Why is CELC Skyrocketing in Premarket Trading Today?

Celcuity Inc. (NASDAQ: CELC) is experiencing a massive surge in premarket trading, with shares jumping over 112% to $29.23 as of 6:54:59 AM EDT on July 25, 2025. The clinical-stage biotechnology company has announced breakthrough results from its Phase 3 VIKTORIA-1 trial, showing clinically meaningful improvements in progression-free survival for breast cancer patients.

This represents a major milestone for the company’s lead drug candidate Gedatolisib, which targets a critical pathway involved in cancer cell growth and survival.

Celcuity’s Cancer Breakthrough: Understanding the VIKTORIA-1 Trial Results

Celcuity has achieved a significant milestone with its Phase 3 VIKTORIA-1 trial for Gedatolisib, a targeted therapy designed to treat hormone receptor-positive, HER2-negative advanced breast cancer. The trial demonstrated clinically meaningful improvements in progression-free survival (PFS), which measures how long patients live without their cancer getting worse. This is particularly important for breast cancer patients who have limited treatment options after their cancer has progressed despite initial therapies.

Gedatolisib works by targeting two specific proteins called mTORC1 and mTORC2, which are part of a cellular pathway that cancer cells often hijack to fuel their growth and survival. Think of these proteins as switches that cancer cells turn on to multiply rapidly – Gedatolisib essentially helps turn off these switches, slowing down or stopping cancer progression.

The drug also targets PI3K, another protein involved in cancer cell signaling, making it a multi-target approach that could be more effective than single-target treatments.

The positive results from this wild-type cohort of the PIK3CA trial represent a crucial step toward potential FDA approval. For patients and their families, this could mean access to a new treatment option that may extend the time before their cancer progresses, potentially improving quality of life and overall outcomes. The company is also conducting the VIKTORIA-2 trial, testing Gedatolisib as a first-line treatment, which could expand its potential patient population significantly.

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Impressive Trail Results Lead to Stock Surge in Premarket Trading for Celcuity

The market’s explosive reaction to Celcuity’s trial results is reflected in the stock’s premarket performance, surging from a previous close of $14.05 to $29.23, representing a gain of $15.46 or 112.27%. This dramatic move has pushed the stock well above its 52-week range of $7.57 to $18.87, indicating strong investor confidence in the trial results.

The company’s market capitalization has jumped to $521.42 million, while trading volume of 1.4 million shares significantly exceeds the average volume of 208,400 shares.

From a financial perspective, Celcuity remains a pre-revenue biotechnology company with challenging metrics typical of clinical-stage firms. The company reports negative earnings per share of -$3.05 and negative returns on both assets (-39.04%) and equity (-115.39%), reflecting the substantial investment required for drug development.

However, the company maintains a strong balance sheet with $205.69 million in total cash, providing runway for continued operations and trial execution.

Analyst sentiment has been increasingly positive, with recent recommendations showing a mix of Buy and Strong Buy ratings. The average analyst price target of $28.71 was essentially reached in premarket trading, though the high target extends to $33.00, suggesting potential for further upside.

The company’s recent patent extension for Gedatolisib into 2042 also provides long-term intellectual property protection, adding to the investment thesis for those betting on successful commercialization of this promising cancer therapy.

Disclaimer: The author does not hold or have a position in any securities discussed in the article. All stock prices were quoted at the time of writing.