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Tag: Celcuity Inc

  • Celcuity (CELC) Stock Surges After Announcing Landmark Trial Success

    Celcuity (CELC) Stock Surges After Announcing Landmark Trial Success

    Following the announcement of noteworthy clinical trial advancements, Celcuity Inc. (NASDAQ: CELC) stock saw a surge in value. The CELC stock was trading at $38.31 as of the most recent check, representing a remarkable 178.18% increase. The company’s Phase 3 VIKTORIA-1 trial’s PIK3CA wild-type group showed encouraging topline findings.

    After advancement on a CDK4/6 inhibitor and an aromatase inhibitor, the research compared gedatolisib with fulvestrant—with or without palbociclib—against fulvestrant in patients with hormone receptor (HR)-positive, HER2-negative, PIK3CA wild-type, locally advanced, or metastatic breast cancer.

    Revolutionary Progression-Free Survival Results

    In comparison to fulvestrant, the gedatolisib triplet showed a 76% decrease in the probability of disease progression or death, resulting in a statistically significant and clinically relevant increase in progression-free survival (PFS) (HR 0.24, 95% CI).

    According to the blinded independent central review (BICR), the median PFS was 9.3 months as opposed to 2.0 months with fulvestrant, representing a 7.3-month incremental improvement. With a 67% risk reduction and a 5.4-month advantage in mPFS from 2.0 months to 7.4 months, the gedatolisib doublet demonstrated comparable remarkable outcomes.

    Significant Advances in the Treatment of Advanced Breast Cancer

    For patients with HR+/HER2-advanced breast cancer receiving at least a second-line treatment, these results represent the highest favorable hazard ratios and PFS improvements yet documented in Phase 3 studies.

    Following CDK4/6 inhibitor advancement, gedatolisib becomes the first PI3K/AKT/mTOR pathway inhibitor to provide favorable Phase 3 results in HR+/HER2-/PIK3CA wild-type patients. Notably, both gedatolisib regimens showed better tolerability, fewer cases of stomatitis and hyperglycemia, and lower treatment dropout rates than observed in previous studies.

    Regulatory Route and Prospects

    The findings offer gedatolisib as a potentially revolutionary alternative for patients with HR+/HER2-/PIK3CA wild-type advanced breast cancer. In Q4 2025, Celcuity intends to file a New Drug Application with the US Food and Drug Administration.

    By the end of 2025, topline findings for the VIKTORIA-1 PIK3CA mutation cohort are also expected. The trial’s significant PFS improvement points to a paradigm shift in the treatment strategy for this difficult patient group.

  • Celcuity (CELC) Surges After-Hours On Positive Financial Performance

    Celcuity (CELC) Surges After-Hours On Positive Financial Performance

    After the closure of the market yesterday, Celcuity Inc. (NASDAQ: CELC) witnessed a significant uptick in its shares during the extended trading session. As per the latest update, CELC stock experienced a 4.70% increase, reaching $18.04 on the US stock market charts, following a 2.01% rise in the regular session, closing at $17.23.

    Strategic Milestones And Clinical Advancements

    During this quarter, Celcuity (CELC) demonstrated commendable progress. The VIKTORIA-1 study maintained its trajectory, and CELC successfully administered the initial dose to the first patient in its Phase 1b/2 trial targeting metastatic castration-resistant prostate cancer.

    Bolstering its leadership team, Celcuity appointed a Chief Commercial Officer, marking the initiation of essential groundwork for the potential commercial introduction of gedatolisib. Furthermore, Celcuity anticipates presenting crucial topline data from the PIK3CA wild-type patient subgroup later this year.

    Financial Insights And Operational Highlights

    Celcuity reported $22.5 million in total operating costs for the first quarter of 2024, of which $20.7 million was allocated to research and development (R&D). Significantly, R&D spending increased by around $9.4 million, mostly because of work related to the VIKTORIA-1 Phase 3 study and the start of the CELC-G-201 Phase 1b/2 clinical trial.

    An additional $1.5 million of this increase came from higher personnel and consultant costs. The net loss, which came to $21.6 million, or $0.64 loss per share, in spite of these investments was less than the $11.9 million, or $0.55 loss per share, reported in the same period of the prior year. Celcuity reported having $177.7 million in liquid assets as of March 31, 2024.

    Forward-looking Strategies And Clinical Trials Progress

    Topline findings for the PIK3CA mutant patient cohort are anticipated to be released in the first half of 2025 by Celcuity’s VIKTORIA-1 Phase 3 investigation, and for the PIK3CA wild-type patient subgroup in the second half of 2024. There is still room for more volunteers in the Phase 3 VIKTORIA-1 clinical investigation, which is being carried out at more than 220 sites throughout 23 countries in North and South America, Europe, and Asia.”

    In the meanwhile, a Phase 1b/2 clinical investigation for metastatic castration-resistant prostate cancer (mCRPC) is making good progress with the evaluation of gedatolisib in combination with darolutamide. Eldon Mayer’s appointment as Chief Commercial Officer, a calculated strategic move, fits with Celcuity’s goal of being ready for gedatolisib’s possible commercial debut.