Latest news with #Celcuity
Yahoo
5 days ago
- Business
- Yahoo
Celcuity Inc. Schedules Release of Second Quarter 2025 Financial Results and Webcast/Conference Call
MINNEAPOLIS, Aug. 07, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the second quarter 2025 after the market closes on Thursday, August 14, 2025. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Webcast and Conference Call InformationTo participate in the teleconference, domestic callers should dial 1-800-717-1738 and international callers should dial 1-646-307-1865. A live webcast presentation can also be accessed using this weblink: A replay of the webcast will be available on the Celcuity website following the live event. 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- advanced breast cancer 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. 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- advanced breast cancer is currently enrolling patients. More detailed information about Celcuity's active clinical trials can be found at Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Follow us on LinkedIn and X. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR HealthcarePatti Bank, (415) 513-1284Sign in to access your portfolio
Yahoo
31-07-2025
- Business
- Yahoo
Up 215% YTD, Should You Grab This Growth Stock Before It's Too Late?
Celcuity (CELC), a clinical-stage biotechnology company, has quietly surged more than 215% year-to-date, turning heads on Wall Street. While larger names in oncology dominate headlines, this under-the-radar cancer drug developer is making a name for itself by advancing an innovative approach to treating hormone receptor-positive, HER2-negative (HR+/HER2−) breast cancer, one of the most common and deadly subtypes of breast cancer. More News from Barchart Tesla Just Signed a Chip Supply Deal with Samsung. What Does That Mean for TSLA Stock? Here's What Happened the Last Time Novo Nordisk Stock Was This Oversold Dear Microsoft Stock Fans, Mark Your Calendars for Aug. 1 Tired of missing midday reversals? The FREE Barchart Brief newsletter keeps you in the know. Sign up now! The company announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial on Monday, which fueled the stock rally. Let's find out if it is the right time to grab this growth stock before it soars any higher. What Does Celcuity Do? Valued at $1.39 billion, Celcuity is a clinical-stage biotechnology company that aims to improve cancer treatment through two key innovations: a drug called gedatolisib and a specialty diagnostic tool called the CELsignia platform. The company's experimental drug, gedatolisib, is intended to block the PI3K and mTOR signaling pathways inside cancer cells, which help tumors grow and resist existing treatments. Unlike drugs that target only one part of this pathway, gedatolisib's mechanism of action inhibits multiple components at once, which may make it more effective. Celcuity is conducting Phase 3 clinical trials in breast cancer (VIKTORIA 1 and VIKTORIA 2) as well as a Phase 1/2 trial in prostate cancer to assess the efficacy of this drug in comparison to current treatments. What Led to the Dramatic Surge in CELC Stock? On July 28, Celcuity revealed positive results in patients with advanced HR-positive/HER2-negative breast cancer who did not have PIK3CA mutations (PIK3CA wild-type) and had previously received CDK4/6 inhibitors and hormone blockers. Patients were randomly assigned to one of two treatment groups, both of which included Celcuity's experimental drug gedatolisib: Triplet therapy with gedatolisib, palbociclib (Pfizer's (PFE) Ibrance), and fulvestrant reduced the risk of disease progression or death by approximately 76%. Doublet therapy with gedatolisib and fulvestrant reduced risk by 67%. This is the first Phase 3 breast cancer trial in which a PI3K/mTOR inhibitor has demonstrated strong efficacy in PIK3CA wild-type patients. It suggests that gedatolisib acts on multiple targets. Celcuity intends to submit a New Drug Application (NDA) to the FDA in the fourth quarter based on topline data. The new combination therapy significantly delayed cancer progression in the trial groups while causing no major new side effects, representing a breakthrough in this difficult-to-treat group. Investors are optimistic about a potential FDA approval late in 2025 and the possibility of a change in treatment options for many patients. Furthermore, the company has dosed the first patient in the VIKTORIA-2 Phase 3 trial. Celcuity had $205.7 million in cash and equivalents at the end of its first quarter, which ended on March 31. Operating expenses have steadily increased as the company expands its clinical footprint, but management has stated that current resources are sufficient to fund operations until 2026. Is Celcuity Stock a Buy Now? On Wall Street, overall, Celcuity stock is a 'Strong Buy.' Out of the eight analysts that cover the stock, seven rate it a 'Strong Buy,' and one suggests a 'Moderate Buy.' Led by the dramatic surge on Monday, the stock has surpassed its average target price of $28.71. However, following the positive trial results, Leerink increased the stock's target price to $60, implying 53% upside potential from current levels. In addition, H.C. Wainwright raised the target price to $50 and assigned a 'Buy' rating. The Bottom Line If the VIKTORIA-1 trial is successful, Celcuity could quickly become a commercial-stage company, given the size of the HR+/HER2− breast cancer market. However, despite its strong trajectory, Celcuity remains a high-risk investment. As with any biotech company in a critical development stage, risks include clinical trial failures or delays in regulatory approval, all of which can cause massive stock swings (both up and down). As a result, Celcuity stock remains a solid pick for investors with a long-term mindset and a high risk tolerance who are willing to deal with the short-term volatility. On the date of publication, Sushree Mohanty did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Sign in to access your portfolio
