We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Celcuity Inc. is one of them. Celcuity Inc. (NASDAQ:CELC) is a clinical-stage biotechnology company developing targeted oncology therapies, with a focus on solid tumors such as advanced breast cancer. Its lead drug candidate, gedatolisib, targets the PI3K and mTOR pathways, key drivers of tumor growth and resistance, aiming to improve outcomes for patients with hormone receptor-positive (HR+), HER2-negative advanced ...

Industry Overview - Healthcare spending in the US is projected to reach $5.3 trillion in 2023, making it one of the largest sectors globally [1] - The healthcare industry has shown mediocre returns over the past three years, with a decline of 3.6% in 2022, followed by slight increases of 0.3% in 2023 and 0.9% in 2024 [2] - The healthcare sector is one of four S&P 500 sectors experiencing negative returns in 2025 [2] Regulatory and Political Environment - The underperformance of the healthcare sector in 2025 is attributed to the Trump administration's actions, including pressure for reduced drug pricing and tariffs on pharmaceuticals [3] - Cuts to programs like Medicaid and health research have exacerbated the challenges faced by healthcare organizations [3] - Ongoing political and regulatory uncertainties deter investment interest in the sector [4] Long-term Outlook - Despite recent poor performance, the long-term outlook for the healthcare industry remains favorable due to the essential nature of its goods and services [4] - Many equities in the sector are currently trading at significant discounts, indicating potential investment opportunities [4][5] Investment Strategy - The article emphasizes the importance of hedge fund interest in stocks, suggesting that mimicking top hedge fund picks can lead to market outperformance [8] - A methodology was employed to identify the best-performing healthcare stocks, focusing on those with year-to-date returns of 20% or more and ranked by hedge fund holdings [7] Company Highlights - **Celcuity Inc. (NASDAQ:CELC)**: A clinical-stage biotechnology company focused on oncology therapies, with a lead drug candidate, gedatolisib, recently accepted for NDA by the FDA [10][11] - **ABIVAX Société Anonyme (NASDAQ:ABVX)**: Developing therapies for chronic inflammatory diseases, with positive Phase 3 trial results for its lead candidate, obefazimod, and plans for regulatory submissions in 2026 [13][15][16] - **Indivior PLC (NASDAQ:INDV)**: A pharmaceutical company specializing in opioid use disorder treatments, reporting strong Q2 results with a revenue increase and raised full-year guidance [17][18][19]

Core Insights - Celcuity Inc. announced that clinical data from the Phase 3 VIKTORIA-1 trial will be presented at the ESMO Congress, highlighting the efficacy and safety of gedatolisib in treating advanced breast cancer [1][2] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with its lead candidate being gedatolisib, a pan-PI3K and mTORC1/2 inhibitor [3] - The VIKTORIA-1 trial evaluates gedatolisib in combination with fulvestrant, with or without palbociclib, specifically for patients with HR+/HER2- advanced breast cancer [3] - The company is also conducting other clinical trials, including VIKTORIA-2 and CELC-G-201, targeting different cancer indications [3]

Core Viewpoint - Celcuity Inc. announced that the FDA accepted its New Drug Application for gedatolisib in HR+/HER2- advanced breast cancer for review under the Real-Time Oncology Review program, facilitating an earlier evaluation process [1][2] Group 1: FDA Review and Application - The FDA's acceptance of the NDA for gedatolisib is part of the RTOR program, which allows for earlier submission of topline efficacy and safety results [1][3] - Celcuity plans to initiate a rolling submission of its NDA in September 2025, targeting completion by Q4 2025 [1][2] Group 2: Clinical Trial Results - The NDA submission is based on positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial [2] - The gedatolisib-triplet (gedatolisib, fulvestrant, and palbociclib) reduced the risk of disease progression or death by 76% compared to fulvestrant, with a median progression-free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant, an improvement of 7.3 months [2] - The gedatolisib-doublet (gedatolisib and fulvestrant) reduced the risk of disease progression or death by 67%, with a median PFS of 7.4 months compared to 2.0 months for fulvestrant, an improvement of 5.4 months [2] Group 3: Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for various solid tumors, with gedatolisib as its lead candidate [4] - Gedatolisib is a potent pan-PI3K and mTORC1/2 inhibitor, differentiating its mechanism of action from other therapies targeting PI3Kα, AKT, or mTORC1 [4] - The company is conducting multiple clinical trials, including the ongoing Phase 1/2 trial for metastatic castration-resistant prostate cancer and the Phase 3 VIKTORIA-2 trial for first-line treatment in HR+/HER2- ABC [4]

