Core Insights - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted therapies for oncology, specifically for multiple solid tumor indications [3] - The company will participate in the Guggenheim Emerging Outlook: Biotech Summit 2026 in New York on February 11-12, 2026 [1] - Brian Sullivan, CEO and Co-founder of Celcuity, is scheduled for a fireside chat on February 11, 2026, at 9:30 a.m. ET, with a live webcast available [2] Company Overview - Celcuity's lead therapeutic candidate is gedatolisib, a potent pan-PI3K and mTORC1/2 inhibitor that targets the PI3K/AKT/mTOR pathway [3] - The company has completed enrollment for the Phase 3 clinical trial VIKTORIA-1, which evaluates gedatolisib in combination with fulvestrant in patients with HR+/HER2- ABC, and has reported results for the PIK3CA wild-type cohort [3] - The ongoing Phase 3 clinical trial VIKTORIA-2 is assessing gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for HR+/HER2- ABC patients [3] - A Phase 1/2 clinical trial, CELC-G-201, is evaluating gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer [3]

Apis Capital Advisors’ Apis Flagship Fund released its Q4 2025 investor letter. A copy of the letter can be downloaded here. Apis Flagship Fund delivered strong performance in the fourth quarter of 2025, with the Fund up 10.0% net for the quarter and gaining 55.1% for the full year, significantly outperforming the MSCI ACWI global benchmark by approximately 7.0% in Q4 and 33.0% for the year. Long positions drove the majority of gains as they generated 11.9% gross contribution, while shorts added a further 0 ...

行 业 研 究 华福证券 医药生物 2026 年 02 月 01 日 靶向 PAM 通路潜在百亿美元市场：和黄医药及 Celcuity 投资要点： 行 业 定 期 报 告 行情回顾：本周（2026 年 1 月 26 日- 2026 年 1 月 30 日）中信医药指数下 跌 3.3%，跑输沪深 300 指数 3.4pct，在中信一级行业分类中排名第 22 位；2026 年初至今中信医药生物板块指数上涨 3.0%，跑赢沪深 300 指数 1.3 pct，在中 信行业分类中排名第 18 位。本周涨幅前五的个股为：凯普生物（+ 26.5%）、 华兰疫苗（+ 12.8%）、德展健康（+ 8.8%）、万泽股份（+ 7.9%）、华康医疗 （+ 6.9%）。 靶向 PAM 通路市场空间大，关注 Celcuity、和黄医药：PAM 通路突 变发生在 38%肿瘤患者中，其中覆盖乳腺癌和前列腺癌两大癌种。靶向 PAM 潜在收入与 CDK4/6 和 AR 疗法相当（80-100 亿美金），由于过往开 发药物的疗效有限，PAM 抑制剂的药物收入在其他靶向治疗类别中占比很 小。Celcuity 开发的 Gedatolisib 是唯一在 ...

Celcuity Inc.'s ( CELC ) rapid ascension to a mature valuation (just over $5 billion in market cap as I write this) comes only a few months after my last coverage of theI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and not get burned by the pitfalls of investing in this space.Analyst’s Disclosure ...

FDA grants Priority Review and assigns a PDUFA goal date of July 17, 2026 MINNEAPOLIS, Jan. 20, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that the U.S. Food and Drug Administration (“FDA”) has accepted for filing its New Drug Application (“NDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), PIK3CA wild-type advanced ...

Core Insights - Artificial intelligence (AI) is identified as the greatest investment opportunity of the current era, with a strong emphasis on the urgent need for energy to support its growth [1][2][3] Group 1: AI and Energy Demand - AI technologies, particularly large language models like ChatGPT, are extremely energy-intensive, with data centers consuming as much energy as small cities [2] - The increasing demand for AI is straining global power grids, leading to rising electricity prices and a need for utilities to expand capacity [2] - Industry leaders, including Sam Altman and Elon Musk, have highlighted the critical link between AI development and energy availability, warning of potential shortages [2] Group 2: Investment Opportunity - A specific company, largely overlooked by AI investors, is positioned to capitalize on the anticipated surge in energy demand from AI data centers [3][6] - This company owns essential energy infrastructure assets and is involved in the engineering, procurement, and construction (EPC) of large-scale projects across various energy sectors [7] - It is uniquely positioned to benefit from the U.S. LNG export market, which is expected to grow under the current administration's energy policies [7] Group 3: Financial Strength and Market Position - The company is debt-free and has significant cash reserves, amounting to nearly one-third of its market capitalization, providing it with a strong financial foundation [8] - It also holds a substantial equity stake in another AI-related company, offering investors indirect exposure to multiple growth opportunities without high premiums [9] - The stock is currently trading at less than 7 times earnings, making it an attractive investment compared to other firms in the sector [10] Group 4: Future Trends and Talent Pool - The ongoing influx of talent into the AI sector is expected to drive continuous innovation and advancements, reinforcing the importance of investing in AI [12] - The convergence of AI, energy infrastructure, and onshoring trends presents a unique investment landscape that savvy investors are beginning to recognize [6][14]

Key Takeaways CELC filed an NDA for gedatolisib in HR , HER2- advanced breast cancer, with an FDA decision due in 2026.Phase III VIKTORIA-1 data showed strong PFS gains, supporting gedatolisib as a second-line option.Celcuity completed enrollment in another VIKTORIA-1 cohort, with more cancer studies underway.Celcuity (CELC) has made significant clinical and regulatory progress in the past few months. In November, Celcuity submitted a new drug application (“NDA”) to the FDA seeking approval for its lead pip ...

