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]

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]

Industry Overview - The drug and biotech sector has shown recovery after a weak first half, with large drugmakers like Pfizer, AstraZeneca, Eli Lilly, and Novo Nordisk signing drug pricing agreements with the Trump administration [1] - A rebound in mergers and acquisitions (M&A) has increased investor confidence, with the Large Cap Pharmaceuticals industry outperforming the S&P 500 index over the past three months [1] - Innovation is at its peak, particularly in areas such as obesity, gene therapy, inflammation, and neuroscience, with the FDA approving 41 drugs as of December 15, 2025 [2] Biotech Breakthrough Stocks - Five biotech stocks are highlighted for potential investment: Mind Medicine (MindMed), Ocugen, Keros Therapeutics, Kyverna Therapeutics, and Celcuity, which have shown promising clinical results or have significant upcoming FDA decisions [3][4] - All highlighted stocks have outperformed the industry's increase of 15.3% in the past three months [6] Mind Medicine (MindMed) - MindMed is developing MM120, an orally disintegrating tablet for generalized anxiety disorder (GAD) and major depressive disorder (MDD), with pivotal phase III studies currently enrolling [10] - The FDA has granted breakthrough therapy designation to MM120 for GAD, with top-line data from the Voyage study expected in the first half of 2026 [11] - MindMed's recent financing of $258.9 million strengthens its balance sheet, allowing for accelerated development of MM120 [13] Ocugen - Ocugen is advancing gene therapy programs for retinal diseases, with a phase III study on OCU400 for retinitis pigmentosa (RP) nearing completion and top-line data expected in Q4 2026 [15] - The company plans to file a biologics license application (BLA) for OCU400 in 2026, with a rolling BLA submission starting in the first half of 2026 [15] - Ocugen is also developing OCU410 for geographic atrophy (GA), with data from the phase II study expected in Q1 2026 [18] Keros Therapeutics - Keros plans to initiate a phase II study of KER-065 for Duchenne muscular dystrophy (DMD) in Q1 2026, having received orphan drug designation from the FDA [20] - The company has shifted focus from cibotercept to KER-065, which has shown promising results in earlier studies [20] - Keros has a partnership with Takeda, which is expected to generate near-term revenues through milestone payments and royalties [21] Kyverna Therapeutics - Kyverna's lead CAR T-cell therapy candidate, mivocabtagene autoleucel (miv-cel), is in a pivotal phase II study for stiff person syndrome (SPS), with top-line data showing significant improvements in patient outcomes [22][23] - The company plans to file a BLA for miv-cel in the first half of 2026 [23] - Kyverna is also evaluating miv-cel in generalized myasthenia gravis and has secured a loan facility of up to $150 million to support its pipeline [25] Celcuity - Celcuity has submitted a new drug application for gedatolisib for HR+, HER2- advanced breast cancer, with FDA decision expected in 2026 [26] - Top-line data from the VIKTORIA-1 study showed significant improvements in median progression-free survival compared to existing treatments [27] - Enrollment is complete for the PIK3CA mutant cohort of the study, with data expected in the first half of 2026 [28]

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]

Company Overview - Celcuity Inc. is a clinical-stage biotechnology company focused on developing targeted cancer therapies and companion diagnostics, leveraging its proprietary CELsignia platform and a pipeline led by Gedatolisib to address unmet needs in breast and ovarian cancer treatment [6][8] - The company operates a clinical-stage biotechnology business model, focusing on advancing drug candidates through clinical trials and has a license agreement with Pfizer, Inc. for Gedatolisib [8] Financial Performance - As of the latest market close, Celcuity's stock price is $97.50, with a market capitalization of $4.5 billion [4] - The company reported no revenue for the trailing twelve months (TTM) and a net income loss of $162.7 million [4] - In the third quarter, Celcuity's operating expenses increased as it prepared for product launch, with a net loss of $43.8 million reflecting ramp-up costs ahead of commercialization [10] Investment Activity - Tang Capital Management initiated a new position in Celcuity, purchasing nearly 1.2 million shares valued at $56.8 million, representing 2.2% of the fund's $2.6 billion U.S. equity holdings for the quarter ended September 30 [2][9] - This investment suggests confidence in Celcuity's accelerating path toward commercialization, supported by pivotal data [7] Market Performance - Celcuity's stock has surged 672% over the past year, significantly outperforming the S&P 500, which is up 13% in the same period [3] - The recent momentum in Celcuity's stock price indicates genuine clinical progress rather than market hype, as the company prepares for a new drug application [11]