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 ...

We drive into the future using only our rearview mirror, as famously said by Canadian scholar Marshall McLuhan. With 2025 drawing to a close, it's the perfect time to reflect on how some of the stocks we profiled performed over the year and to look ahead for potential hidden gems in the New Year. Below is a list of lesser-known stocks that went on to deliver significant returns, which we identified early.Palvella Therapeutics Inc. (PVLA)Palvella is a clinical-stage biopharmaceutical company, exclusively fo ...

If you are interested in keeping up to date with stocks making moves within the biotech, pharma and healthcare industries, and understanding the key trends and catalysts driving valuations ahead of the market, why not subscribe to my weekly newsletter via my Investing Group, Haggerston BioHealth ?This is my first time initiating coverage of Celcuity Inc. ( CELC ) for Seeking Alpha. The Minneapolis based biotech raised a modest $26.2m in its September 2018 IPO, at a share price of $9.5, andEdmund Ingham is a ...

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]

Core Insights - Jefferies has released a report on the outlook for the U.S. biotech industry in 2026, highlighting key clinical trial data disclosures, new drug approvals, and policy dynamics that could lead to value re-evaluation for companies in the sector [1] Six Preferred Stocks - Jefferies identified six companies as core recommendations for 2026 based on market catalysts and valuation potential: - Dianthus Therapeutics (DNTH.US), target price $66: Focused on claseprubart for various neuromuscular diseases, with peak revenue estimated at $2 billion [2] - Taysha Gene Therapies (TSHA.US), target price $11: TSHA-102 for Rett syndrome, with peak revenue potential of $2 billion and a key trial data disclosure expected by the end of 2026 [2] - Tyra Biosciences (TYRA.US), target price $32: Dabogratinib for bladder cancer and achondroplasia, with critical data expected next year [3] - Tango Therapeutics (TNGX.US), target price $14: Collaboration with Revolution Medicines for a pancreatic cancer treatment, with data expected in mid-2026 [3] - ORIC Pharmaceuticals (ORIC.US), target price $23: Two potential assets targeting prostate cancer and lung cancer, with key data expected next year [4] - Solid Biosciences (SLDB.US), target price $15: Focused on gene therapy for Duchenne muscular dystrophy, with critical meetings with the FDA planned for 2026 [4] Seven Undervalued Companies - The report also highlighted seven undervalued companies with significant catalysts: - Ultragenyx Pharmaceutical (RARE.US), target price $114: Expected key catalysts in 2026, including data for treatments for osteogenesis imperfecta and Angelman syndrome [5] - Beam Therapeutics (BEAM.US), target price $41: Updates on AATD therapy and SCD therapy expected in 2026, showcasing strong potential [5] - Aurinia Pharmaceuticals (AUPH.US), target price $21: Steady growth in lupus nephritis treatment, with new drug development paths expected to expand growth [6] - Kodiak Sciences (KOD.US), target price $39: Anticipated data from three pivotal trials in 2026, with significant potential for stock volatility [7] - Intellia Therapeutics (NTLA.US), target price $45: Key data for hereditary angioedema therapy expected in mid-2026, with sufficient cash reserves to support operations [7] - Compass Therapeutics (CMPX.US), target price $8: Data for cholangiocarcinoma therapy expected in early 2026, with a significant market opportunity [8] - KalVista Pharmaceuticals (KALV.US), target price $38: First oral treatment for hereditary angioedema expected to see rapid growth in 2026 [8] Five Potential Acquisition Targets - Jefferies identified five companies that may become acquisition targets in 2026 due to their unique assets or market positions: - Arrowhead Pharmaceuticals (ARWR.US): Strong RNAi product line for cardiovascular and metabolic diseases [9] - Celcuity (CELC.US): Unique efficacy of gedatolisib in breast cancer [9] - ORIC Pharmaceuticals: High-value prostate and lung cancer projects [9] - Travere Therapeutics (TVTX.US): Potential for significant market expansion in rare kidney diseases [9] - KalVista Pharmaceuticals: First-mover advantage in oral HAE treatment [9]

Key Takeaways Five biotech stocks are highlighted for 2026 due to late-stage trials or upcoming FDA decisions.MindMed expects multiple phase III data readouts in 2026 for its lead program MM120.Ocugen, Kyverna and Celcuity face key inflection points tied to BLAs or pivotal clinical data.After a weak first half, the drug and biotech sector has recovered in the past 2-3 months with large drugmakers like Pfizer, AstraZeneca, Eli Lilly and Novo Nordisk signing drug pricing agreements with the Trump administrati ...