Group 1: Palvella Therapeutics Inc. (PVLA) - Palvella is a clinical-stage biopharmaceutical company focused on developing therapies for rare diseases with no FDA-approved treatments [2] - Its lead product, QTORIN rapamycin, targets microcystic lymphatic malformations and has a multi-billion-dollar market opportunity if approved [2] - The stock rose from $25 on March 10, 2025, to a 52-week high of $114.69 on December 22, 2025, before pulling back to $99.88 [3] Group 2: Cidara Therapeutics Inc. (CDTX) - Cidara is developing a preventive therapy for influenza and has agreed to be acquired by Merck for $221.50 per share, totaling approximately $9.2 billion [4] - The stock was trading at $18.98 when profiled on November 21, 2024 [4] Group 3: Celcuity Inc. (CELC) - Celcuity is focused on targeted therapies for oncology, with its lead drug candidate Gedatolisib aimed at breast and prostate cancers [5] - The stock increased from $12.60 on December 4, 2024, to an all-time high of $112.64 on December 12, 2025, before retreating to $99.16 [6] Group 4: Nanobiotix (NBTX) - Nanobiotix is a late-stage clinical biotechnology company developing physics-based therapies for cancer [7] - Its lead candidate, NBTXR3, is undergoing a phase III study for head and neck squamous cell carcinoma, with interim data expected in the first half of 2027 [8] - The stock rose from $12.23 on September 19, 2025, to a high of $30.35 on October 13, 2025, before trading around $21 [10] Group 5: Terns Pharmaceuticals Inc. (TERN) - Terns Pharma is developing small-molecule candidates for serious diseases, with TERN-701 targeting chronic myeloid leukemia [12] - Recent data showed a 75% major molecular response rate among patients receiving higher doses [13] - The stock increased from $5.98 on August 6, 2025, to an all-time high of $48.26 on December 10, 2025, before pulling back to around $40 [14] Group 6: DBV Technologies S.A. (DBVT) - DBV Technologies is developing an epicutaneous immunotherapy for food allergies, with its lead product, the VIASKIN Peanut patch, showing positive results in a phase 3 study [15] - The company aims to submit a Biologics License Application in the first half of 2026, with potential sales of $1.5 billion by 2030 if approved [15] - The stock rose from $10.64 on October 2, 2025, to a high of $26.18 on December 17, 2025, before trading around $19 [16] Group 7: Nutex Health Inc. (NUTX) - Nutex Health reported a significant turnaround from a $424 million net loss in 2022 to a $59 million net income for the nine months ended September 30, 2025 [17] - Revenue increased from $219 million in 2022 to $723.6 million in the first nine months of 2025 [17] - The stock rose from $33.56 on November 25, 2024, to a 52-week high of $193.07 before closing at $182.23 [18] Group 8: Inhibrx Biosciences Inc. (INBX) - Inhibrx is developing biologic therapies for cancer, with Ozekibart showing significant improvement in progression-free survival in chondrosarcoma [19] - The company plans to submit a biologics license application for Ozekibart in the second quarter of 2026 [20] - The stock rose from $18.35 on July 8, 2025, to an all-time high of $94.57 on December 22, 2025, before trading around $77 [21] Group 9: GRAIL Inc. (GRAL) - GRAIL focuses on early cancer detection with its Galleri test, which is not yet FDA-approved [23] - The company expects to submit a PMA for the Galleri test in Q1 2026 [23] - The stock increased from $48.50 on September 26, 2025, to a high of $115.76 on November 25, 2025, before trading around $88 [24] Group 10: Cogent Biosciences Inc. (COGT) - Cogent is developing precision therapies for genetically defined diseases, with Bezuclastinib being its lead candidate [25] - The company submitted its first NDA to the FDA for Non-AdvSM, with additional submissions planned for GIST and advanced systemic mastocytosis [26] - The stock rose from $7.25 on July 2, 2025, to a 52-week high of $43.73 on December 8, 2025, before easing back to around $35 [26] Group 11: Sol-Gel Technologies Ltd. (SLGL) - Sol-Gel has two FDA-approved products for dermatological conditions and is developing investigational products [27] - A phase III trial for SGT-610 is ongoing, with results expected in Q4 2026 [28] - The stock rose from $7.26 on May 7, 2025, to a high of $52.26 on October 6, 2025, before trading around $43 [28] Group 12: Zenas BioPharma Inc. (ZBIO) - Zenas is focused on therapies for autoimmune diseases, with Obexelimab in phase 3 trials for IgG4-RD [29] - Positive data from a phase 2 trial in multiple sclerosis showed a 95% reduction in new lesions [30] - The stock rose from $8.79 on December 17, 2024, to a high of $44.60 on December 24, 2025, before pulling back to around $35 [31]

Group 1 - Celcuity Inc. (CELC) is a Minneapolis-based biotech company that raised $26.2 million in its September 2018 IPO at a share price of $9.5 [1] - The investing group Haggerston BioHealth, led by a biotech consultant with over 5 years of experience, provides insights into biotech, healthcare, and pharma sectors, including catalysts and buy/sell ratings [1] - The group also offers detailed product sales forecasts, integrated financial statements, discounted cash flow analysis, and market-by-market analysis for major pharmaceutical companies [1]

Group 1 - Celcuity Inc. (CELC) is a Minneapolis-based biotech company that raised $26.2 million in its September 2018 IPO at a share price of $9.5 [1] - The investing group Haggerston BioHealth, led by a biotech consultant with over 5 years of experience, provides insights into biotech, healthcare, and pharma sectors [1] - The group offers detailed reports on over 1,000 companies, including product sales forecasts, integrated financial statements, and market analysis [1]