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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].

PresentationGood morning, and welcome to the Cogent Biosciences webcast. I will now turn the call over to Christi Waarich, Senior Director of Investor Relations.Christi WaarichSenior Director of Investor Relations Thank you, operator. Today's call will cover our SM updates announced over the weekend and this morning. You can find the press releases in the Investors and Media section of our website at cogentbio.com. Before we get started, please be reminded that remarks made during this webcast may be forwa ...

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Cogent Biosciences (NasdaqGS:COGT) Update / Briefing December 08, 2025 08:00 AM ET Company ParticipantsLindsay Rein - Associate Professor of MedicineAndrew Robbins - President and CEOChristi Waarich - Senior Director of Investor RelationsConference Call ParticipantsAncian - AnalystAndrew Berens - AnalystAnupam Rama - AnalystSam Slutsky - AnalystMichael Schmidt - AnalystChristopher Raymond - AnalystOperatorGood morning and welcome to the Cogent Biosciences webcast. I will now turn the call over to Christi Wa ...

-- Bezuclastinib demonstrated rapid and deep clinical benefit in AdvSM patients resulting in an objective response rate (CR+CRh+PR+CI) of 57% per mIWG criteria and 80% per PPR criteria -- -- Bezuclastinib demonstrated a powerful effect on mast cell burden with 89% of patients achieving ≥50% reduction in bone marrow mast cells or clearance of aggregates – -- Bezuclastinib was very well tolerated with only 14.8% of patients requiring dose reduction and no patients requiring discontinuation due to treatment re ...

Core Insights - Cogent Biosciences announced complete results from the SUMMIT clinical trial of bezuclastinib, showing significant improvements in patients with nonadvanced systemic mastocytosis (NonAdvSM) [1][2] - Bezuclastinib is expected to be a best-in-class treatment option, with a New Drug Application (NDA) submission to the FDA planned for December 2025 [2][6] SUMMIT Trial Data - The trial involved 118 patients receiving bezuclastinib and 60 receiving placebo, with a focus on those with moderate-to-severe symptoms despite best supportive care [3][4] - At 24 weeks, bezuclastinib showed a mean change in Total Symptom Score (TSS) of -24.3% compared to -15.4% for placebo, with a p-value of <0.001 [5] - 34.3% of patients on bezuclastinib achieved a ≥50% reduction in TSS, compared to 18.1% on placebo [5] Symptomatic and Objective Improvements - Bezuclastinib demonstrated significant improvements across 11 individual symptoms and objective measures of disease, including serum tryptase levels [6][7] - At 48 weeks, 87.4% of patients achieved a ≥50% reduction in serum tryptase levels, and 75.6% showed a ≥50% reduction in bone marrow mast cells [7] Safety Profile - The majority of treatment-emergent adverse events (TEAEs) were low grade, with 98.3% in the bezuclastinib arm versus 88.3% in the placebo arm [9] - Common TEAEs included hair color change (69.5% in bezuclastinib vs. 5.0% placebo) and nausea (22.0% in bezuclastinib vs. 13.3% placebo) [9] Future Plans - Cogent plans to present longer-term follow-up data from the SUMMIT trial at a scientific meeting in Q1 2026 [10] - An investor conference call is scheduled for December 8, 2025, to discuss the additional data from the SUMMIT trial [11]

Core Insights - Several biotech and life sciences companies experienced significant gains in after-hours trading on November 26, indicating strong investor interest despite a quiet news cycle [1] Company Summaries - Modular Medical, Inc. (MODD) shares increased by 11.51% to $0.4380 after a previous decline of 1.80% at the close, following the IRB approval for its Pivot insulin delivery system study announced on November 17 [2] - Standard BioTools Inc. (LAB) saw a 4.90% rise to $1.50 after a 0.70% gain during regular trading, following a strategic collaboration with Molecular Instruments announced on November 19 [3] - Werewolf Therapeutics, Inc. (HOWL) rose 4.39% to $1.0199 after a strong 7.33% gain during regular trading, reflecting continued investor optimism despite no new updates [4] - Cogent Biosciences, Inc. (COGT) climbed 6.09% to $42.85 in after-hours trading, building on a 1.69% rise during regular trading, indicating strong investor confidence in its pipeline [5] - Longeveron Inc. (LGVN) shares increased by 4.59% to $0.6772, extending gains from a 7.02% rise during regular trading, with upcoming presentation of Alzheimer's study results at CTAD 2025 highlighting ongoing research [6] - AbCellera Biologics Inc. (ABCL) gained 3.85% to $3.78 after a 0.55% increase during regular trading, reflecting renewed investor interest in its antibody discovery platform [7]

Core Insights - Cogent Biosciences Inc. (NASDAQ:COGT) has seen a significant increase in its stock value, with a notable upward revision of its price target from $21 to $50 by H.C. Wainwright, reaffirming a Buy rating [1][2] - The positive outlook is primarily driven by the results of the Phase 3 PEAK trial, which indicates that the combination of bezuclastinib and sunitinib could become the second-line standard of care for gastrointestinal stromal tumors (GIST) [2][3] - Following the announcement of the trial results, Cogent's shares surged by 119% on the day of the announcement [3] Company Developments - Cogent Biosciences announced the positive results of the Phase 3 PEAK trial on November 10, 2025, and plans to submit a new drug application (NDA) to the U.S. FDA for bezuclastinib in GIST in the first half of 2026 [3][4] - The trial results showed a greater than seven-month improvement in median progression-free survival (mPFS), effectively reducing the rate of progression or death by half for patients with imatinib-resistant or intolerant GIST [4] Industry Context - The results of the PEAK study are seen as a significant advancement for GIST patients, particularly those who have been waiting for nearly 20 years for a new second-line treatment option [4] - The company focuses on developing precision therapies for genetically defined diseases, with a primary emphasis on mastocytosis and gastrointestinal stromal tumors (GIST) [4]

Core Insights - Cogent Biosciences (COGT) shares have surged 120.3% in one month, primarily due to positive data from a late-stage study of its investigational therapy combining bezuclastinib and sunitinib for second-line gastrointestinal stromal tumors (GIST) patients [1][5] - The phase III PEAK study demonstrated a 50% reduction in the risk of disease progression or death, with a median progression-free survival (PFS) of 16.5 months compared to 9.2 months for sunitinib monotherapy [2][5] - The combination therapy achieved a 46% objective response rate (ORR), significantly higher than the 26% ORR for sunitinib alone, indicating superior antitumor activity [3][5] - COGT plans to submit a regulatory filing to the FDA for the bezuclastinib/sunitinib combination in the first half of 2026, aiming to establish it as the new standard of care for GIST [7] Study Data Summary - The bezuclastinib/sunitinib combination showed a statistically significant clinical benefit on the primary endpoint of PFS, with a 50% reduction in disease progression risk [2] - The treatment was well tolerated, with no new safety risks identified compared to sunitinib's established profile, and most treatment-related adverse events were mild to moderate [6] Pipeline Overview - Bezuclastinib is the lead candidate for Cogent Biosciences, with ongoing evaluations for two systemic mastocytosis (SM) indications in separate phase III studies [8] - Positive top-line data from a late-stage study for non-advanced SM patients was reported, with plans to submit a new drug application to the FDA by the end of 2025 [9][11] - The company is also conducting a pivotal phase III study for advanced SM, with top-line results expected in December 2025 [12] Market Performance - Year-to-date, COGT shares have increased by 347.9%, significantly outperforming the industry growth of 15.8% [4]