Core Insights - U.S. stocks experienced a decline, with the Nasdaq Composite dropping over 400 points on Friday [1] - RH reported third-quarter earnings of $1.71 per share, missing analyst estimates by 20.87%, while quarterly revenue of $883.81 million exceeded expectations [1] Company Performance - RH shares increased by 5.8% to $162.14 following the earnings report [2] - Lululemon Athletica Inc. saw a 10.1% gain to $205.80 after beating third-quarter estimates and raising full-year guidance [3] - Frequency Electronics Inc. reported better-than-expected second-quarter sales, leading to a 27.2% increase in share price to $45.84 [3] - CCC Intelligent Solutions Holdings Inc. announced a $500 million share repurchase authorization, resulting in a 6.3% increase in share price to $7.68 [3] Market Reactions - Canopy Growth Corp. shares rose 35.4% to $1.53 due to potential federal marijuana regulation changes [3] - Rivian Automotive Inc. gained 14.9% to $18.88 after announcing entry into the autonomous driving sector with a new AI chip [3] - Clear Secure Inc. experienced an 11.3% increase to $40.36 after an upgrade from JP Morgan [3]

Core Viewpoint - The Russell 2000 index is positioned to potentially be the second-best-performing index in the U.S. stock exchanges as 2025 approaches, driven by a significant shift towards small-cap stocks due to the Federal Reserve's easing cycle [1]. Interest Rate Impact - The Federal Reserve has reduced the benchmark federal funds rate by 25 basis points, bringing it to a range of 3.5-3.75%, down from a high of 5.25-5.5% in 2023 during a tightening cycle aimed at controlling post-pandemic inflation [2]. Small Business Financing - Lower interest rates are favorable for small businesses, particularly as the period from mid-December to early March is historically strong for the Russell 2000 due to tax-loss harvesting and increased investor risk appetite at the start of the new year [3]. Top Performers in Russell 2000 - **Celcuity (CELC)**: - Stock Price: $100 - YTD Return: +695% - Market Cap: $4.71 billion - The company focuses on cellular analysis and precision oncology, experiencing significant stock price increases due to breakthrough clinical trials [5][6]. - **Better Home & Finance (BETR)**: - Stock Price: $48 - YTD Return: +442% - Market Cap: $794.72 million - Operates as an AI-powered mortgage lender and fintech company, with projected annual sales growth of over 50% this year and 67% next year [9][12]. - **Cogent Biosciences (COGT)**: - Stock Price: $40 - YTD Return: +413% - Market Cap: $5.58 billion - Focused on precision therapies for genetically defined diseases, with strong clinical progress on its lead drug, bezuclastinib [13][14]. Earnings Projections - Celcuity is expected to report a loss of -$3.86 per share in FY25 and -$4.05 in FY26, despite positive EPS revisions [8]. - Better Home's EPS revisions for FY25 and FY26 have slightly decreased, indicating potential short-term momentum loss [12]. - Cogent is projected to have a narrower adjusted loss of -$1.77 per share in FY26, with modestly higher EPS revisions in the last 60 days [14]. Investment Considerations - The strong performance of the Russell 2000 suggests that these top-performing stocks may be worth monitoring, although better buying opportunities may arise in the future [16].

