancer

FDA Grants Priority Review for Gedatolisib

Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology firm specializing in targeted oncology treatments, has received significant news regarding its investigational drug, gedatolisib. The U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for gedatolisib, which targets hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), PIK3CA wild-type advanced breast cancer. The FDA has designated it for Priority Review and established a Prescription Drug User Fee Act (PDUFA) goal date of July 17, 2026.

Significance of the Application Submission

The NDA for gedatolisib, submitted under the FDA’s Real-Time Oncology Review (RTOR) program, aims to streamline regulatory review timelines. This application is based on robust clinical data from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial. Notably, gedatolisib has previously received both Breakthrough Therapy and Fast Track designations due to promising early clinical results.

“The FDA’s acceptance of our New Drug Application for gedatolisib... is a pivotal milestone in our efforts to bring a much-needed new treatment option to patients,” said Brian Sullivan, CEO and co-founder of Celcuity.

Understanding Gedatolisib's Mechanism

Gedatolisib represents a novel approach as a multi-target PI3K/AKT/mTOR (PAM) inhibitor. It effectively inhibits all four Class I PI3K isoforms, as well as mTORC1 and mTORC2. This comprehensive inhibition distinguishes gedatolisib from existing single-target PAM inhibitors, which can lead to compensatory activation of uninhibited components and reduced efficacy.

  • Targeted Pathway: Gedatolisib aims to fully suppress the PAM pathway.
  • Clinical Evidence: Demonstrated comparable efficacy against both PIK3CA-mutant and wild-type breast tumor cells in preclinical studies.

About Celcuity's Development Pipeline

Celcuity is focused on developing targeted therapies for various solid tumor types. The company's leading therapeutic candidate, gedatolisib, not only shows promise in advanced breast cancer but also has ongoing clinical trials:

  • The Phase 3 VIKTORIA-1 trial evaluates gedatolisib alongside fulvestrant, with results reported for the PIK3CA wild-type cohort.
  • The Phase 3 VIKTORIA-2 trial assesses gedatolisib combined with CDK4/6 inhibitors for first-line treatment.
  • A Phase 1/2 trial, CELC-G-201, investigates gedatolisib with darolutamide in metastatic castration-resistant prostate cancer.

Additional information on Celcuity's clinical studies can be accessed at ClinicalTrials.gov, and the company is headquartered in Minneapolis.

Forward-Looking Statements

This announcement contains forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These may include anticipated regulatory approvals and therapeutic benefits of gedatolisib, as well as the timelines for ongoing clinical trials. Statements are based on management’s current expectations, which may be subject to uncertainties and are outlined in the company’s filings with the Securities and Exchange Commission.

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