Yahoo
29-07-2025
- Business
- Yahoo
Celcuity shares triple on late-stage results for breast cancer therapy
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Biotechnology firm Celcuity said Monday a late-stage trial testing its experimental breast cancer therapy in combination with other drugs succeeded, positioning the Minneapolis-based company to submit an approval application to the Food and Drug Administration later this year. Treatment involving the biotech's drug, called gedatolisib, significantly reduced the risk of disease progression or death in patients with a certain kind of advanced breast tumor that continued to grow despite initial therapy. Researchers observed this progression-free survival benefit in both patients given a 'doublet' drug combination including gedatolisib and a 'triplet' combination. In a statement, Celcuity said the trial achieved 'several new milestones' in testing of treatments for breast cancer that's positive for hormone receptors but negative for another protein called HER2. Co-principal investigator Sara Hurvitz, head of the hematology and oncology division at the University of Washington's Department of Medicine, called the results 'potentially practice-changing' in the company's statement. With results in hand, Celcuity plans to file in the fourth quarter for FDA approval. Shares in the company tripled in early trading Monday, before settling back to trade higher by almost 200%. The share price gain inflated Celcuity's market value to about $1.5 billion. Celcuity's study enrolled patients with HR+, HER2- tumors that tested negative for common mutations in a gene called PI3KCA. In one group, the company paired gedatolisib with Pfizer's Ibrance and AstraZeneca's Faslodex, which is available as generic fulvestrant. Treatment with the triplet reduced the risk of disease progression by 76% compared to fulvestrant alone. Progression-free survival reached a median of 9.3 months in the triplet group versus just 2 months for those on fulvestrant. Given with just fulvestrant, gedatolisib treatment reduced progression by 67%, leading to a median progression-free survival of 7.4 months. The company said patient discontinuation rates due to treatment-related adverse events was lower in this study than in Phase 3 trials for approved drug combinations for this patient population. Full data from the trial will be presented at an upcoming medical conference later this year. Andrew Berens, an analyst at Leerink Partners, wrote in a client note Monday that the data 'are likely clinically meaningful across multiple subgroups' and provide rationale to use Celcuity's drug as a second-line breast cancer treatment. 'The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm-shifting results,' claimed Igor Gorbatchevsky, chief medical officer of Celcuity, in a statement. Other approved drug combinations in the second-line setting are supported by data showing lower median progression-free survival, of about two to four months, compared to the doublet and triplet regimens using gedatolisib. Celcuity expects to have data for gedatolisib in breast cancer patients with PIK3CA mutations by the end of this year. Recommended Reading Full Arvinas, Pfizer data confirm potential, limits of 'Protac' drug in breast cancer Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-07-2025
- Business
- Yahoo
Celcuity (CELC) Skyrockets 167% on Breast Cancer Treatment Trial
We recently published . Celcuity Inc. (NASDAQ:CELC) is one of the best-performing stocks on Monday. Celcuity soared by 167 percent on Monday to close at $36.79 apiece as investors cheered positive results in its clinical trial for its breast cancer treatment candidate. In a statement on Monday, Celcuity Inc. (NASDAQ:CELC) said it achieved positive topline results from the phase 3 clinical study of gedatolisib combined with palbociclib and fulvestrant—an experimental treatment for adults with two kinds of breast cancer. Called the gedatolisib triple, the three-drug combination reduced risk progression and death by 76 percent as compared with taking fulvestrant alone. Meanwhile, its gedatolisib double, which combines gedatolisib and fulvestrant, lowered the risk of progression and death by 67 percent, also achieving primary endpoints. Celcuity Inc.'s (NASDAQ:CELC) clinical trial success bolsters its chances of filing an approval with the Food and Drug Administration by the fourth quarter of the year. Copyright: bialasiewicz / 123RF Stock Photo Following the results, Celcuity Inc. (NASDAQ:CELC) earned a whopping $60 price target from Leerink, a marked increase from the $28 target previously. It also maintained an 'outperform' rating on its stock. While we acknowledge the potential of CELC as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an extremely cheap AI stock that is also a major beneficiary of Trump tariffs and onshoring, see our free report on the . Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Forbes
29-07-2025
- Business
- Forbes
Celcuity: What's Happening With CELC Stock?