Core Insights - Celcuity Inc. announced updated results from the Phase 3 VIKTORIA-1 trial for gedatolisib, a multi-target PI3K/AKT/mTOR inhibitor, in patients with advanced breast cancer [1] Efficacy Results - For patients with time to progression on prior therapy >18 months, median progression-free survival (PFS) was 12.4 months for the gedatolisib triplet and 10.0 months for the gedatolisib doublet, compared to 1.9 months for fulvestrant [2][6] - In patients from the U.S., Canada, Western Europe, and Asia Pacific, median PFS was 16.6 months for the gedatolisib triplet and 7.1 months for the gedatolisib doublet, versus 1.9 months for fulvestrant [2][6] Safety Analysis - Stomatitis was effectively managed, with median time to improvement for Grade 2 or 3 stomatitis being 12 and 14 days for the triplet, and 8 and 9 days for the doublet [3][6] - Gedatolisib did not cause clinically relevant hyperglycemia, and glucose levels remained stable over time [3][6] Patient-Reported Outcomes - Both gedatolisib regimens delayed time to definitive deterioration in well-being measures compared to fulvestrant, with median time to deterioration being 23.7 months for the triplet and not reached for the doublet, versus 4.0 months for fulvestrant [4][6] Company Perspective - The Chief Medical Officer of Celcuity expressed excitement over the results, highlighting nearly two years of delay in definitive deterioration of well-being for patients and the differentiated safety profile of gedatolisib regimens [5][6] Company Overview - Celcuity is a clinical-stage biotechnology company focused on developing targeted therapies for solid tumors, with gedatolisib as its lead candidate [6][7] - The company is conducting multiple clinical trials, including VIKTORIA-2 for first-line treatment in HR+/HER2- advanced breast cancer and CELC-G-201 for metastatic castration-resistant prostate cancer [7]

Summary of Celcuity FY Conference Call (December 03, 2025) Company Overview - **Company**: Celcuity (NasdaqCM:CELC) - **Lead Asset**: Gedatolisib, a pan-PI3K/mTOR inhibitor - **Focus**: Breast cancer treatment, specifically HR-positive, HER2-negative breast cancer Key Points Clinical Trials and Drug Development - **Ongoing Trials**: Three Phase III programs in HR-positive, HER2-negative breast cancer, with one initiated in the first-line setting and two in the second-line setting [3][4] - **Promising Data**: Reported encouraging results for gedatolisib in metastatic castration-resistant prostate cancer and unprecedented data in second-line breast cancer trials [3] - **Victoria Trials**: - **Victoria I**: Focused on post-CDK4/6 treatment in women who are endocrine therapy resistant [6][10] - **Victoria II**: Targets treatment-naive women who did not respond well to adjuvant therapy [6][10] - **Expected Data Releases**: Additional data for mutation patients anticipated by end of Q1 or Q2 2026 [8][17] Mechanism of Action - **Complex Pathway**: Gedatolisib targets the interconnected estrogen receptor, CDK4/6, and PAM (PI3K/AKT/mTOR) pathways, which are crucial for tumor control [5][12] - **Potency**: Gedatolisib is reported to be 300 times more potent than existing single-target inhibitors, demonstrating cytotoxic effects rather than just cytostasis [12][13] Efficacy and Safety - **Hazard Ratios**: The triplet therapy (gedatolisib + fulvestrant + CDK4/6) showed a hazard ratio of 0.24, indicating a significant improvement over historical data [18][20] - **Median PFS**: - Wild-type cohort reported over 9 months median PFS, compared to 7 months for alpelisib in mutation settings [22][23] - Anticipated that a 10% improvement in the triplet therapy could double the current standard of care [23] - **Tolerability**: Reported low levels of hyperglycemia (10% all-grade, 2% grade 3) compared to other drugs, suggesting a better safety profile [27] Market Potential - **Market Size**: The overall market potential for the second-line setting is estimated at around $6 billion, with 40% of patients having mutations [25] - **Patient Population**: Approximately 37,000 patients in the second-line setting, with 60% wild-type and 40% mutant [25] Commercial Strategy - **Launch Preparations**: The company is preparing for the drug launch in Q1 2024, having built most of the necessary team [35] - **Sales Force**: Anticipated sales team size is between 80 and 90 representatives, which is standard for breast cancer drugs [35] - **Pricing Strategy**: Current PI3K inhibitors are priced around $25,000 per cycle, which will serve as a benchmark for gedatolisib's pricing [36] Future Outlook - **OS Updates**: Further updates on overall survival (OS) data expected in Q1 2027, with additional data related to safety and subgroup analyses to be presented on December 11, 2025 [28][29] Additional Insights - **Treatment Paradigm Shift**: The evolving treatment landscape for breast cancer is moving beyond traditional therapies, with a focus on comprehensive pathway inhibition [4][5] - **Regulatory Environment**: The company is adhering to regulatory standards, with no interim analyses planned for ongoing trials [17]