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  • 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.

  • Celcuity Inc. (CELC) stock soared in the after-market trading session; here’s what recently happened

    Celcuity Inc. (CELC) stock soared in the after-market trading session; here’s what recently happened

    Celcuity Inc. (CELC) shares went up by 4.87% to trade at $29.3 in after-market at the time of writing. CELC stock closed Monday’s session at $27.94 which is a 29.35% gain. The CELC stock volume traded around 4.86 million shares, which was higher than the average daily volume of 0.46 million shares within the past 50 days

    What is the recent news on Cecluity’s operational activities?

    On 12th April, Celcuity participated in the American Association for Cancer Research (AACR) Annual Meeting and there presented the outcomes of its studies which evaluated gedatolisib, inavolisib, and navitoclax in breast and ovarian patient tumors. Gedatolisib is a pan-P13K/mTOR inhibitor, inavolisib is a P13K-α inhibitor and navitoclax is a BCL inhibitor. Two e-posters were used by the company for the presentation of these studies and result.

    Results and characteristics of the study

    The posters presented the use of CELsignia test to characterize the role of RAS network nodes; CELsignia RAS Network Activity test that is used by the company identifies hyperactive RAS network signal done by the ovarian or breast cancer patients’ tumors. Furthermore, CELsignia also characterizes gedatolisib, inavolisib, navitoclax as well as RAS signaling role in the phospholipid-initiated signaling activity that is done through the lysophosphatidic acid (LPA) receptor family of GPCRs in the tumor cells and cell lines of ovarian and breast cancer patients.

    The results of these studies indicated that there is a potential advantage of not just inhibiting P13k-α signaling but inhibiting all Class 1 P13K isoforms as well as mTOR for treating P13K signaling tumors.

    Licensing agreement with pharma-giant Pfizer

    The CELC stock soared more than 50% on 9th April after it announced a licensing agreement with the world-renowned pharma-company Pfizer PFE. In the agreement, Celcuity paid $10 million to Pfizer in upfront payment as per the terms and Pfizer will receive up to $330 million in development and sales-based milestone from Celcuity along with royalties on future sales.

    Furthermore, Celcuity also announced a promise to present the preliminary data on the recent ongoing phase 1b  study evaluating gedatolisib in combination with Pfizer’s Ibrance as well as an endocrine therapy in Er+/HER2 – advanced or metastatic breast cancer patients. Phase II/III study of gedatolisib with the pfixer combo is expected to start in mid of 2022.

    Insight on Celcuity’s overall background

    Celcuity is a clinical stage biotechnology company that is specifically creating novel therapies and treatments in a unique and innovative approach towards cancer treatments. The company is differentiated based on its focus on creating integrated companion diagnostics and therapeutic strategy for cancer patients. The objective of this focus is to enhance and extend the lives of cancer patients.

    The companion diagnostics is able to identify the cancer driver in the patient and then the therapeutic efforts target the cancer driver molecularly. The proprietary diagnostic platform of CELC stock is known as CELsignia which has the tech-ability to analyze the live tumor cells that then identify new groups of cancer patients for whom targeted therapies are favorable. This diagnosis is furthered by CELsigniaCDx that supports the advancement new developing indications for the established targeted therapies.

    Based on this therapeutic strategy and integrated companion diagnostic, Celcuity is positioned in the cancer treatment and therapy market uniquely to treat the cancer driver in the most suited way possible for the patients.