CANADA - 2025/07/28: In this photo illustration, the Celcuity logo is seen displayed on a smartphone ... More screen. (Photo Illustration by Thomas Fuller/SOPA Images/LightRocket via Getty Images) Celcuity stock (NASDAQ: CELC), a clinical-stage biotechnology company, experienced an extraordinary 3x surge in a single trading session, with shares rocketing from approximately $14 to a peak of $46 before stabilizing around $37. This dramatic price movement was triggered by positive topline results from the PIK3CA wild-type cohort of the company's Phase 3 VIKTORIA-1 clinical trial for gedatolisib, a targeted therapy for HR+/HER2- breast cancer. The clinical results demonstrated that gedatolisib, when combined with one or two other medicines, significantly reduced the risk of disease progression or death compared to the control group. This outcome validates the company's therapeutic approach and positions the drug for potential regulatory submission. Big Commercial Opportunity Gedatolisib represents a substantial commercial opportunity with peak sales potential exceeding $2 billion. The drug targets hormone receptor-positive, HER2-negative breast cancer, a significant patient population with limited treatment options after endocrine therapy resistance develops. The FDA has already granted gedatolisib Breakthrough Therapy Designation, which could expedite the regulatory review process. The company plans to file for FDA approval in Q4 2025, with additional Phase 3 trials (VIKTORIA-2) evaluating the drug as a first-line treatment already underway. This multi-indication strategy could expand the addressable market significantly. Financial Flexibility As a pre-revenue biotech company, Celcuity operates with an expected cash burn profile, recording operational cash outflows of $127 million over the last twelve months. The company recently announced its intention to conduct public offerings totaling $225 million, comprising $150 million in convertible senior notes due 2031 and $75 million in common stock. The proceeds will help fund clinical trials and research & development activities. This substantial capital raise aims to bolster financial flexibility and support ongoing oncology research, providing significant runway to advance clinical programs toward commercialization. But There Are Risks While Celcuity has shown promising clinical results, several significant risks could impact its future trajectory and the successful development and commercialization of its lead drug, gedatolisib. Investment Outlook The positive Phase 3 results represent a significant validation of Celcuity's platform and therapeutic approach. With regulatory submission planned for Q4 2025 and Breakthrough Therapy Designation already secured, the company appears well-positioned for potential approval. However, investors should carefully weigh the substantial commercial opportunity against the inherent risks associated with biotech development and regulatory approval processes. The current valuation reflects significant optimism about regulatory success, making the investment sensitive to any setbacks in the approval timeline or additional clinical requirements from regulators. In fact, CELC stock is down 10% in extended trading post the dramatic 3x surge on Monday, July 28. See, regulatory risk is just a small part of the risk assessment framework we apply while constructing the 30-stock Trefis High Quality (HQ) Portfolio, which has a track record of comfortably outperforming the S&P 500 over the last 4-year period. Why is that? As a group, HQ Portfolio stocks provided better returns with less risk versus the benchmark index; less of a roller-coaster ride, as evident in HQ Portfolio performance metrics.