Core Insights - Celcuity Inc. reported significant advancements in its clinical trials, particularly the Phase 3 VIKTORIA-1 trial, which demonstrated a substantial reduction in disease progression risk for patients with HR+/HER2- advanced breast cancer [2][4][5] - The company plans to submit a New Drug Application (NDA) for its lead candidate, gedatolisib, to the FDA in the fourth quarter of 2025, based on promising data from the PIK3CA wild-type cohort [2][4][5] - Financial results for Q2 2025 showed a net loss of $45.3 million, an increase from $23.7 million in Q2 2024, with total operating expenses rising to $44.0 million [6][9][19] Business Developments - Positive topline data from the PIK3CA wild-type cohort indicated a 76% reduction in the risk of disease progression or death with the gedatolisib triplet therapy compared to fulvestrant [5] - The company has initiated enrollment in the PIK3CA mutant cohort of the VIKTORIA-1 trial, with topline data expected by the end of 2025 [4][5] - A new patent for gedatolisib's dosing regimen was issued, extending exclusivity until 2042 [12] Financial Performance - Total operating expenses for Q2 2025 were $44.0 million, up from $24.3 million in Q2 2024, with R&D expenses accounting for $40.2 million [6][7][19] - The net cash used in operating activities increased to $36.2 million in Q2 2025 from $18.1 million in Q2 2024 [10] - As of June 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling $168.4 million, which, after recent financing, is projected to support operations through 2027 [11][12]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that blocks the PAM pathway comprehensively [3] - Celcuity is headquartered in Minneapolis and provides further information on its website [3] Clinical Trials - A Phase 3 clinical trial, VIKTORIA-1, is currently enrolling patients to evaluate gedatolisib in combination with fulvestrant with or without palbociclib for HR+/HER2- advanced breast cancer [3] - A Phase 1/2 clinical trial, CELC-G-201, is ongoing to assess gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3] - Another Phase 3 clinical trial, VIKTORIA-2, is enrolling patients to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- advanced breast cancer [3] Upcoming Financial Results - Celcuity will release its financial results for the second quarter of 2025 after the market closes on August 14, 2025 [1] - Management will host a webcast/teleconference on the same day at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update [1]

2021年4月，一笔不起眼的BD交易在美国悄然完成。 Celcuity宣布与辉瑞达成全球许可协议，获得泛PI3K-mTORC1/2抑制剂gedatolisib在全球范围内的开发和 商业化权益。 作为一款泛PI3K与mTORC1/2双重抑制剂，它对p110α/β/γ/δ四种PI3K催化亚型以及mTORC1、mTORC2 均保持低纳摩尔级活性。这意味着，Gedatolisib可以一次性切断PI3K/AKT/mTOR（PAM）轴的全部关 键节点，而不仅是其中某一条分支。 由于gedatolisib尚处早期阶段，属于被辉瑞放弃的管线，因此交易价格极其划算：前期付款1000万美 元，其中500万美元现金支付，另外500万美元以股权支付即可。 即便加上后续3.3亿美元的里程碑款，总金额不超过3.5亿美元。这样的BD，在动辄十亿、百亿交易的面 前，很难引发市场关注。 只是谁也没想到，4年后的今天，剧情让辉瑞有些难绷。 7月28日，Celcuity宣布，gedatolisib在III期VIKTORIA-1临床PIK3CA野生型队列中取得积极初步结果： gedatolisib三联疗法在患者中，达到统计学显著且具有临床意义的PF ...

Group 1 - Celcuity (NASDAQ: CELC) recently announced positive results from its phase 3 VIKTORIA-1 trial, which tested its drug gedatolisib in combination with other therapies for treating patients with PIK3CA wildtype HR+/HER2- advanced breast cancer [2] - The trial involved a triplet therapy approach, indicating a potential advancement in treatment options for this specific type of breast cancer [2] Group 2 - The Biotech Analysis Central service offers in-depth analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2] - The service is available for $49 per month, with a discounted yearly plan at $399, providing a 33.50% savings for subscribers [1]

Core Viewpoint - Celcuity Inc. has announced the pricing of its public offerings, including $175 million in convertible senior notes and approximately 1.84 million shares of common stock at $38.00 per share, aiming to raise a total of approximately $248.7 million for various corporate purposes [1][6]. Offering Details - The company is offering $175 million in 2.750% convertible senior notes due 2031, with an option for underwriters to purchase an additional $26.25 million to cover over-allotments [1][2]. - The common stock offering includes 1,836,842 shares priced at $38.00 each, with pre-funded warrants available at $37.999 per warrant [1][2]. Financial Terms - The convertible notes will accrue interest at 2.750% per year, payable semiannually, and will mature on August 1, 2031 [3]. - The initial conversion rate for the convertible notes is set at 19.4932 shares of common stock per $1,000 principal amount, equating to a conversion price of approximately $51.30 per share, representing a 35% premium over the common stock offering price [4]. Closing Timeline - The expected closing date for the convertible notes offering is August 1, 2025, while the common stock offering is anticipated to close on July 31, 2025, subject to customary closing conditions [5]. Use of Proceeds - The net proceeds from both offerings are estimated to be approximately $248.7 million, which will be used for working capital, clinical trial expenditures, and other general corporate purposes [6]. Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, with its lead candidate, gedatolisib, currently undergoing multiple clinical trials for various cancer indications [11].

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) 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 ...